Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B, 39022-39102 [05-12938]
Download as PDF
<![CDATA[
39022
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 414
[CMS–1325–IFC]
RIN 0938–AN58
Medicare Program; Competitive
Acquisition of Outpatient Drugs and
Biologicals Under Part B
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
AGENCY:
SUMMARY: This interim final rule with
comment period implements provisions
of the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 that require the implementation of
a competitive acquisition program for
certain Medicare Part B drugs not paid
on a cost or prospective payment system
basis. Beginning January 1, 2006,
physicians will generally be given a
choice between obtaining these drugs
from vendors selected through a
competitive bidding process or directly
purchasing these drugs and being paid
under the average sales price system.
DATES: Effective date: The amendments
to § 414.906(c); § 414.908(b), (c), (d), and
(e); § 414.910, and § 414.912(a) are
effective on July 6, 2005. All other
amendments are effective September 6,
2005.
Comment date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
September 6, 2005.
ADDRESSES: In commenting, please refer
to file code CMS–1325–IFC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
three ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.cms.hhs.gov/regulations/
ecomments. (Attachments should be in
Microsoft Word, WordPerfect, or Excel;
however, we prefer Microsoft Word.)
2. By mail. You may mail written
comments (one original and two copies)
to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–1325–
IFC, P.O. Box 8013, Baltimore, MD
21244–8013.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments (one original
and two copies) before the close of the
comment period to one of the following
addresses. If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
7195 in advance to schedule your
arrival with one of our staff members.
Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500
Security Boulevard, Baltimore, MD
21244–1850.
(Because access to the interior of the
HHH Building is not readily available to
persons without Federal Government
identification, commenters are
encouraged to leave their comments in
the CMS drop slots located in the main
lobby of the building. A stamp-in clock
is available for persons wishing to retain
a proof of filing by stamping in and
retaining an extra copy of the comments
being filed.)
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
Submission of comments on
paperwork requirements. You may
submit comments on this document’s
paperwork requirements by mailing
your comments to the addresses
provided at the end of the ‘‘Collection
of Information Requirements’’ section in
this document.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Lia
Prela, (410) 786–0548.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this rule to assist us in
further considering issues and
developing policies. You can assist us
by referencing the file code CMS–1325–
IFC and the specific ‘‘issue identifier’’
that precedes the section on which you
choose to comment.
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all electronic
comments received before the close of
the comment period on its public Web
site as soon as possible after they have
been received. Hard copy comments
received timely will be available for
PO 00000
Frm 00002
Fmt 4701
Sfmt 4700
public inspection as they are received,
generally beginning approximately 3
weeks after publication of a document,
at the headquarters of the Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore,
Maryland 21244, Monday through
Friday of each week from 8:30 a.m. to
4 p.m. To schedule an appointment to
view public comments, phone 1–800–
743–3951.
Information on the competitive
acquisition program, including a copy of
this interim final rule with comment
period, can be found on the CMS
homepage. You can access this data by
going to the following Web site:
https://www.cms.hhs.gov/providers/
drugs/compbid.
To assist readers in referencing
sections contained in this preamble, we
are providing the following table of
contents.
Outline of Contents
I. Background
A. Covered Drugs and Biologicals
1. Drugs Furnished Incident to a
Physician’s Service
2. Durable Medical Equipment (DME)
Drugs
3. Statutorily Covered Drugs and Other
Drugs
4. Types of Providers
5. Drugs Paid on a Cost or Prospective
Payment Basis
B. Revised Drug Payment Methodology
C. Competitive Acquisition Program (CAP)
D. Requirements for Issuance of
Regulations
II. Provisions of the March 4, 2005 Proposed
Rule and Our Summary of and
Responses to Public Comments
A. Policy for the CAP
1. General Overview of the CAP
2. Categories of Drugs To Be Included
Under the CAP
3. Competitive Acquisition Areas
B. Operational Aspects of the CAP
1. Statutory Requirements Concerning
Claims Processing
2. Proposed Claims Processing and
Operational Overview
3. Dispute Resolution
C. CAP Contracting Process
1. Quality and Product Integrity Aspects
2. Bidding Entity Qualifications
3. CAP Bidding Process—Evaluation and
Selection
4. Contract Requirements
5. Judicial Review
D. Implementation of the CAP
1. Physician Election Process
2. Vendor or Physician Education
3. Beneficiary Education
III. Provisions of the Interim Final Rule
IV. Waiver of Delayed Effective Date
V. Response to Comments
VI. Collection of Information Requirements
VII. Regulatory Impact Analysis
A. Overall Impact
B. Anticipated Effects
C. Impact of Establishment of a
Competitive Acquisition Program
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
D. Alternatives Considered
E. Impact on Beneficiaries
In addition, because of the many
organizations and terms to which we
refer by acronym in this interim final
rule with comment period, we are
listing these acronyms and their
corresponding terms in alphabetical
order below.
Alphabetical List of Acronyms Appearing in
the Interim Final Rule With Comment Period
ABN—Advanced Beneficiary Notice
ASP—Average sales price
AWP—Average wholesale price
BBA—Balanced Budget Act of 1997, Pub. L.
105–33
CAP—Competitive Acquisition Program
CERT—Comprehensive Error Rate Testing
CFR—Code of Federal Regulations
CMS—Centers for Medicare & Medicaid
Services (formerly Health Care Financing
Administration)
COBC—Coordination of Benefits Contractor
DAW—Dispense as written
DME—Durable medical equipment
DMERC—Durable medical equipment
regional carrier
DOJ—Department of Justice
EAC—Estimated acquisition cost
ESRD—End-stage renal disease
FAR—Federal Acquisition Regulation
FDA—Food and Drug Administration
GAO—Government Accountability Office
GPOs—Group Purchasing Organizations
GPO Access—Government Printing Office
Access
HCPCS—Healthcare Common Procedure
Coding System
HHS—Health and Human Services
HIC—Health Insurance Number
HIPAA—Health Insurance Portability and
Accountability Act of 1996, Public Law
104–191
ICD–9—International Classification of
Diseases—Ninth Edition
IVIG—Intravenous immune globulin
LCDs—Local coverage determinations
MMA—Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173
MSN—Medical summary notice
NDC—National Drug Code
OIG—Office of Inspector General
OPPS—Outpatient prospective payment
system
PPAC—Practicing Physicians Advisory
Council
PIN—Provider identification number
PSCs—Program Safeguard Contractors
RAC—Recovery Audit Contractor
RFA—Regulatory Flexibility Act (September
19, 1980, Pub. L. 96–354)
RFI—Request for information
RTI—Research Triangle Institute
UPIN—Unique provider identification
number
WAC—Wholesale acquisition cost
I. Background
A. Covered Drugs and Biologicals
Medicare Part B currently covers a
limited number of prescription drugs.
For the purposes of this interim final
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
rule with comment period, the term
‘‘drugs’’ will hereafter refer to both
drugs and biologicals. Currently covered
Medicare Part B drugs generally fall into
three categories: Drugs furnished
incident to a physician’s service, drugs
administered via a covered item of
durable medical equipment (DME), and
drugs covered by statute.
1. Drugs Furnished Incident to a
Physician’s Service
Injectable or intravenous drugs as
well as non-injectable or nonintravenous drugs are administered
incident to a physician’s service as
specified under section 1861(s)(2)(A) of
the Social Security Act (the Act). Under
the ‘‘incident-to’’ provision, the
physician must incur a cost for the drug,
and must bill for it. The Medicare
Prescription Drug, Improvement, and
Modernization Act (MMA) of 2003 (Pub.
L. 108–173, enacted on December 8,
2003) revised the ‘‘incident-to’’
provision, permitting payment of
‘‘incident-to’’ drugs under the CAP even
though the physician participating in
the CAP would not, in fact, incur a cost
for the drug or actually bill for the drug.
The Act limits ‘‘incident-to’’ coverage to
drugs that are not usually selfadministered. Examples include
injectable drugs used in connection
with the treatment of cancer (such as
epoetin alpha), intravenous drugs used
to treat cancer (such as paclitaxel and
docetaxel used to treat breast cancer),
injectable anti-emetic drugs used to treat
the nausea resulting from
chemotherapy, infliximab or other
similar products used to treat
rheumatoid arthritis, rituximab or other
similar products used to treat nonHodgkin’s lymphoma, and Dermagraft
or other similar products used to treat
skin ulcers.
2. Durable Medical Equipment (DME)
Drugs
DME drugs are administered through
a covered item of DME, such as a
nebulizer or pump. Two of the most
common drugs in this category are the
inhalation drugs albuterol sulfate and
ipratropium bromide.
3. Statutorily Covered Drugs and Other
Drugs
Drugs specifically covered by statute
include—immunosuppressive drugs;
hemophilia blood clotting factor; certain
oral anti-cancer drugs; oral anti-emetic
drugs; pneumococcal, influenza and
hepatitis B vaccines; antigens;
erythropoietin for trained home dialysis
patients; certain other drugs separately
billed by end-stage renal disease (ESRD)
facilities (for example, iron dextran,
PO 00000
Frm 00003
Fmt 4701
Sfmt 4700
39023
vitamin D injections); and osteoporosis
drugs.
4. Types of Providers
Types of providers and suppliers that
are paid based on the current ASP
system for all or some of the Medicare
covered drugs they furnish include the
following: physicians and certain nonphysician practitioners, pharmacies,
DME suppliers, hospital outpatient
departments, and ESRD facilities.
5. Drugs Paid on a Cost or Prospective
Payment Basis
Drugs paid on a cost or prospective
payment basis that are outside of the
scope of this interim final rule
include—drugs furnished during an
inpatient hospital stay (except clotting
factor); drugs paid under the outpatient
prospective payment system (OPPS);
drugs furnished by ESRD facilities
whose payments are included in
Medicare’s composite rate; and drugs
furnished by critical access hospitals,
skilled nursing facilities (unless outside
of a covered stay), comprehensive
outpatient rehabilitation facilities, rural
health facilities, and federally qualified
health centers.
B. Revised Drug Payment Methodology
The MMA revised the drug payment
methodology by creating a new pricing
system based on a drug’s Average Sales
Price (ASP). The MMA also provides for
a program beginning in 2006 to give
physicians a choice between—(1)
Obtaining these drugs from vendors
selected through a competitive bidding
process; or (2) directly purchasing these
drugs and being paid under the ASP
system.
Effective January 2005, Medicare pays
for the majority of Part B covered drugs
using a drug payment methodology
based on the ASP. In accordance with
section 1847A of the Act, manufacturers
submit to us the ASP data for their
products. These data include the
manufacturer’s total sales (in dollars)
and number of units of a drug to all
purchasers in the United States in a
calendar quarter (excluding certain sales
exempted by statute), with limited
exceptions. The sales price is net of
discounts such as volume discounts,
prompt pay discounts, cash discounts,
free goods that are contingent on any
purchase requirement, chargebacks, and
rebates (other than rebates under section
1927 of the Act). The Medicare payment
rate is based on 106 percent of the ASP
(or for single source drugs, 106 percent
of wholesale acquisition cost (WAC), if
lower), less applicable deductible and
coinsurance. The WAC is defined, with
respect to a drug or biological, as the
E:\FR\FM\06JYR2.SGM
06JYR2
39024
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
manufacturer’s list price for the drug or
biological to wholesalers or direct
purchasers in the United States, not
including prompt pay or other
discounts, rebates, or reductions in
price, for the most recent month for
which the information is available, as
reported in wholesale price guides or
other publications of drug or biological
pricing data.
C. Competitive Acquisition Program
(CAP)
Section 303(d) of the MMA provides
for an alternative payment methodology
for most Part B covered drugs that are
not paid on a cost or prospective
payment basis. In particular, section
303(d) of the MMA amends Title XVIII
of the Act by adding a new section
1847B, which establishes a competitive
acquisition program for the acquisition
of and payment for competitively
biddable Part B covered drugs and
biologicals furnished on or after January
1, 2006.
Beginning January 1, 2006, physicians
will have a choice between—(1)
Obtaining these drugs from entities
selected to participate in the CAP in a
competitive bidding process; or (2)
acquiring and billing for Part B covered
drugs under the ASP system. The
provisions for acquiring and billing for
drugs through this new system, as well
as additional information about this
new drug payment system are described
in this interim final rule.
The CAP may provide opportunities
for Federal savings to the extent that
aggregate bid prices are less than 106
percent of ASP. However, the CAP has
other purposes than the potential to
achieve savings. The competitive
acquisition program provides
opportunities for physicians who do not
wish to be in the business of drug
acquisition. Engaging in drug
acquisition may require physicians to
bear financial burdens such as
employing working capital and bearing
financial risk in the event of nonpayment for drugs. The CAP is
designated to reduce this financial
burden for physicians. In addition,
physicians who furnish drugs often cite
the burden of collecting coinsurance on
drugs, which can represent a substantial
dollar amount to a beneficiary and
physicians’ practice. The competitive
acquisition program eliminates the need
for physicians to collect coinsurance on
CAP drugs from Medicare beneficiaries.
D. Requirements for Issuance of
Regulations
Section 902 of the MMA amended
section 1871(a) of the Act and requires
the Secretary, in consultation with the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
Director of the Office of Management
and Budget, to establish and publish
timelines for the publication of
Medicare final regulations based on the
previous publication of a Medicare
proposed or interim final regulation.
Section 902 of the MMA also states that
the timelines for these regulations may
vary but shall not exceed 3 years after
publication of the preceding proposed
or interim final regulation except under
exceptional circumstances. We intend to
publish the final rule within the 3-year
timeframe established under section 902
of the MMA.
II. Provisions of the March 4, 2005
Proposed Rule and Our Summary of
and Responses to Public Comments
We received approximately 570
timely pieces of correspondence
containing multiple comments in
response to the March 4, 2005 proposed
rule. Summaries of the public comments
and our responses are set forth in the
various sections of this preamble under
the appropriate heading.
A. Policy for the CAP
1. General Overview of the CAP
In the March 4, 2005 proposed rule,
we discussed the activities to
implement the CAP that need to be
completed before January 1, 2006,
including—designating or developing
quality, service, and financial
performance standards for vendors;
creating a pricing methodology;
designing and running a bidding
process from solicitation through
contract award; providing physicians
with an opportunity to elect to
participate and select a vendor;
educating beneficiaries about the
program; and other activities specified
in section 1847B of the Act.
The statute provides some flexibility
in the development of the CAP by
requiring an appropriate ‘‘phase-in’’ of
the program and providing the Secretary
with the discretion to select appropriate
categories of drugs and appropriate
geographic areas for the program.
Section 1847B(a)(1)(B) of the Act states
that for purposes of implementing the
CAP, ‘‘the Secretary shall establish
categories of competitively biddable
drugs and biologicals. The Secretary
shall phase in the program with respect
to those categories beginning in 2006 in
such manner as the Secretary
determines to be appropriate.’’
Additionally, the statute states that the
competitive acquisition areas for the
CAP on which contracts are to be
awarded (and vendors chosen) are
‘‘appropriate geographic regions
established by the Secretary.’’
PO 00000
Frm 00004
Fmt 4701
Sfmt 4700
We also briefly discussed the
activities we had initiated to enable us
to implement the statutory provisions of
section 1847B of the Act including:
• The award of a contract to Research
Triangle Institute (RTI) to obtain
information and develop alternatives
regarding the implementation of a drug
and biological competitive bidding
program.
• Convening a Special Open Door
Listening Session on April 1, 2004, to
gather input and allow interested parties
to hear and be heard by other members
of the healthcare industry.
• Establishment of an electronic
mailbox,
MMA303DDrugBid@cms.hhs.gov, for
interested parties to submit comments
on the CAP program before the issuance
of the March 4, 2005 proposed rule.
• Issuance of a Request for
Information (RFI) on December 13, 2004
to assess public interest in bidding on
contracts to supply drugs and
biologicals for the CAP.
Comment: A few commenters
referenced the discussion in the
proposed rule concerning the activities
that we initiated to implement the
statute. These commenters questioned
the fact that we only received 15
responses from the issuance of an RFI,
given the number of Medicare
beneficiaries, specialty groups
(particularly oncology), State
organizations, and providers that could
be impacted by the proposed rule.
Another commenter commended us for
acknowledging the need to gather
information and obtain industry input
through informal processes and
encouraged us to continue to solicit
input from the public through formal
and informal means, while an
additional commenter implored us to
give serious consideration to the
comments on the proposed rule from
affected specialty societies.
Response: The discussion in the
March 4, 2005 proposed rule provided
examples of activities and resources we
used to establish the framework for the
proposed rule. The reference to 15
responses was specific to the RFI that
we issued on December 13, 2004, which
was vendor interest specific. As
mentioned in the March 4, 2005
proposed rule, our contractor, RTI, also
consulted with groups and
organizations, including medical
specialty organizations and a national
oncology practice to obtain input
concerning establishment of a CAP
program. As with any rulemaking
process, we have given serious
consideration to the comments from
both specialty groups as well as
individuals on the proposed rule.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Comment: Some commenters were
supportive of the proposal for the CAP,
with several commenters stating that the
current buy and bill reimbursement
system has created undue barriers.
These commenters believe the CAP
would at least provide an alternative to
buy and bill arrangements for
consumers and providers, by
simplifying the reimbursement process.
Response: As discussed in the March
4, 2005 proposed rule, and also later in
this preamble, participation in the CAP
is voluntary on the part of the
physician. As pointed out by
commenters, implementation of the
CAP provides an alternative to the
current buy and bill system. To the
extent that a physician or physicians’
group believes that the CAP is not a
viable alternative to the current buy and
bill system, that physician or
physicians’ group can continue to use
the current system and not elect to
participate in the CAP.
Comment: Many commenters believe
that we should beta test the CAP or have
a limited trial period or phase-in of
some sort, to confirm the quality of the
CAP before full implementation. These
commenters expressed concern that
introducing the CAP system,
particularly given the short timeframe,
without any formal testing or analysis is
risky to patient care because it is a
dramatic potential change to the current
system. Some commenters referenced
the Government Accountability Office’s
(GAO) final report assessing the durable
medical equipment, prosthetic,
orthotics, and supplies (DMEPOS)
competitive bidding demonstrations
that suggests that further
demonstrations be conducted for the
DMEPOS before implementation. These
commenters believe the GAO report
supports taking a slower approach for
implementing the CAP for Part B drugs.
The commenters suggested that a slower
approach would allow us to refine our
application and vendor selection
process. Other commenters, while
cognizant of the January 2006 effective
date, suggested we delay the effective
date of the CAP to allow us to fully
structure the CAP to meet congressional
objectives and benefit physicians
without compromising beneficiary
access to drug therapies and treatment.
In addition, commenters argued that the
introduction of Part D beginning in 2006
may cause significant stress to providers
and beneficiaries, and introducing the
CAP at the same time could create
confusion.
Response: Although we understand
the concerns of the commenters, we
believe the regulatory framework
established through this rulemaking
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
provides a firm basis for implementing
the CAP program in January 2006. We
recognize that the timeframe for
implementation is ambitious but we
believe that it is important to provide
the physicians’ community with an
alternative to the current buy and bill
system as soon as possible. In addition,
the statute also requires that we
coordinate the physician’s election to
participate in the CAP with the
Medicare Participating Physician
Process described in section 1842(h) of
the Act. The use of a designated carrier
for processing vendor claims is one of
the approaches we will be using to
ensure a smooth implementation. Other
aspects of the CAP discussed later in the
preamble also provide information on
how we are addressing the
implementation of CAP within this
restricted timeframe. Additionally, the
Congress did not intend this to be a
demonstration, but instead established
the CAP as an operational program.
We recognize that the Medicare
community will be faced with many
new challenges and options in 2006. We
will be working to ensure that providers
and beneficiaries are aware of these new
choices and programs and that the
transition is as smooth as possible.
Comment: One commenter requested
that we continue to issue guidance to
further clarify and refine the CAP
requirements. The commenter also
encouraged us to continue our efforts to
educate and seek input through venues
such as the ‘‘Open Door’’ sessions.
Response: We agree that it is
important to continue our educational
efforts and obtain feedback from the
provider community and plan to
convene special ‘‘Open Door’’ sessions
as part of the implementation of the
CAP. Additional discussion of this
important aspect of the CAP is provided
later in the preamble.
Comment: A few commenters
expressed concern that we were limiting
the CAP to oncology drugs.
Response: As discussed in the
proposed rule, we were considering
several alternative approaches to
phasing in the CAP with respect to drug
categories, one of which was initially
including only all oncology drugs. The
specific drug categories for the CAP that
will be effective January 1, 2006 are
discussed in detail later in this section
of the preamble.
Comment: A number of commenters
raised concerns about maintaining the
safety of the drug delivery system or
‘‘medication pipeline,’’ particularly in
light of the frequent changes in the
disease status of certain patient
populations (for example, cancer
patients).
PO 00000
Frm 00005
Fmt 4701
Sfmt 4700
39025
Response: We understand the
commenters concerns, and, as discussed
in more detail later in the preamble, we
have established financial and quality
standards to ensure that reputable and
experienced vendors are chosen to
participate in the CAP. We have also
indicated that under the dispute
resolution requirements, issues
connected with drug quality will be
given top priority.
Comment: One commenter stated that
private insurers have tried models
similar to the CAP and all of them have
resulted in minimal savings but
increased administrative overhead and
patient inconvenience.
Response: We are mindful of the
points that the commenter raised
concerning private insurers attempts at
similar models and have sought to
address these points in establishing the
CAP as reflected in the requirements we
are establishing concerning the
operational aspects of CAP (section II.B
of this interim final rule) as well as
those discussed in the CAP contracting
process (section II.C of this interim final
rule).
Other Comments
We also received many comments
concerning: Payment for drug
administration services, infusion
services, and evaluation and
management services for cancer
patients; the chemotherapy
demonstration project; price controls for
drugs; and the new Medicare Part D
Prescription Drug Program. These issues
were outside the scope of this
rulemaking, and, therefore, we will not
be responding to these comments as part
of this interim final rule.
Comment: Several commenters
contended that our proposed rule did
not satisfy all the requirements of the
Administrative Procedure Act (APA). In
particular, these commenters pointed
out that the proposed rule did not
include a specific proposal about the
drug categories that would be adopted
in the initial implementation of the
CAP, or a specific proposal about the
competitive acquisition areas that
would be established. The commenters
contended that the proposed rule
therefore did not provide sufficient
factual detail and rationale to permit
interested parties to comment
meaningfully. These commenters
contend that CMS must either publish a
second proposed rule providing specific
proposals on these issues, or at least
present our decisions about these
matters in the context of an interim final
regulation with opportunity for public
comment. Other commenters
recommended that we implement the
E:\FR\FM\06JYR2.SGM
06JYR2
39026
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
CAP through the issuance of an interim
final rule. This would provide an
extended opportunity for public
comment and facilitate the approval of
required program modifications.
Response: We do not believe that our
proposed rule failed to satisfy the
requirements of the APA. In our March
4, 2005 proposed rule, we presented
specific options concerning the drug
categories and competitive acquisition
areas that we were considering for
adoption in the final rule. We also
discussed the advantages and
disadvantages of each option to provide
a basis for informed comment, and we
received several comments on these
options. These comments addressed in
detail the options that we discussed,
and addressed the specific
considerations that we had discussed.
The commenters offered specific
recommendations and proposals based
on the options that we had presented.
The comments themselves thus are
convincing evidence that our proposed
rule provided adequate basis for
meaningful comment from interested
parties. Although we do not believe that
we are required under the provisions of
the APA to publish another proposed
rule with more specific proposals, as
requested by some commenters, we are
exercising our discretion and publishing
this rule as an interim final rule to allow
our provisions to take effect and to
provide the public with the opportunity
to comment on our final provisions. We
believe that additional public comment
on this new and complex program
would be valuable. We especially
welcome comments on issues related to
phasing in the program. For example,
we describe below how we have
decided to exercise our statutory
authority to determine and phase in
categories of drugs under the CAP. We
specifically invite comments on the
further development of appropriate drug
categories after this initial stage of
implementing the program. We also
welcome comments on other issues
regarding the CAP program.
Regulations
In the March 4, 2005 rule, we
proposed to codify the requirements and
provisions for the CAP in regulations at
42 CFR Part 414, Subpart K. We
proposed to revise the heading for
subpart K to read ‘‘Payment for Drugs
and Biologicals under Part B’’; amend
existing sections and section headings;
and add new definitions and sections to
set forth the proposed requirements
with respect to the CAP. Specifically,
we proposed to make the following
changes:
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
• Revise existing § 414.900, which
sets forth the basis and scope for subpart
K;
• Revise § 414.900(b)(ii) to clarify that
the hepatitis vaccine referred to in this
paragraph is the hepatitis ‘‘B’’ vaccine;
• Add new § 414.906 through
§ 414.920 to address requirements with
respect to payment under the CAP; and
• Revise § 414.902 to add definitions
pertaining to the new CAP addressed in
new § 414.906 through § 414.920.
We did not receive comments on the
proposed organization of subpart K or
the proposed changes to § 414.900,
which sets forth the basis and scope for
subpart K or § 414.900(b)(ii). Therefore,
we finalize them as proposed. Specific
comments pertaining to the proposed
definitions for the CAP as well as
proposed sections § 414.906 through
§ 414.920 are addressed later in this
preamble.
2. Categories of Drugs To Be Included
Under the CAP
Section 1847B of the Act describes a
program that will permit physicians to
elect to obtain drugs from vendors
rather than purchasing and billing for
those drugs themselves. The statute,
therefore, most closely describes a
system for the provision of and the
payment for drugs provided incident to
a physician’s service. For example,
under the mechanisms described in the
statute:
• Only physicians are expressly given
an opportunity to elect to participate in
the CAP.
• The second sentence of section
1847B(a)(1)(A) of the Act explicitly
indicates that such section shall not
apply in the case of a physician who
elects section 1847A of the Act to apply.
• Physicians who elect to obtain
drugs under the CAP make an annual
selection of the contractor through
which drugs will be acquired and
delivered to the physician under Part B.
• Section 1847B(a)(3)(A) of the Act
specifically applies the CAP to drugs
and biologicals that are prescribed by a
physician who has elected the CAP to
apply.
• Payment for drugs furnished under
the CAP is conditioned upon drug
administration.
• The requirement for submission of
information that will be used by in the
contract for collection of cost sharing
applies to physicians.
• The primary site for delivery of
drugs furnished under the CAP is the
physician’s office.
• The statute requires the Secretary to
make available to physicians on an
ongoing basis a list of CAP contractors.
PO 00000
Frm 00006
Fmt 4701
Sfmt 4700
• The statute explicitly defines a
‘‘selecting physician’’ to be one who has
elected the CAP program to apply.
Section 1847B(a)(1)(B) of the Act
specifically requires the Secretary to
establish categories of drugs that will be
included in the CAP, and requires the
Secretary to phase-in the program with
respect to these categories, as the
Secretary determines to be appropriate.
Section 1847B(a)(1)(D) of the Act further
authorizes the Secretary to exclude
competitively biddable drugs and
biologicals from the competitive bidding
system if the application of competitive
bidding to those drugs and biologicals—
(1) Is not likely to result in significant
savings; or
(2) Is likely to have an adverse impact
on access to those drugs and biologicals.
Finally, the statute defines the term
‘‘competitively biddable drugs and
biologicals’’ for purposes of the CAP as
‘‘a drug or biological described in
section 1842(o)(1)(C) of the Act and
furnished on or after January 1, 2006.’’
As discussed in the March 4, 2005
proposed rule, the drugs described in
section 1842(o)(1)(C) of the Act include
most drugs paid under Medicare Part B
and not otherwise paid under cost-based
or prospective payment basis. Medicare
Part B covered vaccines, drugs infused
through a covered item of DME, and
blood and blood products (not including
clotting factor and intravenous immune
globulin (IVIG)) are not included under
this definition because they are
expressly excluded from section
1842(o)(1)(C) of the Act. The statutory
definition of ‘‘competitively biddable
drugs’’ therefore includes drugs
administered incident to a physician’s
service (for example, drugs commonly
furnished by oncologists), drugs
administered through DME (for
example, inhalation drugs) with the
exception of DME infusion drugs, and
some drugs usually dispensed by
pharmacies (for example, oral
immunosuppressive drugs). Although
the statutory definition includes all
these categories of drugs, as noted
above, the specific mechanisms
described under section 1847B of the
Act relate to the provision of and the
payment for drugs provided incident to
a physician’s service. Given our
concerns about the clear direction of the
statute that the election to participate in
this program rests with physicians, in
the proposed rule we indicated that we
do not believe it is possible to include
drugs other than those administered as
incident to a physician’s service as part
of this program. However, we also
recognized that the statute provides a
potentially broader definition of
‘‘competitively biddable drugs and
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
biologicals’’ in section 1847B(a)(2)(A) of
the Act. We, therefore, requested
comments on whether, in the light of
these mechanisms, the CAP is properly
restricted under the statute to drugs
administered incident to a physician’s
service.
We also solicited comments on how
an expansion of the drugs covered
under this program might work, given
that the option to participate clearly
rests with the physician.
Comment: Many commenters
supported our proposal to restrict the
CAP, at least initially, to drugs
administered incident to a physician’s
service. Some of these commenters
endorsed the more restrictive reading of
the statute, under which the CAP is
properly restricted to drugs
administered incident to a physician’s
service. A congressional commenter
advised that the intent of the Congress
was to include all physician injectable
drugs within the CAP. Other
commenters expressed the view that the
statute would allow the program to
include drugs administered incident to
a physician’s service (for example, drugs
commonly furnished by oncologists),
drugs administered through DME (for
example, inhalation drugs) with the
exception of DME infusion drugs, and
some drugs usually dispensed by
pharmacies (for example, oral
immunosuppressive drugs). However,
some of these commenters also
supported restricting the program, at
least initially, to drugs administered
incident to a physician’s service as an
appropriate exercise of the Secretary’s
authority to phase-in the drug categories
established under the CAP. A few
commenters supported including some
categories of drugs administered
through DME or drugs usually
dispensed by pharmacies in the CAP,
either initially or at an early stage of
implementing the program. These
commenters generally cited the
statutory definition of ‘‘competitively
biddable drugs,’’ which in and of itself
is broad enough to include drugs
administered incident to a physician’s
service, drugs administered through
DME (with the exception of DME
infusion drugs), and some drugs usually
dispensed by pharmacies. Some of these
commenters acknowledged that the
general statutory structure of the
program, which defines acquisition
mechanisms applicable only to
physicians, raises practical and/or legal
issues about including drugs
administered through DME and drugs
usually dispensed by pharmacies within
the program.
Response: We continue to believe
that, given the clear direction of the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
statute that the election to participate in
this program rests with physicians, it is
not advisable to include drugs other
than those administered as incident to
a physician’s service as part of this
program. As we discuss further below,
we, therefore, will implement the CAP
initially for a broad range of drugs
administered incident to a physician’s
service. However, we will continue to
consider whether the statute allows
extension of the program to Part B drugs
that are administered through DME or
dispensed by pharmacies. We will
continue to analyze whether drugs other
than those administered as incident to
a physician’s service can be included in
the CAP within the parameters of the
statute. At the same time, we have no
present plans to expand the program
beyond the class of drugs administered
incident to a physician’s service. If we
were to determine that it was warranted
to expand the program beyond the
category of drugs furnished incident to
a physician’s service, we would first
publish a proposed rule and allow for
public comment before proceeding, as
necessary.
The March 4, 2005 proposed rule
included discussions on the merits of
several options for defining the drug
categories to be included within the
CAP, as well as for phasing in the
program with respect to drug categories.
These are summarized below:
Drugs Furnished Incident to a
Physician’s Service
Under this option, all drugs furnished
incident to a physician’s service would
be included in the CAP. The majority
(more than 80 percent) of Medicare Part
B drug expenditures are for drugs
furnished incident to a physician’s
service, such as chemotherapy drugs.
Therefore, it is important to include all
drugs furnished incident to a
physician’s service to provide an
alternative to physicians who did not
want to purchase drugs directly. It may
also provide more opportunity for
realizing savings to the program than
some other options.
Phasing in CAP Drugs by Physician
Specialty
Another option would be to phase-in
the program by implementing the CAP
initially for a limited set of drugs that
are typically administered by a single
physician specialty, such as a set of
drugs commonly furnished by
oncologists. Drugs commonly furnished
by additional specialties could be
included over the next few years of the
program. Drugs typically furnished by
oncologists constitute a large portion of
the Part B drug market. Drugs typically
PO 00000
Frm 00007
Fmt 4701
Sfmt 4700
39027
administered by other physician
specialties represent smaller portions of
physician-administered drugs. A basic
decision with respect to a phase-in for
drugs administered in physician offices
would be whether to begin
implementation of the program only
with drugs typically administered by
oncologists, or with some set of drugs
that other specialties (for example,
urology) tend to administer.
A few of the alternative approaches
that could be used to phase-in the CAP
with respect to drug categories
discussed in the proposed rule were:
• Initially include all drugs typically
administered by oncologists within the
program.
• Begin with some set of the drugs
that are typically administered in
physician offices by other specialties
(for example, drugs typically
administered by urologists).
• Implement the CAP for all Part B
drugs that are furnished incident to a
physician’s service.
We stated that we were actively
considering all these options, and
encouraged comments on all the options
that we have discussed. We also
welcomed recommendations of other
options for consideration that could be
adopted. We especially encouraged
comments from physicians concerning
their preferences about how a phase-in
should be designed and more generally
how the categories of drugs under the
CAP should be structured.
Comment: Many commenters
(especially from the oncology
community) recommended beginning
the phase-in with drugs that are
typically used by some specialty that is
less drug-intensive than oncology.
However, many other commenters
recommended beginning a phase-in
with oncology drugs, on the grounds
that doing so would provide much of
the potential benefit of the CAP
immediately. Other commenters,
including some members of the
oncology community, recommended
inclusion of all physicians’ drugs within
the program immediately, in order to
provide an alternative method of
obtaining drugs for all physicians. A
congressional commenter recommended
that the program start with a sufficiently
large category of drugs to provide a
sufficiently sized market for vendors
and that the program ramp up quickly
to include all physician-administered
Part B drugs.
Response: We have been convinced
by the commenters that it is feasible and
appropriate to implement the CAP
initially for the broad range of drugs
administered incident to a physician’s
service. As we discuss in more detail
E:\FR\FM\06JYR2.SGM
06JYR2
39028
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
below, in response to these comments,
we have identified a set of 169 drugs
that are most commonly administered
incident to a physician’s service for
inclusion in the initial stage of the CAP.
We have not included drugs with very
low volumes of billing by physicians
because we believe including such
drugs at this time would impose a
greater burden on vendors, and
undercut the goal of providing a
sufficiently sized market. As described
in further detail below, in response to
concerns raised by commenters we have
also not included certain drugs whose
patterns of use do not make them
suitable for inclusion under the CAP.
For example, certain vaccines, such as
tetanus and diphtheria vaccines, are
most commonly used in emergency
situations. These drugs are therefore
poorly suited for the normal ordering
and billing procedures contemplated by
the CAP statute. Physicians often will
not be in the position to submit to their
approved CAP vendor in advance a
patient-specific order for these drugs.
Although section 1847B(b)(5) of the Act
outlines special rules to allow approved
CAP vendors to resupply drugs used in
emergency situations, we do not believe
that it is advisable to include within the
CAP drugs for which this special
mechanism will be routinely employed,
at least during this initial stage of
implementing the program. (It is
important to note that the statute
specifically excludes pneumococcal
vaccine, influenza vaccine, and
hepatitis B vaccine from the CAP.) As
we discuss in response to the specific
comments below, we have also not
included, at least initially, certain types
of drugs that pose special issues. For
example, we have not included drugs
that pose special implementation issues
such as some controlled substances and
orphan drugs.
Comment: One commenter asked
about the status of opioid medications
administered intrathecally through
implanted variable-rate infusion devices
(for example, Prialt). The commenter
notes that historically, when these pain
medications have been furnished by
physicians in their offices, they have
been covered and billed through the
local carriers as drugs administered
incident to physicians’ services, rather
than as drugs infused through covered
durable medical equipment billed
through the DMERCs. In the light of
this, the commenter requested that we
confirm specifically that those
medications will be eligible for the CAP,
at least once the program is fully phased
in.
Response: We agree in principle that
opioid medications administered
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
intrathecally through implanted
variable-rate infusion devices could be
included under the CAP, when they are
administered by physicians in their
offices incident to their services. In the
specific case of Prialt, we have not
been able to include the drug in this
initial phase of the CAP because it is
very new and has not yet been assigned
a code. (We discuss treatment of new
drugs in greater detail below.) However,
our analysis has suggested that some
pain medications may be inappropriate
for inclusion in the CAP, at least in the
initial stage. Specifically, we are
concerned that the special
recordkeeping and other requirements
that apply to Schedule II, III, and IV
controlled substances would make
inclusion of these drugs in the CAP
problematic. Under the CAP, the
approved CAP vendor retains title to the
drug, even after it is shipped to the
physician, which may make it more
difficult to ensure compliance with the
special rules for controlled substances.
We, therefore, are not including
Schedule II, III, and IV controlled
substances in the initial stage of
implementing the CAP. We welcome
comments on the implications of these
special requirements for including these
drugs in the CAP during later stages of
implementation.
Comment: Several commenters
recommended that we exclude orphan
drugs from the CAP. (‘‘Orphan drug’’ is
defined by FDA, under 21 CFR
316.3(b)(10), as a ‘‘drug intended for use
in a rare disease or condition as defined
in section 526 of the Federal Food,
Drug, and Cosmetic Act.’’) These
commenters pointed out that orphan
drugs often pose access challenges.
Specifically, one commenter noted that
vendors may not be able to provide
orphan drugs adequately in a timely
manner. The same commenter noted
that CMS has provided a special
exception for payment of orphan drugs
in the outpatient prospective payment
system.
Response: We agree with the
commenters that access problems
provide a sound reason for not
including some orphan drugs from the
CAP, at least in the initial stages of the
program. However, we do not believe
that it is necessary to decline to include
all orphan drugs from the program, even
in this initial stage of implementation.
This is because many orphan drugs are
not approved exclusively for the
treatment of orphan indications, but
they are also approved for other nonorphan indications that affect broader
groups of the public. In contrast, other
orphan drugs are approved exclusively
for the treatment of orphan indications.
PO 00000
Frm 00008
Fmt 4701
Sfmt 4700
The latter group of orphan drugs poses
much more severe access issues than
other orphan drugs precisely because
their use is generally limited to
relatively rare orphan indications. As
one commenter noted, we provide
special payment consideration under
the outpatient prospective payment
system (OPPS) to this latter set of
orphan drugs. Specifically, we designate
drugs that meet the following criteria as
single indication orphan drugs under
the OPPS:
• The drug is designated as an orphan
drug by the FDA and approved by the
FDA only for treatment of only one or
more orphan conditions(s); and
• The current United States
Pharmacopoeia Drug Information
(USPDI) shows that the drug has neither
an approved use nor an off-label use for
other than the orphan condition(s).
In this interim final rule, we, therefore,
are not including those orphan drugs
that meet the above criteria within the
CAP, at least during the initial stage of
implementing the program. Under these
criteria, the following drugs are not
included, at least for the initial stage of
CAP:
J0205 (Injection, Alglucerase, per 10
units);
J0256 (Injection, Alpha 1-proteinase
inhibitor, 10 mg);
J9300 (Gemtuzumab ozogamicin, 5mg);
J1785 (Injection, Imiglucerase, per
unit);
J2355 (Injection, Oprelvekin, 5 mg)
J3240 (Injection, Thyrotropin alpha,
0.9 mg);
J7513 (Daclizumab, parenteral, 25 mg);
J9010 (Alemtuzumab, 10 mg);
J9015 (Aldesleukin, per single use
vial);
J9017 (Arsenic trioxide, 1 mg);
J9160 (Denileukin diftitox, 300 mcg);
and
J9216 (Interferon, gamma 1–b, 3
million units).
We welcome comments on whether
these drugs should be included in the
CAP during later stages of
implementation.
Comment: Several commenters also
recommended that we not include
contrast agents within the CAP. Some of
these commenters recommended
permanent exclusion of contrast agents
from the program. Others recommended
that we phase-in these agents during
later stages of implementing the CAP.
Contrast drugs are used only in
diagnostic imaging tests. The
commenters cited various reasons for
excluding contrast agents. These
included the difficulty of determining
appropriate categories for these
products, fast pace of change in this
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
field, and the rapid changes in coding
and payment for these products. These
changes may not yet be well understood
among physicians, and this may hamper
their ability to select the vendor that
provides the most appropriate contrast
agents for their patients.
Response: We agree with the
commenters that the rapid pace of
change in this field, in conjunction with
major changes in coding and payment in
recent years, may pose special
possibilities for confusion during the
initial stage of the CAP. We, therefore,
are not including contrast agents under
the CAP during this initial stage of
implementing the program. We,
however, will consider including them
as we refine and develop the drug
categories under the program in future
stages of implementation.
Comment: Several commenters
requested that CMS clarify whether
carriers’ least costly alternative (LCA)
policies would apply under the CAP.
Most of these commenters maintained
that those policies should not be
applied under the CAP. For example,
one commenter argued that substituting
one manufacturer’s price for another is
inconsistent with a system of
establishing prices for HCPCS codes on
the basis of submitted bids. Others
pointed out that it would be
administratively difficult to apply LCA
policies within the CAP claims
processing system.
Response: As we note in section II.B
of this interim final rule, least costly
alternative policies are established by
our contractors. Nothing in this interim
final rule is intended to disrupt the
longstanding ability of contractors to
apply this policy under section
1862(a)(1)(A) of the Act. Section
1862(a)(1)(A) provides that
notwithstanding any other provision in
the Medicare statute (that is, including
section 1847B), no payment may be
made under Part A or Part B for any
expenses incurred for items and services
that are not reasonable and necessary.
Medicare carriers establish local
coverage determinations (LCDs), under
which coverage for a particular drug is
limited to the coverage level for its least
costly alternative. As stated in the
March 2005 proposed rule, physicians
who submit claims under the CAP must
comply with applicable LCDs.
However, we acknowledge that the
existence of LCA policies, and the fact
that they will apply under the CAP just
as they apply outside the CAP, have
obvious implications for the provision
of certain drugs under the CAP. If a
carrier applies an LCA policy to a
particular drug, the approved CAP
vendor’s claim for that drug, when
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
ordered by a participating CAP
physician in that carrier’s jurisdiction,
would be subject to LCA. We are aware
of one instance in which every carrier
has applied the ‘‘least costly
alternative’’ policy to a drug that would
otherwise meet the criteria outlined in
this section for inclusion in the CAP.
Every carrier has applied an LCA policy
to injectable forms of leuprolide (not,
however, to leuprolide implant). Under
these polices, claims for leuprolide are
paid at the level of its least costly
alternative (goserelin). We are
implementing the CAP initially through
a single, broad drug category and a
single, national competitive acquisition
area; therefore, because leuprolide is
subject to LCA policies in all carrier
jurisdictions, its inclusion in the current
CAP drug category would have the
effect of requiring vendors to supply the
drug at the cost of goserelin in each
instance in which a participating CAP
physician orders it, regardless of the
price established for leuprolide under
the bidding and single price
determination processes that we
describe below, and regardless of the
geographic location (and local carrier
jurisdiction) of the participating CAP
physician. For this reason, we have
decided to exercise our authority under
1847B(a)(1)(B) not to include leuprolide
in this initial stage of implementing the
CAP. This decision is based on our
authority under the CAP statute, and
does not affect the applicability of LCA
policies to leuprolide. We welcome
comments on how to deal with this
issue in later stages of implementing the
program.
Comment: We received a number of
comments recommending that we
exclude blood clotting factors and
intravenous immune globulin (IVIG)
from the CAP. A number of these
commenters recommended that we
employ the authority under section
1847B(a)(1)(D) of the Act to exclude
these products on the grounds that their
inclusion within the program would not
result in significant savings or would
have an adverse impact on access. Many
of these commenters also argued that
IVIG is implicitly excluded from the
CAP by section 1842(o)(1)(E)(ii) of the
Act (section 303(b)(1)(E)(ii) of the
MMA), which provides that the
payment for IVIG ‘‘in 2005 and
subsequent years’’ is the amount
determined under the ASP system.
Some commenters also pointed to the
Conference Report on the MMA, which
states that ‘‘[c]ompetitively biddable
drugs and biologicals exclude IVIG
products and blood products.’’ Other
commenters contended that IVIG is
PO 00000
Frm 00009
Fmt 4701
Sfmt 4700
39029
inappropriate for inclusion under the
CAP because it is frequently not
administered incident to a physician’s
services. A number of commenters also
pointed out that hemophilia patients
commonly receive treatment with blood
clotting factor at special treatment
centers, or self-administer blood clotting
factor at home. As in the case of IVIG,
these commenters contended that blood
clotting factor is therefore inappropriate
for inclusion in a program intended and
designed primarily for drugs
administered incident to a physician’s
services.
Response: In this interim final rule,
we continue to rely solely on the
Secretary’s statutory authority under
section 1847B(a)(1)(B) of the Act to
establish categories of drugs that will be
included in the CAP, and to phase-in
the program with respect to these
categories. Using this authority, we have
not included blood clotting factors or
IVIG within the CAP. If we were to
consider including blood clotting factors
or IVIG, we would first publish a
proposed rule and seek public
comment.
We are also exercising our statutory
authority to establish and phase-in drug
categories in deciding not to include
other immune globulins from the CAP
in this initial stage of implementing the
program. As in the case of tetanus and
diphtheria vaccines, these products are
commonly used in emergency
situations, and are therefore poorly
suited for the normal ordering and
billing procedures contemplated by the
CAP statute. We do not believe that it
is advisable to include within the CAP
drugs for which the special emergency
mechanism will be routinely employed,
at least during this initial stage of
implementing the program. In addition,
immune globulins are considered by
some to belong to the category of blood
products, which are explicitly excluded
under the definition of competitively
biddable drugs (see section
1847B(a)(2)(A) of the Act). Although we
do not necessarily agree that immune
globulins are properly classified as
blood products within the meaning of
the statute, we will not include them in
our initial drug category in order to
provide opportunity for further
comment on whether they should
properly be excluded on a permanent
basis.
Comment: Numerous members of the
mental health community (physicians,
representatives of mental health clinics,
and other mental health professionals)
have requested inclusion of physicians’
injectable psychiatric medications (for
example, long-acting anti-psychotic
drugs) in the initial phase-in of the CAP.
E:\FR\FM\06JYR2.SGM
06JYR2
39030
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
These commenters contend that
including these medications within the
CAP would enhance access to
treatments of proven therapeutic value
to a very vulnerable population. Some
commenters specifically requested
inclusion of these drugs in the CAP in
order to make it more feasible for
community mental health centers
(CMHCs) to acquire and provide these
therapies for their patients. Other
commenters also noted that coinsurance
for these drugs can be approximately 50
percent (in contrast to the 20 percent
coinsurance for other Part B drugs)
under the mental health limit (section
1833(c) of the Act, § 410.155 of our
regulations).
Response: We will include drugs
commonly billed incident to the
services of psychiatrists in this initial
stage of implementing the CAP. The
single drug category that we are
establishing for this initial stage of the
program does in fact include many of
the drugs that commenters specifically
recommended for inclusion in the CAP.
However, it is important to note that,
under the statutory structure of the CAP
as we are implementing it, CMHCs
themselves will not be able to elect to
participate in the CAP for provision of
Part B drugs. This is because, as we
have noted before, the specific
mechanisms described under section
1847B of the Act as we have
implemented them relate to the
provision of and the payment for drugs
provided incident to a physician’s
service. Therefore, only physicians are
eligible to elect participation in the CAP
for provision of the drugs that they
administer incident to their services.
The issue of the appropriate
coinsurance for mental health drugs in
the light of the mental health limit
provision is outside the scope of this
regulation.
Comment: Several commenters asked
for clarification of how codes for drugs
that are not otherwise classified (NOC
codes, including codes J3490, J3590,
J7199, J7599, J7699, J7799, J9999, and
Q0181) would be treated for purposes of
the CAP.
Response: We do not believe that it
would be appropriate to include the
drugs billed under these codes within
the CAP. Bidding and determination of
payment for these codes would present
insurmountable problems and pose
unwarranted risks for potential vendors
under the CAP. These are codes into
which new drugs are assigned before
receiving an appropriate permanent
code. Some new drugs are assigned to
these codes on a temporary basis, and
each code thus represents a shifting
collection of miscellaneous, unrelated
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
products. It is not feasible for potential
vendors to develop meaningful bids on
these codes, given the fact that the codes
represent such disparate products and
that the specific drugs assigned to these
codes are constantly changing.
Comment: Some commenters
recommended that we establish
narrowly defined drug categories. These
commenters argued that broader
categories would place a greater burden
on vendors, who would have to bid and
supply all drugs within broad
categories. However, other commenters
strongly supported the establishment of
drug categories that are broadly defined
to include all the drugs typically
administered by a given medical
specialty. These commenters argued
that broadly defined categories would
simplify the program for vendors,
physicians, and the agency. Specifically,
broad categories would allow most
physicians to be able to choose one CAP
vendor to meet all their Part B drug
needs. One commenter in particular
recommended establishing a single
category including all Part B drugs
administered incident to a physician’s
services. This commenter argued that
such a broad category would make the
CAP most accessible to all physicians,
and allow vendors to bid on a wide
array of products, give them a wider
market, and allow for greater flexibility
in designing their bids.
Response: We are persuaded that
establishing relatively broad categories
of drugs is the most appropriate and
feasible approach for implementing the
CAP, at least in the initial stage. We
agree with the commenters that broad
categories will promote greater access to
the program for physicians, and provide
vendors with flexibility in designing
their bids. Broad categories will also, as
noted by a number of commenters,
allow most physicians to meet all (or
almost all) their Part B drug needs.
We are also convinced by the
arguments for establishing one broad
category, at least for this initial stage of
implementing the CAP. Such a broad
category would make the CAP most
accessible to all physicians. It would
also allow vendors to bid on a wide
array of products, give them a wider
market, and provide them with greater
flexibility in designing their bids. We,
therefore, believe that employing a
single category for the broad range of
drugs administered incident to a
physician’s service is an appropriate
measure, at least for the initial stage of
implementing the CAP. We intend this
single drug category as an interim
measure, for this initial stage of
implementing the program. We believe
that establishing a single, broad drug
PO 00000
Frm 00010
Fmt 4701
Sfmt 4700
category in this initial stage of
implementing the CAP is an appropriate
exercise of the Secretary’s authority
under the statute to establish categories
of competitively biddable drugs and to
phase-in the program with respect to
those categories. We expect to phase-in
multiple drugs categories, probably
defined around the drugs commonly
used by physicians’ specialties (for
example, urology, rheumatology), as we
refine and develop the CAP. We
welcome comments on how to develop
and refine multiple drug categories for
later stages of implementing the
program.
As described below, we are therefore
providing in this interim final rule for
the establishment of a single category
consisting of 169 drugs commonly
provided incident to physicians’
services. This broad category
incorporates drugs commonly used by a
wide range of specialties that bill for
Part B drugs. The category also
incorporates approximately 85 percent
of physicians’ Part B drugs by billed
charges. In response to commenters’
concerns, we have elected not to
include at this time certain low volume
drugs, as described further below.
The procedure that we used to select
drugs for CAP bidding employed
multiple sources of data to find Part Bcovered drugs that are used in sufficient
quantities by a variety of Part Badministering physicians. We believe
that the broad drug category that we
have developed through this procedure
should tend to increase the interest of
potential vendors and physicians in
participating by making it more likely
that (1) the fixed costs of being a vendor
can be covered across the broad array of
Part B physician-administered drugs
that are included; (2) the impact of
spoilage can be reduced; and (3)
physicians electing can select one
vendor to provide all, or almost all, of
the Part B drugs that they administer.
We derived our basic utilization data
(restricted to physicians’ specialties
administering drugs in an office setting)
from 2003 claims, the most recent
available data. We supplemented these
data with data on 2004 Medicare Part B
drug utilization in office settings
extracted from the Part B Extract and
Summary System (BESS) to provide
volume data on new drugs.
In the light of these considerations,
we employed the following specific
steps to develop a single category of the
drugs most commonly used incident to
a physician’s services:
(1) We determined the claims volume
for all Part B drugs in calendar year
2003. We did so by counting, in the
claims from both the 100 percent carrier
E:\FR\FM\06JYR2.SGM
06JYR2
39031
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
and DMERC SAFs for 2003, the number
of separate claims on which each Part B
drug HCPCS appeared as a line item. If
a particular HCPCS appeared multiple
times on a single claim (for example, if
the dates of service for the claim
spanned more than a single day), this
claim would only count once toward the
HCPCS’ claim count. We also tabulated
separate counts for a number of
physicians’ specialties, specifically:
• Oncology specialties (including
hematology, hematology/oncology,
medical oncology, surgical oncology,
urology, gynecology/oncology, and
interventional radiology).
• Ophthalmology.
• Psychiatry (psychiatry, addiction
medicine, and neuropsychiatry).
• Rheumatology.
• We determined separate counts for
each of these specialties in order to be
able to ensure that a broad spectrum of
the Part B drugs used by physicians was
included in this initial drug category for
the CAP. In some cases (oncology,
rheumatology) we included a separate
count for the specialty because of the
significance of drug billing by
physicians in the specialty relative to
overall billing for Part B drugs. In other
cases (psychiatry, ophthalmology), we
included distinct counts in order to
respond adequately to comments
specifically recommending the drugs
commonly billed by those specialties for
inclusion in the program. By
specifically considering these drugs, we
are responding to comments from
member of these specific specialties in
favor of including these drugs under the
CAP. In addition, many of these drugs
are highly specialized and unlikely to be
present in the utilization data for other
specialties. (Many other specialties are
represented in this analysis because the
drugs they commonly administer are
also furnished by specialties that are
specifically included. For example,
most drugs commonly billed by
urologists are also commonly billed by
oncologists.) Finally, we tabulated a
count for all other specialties not
specifically identified above.
(2) We determined the proportion of
each specialty group’s claims on which
each Part B drug appears. Once the
claim counts from step (1) were
computed, they were divided by the
total number of claims submitted by the
specialty groups for Part B drugs in an
office setting. (Note that the sum over all
drugs of these proportions will generally
exceed 1.0 because multiple drugs can
appear on the same claim.) Table 1
below shows these total claim counts,
along with the number of Part B drug
line items and total allowed Part B drug
charges for each specialty group for
drugs administered in an office setting.
TABLE 1.—CLASS & LINE ITEM VOLUME AND ALLOWED CHARGES FOR THE SPECIALTY GROUPS IN 2003
Specialty group
Number of claims
Oncology ....................................................................................................................
Opthalmology .............................................................................................................
Psychiatry ..................................................................................................................
Rheumatology ............................................................................................................
All other specialties ....................................................................................................
(3) We then extracted utilization and
allowed charge data for each Part B drug
in 2004 from BESS. Using BESS,
information on utilization (HCPCS
units) and total allowed charges for each
Part B drug HCPCS code administered
in an office setting were extracted. (For
codes in the range 90200 through 90799
we retained only those CPT codes for
vaccines and immune globulins; the
other codes in that range were
eliminated because they represent drug
administration. We included all HCPCS
J-codes. We also included HCPCS Qcodes corresponding to Part B drugs. We
also excluded blood product HCPCS Pcodes because of the statutory
exemption of blood products from the
CAP.) The resulting BESS output files
were merged to create a single 2004
utilization file.
(4) We then crosswalked 2003 and
2004 Part B drug HCPCS to 2005
HCPCS. We did this in order to account
for updates of the HCPCS codes.
Specifically, several HCPCS codes from
2003 and 2004 were updated to 2005
codes in the Part B drug utilization data
from steps (2) and (3). In most cases,
this merely required changing the old
HCPCS code to the new code and
converting the units of service.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
7,311,248
169,061
43,752
952,381
12,034,708
However, two drugs required special
treatment. In the case of lidocaine
(which was formerly J2000, and is now
J2001), the unit of service changed from
50 cc to 5 ml, and the NDCs included
in the new code suggested a significant
change in the mode of administration.
In the case of octreotide acetate (which
was formerly J2352 and Q4053, and is
now J2353 and J2354), a new distinction
was made between the depot and nondepot formulations that did not appear,
from utilization data and NDC lists, to
have been made previously. For these
drugs, we summed the allowed charges,
and imputed the number of claims to be
the maximum of the number of claims
for the old HCPCS.
(5) We merged the crosswalked drug
utilization data for 2003 and 2004 by the
2005 HCPCS. The data from step (4) for
the 2003 and utilization data were
merged by the 2005 HCPCS.
(6) We then identified the drugs that
we have determined not to include in
the CAP drug category at this time. (We
have discussed the reasons for not
including most of these drugs above.)
The types of drugs that are not included
in the CAP drug category are:
• Clotting factors and immune
globulins.
PO 00000
Frm 00011
Fmt 4701
Sfmt 4700
Number of line
items
14,628,558
178,604
55,599
1,211,630
15,448,287
Allowed charges
$5,647,268,606
154,720,837
3,626,108
404,027,916
1,369,525,241
• Drugs administered through durable
medical equipment.
• HCPCS used for erythropoietin
administered to ESRD patients.
• HCPCS used for specific drugs
administered in hospital outpatient
departments and covered by section
1861(s)(2)(B) of the Act (codes Q2001
through Q2022).
• Orally-administered anti-cancer and
anti-emetics.
• Orphan drugs that meet the criteria
to be single indication orphan drugs for
purposes of OPPS, as discussed above.
• Controlled substances on Schedules
II, III, IV, and V.
• Tissues (for example, dermal,
metabolically active, etc.). (Tissues are
not considered drug products, and do
not appropriately belong under the
category of physician administered
drugs that we have devised in response
to the comments.)
• Influenza, pneumococcal, hepatitis
B, tetanus, and diphtheria vaccines.
• Not otherwise classified (NOC)
drugs (HCPCS J3490, J3590, J7199,
J7599, J7699, J7799, J9999, and Q0181).
• Leuprolide
(7) We identified drugs to be included
in our initial CAP category using the
utilization data described above.
Specifically, in order to be included in
E:\FR\FM\06JYR2.SGM
06JYR2
39032
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
the category, a drug needed to satisfy at
least one of the following conditions:
• Be identified as an oncolytic,
chemotherapy adjunct, anti-emetic,
hematologic, or have a HCPCS in the
J9000 series (except for J9999, which is
excluded as a NOC code).
• Appear on more than 0.1 percent of
claims for the oncology or all other
specialty groups.
• Appear on more than 1 percent of
claims for the ophthalmology,
psychiatry, or rheumatology specialty
groups.
• Have more than $250,000 in
allowed charges in office settings in
2004 and be identified as an
antibacterial, antifungal, antiparasitic,
antidote, or cardiovascular agent.
• Have more than $1 million in
allowed charges in office settings in
2004.
In addition to satisfying one of the
above conditions, a drug must also
satisfy both of the following conditions:
• Not be on the list specified in step
(6) above of drugs that are not included
in the CAP drug category.
• Have more than $50,000 in allowed
charges in office settings in 2004
(another measure designed to avoid
including very low volume drugs in this
initial category).
We employed the criteria above to
ensure that our single drug category
would include a broad spectrum of the
Part B drugs billed by physicians
generally and by various physicians’
specialties in particular. Our intent was
to provide the physician with a single
source for drugs (that is, the approved
CAP vendor) that would be able to
furnish the majority of drugs used in a
practice regardless of the practice
specialty or the diversity of prescribing
patterns in that practice. Furthermore,
we intended to provide the physician
with choice and flexibility within
groups of drugs that might be used by
different specialties for the treatment of
various conditions. This list of drugs is
intended to accommodate a variety of
physician practice patterns and a variety
of specialties with the understanding
that many drugs, for example, antiemetics, are used by more than one
specialty.
As noted above, we believe that in
many cases, there is significant overlap
in the types of Part B drugs
administered by most physician
specialties, including oncology. For this
reason, we decided that oncolytics,
chemotherapy adjuncts, anti-emetics,
hematologics, and drugs having a
HCPCS in the J9000 series (except for
J9999), should be included in the CAP
even if they did not meet the specialty
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
claims percentage thresholds described
in step (7) above. We believe that these
drugs should be included in the CAP (so
long as they meet the baseline claims
volume threshold specified above and
are not on the list specified in step (6)
above). We believe it is necessary to
include these drugs, even at lower
volumes, because they may often be
used in conjunction with one another,
both by oncologists and by physicians
in many other specialties.
However, for other drugs, we looked
at claims volume in the aggregate of all
specialties except those identified below
to determine a threshold that would
allow for a sufficiently sized market for
vendors, while at the same time making
the CAP a meaningful alternative for
most physician specialties. At the same
time, in response to specific comments
about specialties where there is not
significant overlap between small but
highly utilized groups of drugs, the
drugs that physicians in those
specialties use, and drugs commonly
used by other physician specialties, we
identified psychiatry, ophthalmology,
and rheumatology as specialties whose
drugs claim threshold should be
different. In order to lessen the
inventory burden for vendors, we
wanted to minimize the number of
drugs included in the CAP that are
billed in very low volumes, so we have
applied a $50,000 minimum threshold
for all drugs that otherwise would be
included in the CAP (see step (7) above).
We determined separate counts for
several specialties, in order to be able to
ensure that a broad spectrum of the Part
B drugs used by physicians was
included in this initial drug category for
the CAP. In some cases (oncology), we
included a separate count for the
specialty because of the significance of
drug billing by these physician
specialists relative to overall billing for
Part B drugs. In other cases (psychiatry,
ophthalmology, and rheumatology), we
included distinct counts in order to
respond adequately to comments
specifically recommending the drugs
commonly billed by those specialties for
inclusion in the program, which, as
noted above, are not frequently used by
physicians in other specialties. As we
have discussed above, we agree with the
comment that we should include within
this initial stage of the CAP drugs that
provide a sufficiently large market for
the program to be viable for vendors.
For this reason, we decided not to
include most very low volume drugs in
this initial drug category. However,
because overall volume of billing for
Part B drugs varies widely from one
physician category to another, we
determined that the threshold for
PO 00000
Frm 00012
Fmt 4701
Sfmt 4700
determining ‘‘low volume’’ had to vary
somewhat among the specialties that we
have separately identified in this
analysis. In this context, we have
determined that the low volume
threshold should be relative to the size
of the specialty and the overall volume
of billing for Part B drugs by the
specialty: The universe of Part B drugs
billed by oncologists is roughly
comparable to those in all other
specialties in the aggregate and is much
larger than the universe of Part B drugs
billed by ophthalmology, psychiatry, or
rheumatology. Specifically, the overall
volume of billing for Part B drugs by
oncologists is very high, while the
overall volume of billing for Part B
drugs by psychiatry and ophthalmology
is relatively low. The same percentage
threshold for these specialties would
therefore yield very different numbers of
claims for exclusion. We therefore
determined that it would be appropriate
to establish different percentage
thresholds for including drugs billed by
these specialties in the CAP. We
accordingly set the percentage threshold
for the oncology and all other specialty
groups at 0.1 percent of claims
submitted by the specialty. We set the
threshold for ophthalmology,
psychiatry, and rheumatology, at 1.0
percent of claims. A low percentage
threshold (0.1 percent) for oncology
claims (and claims for the other
specialty category) is appropriate in
relation to the overall high numerical
volume of billing by oncologists for Part
B drugs: a higher percentage threshold
for this specialty would exclude some
relatively high volume drugs from the
category. Conversely, a similarly low
percentage threshold for psychiatric
drugs would not be appropriate because
it would allow some very low volume
drugs into the CAP. A higher percentage
threshold in this case is necessary to
exclude some very low volume drugs
from the CAP. We decided on these
specific percentage thresholds after
examining various alternative levels (for
example, 0.01 percent) and different
combinations of levels (for example, 0.1
percent for oncology drugs, 0.01 percent
for ophthalmology and psychiatry).
After examining a number of
alternatives, we determined that these
levels strike an appropriate balance:
they are high enough to prevent truly
low volume drugs from being included
in the category, and low enough to
incorporate within the category a truly
broad spectrum of the Part B drugs
commonly billed by physicians. When
we considered cutting the list off at a
higher threshold (for example, 1.0
percent) for oncology drugs (and the
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
‘‘other specialty’’ category), we realized
that numerous commonly billed drugs
would have been excluded. Similarly,
when we considered a lower threshold
(for example, 0.1 percent) for
ophthalmology, psychiatry, and
rheumatology, we realized that many
drugs billed in small numbers would be
included.
Finally, we set several other
thresholds based on claims volume that
we believe would be appropriate for
balancing the goal of providing
approved CAP vendors with a
sufficiently sized market with that of
allowing physicians to obtain a broad
array of drugs through the CAP. For this
reason, we determined that a $250,000
threshold would be appropriate for
drugs identified as an antibacterial,
antifungal, antiparasitic, antidote, or
cardiovascular agents. These drugs are
often used by particular specialties like
infectious disease or cardiology, but
many of these drugs may be used by
other specialties, and the $250,000
threshold ensures that only those drugs
of this type that are commonly used are
included in the CAP. Finally, for the
same reasons, we believe that any drug
that otherwise meets the criteria for
inclusion in the CAP (as specified
above), but does not meet one of the
other four specific criteria outlined in
step (7) above, should be included if the
volume of claims for the drug is
significant. We have set that threshold
at $1 million. The result of performing
this methodology is a list of 169 drugs.
Table 2 gives the percentage of total
allowed charges for Part B drugs for
each of the five specialty groups shown
in Table 1.
TABLE 2.—PERCENT OF 2003 TOTAL
ALLOWED CHARGES ACCOUNTED
FOR BY THE CAP BIDDING DRUGS
Oncology ...........................................
Ophthalmology ..................................
Psychiatry .........................................
Rheumatology ...................................
Other specialties ...............................
All non-oncology specialties .............
All physicians (in office) ....................
84.92
99.97
46.14*
99.29
80.57
86.00
85.20
* Note: Our data on drug billing by psychiatrists showed a high proportion (53 percent) of
allowed charges for Rho D immune globulin,
which is not included in our single drug category for the reasons discussed above. The
drugs that we have included represent 97.94
percent of allowed charges for all other drugs
commonly used by psychiatrists.
Using these steps, we have identified
a list of 169 drugs for inclusion in our
single drug category. We show the list
of these drugs in Addendum A. These
drugs represent a large proportion of the
440 drugs billed incident to physicians’
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
services in our Part B billing data. More
importantly, they represent about 85
percent of the charges for all the Part B
drugs billed by physicians. We also
have revised the definition of ‘‘CAP
drug’’ in the regulations at § 414.902 to
clarify that the provisions of the CAP
program apply to drugs that we have
included in the drug category.
Comment: Several commenters noted
that, in light of the congressional intent
to provide physicians with an
alternative method for obtaining the Part
B drugs that they use, it would be
especially appropriate to incorporate
into the CAP at an early stage of
implementation those drugs that have
been identified as posing acquisition
problems for physicians under the ASP
system.
Response: The methodology that we
described above does not specifically
account for those drugs. However, we
have reviewed the resulting list of 169
drugs against a list that we have
maintained of drugs that have been
reported to us as posing access problems
for physicians under the ASP system.
Most of the drugs on that list appear in
the drug category that we are
establishing for this initial phase of
implementing the CAP. These include:
J7050 Normal Saline 250 mL
J9245 Melphalan/Alkeran 50 mg
J2430 Pamidronate
J2920 Methylprednisolone
J2930 Methylprednisolone
J7317 Sodium Hyaluronate
J7320 Hylan G-F 20
J9310 Rituximab
J1750 Iron Dextran 50 mg Injection
J2405 Odansetron 1 mg Injection
To account for the drug category that
we are adopting in this interim final
rule with comment period, we have
revised the proposed regulations at
§ 414.902 to specify that CAP drugs are
those physician-administered drugs or
biologicals furnished on or after January
1, 2006 described in section
1842(o)(1)(C) of the Act and supplied by
an approved CAP vendor under the CAP
as provided in this subpart.
Vendor Implications
We pointed out that the categories
established for physicians to select
would be the same categories that
would be open for bids by potential
vendors. Vendors would not be able to
submit bids on only some of the HCPCS
codes in the category, and physicians
would not be able to elect to acquire
only some of the HCPCS codes in that
category from the approved CAP
vendor. Note that in § 414.902 the
proposed definition for ‘‘approved
vendor’’ at § 414.902 has been revised to
PO 00000
Frm 00013
Fmt 4701
Sfmt 4700
39033
‘‘approved CAP vendor’’ and clarified to
specifically reference 1847B of the Act.
In addition, it is important to keep in
mind that HCPCS codes can often
describe products represented by
multiple National Drug Codes (NDC).
For example, the drug
cyclophosphamide is manufactured by a
number of different pharmaceutical
companies and has multiple NDC codes.
In proposed § 414.908(d), we
indicated that vendors will not be
required to provide every National Drug
Code associated with a HCPCS code.
Section 1847B(b)(1) of the Act states
that ‘‘in the case of a multiple source
drug, the Secretary shall conduct such
competition among entities for the
acquisition of at least one competitively
biddable drug and biological within
each billing and payment code within
each category for each competitive
acquisition area.’’ However, we also
proposed that vendors be required to
provide potential physician participants
in the competitive acquisition program
the specific NDCs within each HCPCS
code that they will be able to provide to
the physician. Potential vendors would
also need to provide this same
information to us as part of the bidding
application. This information would be
provided to physicians who request it
no later than the beginning of the
election period during which the
physician chooses whether to
participate in the CAP and, if so, selects
a vendor.
Comment: Many commenters
supported our proposal to require
vendors to submit bids on at least one
drug for each HCPCS code within a
category. Many of these commenters
urged us to resist any recommendation
that vendors be permitted to establish
drug formularies by offering drugs from
only some of the codes included in a
category. Many other commenters
expressed opposition to any attempt by
the agency to establish a formulary as an
element of implementing the CAP. A
few commenters representing potential
vendors did make such a
recommendation. Other commenters
recommended that we establish a more
stringent standard, such as: requiring
that vendors offer at least one drug for
each distinctive treatment or therapy
represented within a HCPCS code;
requiring that vendors be required to
offer at least one formulation (that is, at
least one NDC) for each single-source
drug that falls within the same HCPCS
code; or requiring that vendors be
required to provide all available FDAapproved drugs within a HCPCS code.
Finally, some commenters
recommended that information about
which specific NDC codes vendors will
E:\FR\FM\06JYR2.SGM
06JYR2
39034
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
be offering be made generally available,
perhaps through the CMS Web site, and
not merely made available to physicians
upon request.
Response: In this interim final rule,
we are finalizing our proposal to require
vendors to submit bids on at least one
drug for each HCPCS code within a
category. At the same time, we do not
believe that it is advisable or feasible to
require vendors to provide all available
FDA-approved drugs within a HCPCS
code. We are concerned that such a
requirement may exclude vendors who
are unable to provide even one drug in
a category, unduly limiting the number
of vendors that would participate in the
program. We also do not believe that it
is advisable to establish a standard
requiring that vendors offer at least one
drug for each distinctive treatment or
therapy represented within a HCPCS
code. Such a provision would be
difficult to distinguish from establishing
the type of formulary that many
commenters opposed. Consistent with
the requirement of 1847B(b)(1) of the
Act, we have therefore decided to
finalize our proposal to require vendors
to submit bids on at least one drug for
each HCPCS code within a category. We
believe that the program will provide a
strong incentive for vendors to include
a broad selection of drugs within
individual codes. It will be difficult for
vendors to attract business from
physicians under the program if the
choice among drugs within specific
codes is unduly restrictive. We expect
that this incentive will be sufficient to
prompt vendors to offer a wide range of
drugs, including multiple NDCs within
a single drug code, and thus protect
physicians’ ability to choose the most
medically appropriate therapies for their
patients. In addition, our decision to
include our proposed ‘‘furnish as
written’’ provision in this interim final
rule should provide protection for
physicians in those cases when an
approved CAP vendor does not offer the
specific drug or formulation that is
medically necessary for a patient. (See
section II.B of this interim final rule.) In
addition, in this interim final rule, we
are finalizing our proposed policy that
vendors will be required to provide to
potential physician participants in the
CAP the specific NDCs within each
HCPCS code that they will be able to
provide to the physician. We are not
accepting the recommendation that
vendors be permitted to establish drug
formularies by offering drugs from only
some of the codes included in a
category. The statute expressly requires
that for multiple source drugs, a
competition be conducted for the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
acquisition of at least one drug per
billing code within the category. Thus,
the statute does not contemplate a
formulary. Finally, we agree with the
suggestion that the specific NDC codes
vendors will be offering be made
generally through our Web site. By
October 1, 2005, we will make available,
on the CAP web page, a directory of the
approved CAP vendors and the specific
NDC numbers these vendors will be
providing.
We also note that we have revised the
definition of approved vendor at
§ 414.902 to read ‘‘approved CAP
vendor’’ and we have specifically
referenced 1847B of the Act.
Comment: A number of commenters
asked us to clarify that, if the CAP is
phased in by physicians’ specialty,
physicians of any specialty will still be
able to obtain drugs initially included in
the program from a CAP vendor.
Response: We stated in the proposed
rule (70 FR 10750) that ‘‘if we choose to
phase-in the CAP by restricting the
program initially to drugs typically
administered by members of one
specialty, all physicians who administer
the drugs selected would still be eligible
to elect to obtain these drugs through
the CAP and to select a vendor of these
drugs. For example, if we choose to
phase-in the program initially with
drugs typically administered by
oncologists, participation in the CAP
would not be restricted to oncologists:
non-oncologists who prescribe these
drugs would still be eligible to elect the
CAP and to select a vendor from which
to obtain these drugs.’’ In this interim
final rule, we are establishing one broad
category of drugs commonly furnished
incident to a physician’s services for the
initial stage of implementing the
program. Physicians of any specialty are
eligible to elect the CAP and to select a
vendor from which to obtain these
drugs. As we refine and expand the
program, and expand our single
category into multiple drug categories,
we will maintain the policy that any
physician, regardless of specialty, who
administers the drugs in a specific
category, may elect to obtain those drugs
through the CAP in accordance with the
statute and implementing regulations.
Finally, in the proposed rule, we
emphasized that, in framing these
options, we relied solely on the
Secretary’s statutory authority under
section 1847B(a)(1)(B) of the Act to
establish categories of drugs that will be
included in the CAP, and to phase-in
the program with respect to these
categories. Although we did not propose
to rely at this time on the Secretary’s
authority under section 1847B(a)(1)(D)
of the Act to exclude competitively
PO 00000
Frm 00014
Fmt 4701
Sfmt 4700
biddable drugs and biologicals from the
CAP on the grounds that including
those drugs and biologicals would not
result in significant savings or would
have an adverse impact on access to
those drugs and biologicals, we
proposed to set forth the circumstances
for which we may exclude
competitively biddable drugs and
biologicals (including categories of
drugs) from the CAP at § 414.906(b) of
our regulations. In this interim final
rule, we continue to rely solely on the
Secretary’s statutory authority under
section 1847B(a)(1)(B) of the Act to
establish categories of drugs that will be
included in the CAP, and to phase-in
the program with respect to these
categories.
3. Competitive Acquisition Areas
Definition of Competitive Acquisition
Areas
Section 1847B(a)(1)(A)(i) of the Act
provides that, under the competitive
acquisition program (CAP), competitive
acquisition areas are established for
contract award purposes. Section
1847B(a)(2)(C) of the Act further defines
the term ‘‘competitive acquisition area,’’
for purposes of the CAP, as ‘‘an
appropriate geographic region
established by the Secretary.’’ Section
1847B(b)(1) of the Act also requires that
the Secretary conduct a competition
among entities for the acquisition of at
least one competitively biddable drug
within each billing and payment code
within each category of competitively
biddable drugs for each competitive
acquisition area. Finally, section
1847B(b)(3) of the Act states that the
Secretary may limit (but not below two)
the number of qualified entities that are
awarded contracts for any competitively
biddable drug category and competitive
acquisition area.
Under this statutory scheme,
competitive acquisition areas (that is,
the geographic areas the contractor
would be responsible for serving) have
an important role in the CAP. These
areas constitute the geographic
boundaries within which entities will
compete for contracts to provide
competitively biddable drugs.
As explained in the March 4, 2005
proposed rule, the definition of these
areas will be a crucial factor in
determining—the number of entities
that bid for contracts; the number of
entities that are ultimately awarded
these contracts; the level of savings from
the successful bids; and the efficiency
with which the system delivers
competitively biddable drugs to
physicians.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Because the statute grants the
Secretary broad discretion in defining
competitive acquisition areas under the
CAP, we discussed several factors that
must be considered in defining
competitive acquisition areas for
competitively biddable drugs and
biologicals, including how promptly
physicians need drugs provided to their
practices if distribution capacity varies
geographically, as well as aspects of
vendors and their distribution systems,
such as:
• Current geographic service areas;
• Density of distribution centers,
distances drugs and biologicals are
typically shipped, and costs associated
with shipping and handling;
• The relationships between vendors
and their suppliers (manufacturers,
wholesalers, etc.); and
• State licensing laws that may
preclude vendors from operating in a
State are to be taken in account. These
factors can affect the price of supplying
drugs to different regions as well as the
size of the market in which vendors are
allowed or able to operate.
Section 1847B(a)(1)(B) of the Act
specifically requires the Secretary to
phase-in the CAP with respect to the
categories of drugs and biologicals in
the program, in such a manner as the
Secretary determines to be appropriate.
We believe that this provision,
particularly in conjunction with the
statutory definition of ‘‘competitive
acquisition area’’ (‘‘an appropriate
geographic region established by the
Secretary’’) (emphasis added), provides
broad authority for the Secretary to
phase-in the CAP with respect to the
geographical areas in which the program
will be implemented.
In the proposed rule, we identified
several basic options for defining the
competitive acquisition areas required
under the CAP along with possible
advantages and disadvantages for these
options. The specific options discussed
included: establishing a national
competitive acquisition area;
establishing regional competitive
acquisition areas; and establishing
statewide competitive acquisition areas.
We requested comments on all the
options that we have discussed and also
welcomed recommendations of other
options for consideration but stated that
defining competitive acquisition areas,
at least initially, on the basis of a level
no smaller than the States is the most
feasible approach.
Comment: Many commenters
addressed these two related issues: (1)
Whether to implement the CAP
immediately on a national scale, or to
phase-in the program by beginning in
one or more smaller areas; and (2)
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
whether to establish a national
competitive acquisition area, regional
competitive acquisition areas, or
statewide competitive acquisition areas
on a permanent basis.
Commenters were divided about
whether to implement the CAP
nationally on January 1, 2006, or to
phase-in the program by beginning on a
more limited scale. Those commenters
in favor of immediate national
implementation emphasized
congressional intent to establish a
national program or the importance of
providing physicians immediately with
an alternative method for procuring
drugs. Commenters in favor of a
geographic phase-in argued that the
CAP should be tested on a smaller scale
in order to ensure that major
implementation issues are solved before
extending the program nationally. These
commenters were divided on how to
begin a geographic phase-in. Most of the
commenters in favor of a phase-in
endorsed beginning on a state or
regional level. Some commenters
specifically recommended beginning the
program on a limited geographic basis
in one or more of the most highly
populated States, such as California,
New York, or Texas. Other commenters
recommended implementing the
program initially with a few vendors
serving a nationwide area.
Some commenters recommended
establishing a single, national
acquisition area on a permanent basis.
Other commenters supported either
State-based or regional acquisition areas
on a permanent basis. Supporters of
State areas emphasized that the
licensing requirements operate at the
State level, and that State-based areas
would permit participation by smaller
vendors. Supporters of regional areas
pointed to the regional administration of
other Medicare programs. Others
pointed out that vendors may not bid to
provide drugs for some small, low
population states if the acquisition areas
are established on a statewide basis.
Response: We are persuaded by those
commenters who advocated national
implementation of the CAP beginning
January 1, 2006. We agree with these
commenters that it is important to
provide an alternative to the ‘‘buy-andbill’’ method of drug acquisition for
physicians as widely and quickly as
possible. We have therefore decided to
implement the program for the broad
drug categories that we have previously
described on a nationwide basis January
1, 2006.
We also agree with those commenters
who recommended initially
implementing the program in a single,
nationwide competitive acquisition area
PO 00000
Frm 00015
Fmt 4701
Sfmt 4700
39035
for several reasons. First, in a single
national area, the number of Medicare
beneficiaries and physicians is
sufficiently large to encourage vendors
to participate. In addition, starting with
a nationwide competitive acquisition
area allows additional time to consider
whether smaller, regional competitive
acquisition areas should consist of
single States or multiple States. Also,
implementing the program initially in a
single nationwide area would impose
less administrative burden on potential
bidders than other options, because
each applicant would be submitting
bids for contracts to cover one
geographic area. Finally, implementing
a nationwide competitive acquisition
area initially allows us to develop and
evaluate the administrative structures of
the new program in conjunction with
the relatively smaller number of vendors
that can operate on a national level
before extending the program to the
larger number of vendors that might
operate on a State or regional level,
while still providing all physicians the
opportunity to participate from the
outset. It is important to note that we
received 15 responses to our December
13, 2004 Request for Information. All
these responders expressed an interest
in participating in the CAP. Most of
these responders indicated a willingness
to provide selected Part B drugs on a
nationwide basis. We therefore believe
that implementing the CAP initially in
a single nationwide competitive
acquisition area will allow for an
appropriate level of competition among
vendors to provide drugs for physicians.
We also agree with those commenters
who supported phasing in the CAP. We
agree with these commenters that
phasing in the CAP would give us the
opportunity to test and refine the
administrative apparatus with a limited
number of vendors before expanding the
program to allow larger numbers of
vendors to participate. Most of the
commenters in favor of a phase-in
recommended implementing the
program initially on a limited
geographic scale, such as one or more
States or regions of the country.
However, a few commenters supported
an alternative phase-in approach that
we discussed in the proposed rule. As
we stated there, one way to phase-in the
program is to begin with the limited
number of vendors that can deliver
drugs on a nationwide basis: ‘‘the
program could be phased in by initially
employing a national competitive
acquisition area. This would limit
participation in the program initially to
those vendors that could compete to bid
and supply drugs nationally, to the
E:\FR\FM\06JYR2.SGM
06JYR2
39036
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
exclusion of the vendors that could bid
and supply drugs on a regional or State
basis. Under such a phase-in plan, the
definition of competitive acquisition
area would ultimately be established on
the basis of regions, States, or some
other smaller geographic area, which
might expand the number of vendors
that could bid to participate in the
program.’’
In this interim final rule, we are
establishing a single, national
distribution area for the initial stage of
the CAP. This national distribution area
will embrace the 50 States, the District
of Columbia, Puerto Rico, and U.S.
territories. In order to participate in this
initial stage of the program, vendors will
need to be appropriately licensed in all
50 States and the District of Columbia
(as well as Puerto Rico and the U.S.
territories). It is important that, as we
discuss in section 2.C.1 of this interim
final rule, vendors submitting bids to
participate in the program may employ
subcontractors, including vendors that
operate on a State-wide or regional
basis, to provide for distribution of
drugs across the nationwide area that
we are establishing. Under this phase-in
plan, we expect that the definition of
competitive acquisition areas will
ultimately be established on the basis of
regions, States, or some other smaller
geographic area, which we expect to
increase the number of vendors that
could bid to participate in the program.
We will consider how to establish
smaller competitive acquisition areas
(regional or State-based) as this initial
phase of implementation proceeds. We
welcome additional comments in
response to this interim final rule on
how to proceed with the development of
smaller competitive acquisition areas for
later stages of implementing the
program. We anticipate that our final
plan for those areas will not only allow
smaller, State-based or regional vendors
to compete for contracts under the CAP,
but also preserve the opportunity for
large vendors to participate in the
program on a nationwide basis.
B. Operational Aspects of the CAP
1. Statutory Requirements Concerning
Claims Processing
Section 1847B(a)(3)(A) of the Act sets
forth specific requirements that have a
direct impact on the administrative and
operational parameters for instituting a
CAP. This section of the statute requires
the following: (1) Vendors participating
in the CAP bill the Medicare program
for the drug or biological supplied, and
collect any applicable deductibles and
coinsurance from the Medicare
beneficiary. (For purposes of the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
preamble the term ‘‘vendor’’ means the
term ‘‘contractor’’ as referred to in the
statute.) (2) Any applicable deductible
and coinsurance may not be collected
unless the drug was administered to the
beneficiary. (For purposes of the
preamble the term ‘‘drug’’ refers to
drugs and biologicals.) (3) Medicare can
make payments only to the vendor, and
these payments are conditioned upon
the administration of the drug.
The statute requires the Secretary to
provide for a process for adjustments to
payments when payment was made for
the drugs, but they were not actually
administered to the beneficiary. The
Secretary is also required to provide a
process by which physicians submit
information to vendors for purposes of
the collection of applicable deductible
or coinsurance. Payment may not be
made for competitively biddable drugs
supplied to a physician who has elected
to participate in the CAP unless the
vendor supplying the drugs has a
contract to provide them in that
geographic area and the physician
receiving them has elected the vendor to
supply that category of drug in that
geographic area.
Section 1847B(b)(4)(E) of the Act
requires that the vendor supply drugs
directly only to the selecting physicians
and not directly to individuals, except
under circumstances and settings where
the individual currently receives drugs
in his or her home or another nonphysician office setting, as provided by
the Secretary. In addition, the vendor
may not provide drugs to a physician
participating in the CAP unless the
physician submits a written order or
prescription, and any other data
specified by the Secretary, to the
vendor.
However, the statute also makes it
clear that the physician is not required
to submit an order (prescription) for
individual treatments of a drug or
biological, and that the statute is not
intended to change a physician’s
flexibility to choose whether to write a
prescription for a single treatment or a
course of treatments. In certain sections
of the proposed rule, we used the term
‘‘prescription’’ and the term ‘‘order’’
interchangeably. Section 1847B of the
Act uses the term ‘‘prescription’’ but
does not define it. For purposes of the
CAP, we proposed to interpret the term
to include a written order submitted to
the vendor.
We also noted that section
1847B(b)(4)(E) of the Act, in requiring
that vendors deliver drugs only upon
receipt of a ‘‘prescription,’’ expressly
indicates that the statute does not
‘‘require a physician to submit a
prescription for each individual
PO 00000
Frm 00016
Fmt 4701
Sfmt 4700
treatment’’ or ‘‘change a physician’s
flexibility in terms of writing a
prescription for drugs or biologicals for
a single treatment or a course of
treatment.’’ As we stated in the
proposed rule, it is not our intention to
restrict the physician’s flexibility when
ordering drugs from a CAP vendor.
Resupplying Inventory
Section 1847B(b)(5) of the Act
requires the Secretary to establish rules
under which drugs acquired under the
CAP may be used to resupply
inventories of these drugs administered
by physicians. The statute contains four
criteria that must be met in order for the
physician to use this provision: the
drugs are required immediately; the
physician could not have anticipated
the need for the drugs; the vendor could
not have delivered the drugs in a timely
manner; and the drugs were
administered in an emergency situation.
Comment: One commenter stated that
the statutory requirement to provide for
a process of adjustments to payments in
cases where payment was made for a
drug that was not actually administered
to the beneficiary was unnecessary and
should be removed or clarified since
under the proposed claims processing
system payment to the vendor would
not be made until administration was
verified, unless CMS adopted the partial
payment methodology.
Response: We agree with the
commenter that generally the claims
processing system we are adopting in
this interim final rule makes it less
likely that we will need to recover
payments made in error to vendors for
drugs that were not actually
administered to the beneficiary, because
we will not pay the vendor until the
drug administration claim has been
processed. However, it is still possible
that claims filing and processing errors
could occur and that as a result, a
vendor could be paid in error. In that
event, we will use existing overpayment
recovery processes to recover claims
payments made in error. Therefore, we
are retaining the language at
§ 414.906(d).
Comment: Some commenters
requested that we define the term
prescription and/or order in the final
rule preamble and regulations. Other
commenters stated that because the
statute uses the word prescription, CMS
does not have the authority to redefine
the term to mean an order. Several
commenters characterized the drug
order process described in the proposed
rule as the filling of a prescription for
a patient, and stated that only a licensed
pharmacist may fill a prescription under
State and Federal law. Another
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
commenter noted that ‘‘prescription’’
and ‘‘order’’ have very different
meanings in the marketplace, with
prescription being associated with
precise pharmacy rules, and order being
more commonly used to describe a
distribution system. Some commenters
requested that CMS define the program
as either a pharmacy program or a
distribution program and use consistent
language within the regulation. Other
commenters felt that there was no doubt
that the statute required CMS to define
the patient-specific drug order as a
prescription and that CMS should
consistently describe it as such.
Response: As we stated in the
proposed rule, the statute uses the term
prescription but does not define it.
Further, the process envisioned in the
statute contains elements more
commonly consistent with orders as
well as elements usually associated with
prescriptions. We do not believe that the
Congress intended us to abide by a rigid
definition of a prescription. We note
that CAP vendors must comply with
State licensing requirements in all cases,
and that our definition of prescription
as used in the statute is not meant in
any way to override those requirements.
For purposes of this interim final rule,
we will define the CAP drug ordering
process as a prescription order and will
add a definition of the term to the
regulations text at § 414.902. For
purposes of the CAP, we define a
prescription order as a written order
submitted by the physician to the
vendor in accordance with the
requirements of the CAP. (The
discussion of whether CAP requires a
drug distributor’s license or a pharmacy
license is dealt with in more detail in
section II C, the CAP contracting
process.)
Comment: One commenter believed
that it was a violation of physician
flexibility to require that in the case of
a multiple source drug, vendors supply
only one drug within each billing and
payment code within each category.
Response: Section 1847B(b)(1) of the
Act explicitly states the requirement,
and we will implement it as stated in
the statute: ‘‘In the case of a multiple
source drug, the Secretary shall conduct
such competition among entities for the
acquisition of at least one competitively
biddable drug and biological within
each billing and payment code within
each category for each competitive
acquisition area.’’
Comment: Another commenter
believes that CAP vendors should be
prohibited from acting differently than
the drug distributors or wholesalers
with which the physician currently does
business. That is, the vendor should be
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
prohibited from exercising the
responsibilities of a physician or a
pharmacist with regard to drug
interactions, appropriate dosing, or
other issues such as substituting drugs
in the physician’s order.
Response: We expect vendors to
perform their responsibilities consistent
with applicable State law and this
interim final rule. To the extent that the
vendor is required by State law to
include a pharmacist in the CAP process
or to act as a pharmacy, the vendor may
be required to discuss possible drug
interactions or to perform other duties
commonly performed by pharmacies.
Although the CAP legislation does not
require these activities as part of the
CAP, neither does it excuse vendors
from any applicable requirements under
State law.
Comment: Some commenters
supported the resupply criteria. Others,
including an association of cancer
centers, expressed concern about the
strict requirements for physician
compliance with the criteria for the
resupply provision described in section
1847B(b)(5) of the Act and requested
that CMS liberalize the provisions.
Response: The four criteria that
govern the resupply option are
contained in section 1847B(b)(5) of the
Act, as specified above. The statute also
states that the physician may use drugs
and biologicals obtained from a CAP
vendor to resupply drugs and
biologicals that he or she has taken from
his or her own stock to treat the
beneficiary if the physician can
demonstrate to us that all four of the
criteria have been met. Because the
criteria and the responsibility to comply
with all of them are statutory, we do not
have the authority to change them, or to
allow that some of them be optional.
However, we interpret ‘‘timely manner,’’
for purposes of the resupply provisions
of the CAP, to mean the ability to meet
emergency delivery standards for timely
delivery as defined in § 414.902. That is,
if the vendor could not have delivered
the drugs to the physician to respond to
the patient’s clinical need for the drug
under the emergency delivery process,
then the vendor could not have
delivered the drug in a timely manner
for purposes of the resupply provisions.
Further, we interpret the term
‘‘emergency situation,’’ for purposes of
the resupply provisions of the CAP, to
mean a situation that in the physician’s
clinical judgment requires immediate
treatment of the patient. We have made
some technical changes to these
definitions in § 414.902. (These
comments are further addressed in the
claims processing/operational overview
section that follows).
PO 00000
Frm 00017
Fmt 4701
Sfmt 4700
39037
Comment: Some commenters
suggested that in an emergency
situation, the physician should be given
the option of using the drug
replacement option or of billing for the
replacement drug using the ASP
methodology.
Response: We believe that the
Congress created the emergency
resupply provision to address situations
when a physician participating in the
CAP would need immediate access to
drugs but would not have the time to
obtain them from the vendor. This
provision allows a physician to treat the
patient in situations that comply with
the four criteria specified in the Act,
and then obtain replacement drugs from
the CAP vendor. This provision
specifies that the physician obtain
replacement drugs from the CAP vendor
and thus does not allow the physician
to bill under ASP in this situation.
2. Proposed Claims Processing and
Operational Overview
To comply with the statutory
requirements described above, in the
March 4, 2005 rule, we proposed to
implement a claims processing system
that would enable selected vendors to
bill the Medicare program directly, and
to bill the Medicare beneficiary and/or
his or her third party payor after
verification that the physician has
administered the drug. We set forth the
proposed requirements for payment
under the CAP at § 414.906 of our
regulations. For the initial
implementation of the CAP, we
discussed our plan to designate one
Medicare fee-for-service claims
processing carrier to process all drug
vendors’ Medicare claims (and referred
to this entity as the designated carrier.)
Physicians who elect to participate in
the program will continue to bill their
local Medicare fee-for-service claims
processing carrier for physicians’
services.
Comment: One commenter supported
CMS’ plan to make a single designated
carrier responsible for processing drug
vendor claims. However, the commenter
encouraged CMS to move toward having
the Part B carriers process both the
physician’s claim and the drug vendor’s
claim at some point. The commenter
also suggested that CMS consider
aligning the CAP areas with the claims
processing jurisdictions that CMS will
adopt for the Medicare Administrative
Contractors.
Response: We will continue to
evaluate the operation of the CAP and
will conduct the evaluation in the
context of the implementation of
Medicare contracting reform.
E:\FR\FM\06JYR2.SGM
06JYR2
39038
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Roles of the Contractor
We proposed that both the designated
carrier and the physician’s local carrier
would be charged with keeping track of
the physician’s vendor selection and
making sure that the physician is
administering drugs provided by the
vendor with whom he or she has elected
to participate. This process also would
involve our central claims processing
system.
The March 4, 2005 rule (70 FR 10754)
also discussed the proposed operational
structure for the CAP and the
relationship and responsibilities of the
participating CAP physician and
approved vendor with respect to the
ordering, delivery, and administration
of the CAP drug and the payment
aspects associated with the CAP drug. A
summary of this proposed operational
structure follows.
Ordering the CAP Drugs
We proposed that when a physician
who has elected to participate in the
CAP prepares an order for a drug to be
administered to a Medicare beneficiary,
the physician would provide basic
information about the beneficiary and
the beneficiary’s third party insurance
to the drug vendor. In addition, the
physician would check that he or she
was planning to use the drug consistent
with any local coverage determination
policies (LCDs), just as he or she would
do now if obtaining a drug under the
current payment methodology.
We proposed that the order
transmitted between the physician and
the drug vendor could occur in a variety
of HIPAA-compliant formats, such as by
telephone with a follow-up written
order.
Comment: Several commenters stated
that the drug ordering process outlined
in the proposed rule will make it
difficult for the physician to treat a
patient on the patient’s first visit to the
office, which will necessitate at least a
1-day delay in treatment. If the patient’s
condition changes and a different drug
or a different amount of the same drug
is needed, delays could occur and
additional work by the physician’s staff
to work with the vendor to make the
necessary revisions may be necessary.
The commenters requested that CMS try
to incorporate more flexibility into the
drug ordering process.
Response: The CAP drug ordering
process must be considered in the
context of the statutory requirements of
a patient-specific drug ordering process,
the requirement that payment to the
vendor requires verification that the
drug was administered, and the
requirement that the vendor bill the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
Medicare program and the beneficiary
or the beneficiary’s third party
insurance. We have defined delivery
timeframes at § 414.902 in such a way
that the physician should be able to
obtain needed drugs quickly, since the
vendor is required to provide routine
delivery within two business days, and
emergency delivery within one business
day. The vendor may be required to ship
drugs more quickly if the integrity of the
product requires it. If the vendor’s
routine and emergency delivery
processes would not enable the
physician to obtain the drug quickly
enough for a particular patient, the
physician will have the option of
obtaining the drug order under the
emergency replacement process if the
situation complies with the four criteria
governing this process specified in the
statute. There could be some rare
occasions when the physician is unable
to obtain a drug to treat a patient at the
desired time. In that case, the physician
could choose to refer the patient to
another health service provider or
hospital outpatient department for
immediate treatment, or to ask the
patient to return to the office for
treatment on another day. Physicians
may already face this prospect under the
buy and bill methodology currently in
effect. We hope that these situations
will be rare under either the CAP or the
ASP system. Physicians who find that
the CAP requirements and advantages
do not fit the needs of their practice
have the option to continue to obtain
Part B drugs for their practice under the
ASP system rather than electing to
participate in the CAP. Note that we
have made a technical revision to the
proposed definition of designated
carrier and local carrier under § 414.902
to specifically reference ‘‘CAP’’ rather
than ‘‘Part B Competitive Acquisition
Program’’.
Comment: Some commenters asked
for more information on how the
carriers would apply coverage policies
under the CAP, and whether CMS was
planning to change its process for
determining if drugs were covered for
off-label uses. The Practicing Physicians
Advisory Council (PPAC) recommended
that CMS require CAP vendors to
provide drugs for off-label use when
evidence supports such use. In these
cases, PPAC suggested that vendors
could use established CMS processes for
determining medical necessity.
Response: Determinations of medical
necessity are made by the Medicare
carriers and are not made by suppliers,
such as the approved CAP vendor. As
we stated in the proposed rule, the local
carrier will be responsible for
adjudicating the physician’s claim for
PO 00000
Frm 00018
Fmt 4701
Sfmt 4700
drug administration and checking that
the claim is compliant with all local
coverage determinations (LCDs). If the
local carrier determines that the claim is
not compliant with an LCD, the local
carrier will deny the physician’s claims
for administering the drug and send a
message to the CMS central claims
processing system that the drug
vendor’s claim for the drug is also not
payable. The local carrier will enforce
its LCDs because they govern the rules
in effect where the drug was
administered. The designated carrier’s
LCDs would not play a role in
determining whether the vendor’s claim
was payable except in its carrier
jurisdiction if it is acting as a local
carrier in that jurisdiction. It is not our
intention to change our policy on the
carrier’s authority to make decisions
about whether a particular medication
will be covered. Under the CAP, the
local carrier will continue to exercise
the same process it currently uses for
determining if a drug is payable. Similar
to the scenario we have outlined for
enforcement of the local carrier’s LCDs,
we anticipate that the local carrier will
review a drug prescribed and make a
decision about whether the physician’s
claim for administering the drug and the
vendor’s claim for the drug is payable
under those circumstances. The local
carrier will notify our central claims
processing system about its decision,
and the vendor’s claim will be paid or
denied accordingly. If payment for the
drug administration claim is denied, the
physician will have a responsibility to
appeal the denial. As noted in section
II.B.3 of this interim final rule, the
vendor also may appeal the denial of the
drug claim. The vendor also can ask the
designated carrier for assistance under
the dispute resolution process in
making sure the physician’s appeal was
filed properly or in determining other
steps that the vendor can take to resolve
the situation. (For a more detailed
discussion of this, see the section on
dispute resolution at the end of this
section.)
Comment: Some commenters
requested guidance about how the
Comprehensive Error Rate Testing
Program (CERT) and the Recovery Audit
Contractor Demonstration would apply
to the CAP.
Response: We anticipate that the
CERT Program will apply to the CAP
claims, but the process for doing so has
not been determined at this point. The
Recovery Audit Contractor (RAC)
Demonstration will not apply to the
CAP, because there is an explicit
exemption in the demonstration for
claims that are adjudicated under
special processing rules. Claims
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
processed for drugs provided under the
CAP receive special treatment relative to
the balance of Part B claims.
Comment: A commenter suggested
that the final rule address the steps
necessary for a non-CAP physician to
refer a patient for treatment to a
participating CAP physician.
Response: If a non-participating CAP
physician refers a patient to a
participating CAP physician, the
participating CAP physician will treat
the beneficiary as he or she would any
other patient, because the decision to
participate in the CAP is made at the
physician level rather than on a
beneficiary-by-beneficiary basis. The
participating CAP physician would
need to provide the same education
about the CAP to the beneficiary
referred by the non-participating CAP
physician as he or she did for his or her
regular patients. If the participating CAP
physician needs to provide a drug to the
referred patient and the drug is a CAP
drug, the drug may be obtained from the
approved CAP vendor. If it is medically
necessary that the patient receive a
specific formulation of a drug not
available from the approved CAP
vendor, the physician may obtain the
drug under the ‘‘Furnish As Written’’
provision. Finally, if the drug the
patient needs is not one that is included
in the CAP category the physician
would buy the drug and bill for it under
the normal ASP system.
Comment: Several commenters
requested guidance about whether the
vendor would be able to refuse to ship
an order if the vendor believed it was
inconsistent with an LCD or if the
designated carrier had denied payment
for the drug previously for some other
reason. Some commenters stated that
the vendor should be prevented from
substituting its decision making for that
of the physician by refusing to ship an
ordered drug or changing the dose of a
particular drug.
Response: If the vendor believes a
drug order is not consistent with an
LCD, the vendor may call the physician
to discuss the order and try to determine
why the physician believes it will be
covered under the local carrier’s LCD. If
the physician declines to change the
order, but the vendor still believes the
local carrier will not cover the drug, the
vendor may ask the beneficiary to sign
an Advanced Beneficiary Notice (ABN).
Because approved CAP vendors will be
Medicare suppliers, they will have the
same right to issue ABNs that any other
Medicare supplier has. A signed ABN
would make the beneficiary liable to
pay for the drug if the carrier denied the
claim. However, in the event the vendor
is not successful in collecting an ABN
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
from the beneficiary, and the physician
refuses to change the order, the vendor
will still be required to provide the drug
to the physician under its contract with
us. If the claim for the drug
administration is denied, the physician
would be required to pursue an appeal
of the denial with the local carrier. The
vendor also may appeal the denial of the
drug claim. If the claim ultimately
remains unpaid, the vendor may ask the
designated carrier for assistance under
the dispute resolution process. (This
process is described in more detail in
the section on dispute resolution
(section II.B.3 of this interim final rule).)
We are requiring the vendor to deliver
the drug to ensure that the physician’s
judgment about the appropriate
treatment for the beneficiary is primary
in the decision-making process. In
addition, the local carrier’s coverage
determination (rather than the
designated carrier’s) must apply in the
local carrier’s jurisdiction so that the
same coverage policies are in force in an
area regardless of whether a drug is paid
for under the CAP or under the ASP
system. The only exception to this
policy is that if the beneficiary does not
pay his or her cost sharing in certain
circumstances, the vendor may refuse to
ship additional drugs to the
participating CAP physician for that
beneficiary. For more information on
this process, please see the discussion of
beneficiary cost sharing later in this
section.
Comment: One commenter requested
that CMS clarify whether the local
carrier may also apply its least costly
alternative policy to the claim submitted
under the CAP, despite the
establishment of pre-determined CAP
reimbursement rates.
Response: Least costly alternative
policies are established by our
contractors. Nothing in this interim final
rule is intended to disrupt the
longstanding ability of contractors to
apply this policy under section
1862(a)(1)(A) of the Act. Section
1862(a)(1)(A) provides that
notwithstanding any other provision in
the Medicare statute (that is, including
section 1847B of the Act), no payment
may be made under Part A or Part B for
any expenses incurred for items and
services that are not reasonable and
necessary. Medicare carriers establish
local coverage determinations (LCDs),
under which coverage for a particular
drug is limited to the coverage level for
its least costly alternative. If there is an
LCD on a particular drug that contains
a least costly alternative provision, and
the drug is included in the CAP, when
the participating CAP physician orders
that drug, the drug claim will be paid
PO 00000
Frm 00019
Fmt 4701
Sfmt 4700
39039
subject to the LCA policy, rather than
the CAP-established price. Both the
physician and the drug vendor should
be aware of any LCDs that are in effect
in a particular jurisdiction. When
ordering drugs we ask that the physician
be mindful of the fact that the vendor’s
claim for drug payment will be
dependent on the local carrier’s
coverage policies, including least costly
alternative policies. As stated above,
under its contract with us, the vendor
would need to ship an ordered drug if
the vendor believes it will receive a
reduced payment because of a carrier
payment policy. The vendor may call
the physician to discuss the order, but
if the physician confirms the order, the
vendor must ship it. (The vendor would
have the same right to collect an ABN
from the beneficiary in this situation, as
described elsewhere in this section. In
addition, the vendor could appeal the
drug claim denial. Further, the vendor
may ask the designated carrier for
assistance under the dispute resolution
process.)
Comment: Some commenters support
our proposal that the CAP order may be
initiated via a Health Insurance
Portability and Accountability Act
(HIPAA) compliant phone call or fax
with a follow-up written order. The
vendor could begin filling the order but
wait to finalize shipment until the
written order is received. These
commenters believe that this process
would provide drugs to patients more
quickly than if the vendor is required to
wait until it has a written order in hand
before it begins preparing the order.
Additionally, one commenter asked that
we clarify that electronic transmission
of the drug order between the physician
and vendor would be permitted.
Response: We appreciate that
commenters supported our proposal.
Both the participating CAP physician
and the approved CAP vendor will be
enrolled Medicare suppliers. As noted
elsewhere, the approved CAP vendor
will be a covered entity for purposes of
the HIPAA rules. If a participating CAP
physician meets the criteria under the
HIPAA rules, he or she may also be a
covered entity. Covered entities must
comply with HIPAA privacy and
security requirements. Where
transmission of protected health
information via electronic means would
be permitted under the HIPAA privacy
and security rules, covered entities may
do so. The CAP statute and these
implementing regulations are not
intended to affect the manner in which
HIPAA-compliant communications may
occur.
Comment: One commenter requested
clarification as to how, if at all,
E:\FR\FM\06JYR2.SGM
06JYR2
39040
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
physicians will be required to
incorporate e-prescribing technologies if
ordering drugs currently under the Part
B program or acquiring drugs through
the CAP.
Response: The MMA electronic
prescription program provisions apply
to the electronic prescription of
Medicare Part D drugs for Part D
enrolled individuals, not specifically
Part B drugs. The MMA provides that
not later than one year after the
promulgation of final standards for
Medicare Part D drugs for Part D
enrolled individuals, prescription and
certain other related information
transmitted electronically can only be
transmitted according to the adopted
final standards. The Medicare
Prescription Drug Benefit final rule (70
FR 4198, January 28, 2005) states that
Part D sponsors that participate in the
Part D program are required to support
and comply with adopted electronic
prescription standards. Physicians
would not be required to write
prescriptions electronically and
therefore their participation in Part D
electronic prescription drug programs
would be voluntary. Those physicians
that decide to prescribe Part D drugs
electronically, however, would be
required to comply with the adopted
final standards. We proposed a
foundation set of final standards in
February 2005 (70 FR 6256, February 4,
2005) and hope to finalize those
standards and require compliance by
January 2006, when the Medicare Part D
prescription drug benefit begins. We
will also monitor the program as it
develops to determine if some aspects of
it could be adapted for use in the CAP
drug ordering process.
Content of the CAP Drug Order
We proposed that the physician
would transmit the following specific
information to the CAP drug vendor
from whom he or she has elected to
receive drugs. (Abbreviated information
could be sent for repeat patients.)
• Date of order
• Beneficiary name
• Physician identifying information:
Name, practice location, group practice
information (if applicable), PIN and
UPIN, Drug name
• Strength
• Quantity ordered
• Dose
• Frequency/instructions
• Anticipated date of administration
• Beneficiary Medicare information/
Health insurance (HIC) number
• Supplementary Insurance
information (if applicable)
• Medicaid information (if
applicable)
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
• Shipping address
• Additional Patient Information:
date of birth, allergies, Height/Weight/
ICD–9.
We specifically requested comments on
this proposed information as well as any
additional information that might be
necessary.
Comment: We received several
comments about the proposed content
of the physician’s order. Some
commenters stated that the proposed
items duplicate those submitted on a
claim for service and do not reflect the
information typically included in a drug
order or prescription. Other commenters
were concerned about compliance with
HIPAA guidelines and requested that
unnecessary patient-specific
information be deleted from the order
form. Commenters also stated that the
detailed list of order information should
be needed only for the initial order for
a new patient. They noted that
subsequent orders could be greatly
abbreviated.
Response: The statute provides that
we must establish a process for the
sharing of applicable deductible and
coinsurance information between the
participating CAP physician and the
approved CAP vendor. The participating
CAP physician is also required to
submit a prescription order to the
approved CAP vendor to order drugs for
an individual patient. The order form
information that we proposed in the
proposed rule contains information
necessary to comply with both of those
requirements. It is not possible to link
beneficiary-specific information from
our claims processing system with the
physician’s order before the drug
vendors compiling the information
necessary to prepare the drug order and
return it to the physician because it is
not possible for a provider to query the
system and obtain beneficiary billing
information. Allowing suppliers and
providers to obtain beneficiary specific
information from the Medicare claims
processing system could be a violation
of beneficiary privacy rules. In addition,
the statute specifies that this
information will be provided by the
physician. The HIPAA guidelines allow
the sharing of beneficiary-specific
information necessary for treatment
purposes. Without needed information,
the approved CAP vendor will be
prevented from completing the drug
order accurately and providing the drug
to the participating CAP physician so
that the required treatment can be
administered to the patient. We are
specifying in our regulations that the
participating CAP physician will be
required to provide the approved CAP
PO 00000
Frm 00020
Fmt 4701
Sfmt 4700
vendor complete patient information
only for the initial order, or when the
information changes (for example, the
patient develops a new drug allergy).
The approved CAP vendor will specify
which information is necessary on a
follow-up order.
Comment: One commenter stated that
the physician may be uncertain when
the patient will be receiving his or her
treatment, and thus it may not be
possible to determine the anticipated
date of treatment with any accuracy.
This commenter recommended instead
that CMS allow the physician to specify
a range of dates when the treatment may
be administered.
Response: We agree with the
commenter that it may not be feasible
for a physician to establish in advance
an exact date for drug administration.
We will specify that providing the
vendor with a range of dates over a 7day period will be sufficient. We have
selected the 7-day timeframe based on
our understanding that many of the
drugs included in the CAP are used in
a treatment regimen that repeats on a
weekly basis. The 7-day time period is
intended to provide the physician with
flexibility to shift the specific date of
administration of needed drugs within a
specified period without overlapping
the next treatment period. When the
approved CAP vendor submits its claim
for the drug, the vendor will be
instructed to include the first day in the
7-day period as the date of service.
Because the vendor will not know the
actual date the drug is administered
before submitting its claim, the date of
service will not be used to match the
approved CAP vendor’s claim with the
participating CAP physician’s claim.
Instead, as described later in this
section, a unique number will be used
to match the claims.
Comment: Some commenters
recommended that CMS eliminate the
‘‘Additional Patient Information’’ (date
of birth, allergies, height, weight, ICD–
9 codes) specified in the potential list of
data elements. Information related to
height and weight would be used by the
physician to determine the dose, and
the ICD–9 would be included on the
physician’s claim form, so the physician
would not need to provide it. The
commenters stated that this type of
information was not typically included
in a drug order and that the CAP vendor
should not use the information to
perform pharmacy functions.
Response: Based on our decisions
regarding the approved CAP vendor’s
ability to break up shipments in
appropriate circumstances, our
conclusion that approved CAP vendors
may directly appeal the denial of their
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
drug claims, and the fact, with limited
exceptions, that approved CAP vendors
must ship CAP drugs upon receipt of a
prescription order, we believe it is
important for approved CAP vendors to
have the information specified above.
For example, ICD–9 information may
help an approved CAP vendor assess
whether it should seek to obtain an ABN
from the beneficiary. Dosing
information will help an approved CAP
vendor determine whether it can
appropriately split a prescription order
into separate shipments. Patient date of
birth is required by the Medicare claims
processing system and is a required
field on the claim form.
Comment: Another commenter noted
that because the proposed order form
information requested the frequency
with which the drug was to be given,
the physician was being required to
submit a treatment and delivery
schedule that would be difficult to
comply with for some individuals, such
as ‘‘snowbirds’’ who obtain their drugs
from multiple locations.
Response: The expected frequency of
drug administration is needed so that
the approved CAP vendor can
determine how often the drug will be
administered, the amount of drug to
ship at one time and the appropriate
timing of the shipments. Should the
participating CAP physician need to
deviate from the anticipated schedule,
that can be accommodated. However, if
the change in the administration
schedule will require the approved CAP
vendor to ship more drugs, or ship them
on a different schedule, the
participating CAP physician will need
to inform the approved CAP vendor.
Comment: Another commenter
pointed out that a physician may have
several practice locations and that it is
important that a physician’s practice
location be included in the information
that the physician will provide to the
vendor. (Additional elements of this
comment are addressed in the section
below on shipping.)
Response: A physician’s practice
location and his or her shipping address
are both included as required data
elements in the CAP drug order.
Comment: One commenter suggested
that the order form should also include
beneficiary contact information (phone
number, billing address) and credit card
information to enable the vendor to
collect the beneficiary’s coinsurance.
Response: We will add beneficiary’s
address and phone number to the
required list of data elements to enable
the approved CAP vendor to mail the
bill to the beneficiary and to call him or
her should there be an error in mailing
to correct the address. The statute
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
requires that we develop a process for
the sharing of information between the
participating CAP physician and the
approved CAP vendor related to the
payment of deductible and coinsurance.
We have interpreted this to mean
beneficiary contact information,
Medicare information, and third party
insurance information. We will not ask
the physician to collect the beneficiary’s
credit card information and share it
with the vendor because it is not
information necessary to complete the
drug ordering process, nor is it part of
any supplemental insurance coverage
that the beneficiary may have. Should
the beneficiary choose to pay his or her
share of the coinsurance via a credit
card, he or she can provide that
information directly to the approved
CAP vendor after receiving a bill.
Comment: One commenter requested
that CMS begin using the National
Provider Identifier (NPI) as soon as
possible, but not later than May 2007
(the implementation date of the NPI).
Response: We plan to adopt the
National Provider Identifier for use by
the CAP as soon as it is available.
In this interim final rule, we have
made revisions to the required list of
drug order information. We are adding
that ‘‘a range of dates not to exceed 7
days’’ may be noted if the physician is
uncertain of the specific date the drug
will be administered. In addition, we
are adding beneficiary’s address and
phone number; physician’s shipping
address, the National Provider
Identifier, and patient’s gender to the
list. The information on patient’s gender
is required for claim submission and
was inadvertently omitted from the list
in the proposed rule.
The required list of drug order
information will be the following:
• Date of order
• Beneficiary’s name, address, and
phone number
• Physician’s identifying information:
Name, practice location/shipping
address, group practice information (if
applicable), PIN and UPIN (NPI when
available)
• Drug name
• Strength
• Quantity ordered
• Dose
• Frequency/instructions
• Anticipated date of administration
(Range of dates not to exceed 7 days)
• Beneficiary Medicare information/
Health insurance (HIC) number
• Supplementary Insurance info (if
applicable)
• Medicaid info (if applicable)
• Additional Patient Information:
date of birth, allergies, Height/Weight/
ICD–9 code
PO 00000
Frm 00021
Fmt 4701
Sfmt 4700
39041
• Gender
In the March 4, 2005 rule, we
proposed that the participating CAP
physician could place an order for a
beneficiary’s entire course of treatment
at one time, but that the approved CAP
vendor could split the order in to
appropriately spaced shipments. The
approved CAP vendor would create a
separate prescription order number for
each shipment and the physician would
track each prescription order number
separately and place the appropriate
prescription order number(s) on each
drug administration claim. The
physician would have the ability to
modify the course of treatment and
submit a separate prescription order as
necessary.
Comment: Many commenters
supported our proposal that the
physician should be able to place one
order for the entire course of treatment
because it reduces the burden of CAP
ordering on both physicians and
vendors. However, some commenters
supported, while others opposed, our
proposal that the vendor, at its
discretion, could split the order into
different shipments. Those opposed
were concerned that some shipments
might not arrive timely and needed
treatment could be delayed to the
beneficiary. Another commenter stated
that the vendor should not be allowed
to ship more than one visit’s drugs at
one time, because many physicians’
practices will not have the space to store
additional inventory.
Response: We plan to implement our
proposal and allow the approved CAP
vendor to split shipments. We believe
the commenters’ concerns regarding
potential delays in split orders are
adequately addressed by the routine and
emergency delivery timeframes
discussed elsewhere in this interim final
rule because the approved CAP vendor
will still be required to deliver the
initial dose of the drug within two
business days for routine delivery or
one business day for emergency
delivery. Delivery timeframes are
discussed in more detail later in this
section. We will require that if the
approved CAP vendor opts to split
shipments, the approved CAP vendor
must notify the physician in writing that
it is a split shipment and of the
schedule for delivering subsequent
shipments. We will also require that
incremental shipments must arrive at
least two business days before they are
expected to be administered to a patient
(as noted on the prescription order). The
two-business-day time period is
consistent with the routine delivery
timeframe, and should ensure that the
physician has sufficient time to obtain
E:\FR\FM\06JYR2.SGM
06JYR2
39042
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
the drugs under the emergency delivery
timeframe in the event that they are not
delivered within the routine delivery
timeframe. In response to the
commenters who were concerned that
physicians may not have the space to
store an entire course of treatment and
wanted drugs shipped incrementally,
we will allow the physician to specify
to the approved CAP vendor whether or
not he or she can accommodate larger
shipments based on a prescription order
for a course of treatment, if the
approved CAP vendor desires to do so.
The participating CAP physician could
also control the amount of drugs that
were shipped by ordering smaller
quantities of drugs at one time.
Comment: Another commenter
requested clarification of whether one
prescription order number will be
assigned for each patient or whether
multiple prescription order numbers
will be assigned (that is, one for each
drug). These commenters proposed that
each drug should have a separate
prescription order number, which
would include a unique patient
identification number. This number
should be attached to the drug to
decrease the possibility of patient
billing errors.
Response: We will require that each
dose of a drug must have a separate
prescription order number in order to
facilitate claim matching and approved
CAP vendor payment. The prescription
order number will be unique to a dose
of a drug to be administered to a
particular beneficiary in one setting. It
will include an approved CAP vendor
specific identification number, the
HCPCS code for the drug, and a
randomly generated number. The
beneficiary information will be
provided by the HIC number that will be
entered separately on the claim form.
Because of privacy concerns we are not
making the HIC number part of the
prescription order number.
Drug Vendor’s Prescription Order
Process
In the proposed rule, we specified
that the approved CAP vendor would
receive the prescription order from the
physician, check the physician’s CAP
eligibility from a list provided by the
designated carrier and verify the
beneficiary’s Medicare eligibility with
the designated carrier.
After those checks were completed,
the approved CAP vendor would
generate a prescription order number
that would include the approved CAP
vendor’s assigned identification number
and the drug HCPCS code. The
approved CAP vendor would assemble
the prescription order and prepare it for
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
shipping. The approved CAP vendor
would ship the drug to the participating
CAP physician using a delivery method
specified by its contract with us.
Comment: One commenter requested
additional information on the process
that the vendor will use to verify the
patient’s Medicare eligibility with the
designated carrier.
Response: We anticipate that the
approved CAP vendor will contact the
designated carrier by telephone to verify
that the beneficiary has current Part B
coverage. As well as being able to verify
the beneficiary’s coverage the carrier
may also know whether another insurer
is primary to Medicare.
Comment: One commenter requested
clarification on whether the vendor
would ship and bill drugs at the HCPCS
level or the NDC level. The commenter
believes that bidding, ordering and
claims processing should all occur at
either the NDC level or the HCPCS level.
Response: Drug ordering and claims
processing will occur at the HCPCS
level. Billing will occur at the HCPCS
level, as occurs currently for Part B
drugs. The drugs being furnished by the
vendor will be identified at the NDC
level during the bidding process. We
intend for the approved CAP vendors to
be able to furnish CAP drugs in a
manner that minimizes waste,
reshipping and risk of diversion. Noting
that section 1847B of the Act states that
competition shall occur, for multiple
source drugs, for ‘‘at least one
competitively biddable drug * * *
within each billing and payment code
within each category,’’ we encourage
approved CAP vendors to submit bids in
a manner that will provide them with
flexibility in terms of providing more
than one package size or formulation
within a HCPCS code that contains
multiple NDCs. The approved CAP
vendor will be required to specify the
NDCs that it will be providing for a
particular HCPCS code for multi-source
drugs. This information will be
available to the physician when he or
she chooses to participate in the CAP
and may be used by the physician when
selecting an approved CAP vendor.
Comment: Some commenters
suggested that CMS develop a
contingency plan for use in cases where
the CAP runs into ongoing operational
challenges that significantly delay drug
delivery to oncologists and jeopardizes
timely treatment of cancer patients.
Under these procedures, commenters
recommended that CMS consider
permitting physicians to temporarily
revert to billing under the ASP system.
Response: Should a drug delivery
problem develop with one of our
approved CAP vendors, we will work
PO 00000
Frm 00022
Fmt 4701
Sfmt 4700
with the approved CAP vendor through
the designated carrier’s dispute
resolution process to promptly restore
dependable service. If, despite all of our
efforts to resolve the problem, we were
to make a decision to terminate an
approved CAP vendor for failure to
comply with its contractual obligations,
we would allow the affected physicians
to switch to another approved CAP
vendor who could assume the workload.
Those physicians would also be given
the option to revert to billing under the
ASP system for the remainder of the
year. In addition in situations where the
emergency restocking criteria apply, the
physician could use his or her own
inventory and get a replacement from
the vendor.
Submitting Prescription Order Number
Once a shipment is received from the
approved CAP vendor, the participating
CAP physician would store the drug
until the date of drug administration.
When the drug is administered to the
beneficiary, the physician or his or her
staff will place the prescription order
number for each drug administered on
the claim form submitted to the regular
Part B carrier. Similarly, when the
approved CAP vendor bills Medicare for
the drug it shipped to the physician, it
will place the relevant prescription
order number on the claim form
submitted to the designated carrier. We
note that the electronic version of the
Medicare carrier claim form has space
for a series of prescription numbers,
which we have not used previously for
Part B drugs.
In the proposed rule, we stated that
vendors and physicians who elect to
participate in the CAP will need to be
capable of submitting these prescription
order numbers to us in their claims
processing systems. If physicians and
potential vendors are not already billing
other payors using prescription
numbers, they will need to work with
their internal information systems staff
or practice management software
vendors to make the necessary changes
to submit these data elements to
Medicare in a manner consistent with
HIPAA transaction guidelines for
capturing prescription numbers.
Comment: One commenter indicated
that to accommodate the new data
element, his claims processing software
would need to be modified. Another
commenter requested that CMS issue
billing instructions that instruct
physicians regarding the appropriate
HIPAA compliant fields on the 837 and
CMS 1500 forms to use in submitting
the prescription order number on their
claims.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Response: As stated in the proposed
rule, we are aware that our proposed
claims processing system will require
some physicians to modify their claims
processing software if they do not
already have the capability to submit
claims with prescription numbers. After
publication of the interim final rule, we
will issue billing instructions with
guidance about the appropriate fields on
our electronic and paper claim form to
use in billing.
Claims Processing Methodology
Our claims processing methodology
will use the prescription order number
to match the two claims and authorize
payment to the approved CAP vendor.
Payment to the approved CAP vendor
will be dependent upon the filing of the
drug administration claim by the
physician, and the physician’s claim
being approved for payment by our
claims processing system.
Comment: Some commenters stated
that requiring the physician to put the
prescription number on the claim form
will complicate the billing process for
the physician. In addition, one
commenter believes that a separate
billing process will be required for
drugs billed under the emergency
replacement process (discussed below),
and that the physician will also require
another process for drugs billed under
the ‘‘furnish as written’’ methodology
(discussed below). They suggested that
in order to reduce physicians’ cost, CMS
should simplify the process so that one
billing system could be used for all CAP
drugs.
Response: We are aware that adding
the prescription order number to the
claim form will be an additional activity
required for physicians who elect to
participate in the CAP. Under the CAP
program as we are implementing it, the
use of the prescription order number is
necessary to allow our claims
processing system to match the
physician’s claim for administering the
drug with the approved CAP vendor’s
claim for the drug. The physician’s
process for billing a drug administration
claim for a CAP drug acquired through
the regular ordering process and one
acquired through the emergency
replacement process will be essentially
the same, except that the physician will
add an additional modifier to the claim
form indicating that the drug was
acquired under the emergency
replacement provision. The modifier is
necessary to enable the carrier to
identify the replacement claims. For
drugs that the participating CAP
physician acquires under the ‘‘furnish
as written’’ process, the physician will
bill for the drug and the administration
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
under the ASP system that he or she
currently uses. In these situations, the
physician will place a modifier on his
claim form that will allow him to bill for
both the drug and the administration in
that circumstance.
‘‘Furnish As Written’’
We proposed to allow the physician
to obtain a drug under the ASP system
in ‘‘furnish as written’’ cases when
medical necessity requires that a
specific formulation of a drug be
furnished to the patient and that
formulation is not provided by the
approved CAP vendor. This situation
closely parallels dispense as written
(DAW) prescription orders that are used
in retail pharmacies or other locations
where a prescription is written and the
physician wants the pharmacist to fill
the prescription with a particular brand
of the drug. In cases when the approved
CAP vendor does not furnish a specific
formulation of a drug or a product
defined by the product’s NDC number,
and the physician has determined that
it is medically necessary to use another
brand of product within the HCPCS or
an NDC that is not being furnished by
the approved CAP vendor, the physician
could purchase the product for the
beneficiary and bill Medicare for it
using the ASP system. The physician
would be instructed to place a ‘‘furnish
as written’’ modifier on his or her claim
form and bill his or her Medicare carrier
for the drug and the administration fee.
The modifier would alert the carrier to
allow the physician to bill under the
ASP system in this case. We proposed
that the physician’s carrier would, at
times, conduct a post payment review of
the use of the ‘‘furnish as written’’
modifier. If the carrier determined that
the physician had not complied with
‘‘furnish as written’’ requirements and
that a specific NDC or brand name drug
was not medically necessary, the carrier
could deny the claim for the drug and
the administration fee.
We established this method of
alternative payment for a competitively
biddable drug under proposed
§ 414.906(c)(2)(ii) of our regulations.
Comment: Commenters were
generally in favor of the ‘‘furnish as
written’’ proposal. However, some
commenters who support the ‘‘furnish
as written’’ provision felt it should be
simplified and made easier for
physicians to use or that CMS should
create other options for the physician to
accommodate clinical differences
among patients who are on the same
treatment regimen. Other commenters
were concerned that the ‘‘furnish as
written’’ option might be overused and
subject to gaming by some physicians
PO 00000
Frm 00023
Fmt 4701
Sfmt 4700
39043
and manufacturers who were seeking a
way to opt out of the CAP when it was
financially favorable.
Response: We are implementing the
‘‘furnish as written’’ option as described
in the proposed rule. The ‘‘furnish as
written’’ option is intended to be used
only occasionally in limited
circumstances where a patient’s medical
condition requires a particular
formulation of a drug at the NDC level—
it is not intended to be used in routine
situations as a means to circumvent the
normal CAP ordering process. An
example of a situation when the
‘‘furnish as written’’ option would be
appropriate is where a participating
CAP physician is treating a patient with
a documented allergy to certain
excipients or preservatives who requires
a specific formulation of a product that
the approved CAP vendor does not
furnish as a part of its CAP contract. In
this case, documentation of the allergy
is a justification to use another product.
However, this documentation must be
maintained in the patient’s medical
record. Use of the ‘‘furnish as written’’
modifier will permit the physician to
bill under the ASP system in this
limited circumstance even though the
physician has elected to participate in
the CAP. Physicians who believe the
‘‘furnish as written’’ provision and the
emergency replacement provision along
with the drugs available through the
regular CAP drug ordering process will
not meet their patients’ clinical needs
may choose to continue billing under
the ASP system rather than electing to
participate in the CAP.
Comment: One commenter requested
that CMS provide more guidance on
what is meant by the term ‘‘specific
formulation.’’
Response: A patient known not to
respond appropriately to a certain
formulation of a product may require a
specific formulation of a product that is
still within the same HCPCS, but not
furnished under the approved CAP
vendor’s CAP contract because the
approved CAP vendor submitted a bid
to provide a different NDC within the
HCPCS code. Documentation of
treatment failure or adverse effects from
specific formulations may provide
justification to use another product (for
example, if an approved CAP vendor
was contracted to provide HCPCS code,
J9260, which represents the drug
Methotrexate Sodium). Several different
manufacturers produce this drug, and it
may be formulated with or without a
preservative. Each product within
HCPCS code J9260 has a specific NDC
number. If the physician determines
that it is medically necessary to
administer the preservative-free
E:\FR\FM\06JYR2.SGM
06JYR2
39044
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
methotrexate injection for the patient,
but the approved CAP vendor did not
offer that product’s NDC, the physician
would be able to purchase the specific
drug for the patient and bill for it under
the ASP system by using the ‘‘furnish as
written’’ modifier.
Comment: Another commenter asked
whether the vendor might be able to
discontinue providing a drug mid-year
if it discovered that the CMS CAP
payment amount was not covering its
costs. Other commenters asked what
would happen if a CAP vendor had
trouble obtaining a CAP drug or it
became unavailable.
Response: Once a vendor elects to
participate in the CAP and decides for
a multi-source drug which formulation
of the drug (NDC) to provide within a
HCPCS code, the approved CAP vendor
will not be able to switch NDCs midyear should the price increase.
However, as discussed in further detail
in section C.3 below, the statute
provides for adjustments to the
reimbursement for CAP drugs in certain
circumstances in response to changes in
the approved CAP vendor’s reasonable
net acquisition costs.
Mid-year changes will only be
allowed should an NDC become
unavailable or go through a period of
short supply. We expect that the need
for substitutions or changes will occur
rarely. Although we would like to
incorporate flexibility into this process
so that an approved CAP vendor may
react quickly to substitute an
appropriate product, we are concerned
that an unrestricted substitution process
could have negative consequences.
Although many multi-source products
can be considered therapeutically
equivalent, in some situations,
differences in packaging, preservatives,
fillers and dissolution rates for powders
that require reconstitution may have
clinical impact on the beneficiary and
work flow impact on those who are
preparing and administering the drug. If
a vendor is facing a situation where a
certain CAP NDC cannot be supplied,
but a comparable product can be sent
and the approved CAP vendor is willing
to accept payment for that product at
the CAP rate, the approved CAP vendor
must contact the physician’s office in
order to have the office approve the
substitution. This procedure is intended
to be used occasionally and is not
intended to justify a situation where an
approved CAP vendor repeatedly calls a
physician to seek approval for a less
costly item. If the physician and the
approved CAP vendor are unable to
resolve short term issues around drug
availability and substitution on their
own, they may ask the designated
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
carrier’s dispute resolution staff for
assistance.
In a situation where an item becomes
unavailable for an extended period of
time (more than 2 weeks), the approved
CAP vendor must identify a
replacement product or products, obtain
CMS approval to do a long-term
substitution from the designated
carrier’s medical director, and notify all
physicians who have elected to receive
CAP drugs from that approved CAP
vendor in writing of the change.
Payment for the substituted drug will be
at the CAP bid price; the vendor may
seek price adjustment at the following
annual price adjustment period.
Physicians who have elected to
participate with that approved CAP
vendor will be notified before such a
change is made.
We request comments on refinement
and alternatives to the short and long
term substitution processes.
Comment: Other commenters stated
that a physician who uses the ‘‘furnish
as written’’ methodology to obtain
needed drugs for his or her patients may
be charged more by a non-CAP
wholesaler because its volume has
declined because of the physician’s
participation in the CAP. They propose
instead that the physician be
reimbursed for his or her actual
acquisition costs of the drug instead of
paying them under the ASP system.
Response: We do not have the
statutory authority to allow physicians
to be paid their actual acquisition costs
for Part B drugs in this situation.
Physicians have the choice of obtaining
drugs under the ASP system or of
obtaining them from the approved CAP
vendor. The occasional need to
purchase drugs outside of the CAP and
which approved CAP vendor to select
will need to be factored into the
physician’s decision to participate in
the program. If an approved CAP vendor
provides many of the drugs at the NDC
level that a physician routinely uses, the
physician should need to rely on the
‘‘furnish as written’’ provision rarely.
Comment: Some commenters
questioned why the carrier would be
conducting a retroactive review of the
physician’s use of the ‘‘furnish as
written’’ option, because that would
permit the physician to buy and bill the
drugs under the ASP system. The
commenters asserted that because
physicians’ ASP claims are not
routinely reviewed by the carrier,
physicians’ use of this provision in the
CAP should not be either. Another
commenter stated that if the physician’s
use of the ‘‘furnish as written’’ modifier
was denied on the basis of post payment
review, this could trigger an obligation
PO 00000
Frm 00024
Fmt 4701
Sfmt 4700
to appeal on the part of the physician.
Some commenters stated that although
physicians are accustomed to
supporting medical necessity of their
orders, historically this has not involved
a comparison of clinical appropriateness
of one drug within a HCPCS code with
that of another.
Response: The statute is clear that for
multiple source drugs, the approved
CAP vendors are required to supply at
least one drug NDC in each HCPCS
code. It is also clear that physicians
must elect the CAP for an entire drug
category. As such, we believe it is
appropriate to ensure physicians
employ a ‘‘furnish as written’’
instruction only when medically
necessary. As a result, it is important
that physicians document the necessity
of a particular formulation of a drug in
the medical record. If the physician’s
use of the ‘‘furnish as written’’ option is
denied by the local carrier, it will be up
to the physician as to whether to appeal
because payment to the approved CAP
vendor will not be affected.
Comment: Some commenters from
physicians’ groups and some
commenters from potential vendors
have expressed an interest in the
vendor’s providing the needed drug in
a ‘‘furnish as written’’ situation. Many
of the physician commenters suggested
that the vendor should be required to
provide different formulations of a drug
other than the one bid, while some
potential vendors have suggested that
they be given the option to provide it.
Response: As indicated above, we are
implementing the ‘‘furnish as written’’
provision described in the proposed
rule, but we have moved it as an
element to § 414.908(a)(3) as this
placement is more appropriate. The
CAP statute and section 1861(s)(2)(A) of
the Act, as amended by Section 303(i)
of the MMA, contemplate that approved
CAP vendors can submit claims and be
paid for drugs only when they are
provided through the CAP. Thus, we do
not believe the commenter’s proposal to
allow the approved CAP vendor to
provide the drug under the CAP in
‘‘furnish as written’’ situations is
feasible.
Timeframes for Routine and Emergency
Shipment
Section 1847B (b)(2)(A)(i)(II) of the
Act requires that approved CAP vendors
have sufficient capacity to acquire and
deliver drugs in a timely manner within
the geographic area, to deliver drugs in
emergency situations, and to ship drugs
at least 5 days each week. However, the
statute does not provide specific
definitions of these timeframes. In
addition, as noted previously, the
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
statute requires that the approved CAP
vendor may not provide drugs to a
participating CAP physician unless the
physician submits a written prescription
order to the approved CAP vendor.
We proposed that a CAP prescription
order could be initiated by telephone
and followed up with a written order.
We proposed that the delivery time
period would begin when a drug order
was received by the approved CAP
vendor and would end at the time of
delivery to the physician’s office or
other intended setting. We proposed
that routine shipments of drugs
furnished under the CAP would occur
within a one- to two-business-day time
period and that the duration of the
delivery time period must not exceed
the drug’s stability in appropriate
shipping containers and packaging.
Emergency drug orders would need to
be furnished on the next day for orders
received by the approved CAP vendor
before 3 p.m. (approved CAP vendor’s
local time). We requested comment on
how to define timely delivery for
routine and emergency drug shipments
and on the feasibility of requiring a
shorter duration for routine delivery of
CAP drugs and of providing same-day
deliveries for orders received for
emergency situations.
Comment: Comments on the
definition of an appropriate timeframe
for deliveries defined a relatively
narrow potential timeframe. The
shortest recommended timeframes were
daily, or up to twice daily deliveries for
emergencies, while the longest
timeframes were three to five business
days. Most comments suggested a oneor two-business-day timeframe for
delivery in routine cases and overnight
delivery for emergencies. The relatively
short turn around time assumed a
‘‘clean’’ order—one without patient
safety, logistical, or payment problems.
One comment suggested categoryspecific timeframes.
Response: At the program’s start, we
plan to implement a two-business-day
timeframe for routine deliveries and a
one business day timeframe for
emergency deliveries, except for
deliveries to certain U.S. territories in
the Pacific, as discussed below.
However, these timeframes shall not
exceed the drug’s stability in
appropriate shipping and packaging as
defined by manufacturer’s labeling, drug
compendia, or specialized drug stability
references used in the practice of
pharmacy or drug distribution. If drug
stability necessitates a shorter shipping
timeframe, or specialized shipping
conditions, the approved CAP vendor
must comply with them. For example,
some drugs may require insulated
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
packaging and/or cold-packs to prevent
exposure to temperature extremes
during shipping. Furthermore, we are
aware that some drug products are
shipped by express carriers in such
conditions and are marked
‘‘perishable.’’
The delivery timeframe begins when
a complete CAP prescription order is
transmitted from the participating CAP
physician to the approved CAP vendor.
The participating CAP physician may
begin this process with a phone call to
the approved CAP vendor, but must
follow-up with a written prescription
order within 8 hours for routine
deliveries. For emergency deliveries, a
telephone order must be immediately
followed with a written prescription
order. If the participating CAP physician
does not meet these deadlines for
sending the written prescription order,
the emergency or routine delivery
timeframes are delayed accordingly
until the written prescription order is
received. The delivery timeframe ends
when the drug is received at the
participating CAP physician’s office. A
written prescription order may be
transmitted by FAX, e-mail, or mail,
subject to applicable HIPAA privacy
and security requirements, and any
applicable State pharmacy laws. As
specified earlier, all communication
between the physician and the approved
CAP vendor must be conducted in
accordance with applicable HIPAA
privacy and security requirements, and
with any applicable State pharmacy
laws.
The approved CAP vendor is
responsible for complying with the
timeframes for routine and emergency
delivery, as well as with the
requirements for appropriate shipping
conditions for drugs. If the participating
CAP physician is dissatisfied with the
vendor’s compliance with the shipping
timeframes or the manner in which
drugs are being shipped, the physician
should address the issue by means of
the vendor’s grievance procedure. If the
two parties are unable to resolve the
situation to their satisfaction they may
ask the designated carrier’s dispute
resolution staff for assistance.
We believe that the two-business-day
period for most routine prescription
orders will provide an opportunity to
resolve many common problems that
can occur with transmitted drug orders,
like legibility or poor transmission
quality, simple clarification, etc. The
two-business-day timeframe also
provides a greater window of
opportunity for approved CAP vendors
and participating CAP physicians who
are in different time zones to interact.
The intent of the two-business-day
PO 00000
Frm 00025
Fmt 4701
Sfmt 4700
39045
timeframe is to balance the cost of
shipping with potentially changing
clinical requirements of a patient
population and the requirement that
needed drugs must be available
promptly to the physician. The intent of
the one-business-day timeframe for
emergency deliveries is to accommodate
the physician’s need for more rapid
delivery of drugs in certain clinical
situations where the patient’s rapidly
changing condition requires it with the
vendor’s ability to ship the drug and
have it delivered promptly in a
nationwide delivery area. The
emergency delivery option is not
intended to be used routinely. It should
be reserved for those situations when
the patient’s need for the drug could not
have been accommodated under the
routine delivery timeframe. At a
minimum, under both the routine and
emergency delivery timeframes, we
expect vendors to accept new
prescription orders until at least 5 p.m.
(vendor’s local time) on business days
and we expect physicians to be able to
take receipt of deliveries on business
days until at least 5 p.m. (physician’s
local time). For emergency deliveries,
we expect that the vendor will make the
necessary adjustments in order to be
able to prepare the drug for shipping
and to deliver it the next business day.
We note that the physician and the
vendor will each need to be mindful of
the time zones within which each are
located. CAP participating physicians
and approved CAP vendors operating in
different time zones will need to be
aware of cut-off times for placing orders
and coordinate appropriately. We also
point out that in some cases, twobusiness-day shipping may actually
require several calendar days of transit
during weekends and the commonly
observed Federal holidays of New
Years, Memorial Day, Independence
Day, Labor Day, Thanksgiving, and
Christmas. Some degree of coordination
between the vendor and the physician’s
office will be required in those
situations, and we stress that the drugs
shipped must be packaged in a manner
to preserve product integrity during
shipping, for example to withstand
temperature changes during shipping.
Specific examples appear below.
Example 1: The two-business-day
timeframe for routine deliveries means that
the physician’s office may expect to receive
a CAP prescription order on the second
business day after it was placed. Therefore,
an order received in the approved CAP
vendor’s office on a Monday by 5 p.m.
(Vendor’s local time) would arrive in the
physician’s office no later than Wednesday at
5 p.m. (physician’s local time). Orders placed
on Friday would arrive no later than
E:\FR\FM\06JYR2.SGM
06JYR2
39046
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Tuesday. (Note: These orders must comply
with the process specified above if the initial
prescription order is placed by phone, the
follow-up written prescription order must be
received within 8 hours for routine
deliveries.
Example 2: The one-business-day
timeframe for emergency deliveries means
that an order received in writing in the
approved CAP vendor’s office at 1 p.m.
(approved CAP vendor’s local time) on a
Wednesday must be received by the
physician in his or her office by 5 p.m.
Thursday (physician’s local time).
These are minimum standards, and
nothing precludes the approved CAP
vendor from using faster services and
alternative delivery times (for example,
Saturday delivery) when these services
are available and appropriate. If an
approved CAP vendor routinely offers
faster shipping services, the approved
CAP vendor should inform the
physician of their availability.
We believe that the timeframes
defined above, are practical and apply
to the vast majority of situations that
will be experienced at the program’s
implementation. However we anticipate
that there will be occasional situations
where a CAP vendor will not be able to
furnish a drug to an office because the
drug is needed sooner than the available
delivery timeframes allow. In these
situations, the vendor may elect to use
the emergency resupply procedures
described later in this section, if the
situation complies with the relevant
criteria.
The CAP was not designed to supply
drugs that would be needed in
emergencies such as acute care settings.
However, we believe that even with a
national program, an approved CAP
vendor with multiple distribution
points can provide turnaround in less
than one to two business days in many
situations.
Our discussions above reflect our
anticipation that most shipments will
occur within the continental United
States. However, the initial CAP
competitive acquisition area also
includes Alaska, Hawaii, and the United
States Territories. (We note that the
United States territories in which
Medicare pays for services are defined
in § 400.200 of our regulations as the
Commonwealth of Puerto Rico, the U.S.
Virgin Islands, Guam, American Samoa,
and the Northern Mariana Islands.) We
believe that shipping to Alaska, Hawaii
and the eastern territories (that is,
Puerto Rico and the U.S. Virgin Islands)
within the timeframes described above
is feasible, and we will require the
vendor to ship to those areas within the
standard routine and emergency
timeframes. However, we are concerned
that based on available information on
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
shipping costs and delivery time
periods, these timeframes may be too
narrow for territories in the Pacific (that
is, Guam, American Samoa, and the
Northern Mariana Islands). Although
the CAP drug vendor may be able to
meet these timeframes in certain cases,
the financial cost of doing so could
greatly exceed the vendor’s regular
delivery costs. Therefore we are setting
the standard delivery timeframes for the
Pacific Territories, (Guam, American
Samoa, and the Northern Mariana
Islands) based upon delivery
information available from commercial
shippers, to be seven business days for
routine delivery, and five business days
for emergency delivery.
As we gain operational experience
with CAP, we would like to explore
being able to provide more rapid order
turnaround, particularly in urgent
situations. We are requesting comments
on shortening the routine shipping
timeframe to one business day and for
requiring shorter shipping timeframes
for emergency orders, especially the
logistical and cost factors involved for
same day or overnight delivery with
early morning drop off. We are
specifically interested in examples of
circumstances when it would apply,
who would be responsible for the cost
of more rapid shipping methods, how
unnecessary express shipping could be
avoided, how approved CAP vendors
who frequently missed timely delivery
deadlines for same-day shipments
would be sanctioned, and how those
who abuse express shipments by
seeking express delivery unnecessarily
would be sanctioned. We ask that
commenters address whether same day
shipping can provide any real benefit to
beneficiaries, or if overnight delivery
with early morning drop-off is
sufficient. We also welcome comment
on the practicality of the timeframes set
above for the Pacific territories and
other areas outside of the continental
United States. We seek input on
whether the timeframes in general
should be adjusted and whether the
timeframe for delivery to the Pacific
territories are reflective of current
delivery timeframes used by other drug
distributors shipping to those locations.
Comment: Some commenters stated
that the CAP requirements should
specify that the physician could return
without penalty any drug that arrived in
damaged condition or whose integrity
the physician believes may have been
compromised. The commenters
requested that the approved CAP vendor
not be allowed to require the physician
to seek a remedy from the company that
delivered the product.
PO 00000
Frm 00026
Fmt 4701
Sfmt 4700
Response: At the time a shipment of
CAP drugs is received at the
participating CAP physician’s office, we
expect that the individual who takes
receipt of the order will be responsible
for inspecting the external condition of
the package(s) and will be given an
opportunity not to accept the shipment
on the basis of potential compromise of
the product’s integrity or damage during
shipping. This initial inspection is not
meant to be a final inspection, and we
realize that some types of damage or
compromise in integrity may only
become apparent after the package is
opened and the drug is being readied for
use. A physician may return a drug
product to the approved CAP vendor at
any time if the product’s integrity is in
question. We recommend that returns of
product on the basis of product integrity
be coordinated with the approved CAP
vendor so that the approved CAP
vendor may take appropriate action to
follow up on the reason for the breach
of integrity. (Delivery requirements are
also addressed in section II.C.2 of this
interim final rule, ‘‘Bidding Entity
Qualifications.’’)
Resupply Option for Emergency
Situations
We proposed to implement the
criteria specified in section 1847B(b)(5)
of the Act that governs when in
emergency situations, drugs acquired
under the CAP could be used to
resupply inventories of drugs
administered by physicians. The four
criteria contained in the Act are: (1) The
drugs were required immediately. (2)
The physician could not have
anticipated the need for the drugs. (3)
The approved CAP vendor could not
have delivered the drugs in a timely
manner. (4) The drugs were
administered in an emergency situation.
In section II.C.2.a. of this interim final
rule, we requested comment on how to
define timeframes for timely delivery,
for emergency delivery, and for
additional criteria we could use to
define the replacement process.
We proposed that in emergency
situations that met the criteria outlined
above, the physician would treat the
Medicare beneficiary with a drug from
his or her own stock. After
administering the drug to the
beneficiary, the physician would
prepare an order, identifying the drug as
an emergency replacement for a drug
already administered to the beneficiary.
This notation could involve the use of
a modifier to a HCPCS code, or another
standardized means of incorporating the
information into a claim. The approved
CAP vendor would prepare the drug
order, assign the unique transaction
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
identification (or prescription) number,
and ship the replacement product to the
physician. When the drug was received
from the approved CAP vendor, the
physician would return the drug to his
stock. Both the physician and the
approved CAP vendor would bill
normally for the drug or its
administration as applicable. We
anticipated that the physician’s carrier
would, at times, conduct a post payment
review of emergency drug replacement
in order to determine whether
physicians were complying with
conditions for emergency drug
replacement.
Comment: Some commenters were
concerned that neither the statute nor
the proposed rule defines ‘‘emergency,’’
and encouraged CMS to provide a
definition in the final rule. They also
questioned whether the definition of
emergency would cover situations when
the approved CAP vendor failed to
deliver a needed drug within specified
timeframes. Some commenters proposed
that CMS define an emergency to allow
any situation the physician felt required
immediate attention would meet the
criteria.
Response: We believe that the
definition of emergency to be used in
the emergency replacement provision
should be one that enables the
physician to use his or her clinical
judgment to determine when his or her
patient needs immediate treatment. We
will define an emergency for purposes
of this provision as a situation
determined by the physician’s clinical
judgment to be an unforeseen situation
and require prompt action or attention.
Should the more expansive definition of
the term appear to be causing overuse of
this provision, we will consider
adopting a more limited interpretation
in the future. We will require that
physicians ordering drugs under this
provision continue to comply with the
14-day prompt filing requirement. The
approved CAP vendor will provide a
replacement drug from the same HCPCS
category that it is providing in the CAP.
In determining whether the patient’s
need for the drug complies with the
emergency replacement criteria, the
physician will assess whether all of the
criteria are applicable and will
document the patient’s medical record
accordingly. If the approved CAP
vendor’s emergency delivery timeframe
would result in delivery of the drug
after the time necessary to meet the
patient’s clinical need, it shall be
considered that the drug could not have
been delivered timely. (Refer to the
previous section on delivery times for
more detail on the definition of routine
and emergency deliveries.)
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
Comment: Another commenter
expressed concern about enforcement,
especially any documentation
requirements for physicians using the
emergency resupply provision.
Response: The process for billing for
drugs ordered under the emergency
resupply provision will be very similar
to the regular CAP billing process, with
an additional modifier that the
physician will add to the claim. The
physician will be expected to maintain
documentation in the patient’s medical
record to verify that he or she complied
with the criteria governing the resupply
provision.
Comment: One commenter suggested
that CMS design the CAP ordering
process so that the physician could
obtain extra doses of CAP drugs from
the approved CAP vendor to keep in his
or her inventory should the need arise
to administer them to Medicare
beneficiaries in an emergency situation.
This process would be in addition to the
process specified under the emergency
resupply option.
Response: The statute does not
directly address whether an alternative
method for emergency drug replacement
is permissible. However, it contemplates
a beneficiary-specific order, and states
that the approved CAP vendor shall not
deliver drugs to the physician except
upon receipt of the prescription order
and such necessary data as may be
required by the Secretary to carry out
section 1847B of the Act. However, the
statute provides for the replacement of
drugs taken from a physician’s own
inventory in an emergency situation
where the physician has administered
drugs from his or her own stock. In that
case, where the emergency resupply
criteria are met, the participating CAP
physician can replace the drugs that
were used from his or her own
inventory by means of an order to the
approved CAP vendor. Although we
recognize the commenters’ concerns, we
are also concerned about the potential
for abuse if a stock of the approved CAP
vendor’s drugs was placed in
physician’s offices for use only by CAP
patients in very limited circumstances.
We believe because of potential program
integrity and drug diversion concerns
that the emergency replacement
provision specified in the statute is the
more appropriate way of providing
needed drugs to beneficiaries when the
patient’s clinical condition does not
allow time to obtain the drug from the
approved CAP vendor.
Delivery of the CAP Drugs
As we specified in the proposed rule
under § 414.906(a)(4) of our regulations,
approved CAP vendors would deliver
PO 00000
Frm 00027
Fmt 4701
Sfmt 4700
39047
drugs directly to physicians in their
offices. Although the statute allows us
to provide for the shipment of drugs to
other settings under certain conditions,
we did not propose to implement the
CAP in alternative settings at this time.
Comment: A commenter pointed out
that a physician may have several
practice locations. If the patient should
change his or her site of treatment from
the one to which the vendor originally
shipped the drug, the physician will
need an appropriate way of transporting
the drugs from one location to another.
Some potential vendors expressed
concern that drugs could be improperly
moved to an alternative location and
that, as a result, spoilage and breakage
could occur. They expressed concern
that since the vendor retains ownership
of the drug until it is administered to
the beneficiary that they could be held
liable if the drug deteriorates and is
administered to the beneficiary in
substandard condition.
Response: We recognize that a
physician or group of physicians may
maintain multiple office locations and,
as a result, may desire to administer
drugs to patients at any one of these
multiple locations. Under the CAP, we
will require the physician practicing
individually, as well as the physician
who is practicing as part of a group, to
provide the address at which business
will be conducted as part of the CAP
election process. In the March 4, 2005
rule, we proposed that the vendor
provide the ordered drugs to the address
that the physician(s) specified on the
election form. At this time, it is not a
uniform requirement that physicians
with multiple practice locations be
issued a unique practice identification
number (UPIN); therefore, in this
interim final rule, we are expanding the
reporting information on the election
form to allow physicians to provide
multiple addresses if they will be
administering CAP drugs in multiple
locations. We have also revised
§ 414.908(a)(3)(v) to add the physician’s
shipping address to the information that
the physician will provide to the vendor
on the prescription order. In response to
the concern expressed by potential
vendors about the possible damage to
CAP drugs if they are transported by the
physician, we will require that
physicians must have CAP drugs
shipped directly to the location at
which they plan to administer them.
The physician may not transport CAP
drugs from one location to another. We
are adding this requirement to the
regulations at 414.908(a)(3)(xi). We
understand that there may be occasions
where a physician may currently
transport drugs purchased under the
E:\FR\FM\06JYR2.SGM
06JYR2
39048
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
ASP system in order to administer them
to Medicare beneficiaries in their
homes. We seek comment on how this
could be accommodated under the CAP
in a way that addresses the product
integrity concerns expressed by the
potential vendors.
Storing the CAP Drugs
We proposed that the physician’s
office staff would receive the CAP
drug(s) and store them until the time of
administration. Although the statute
discusses a patient-specific drug
ordering process, it does not address the
methods that may be used to store and
inventory drugs in an office or clinic
setting, or the potential burden
associated with storing a patient’s CAP
drugs separately from other drugs. We
believe that less burdensome
alternatives to keeping separate
inventories exist; however, any
alternatives would be required to
maintain program integrity and product
integrity and to minimize the risk of
diversion and medication errors. We do
not believe that separate physical
storage of CAP drugs is required.
However, we proposed that physicians
participating in the CAP would be
required to maintain a separate
electronic or paper inventory for each
CAP drug obtained. We requested
comment on additional requirements
that we should impose on maintaining
CAP inventory.
We also proposed that if for some
reason the drug could not be
administered to the beneficiary on the
expected date of administration, the
physician would notify the vendor and
reach an agreement on how to handle
the unused drug, consistent with
applicable State and Federal law. The
notification would also serve to inform
the vendor not to submit a claim for the
drug. If the vendor and the physician
agreed that the drug could be
maintained in the physician’s inventory
for administration to another Medicare
beneficiary at a later time, the physician
would generate a new order form at that
time. Included in the order would be a
notation that the drug was being
obtained from the physician’s inventory
of the vendor’s drugs and that the
vendor need not ship the drug.
Comment: Some commenters,
responding to the suggestion that CAP
drugs would not need to be separately
physically maintained, indicated that
this would not allow the physician’s
staff to determine visually the amount of
stock on hand and for which patient it
was intended. Another commenter
stated that the physician would actually
need three separate inventory areas (for
non-CAP drugs, for CAP drugs and for
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
CAP emergency drugs) and doing so
would require additional storage space,
and could increase the risk of drug
administration and claims processing
errors.
Response: As we stated in the
proposed rule, the physician is required
to keep track separately of each CAP
drug obtained for each beneficiary.
Beyond this requirement, each
physician may decide the most feasible
way for this to work within the confines
of his or her practice. If the physically
separate storage of the drugs under CAP
works better, then the physician is free
to store the CAP drugs separately. If
space limitations are an issue or if the
separate storage of CAP drugs imposes
an additional untenable administrative
burden or creates confusion, then the
physician is not required to store the
CAP drugs separately. The CAP drugs,
even if they are not stored separately,
must in some way be tracked separately,
either electronically or on paper;
however, this could be something as
simple as an electronic spreadsheet.
Comment: One commenter supported
allowing CAP vendors and physicians to
enter into contracts that would allow
the vendor to receive returns of drugs
that were shipped but not administered
to the beneficiary. Many commenters
expressed safety concerns with returns
of unused drugs, especially partly used
multi-dose vials. Another commenter
addressed the burden of asking the
physician to notify the vendor about the
change of administration plans and
negotiate redirection of the unused
drug. Another commenter pointed out
that State pharmacy laws may not allow
for redirection of unused drugs
dispensed for one patient to another;
some manufacturers do not allow the
return of drugs when they are ordered
through a distributor; and there may be
potential discrepancies between State
law, manufacturers’ requirements, and
the CAP. One commenter asked whether
the vendor could require the physician
to retain the drug and attempt to use it
on another patient. Another commenter
requested that we explain the process
that is to be followed if the vendor
requests that the physician return the
drug, and whether the physician would
be responsible for paying the return
shipping cost. One commenter stated
that communication between the vendor
and the physician should be handled
electronically when a drug was not
administered and that we should
implement an electronic system to
facilitate this communication. One
commenter stated that return on unused
drugs should only be allowed when the
box has not been opened, and no patient
labels are attached. The commenter also
PO 00000
Frm 00028
Fmt 4701
Sfmt 4700
stated that 11 States allow for ‘‘reuse’’
of unused drugs in very limited
circumstances. Typically unused drugs
are destroyed by physician or pharmacy
staff. The commenter requested that any
reference to this possibility be removed
to avoid giving the impression that we
favored such an option in conflict with
State law in many States. The
commenter proposed that the vendor be
compensated for drugs that are not
administered to patients and cannot be
billed. Another commenter suggested
that we include a statement in the final
rule that makes it clear that physicians
participating in the CAP would be
allowed to use CAP drugs ‘‘only’’ for a
patient for whom the drugs were
dispensed and identified by the
beneficiary’s Medicare number.
Response: We defer to State law and
regulations as well as manufacturers’
requirements concerning the disposition
of drugs that are not administered or
drugs that are left over from an
administration. Section
1847B(a)(3)(A)(iii) of the Act states that
payment for CAP drugs is conditioned
upon the administration of such drugs.
Therefore, we do not have the authority
to pay for CAP drugs that were not
administered to the beneficiary. Please
refer to section II.C of this interim final
rule for a more complete discussion of
our policy on drug wastage and the
process for returning unused drugs.
Special contracts between the vendor
and the physician should not be
necessary to provide for the return of
unused drugs because the participating
CAP physician election agreement and
the approved CAP vendor’s contract
with CMS, as well as the requirements
stated in the regulations, address this
issue. We are requiring that when a
physician does not administer a drug
during the time frame specified on the
order form, or administers a smaller
amount of the drug than was originally
ordered, that the physician must contact
the vendor to discuss what to do. If it
is permissible under state law, the drug
is unopened, and both the physician
and the vendor are in agreement, the
physician may retain the drug for
administration to another Medicare
beneficiary. However, before the drug
could be administered the physician
would need to provide the vendor with
a new prescription order for the drug,
and the vendor would need to supply
the physician with a new beneficiary
specific prescription order number.
Comment: One commenter inquired
whether a physician will be able to use
the CAP if he or she is aware that
another insurance is primary to
Medicare. In addition, commenters
asked that we explain what happens if
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
the physician is not aware, before
administering the drug, that another
insurance is primary. The commenters
also wanted to know if the CAP
requirements will be different if the
beneficiary has a Medigap policy.
Response: Many beneficiaries have
coverage in addition to Medicare. For
instance, some beneficiaries have a
Medigap policy or another type of
supplemental insurance that covers
costs that Medicare does not. Some
beneficiaries have retiree coverage
through a former employer that is
secondary to Medicare, and such
coverage is, for practical purposes,
similar to supplemental coverage
because it may cover costs Medicare
does not. (See section on beneficiary
coinsurance for more detail.) However,
many beneficiaries have employer
coverage that is primary to Medicare. In
this instance, Medicare pays secondary.
A beneficiary’s additional coverage may
have an effect on when or from whom
an approved CAP vendor receives
payment. However, the requirements
under the CAP will not be different.
When a beneficiary has supplemental or
secondary insurance, the approved CAP
vendor may bill such insurance as
appropriate (that is, after payment from
Medicare). Where Medicare is the
secondary payer and not the primary
payer for the beneficiary, the vendor
would bill the primary insurer first, and
bill Medicare second, as appropriate, in
accordance with normal Medicare
secondary payment rules.
Restricting Physicians to One Vendor
We requested comment on whether
we should require that CAPparticipating physicians obtain all
categories of drugs that a particular
approved CAP vendor provides from the
vendor, or whether the physician
should be allowed to choose the
categories of drugs he or she wishes to
obtain from the vendor.
Comment: Several commenters
supported allowing physicians to
choose the categories of drugs they
obtain from the CAP. Another
commenter suggested that physicians
should be required to obtain all drugs
for all HCPCS within a designated
specialty for their Medicare patients
from the CAP vendor to increase billing
accuracy, and reduce inventory and
paperwork burden. Finally, several
commenters suggested that physicians
should be allowed to contract with
multiple vendors for different categories
of drugs.
Response: As indicated earlier in this
preamble we are implementing CAP
initially with one category that contains
all CAP drugs. At a later point we plan
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
to add additional categories of drugs.
When there are additional categories
from which to choose, physicians will
be allowed to select the categories of
drugs that they will obtain from the
CAP. We will encourage physicians to
select vendors in a manner that will
minimize the number of vendors used
by one practice, in an attempt to reduce
potential billing errors and beneficiary
confusion. Physicians will be limited to
one vendor per category; however, it
will be possible to select a different
vendor for each category if the
physician decides that it best meets his
or her needs. Physicians billing under a
group billing number will need to reach
agreement among themselves on
whether to participate in CAP and
which vendor to select for each
category. [See Section II.D of this
interim final rule on physician election
for more detailed information on this
requirement.]
Administrative Burden
In the proposed rule, we indicated
that we did not believe that the clerical
and inventory resources associated with
participation in the CAP exceed the
clerical and inventory resources
associated with buying and billing drugs
under the ASP system. The payment for
clerical and inventory resources
associated with buying and billing for
drugs under the ASP system is bundled
into the drug administration payment
under the physician fee schedule.
Taking these factors into account, we
proposed not to make a separate
payment to physicians for the clerical
and inventory resources associated with
participation in the CAP program.
Comment: Some commenters disagree
with our assessment of the clerical and
inventory resources associated with
participation in the CAP. They believe
that the administrative cost of managing
inventory would not be eliminated nor
reduced proportionally based on drug
volume decrease due to the CAP. They
added that with the separate ordering
process for CAP drugs requiring patientspecific orders, the number of
individual orders would be higher with
additional delivery times and likely
increase waste. One commenter noted
that oncologists often use an automated
storage and inventory control system
that automatically tracks the amount of
each drug on hand. Instead of a bulk
ordering system, the CAP will require a
detailed patient-specific order. The
commenters also pointed out that the
billing processes would be similar but
that the CAP claim form would require
the prescription order number for each
drug in addition to the HCPCS code.
Keeping track of the prescription order
PO 00000
Frm 00029
Fmt 4701
Sfmt 4700
39049
number before administering the drug
would also be a new activity. One
physician also stated that his city
requires that he pay tax at the time a
drug is administered to a patient, and
that he believed the CAP should
compensate him for this cost.
Response: Although we agree that a
physician may have to make some
adjustments in his or her practice in
order to comply with the requirements
under the CAP, we believe that the relief
of the financial burden of purchasing
the drugs and billing Medicare for these
drugs will be a substantial improvement
and benefit for many physicians. Again,
as we have stated previously, a
physician is free to a significant extent
to design his or her practice so that the
additional burden of participating under
the CAP is as small as possible. CAP is
a voluntary program, so if a physician
finds it more burdensome, then he or
she is under no obligation to participate.
Although initially a physician’s staff
may have to make software changes to
recognize the CAP system, this would
be a one-time burden. Also, as we have
stated previously, separate drug storage
is not required—it is a suggested option
if such a procedure makes it easier on
the physician’s practice to track the CAP
drugs. Further, in the interest of easing
the burden of information exchange to
the extent possible, we are requiring at
§ 414.908(a)(3)(iii) that the physician
provide the vendor with patient
information for the initial order, or
when the patient’s information changes
(for example, the patient develops a new
drug allergy). The vendor would be able
to specify which information is
necessary on a follow-up order. (We
note that some patient specific
information such as date of birth and
gender are required by the Medicare
claims processing system. For
additional information refer to Content
of the Drug Order earlier in this section.
Drug Administration
We proposed that after administering
the drug, the physician would submit a
claim to his or her local carrier for drug
administration. The claim would
include the HCPCS code for the drug
administered, the drug administration
fee, the prescription code for each drug
administered, and the date of service.
The local carrier would adjudicate the
claim for drug administration and check
that the physician was billing for
appropriate drugs from the selected
drug vendor, and that the claim was
compliant with all local coverage
determinations (LCDs). In general, if the
physician’s claim was inconsistent with
an LCD, the local carrier would deny the
claim for the drug administration and
E:\FR\FM\06JYR2.SGM
06JYR2
39050
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
would notify our central claims
processing system that the drug
vendor’s claim for the drug would not
be paid.
If the claim passes all local carrier
edits, the local carrier would forward it
to our CMS central claims processing
system for additional editing and
approval for payment.
We also proposed to require prompt
claim filing for the drug administration
on the part of physicians who elect to
participate in the CAP in order to
facilitate the match between the
physician claim and the drug vendor
claim so that drug administration can be
verified. We proposed that in their CAP
election agreements, physicians who
choose to participate in the CAP would
be required to agree to bill their claims
within 14 calendar days of the date the
drug was administered to the
beneficiary, unless extenuating
circumstances prevented them from
filing the claim. (Statistics obtained
from Medicare claims filing data
indicated that more than 75 percent of
physician’s claims are currently filed
within 14 days of the date of service.)
We requested comment on how we
should define the extenuating
circumstances that should be
considered for exceptions to the 14
calendar day time frame.
Comment: A commenter representing
an organization of specialty distributors
supported the timely filing of physician
claims requirements in the proposed
rule; however, the commenter noted
that few procedures are proposed to
augment physician compliance. The
commenter supported development of
an enforcement mechanism before the
physician’s dismissal from the program.
Other commenters believe that it is
burdensome for a physician to file a
claim within 14 days after drug
administration. One commenter asked
for more detailed information about our
data on physician claim filing because
the statistics we cited are not reflective
of their knowledge of small group
practices and solo practitioners. They
asserted that requiring CAP physicians
to submit their claims within 14 days is
too drastic a change from the 365 day
current standard, and suggest that the
requirement should be changed to 30
days. In response to our request for
comment on extenuating circumstances
that could be considered for exceptions
to the 14 day filing requirement, the
commenter stated that extenuating
circumstances for claim filing
requirements are already defined in
Chapter 1 section 70.7 of the Medicare
Claims Processing manual and that
providers are allowed an extra 120 days
in which to file claims in certain
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
situations. They believe the same
standards should be applied in the CAP.
Response: Concerning the 14-day
requirement on physicians to file claims
for drug administrations, we point out
that the vendor’s payment depends on
the physician’s administration of the
drug that the vendor has already
purchased and provided. We believe it
is reasonable for the vendor to expect to
be paid timely, and it is a benefit to the
physician to be paid timely as well. The
claim filing data we cited in the
proposed rule were based on all
physician claims where the place of
service was the physician office, so it
represented claims filed by all physician
practices. Based on physicians’ current
claims filing practices, we believe that
complying with this requirement will
not be problematic for most physicians.
We expect that physicians will take the
requirement into account when they
make a decision whether to participate
in CAP and that before electing to
participate they will have procedures in
place that will enable them to meet the
requirement on a routine basis if they
are not already doing so. The local
carrier may grant exceptions on rare
occasions when due to extenuating
circumstances the physician is unable to
submit claims within 14 days. Such
requests should not be granted on a
routine basis. As physician billing
practices increasingly become
automated, we believe that this
requirement will become less of a
burden. We will ask the local carriers to
periodically conduct a post payment
review of participating CAP physicians’
compliance with this requirement. If a
vendor notes repeated non-compliance
with this requirement on the part of a
physician, the vendor may ask the
designated carrier to assist in working
with the physician to resolve this
situation. Failure to comply with this
requirement may be a factor taken into
consideration in the designated carrier’s
recommendation to CMS about
removing a participating CAP physician
from the program.
Comment: One commenter noted that
the proposed rule did not address how
the patient newly eligible for the
Medicare program during a course of
treatment would be handled under the
CAP. The commenter inquired whether
the physician would be required to
change the patient’s therapy because the
vendor might be offering a different
NDC of a drug than the physician had
been using previously.
Response: A physician that is treating
a new Medicare patient is not required
to change that patient’s course of
treatment merely because he or she may
be participating in the CAP if the
PO 00000
Frm 00030
Fmt 4701
Sfmt 4700
‘‘furnish as written’’ conditions are met.
If a patient becomes eligible for
Medicare and the treating physician is
participating in the CAP, and a
particular formulation of a patient’s
drug is not available through the CAP,
but is medically necessary, then the
physician may obtain the drug through
the ‘‘furnish as written’’ methodology
and bill the local carrier for the drug
under the ASP system.
Comment: Several commenters
suggested that the CAP vendors and
physicians should be able to enter into
contracts or agreements that would
allow them to work out details of doing
business under the CAP such as how to
handle drugs that were ordered and
shipped but not administered. Other
commenters proposed that we allow
vendors and physicians to enter into
contracts that would increase vendor
financial incentives to participate in the
CAP while at the same time reducing
the physician’s administrative burden.
As an example, the commenter
suggested allowing the vendor to bill for
both the administration fee on behalf of
the physician and the drug itself. In
addition, another commenter asked if
there are any restrictions concerning a
physician using a CAP vendor for nonMedicare patients. Specifically, the
commenter inquired whether a
participating CAP physician could have
an ancillary agreement with the
approved CAP vendor to obtain drugs
for his or her non-Medicare patients.
Response: This interim final rule does
not prohibit approved CAP vendors and
physicians from entering into a contract
or agreement governing their
arrangements for the provision of CAP
drugs or other items or services.
However, parties to such arrangements
must ensure that the arrangements do
not violate the physician self-referral
(‘‘Stark’’) prohibition (section 1877 of
the Act), the Federal anti-kickback
statute (section 1128B(b) of the Act), or
any other Federal or State law or
regulation governing billing or claims
submission. For example, an agreement
under which the approved CAP vendor
provides billing services to a physician
must comply with the Stark law, antikickback statute, and Medicare rules
regarding billing agents (§ 447.10). On
the other hand, an approved CAP
vendor may not contract to furnish
drugs at below market rates to a
physician or a group for their private
pay patients in exchange for the
physician’s or group’s CAP business.
For additional information on the Stark
and anti-kickback statutes, parties may
wish to consult the CMS and OIG Web
sites.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Payment to Vendor
After shipping the drug to the
physician, we proposed that the drug
vendor could file a claim for the drug
with the designated carrier no sooner
than the expected date of
administration. The claim form would
contain the prescription number for
each drug administered to the
beneficiary on one calendar day, the
unique provider identifier (UPIN) or
(NPI when available) for the physician
to whom the drug was supplied, and the
expected date of service. The designated
carrier would submit the claim to the
central claims processing system after
the claim had passed all edits. The
central claims processing system would
match the physician claim with the
vendor claim using the prescription
number.
As required by the statute, we
proposed that the vendor would not be
allowed to bill the beneficiary or his or
her third party insurance, or both, for
any applicable deductible and
coinsurance until the Medicare carrier
had verified that the physician
administered the drug to the
beneficiary, and final payment was
made by the Medicare program. Proof
that the drug was administered to the
beneficiary would be established by the
physician’s claim being matched with
the drug vendor’s claim in the Medicare
central claims processing system. After
the two claims were matched, the
claims processing system would notify
the designated carrier to issue final
payment to the vendor. We proposed
that issuance of final payment by the
Medicare program would serve as
notification to the vendor that drug
administration had been verified and
that the vendor could proceed with
billing the beneficiary or his or her third
party insurance.
Comment: A specialty distributors
association commented that every day
that a vendor must wait for payment
from Medicare and the beneficiary or
his or her third party insurance
represents additional working capital
invested in the program by the CAP
vendor and added inefficiencies to the
Medicare program. Vendors may
experience at least a 2-month delay in
payment from the time the drug is
shipped to the physician and payment
is received from the Medicare program.
The commenter stated that CAP vendors
will not be able to assume the level of
financial risk that was described in the
proposed rule. They proposed a series of
steps that we could take in the final rule
to attempt to lessen the degree of risk
that CAP vendors will assume. These
include: Establishing a pre-review
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
process to certify the medical necessity
of a drug before the CAP vendor sends
the order to the physician, creating risk
corridors similar to those being used in
the Part D program so that the vendor
and CMS are sharing in the risks and
benefits of the program, and
implementing a process so that the CAP
vendor could collect coinsurance from
the beneficiary at the time the drug is
administered. Commenters also
expressed concern about the potential
for low profit margins and delayed
payment that exist in the CAP and
suggested that we should provide
additional financial safeguards for CAP
vendors.
Response: Following is a response to
the commenters’ proposed suggestions
about how to lessen the degree of risk
that vendors will face in the CAP:
(1) Medicare contractors do not
generally provide advance approval of
potential claims. As stated previously
both the participating CAP physician
and the approved CAP vendor are
expected to familiarize themselves with
LCDs, NCDs, and other Medicare rules
that may affect claims payment. If an
approved CAP vendor encounters a
circumstance where it believes that a
prescription order is inconsistent with
any of these things, the approved CAP
vendor may work with the physician to
amend the order. If the physician
declines to change the order, but the
approved CAP vendor believes the drug
claim will not be paid by Medicare, the
approved CAP vendor may issue an
ABN to the beneficiary. If for some
reason the vendor is unable to obtain a
signed ABN from the beneficiary, the
vendor still will have a responsibility
under its CAP contract to ship the drug
to the physician. (The only exception to
this requirement is in the case of the
beneficiary’s failure to meet his or her
obligation to pay deductible or
coinsurance. This provision is described
in more detail in the discussion of
beneficiary coinsurance later in this
section.)
We will include in the CAP contract
a requirement that the vendor ship the
drug in most situations because we
believe that under the CAP program as
it is being implemented, it would be
inappropriate for the approved CAP
vendor to interfere in the participating
CAP physician’s clinical decision
making. If the payment for the drug is
ultimately denied, then the physician
will be required to appeal the drug
administration claim denial. The
approved CAP vendor may also appeal
to the local carrier in accordance with
the discussion of administrative appeals
below in the dispute resolution section.
PO 00000
Frm 00031
Fmt 4701
Sfmt 4700
39051
(2) We do not have the statutory
authority under section 1847B of the
Act to create risk corridors.
(3) We have designed the CAP
payment system so that the vendor may
bill the beneficiary and or his or her
third party insurance when payment for
the drug has been made by the CMS
claims processing system. In order to
ensure that this process happens as soon
as possible, we are imposing a 14-day
claim submission requirement on the
physician. We have implemented this
requirement because the statute requires
that applicable deductible and
coinsurance may not be collected unless
the drug was administered to the
beneficiary. Currently, we have no way
of verifying drug administration other
than by the matching of the physician’s
claim for drug administration with the
vendor’s claim for the drug. We seek
comment on other ways that
administration could be verified earlier
in the process that minimize the burden
on the approved CAP vendor, the
participating CAP physician, and the
beneficiary.
Partial Payment
Although we noted in the March 4,
2005 rule that we were not proposing to
implement a system for partial claims
payment, we requested comments on
compelling reasons for making such a
payment. We also sought comment on
whether there are demonstrable,
compelling reasons why we should
consider making a partial payment to
the vendor in cases where the drug
administration claim is not received by
our claims processing system within 28
calendar days of the anticipated date of
administration and what the appropriate
percentage of the partial payment
should be.
We briefly described how such a
partial payment methodology might
work, if we decided to implement such
an option. After the designated carrier
made the partial payment, our claims
processing system would continue to
attempt to match the physician claim
and the vendor claim for 90 days. We
would not pay interest on interim
payments. If a match of the two claims
occurred, the vendor would receive
Medicare payment for the remaining
amount of money due on the claim. If
no match between the two claims was
made within 90 days, recovery of the
amount already paid by Medicare would
occur using normal Medicare
overpayment recovery processes. After
the Medicare program made the final
payment, the vendor would be allowed
to bill the beneficiary or the
beneficiary’s third party insurance, or
both.
E:\FR\FM\06JYR2.SGM
06JYR2
39052
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Comment: Some commenters
supported partial payment of the
vendor’s claim at the time the drug is
shipped to the physician, and 20
percent was suggested as an appropriate
amount. Another commenter strongly
opposed partial payment for the vendor
because neither physicians nor
pharmacies nor DME suppliers have
ever received partial payment. The
commenter expressed concern that the
beneficiary would receive a bill on the
partial payment.
Response: After further consideration
of this issue, we will finalize the
proposal to pay only when both the
vendor claim for the drug and the
physician’s claim for administering the
drug have been matched in the claims
processing system. We believe that this
is a more straightforward process and
that it is a process that will assist in
preserving the Medicare trust fund
because it will not involve payment
recovery if a claim is denied or a
physician does not administer the drug.
Beneficiary Coinsurance
Comment: Some commenters stated
that having the vendor collect the
coinsurance adds further ‘‘bureaucracy’’
to patient care and introduces a
middleman between the doctor/patient
relationship.
Response: As stated in the proposed
rule, the statute specifically requires
that the vendors participating in the
CAP collect any applicable deductible
and coinsurance from the beneficiary.
Therefore, we do not have any latitude
in determining who collects the
coinsurance.
Comment: A few commenters
questioned our proposal to prohibit the
vendor from billing for coinsurance
until final payment of claim, stating this
would be a significant change from
current practice. The commenters
believe delayed billing would increase
risk of bad debt and increase collectionrelated efforts and costs and potentially
risk solvency of the vendor and viability
of program.
Response: We understand the
concerns raised by the commenters;
however, the statute specifies that the
collection of any applicable deductible
or coinsurance cannot occur until the
drug is administered and that the
vendor is responsible for billing the
beneficiary for cost sharing. We note
that Medicare allows for the collection
of coinsurance at the time a service is
delivered, however since the approved
CAP vendor is not present at the time
the drug is administered the vendor is
unable to bill the beneficiary at that
time. We agree that the delay in billing
could increase the incidence of
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
beneficiaries who are unable to meet
their coinsurance obligations; however
we note that (as explained in more
detail below) approximately 80 percent
of beneficiaries have supplemental
insurance coverage which covers their
Part B coinsurance. In order to help
ensure more prompt payment to the
vendor, we are requiring that the
participating CAP physician must
submit the claim for drug
administration within 14 calendar days
of the date of administration. In
addition, the existing CMS coordination
of benefits process provides for the
automatic crossover of many Medicare
beneficiaries’ claims to their
supplemental insurance provider after
Medicare has paid its portion of the
claim. For beneficiaries with
supplemental insurance, their
coinsurance obligation is usually met
through the automatic coordination of
benefit process, instead of requiring the
beneficiary to pay the coinsurance at the
time of service. We are currently
consolidating the claims crossover
process, on a national basis, to
introduce standardization and
efficiencies in a national crossover
process that will automatically cross
claims over to supplemental insurers/
payers, including Medigap plans,
employer retiree supplemental plans,
TRICARE, and State Medicaid Agencies,
for their use in calculating their
financial liability after Medicare. Under
this consolidated crossover process,
supplemental insurers/payers will
execute a national Coordination of
Benefits Agreement with a single CMS
contractor, the national Coordination of
Benefits Contractor (COBC), for
purposes of receiving Medicare
crossover claims. We believe that the
majority of supplemental insurers/
payers will participate in the national
consolidated crossover process due to
the consistencies and efficiencies that
result from a standard national process.
Standardization of the crossover process
thereby decreases the likelihood that
beneficiaries’ claims will not be crossed
over.
Comment: Commenters raised
concerns about the requirement that the
approved CAP vendor collect the
coinsurance for the drug from the
beneficiary with respect to the following
three major areas:
• Effect on beneficiaries. Under the
current system, the physician often
works with the beneficiary and social
agencies to obtain payment, or in
appropriate circumstances these costs
may be born by the physician practice
in cases of financial hardship as bad
debt. Commenters expressed concern
that vendors may use overly aggressive
PO 00000
Frm 00032
Fmt 4701
Sfmt 4700
collection techniques, or no longer
provide drugs for patients who are too
far in arrears.
• Effect on approved CAP vendors.
The inability of approved CAP vendors
to collect coinsurance from beneficiaries
could pose a major financial hardship to
vendors. Collection of coinsurance may
also be exacerbated due to the time
delay between the dates of treatment
and payment, as well as the approved
CAP vendor’s lack of a direct personal
relationship with patients.
• Clinical issues. Failure to provide
the drug due to nonpayment of
coinsurance by the beneficiary may
endanger patients and expose
physicians to liability issues.
Commenters stated that regardless of the
patient/vendor dispute, this does not
involve physician services, and failure
of the vendor to provide the required
drug could affect the physician’s plan of
treatment for the beneficiary.
Commenters recommended that the
vendor should not be able to drop the
physician from the CAP or withhold the
shipping of the drugs due to
nonpayment of the coinsurance.
Additionally, commenters suggested
vendors be required to have in place
procedures for assessing indigence and
waiving coinsurance when a nonMedicaid-eligible beneficiary’s income,
assets, and medical expenses meet
certain pre-established criteria. Ideally,
these procedures should incorporate the
assistance of social workers trained to
explore all payment options and
assistance programs available to the
individual. The commenters
recommended that assessment of these
procedures should be part of our vendor
evaluation process. If it is determined
that vendors can refuse to deliver drugs
because of coinsurance issues,
commenters believe this must be made
clear to physicians when they sign up
for the CAP. As an alternative, other
commenters recommended that when
this occurs, physicians should be able to
obtain drugs through the ASP system or
be able to opt out of the CAP
immediately. One commenter suggested
that this option should also be available
if the beneficiary’s secondary insurance
denies the claim.
The Practicing Physicians Advisory
Council (PPAC) expressed similar
concerns about the collection of
coinsurance and recommended that we
require selected CAP vendors be willing
to advance credit for drugs to patients
who are not able to pay the coinsurance.
Other commenters recommended that
the final rule allow CAP vendors to
refuse to distribute products to patients
who have a prior history of failing to
fulfill coinsurance obligations. This
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
would eliminate a significant amount of
financial risk and uncertainty for
vendors.
Response: We appreciate the
commenters’ concerns, and we address
these concerns as outlined below:
• Effect on beneficiaries. With respect
to commenters’ concerns about the
impact of the CAP on beneficiaries, the
purpose of the CAP is to provide an
alternative to physicians for obtaining
Medicare Part B drugs and is not
intended to have a negative impact on
patient care. However, as part of their
enrollment in Medicare, beneficiaries
are obligated to pay the Part B
deductible and coinsurance amounts,
and this cost-sharing assists in
controlling the over utilization of
services. Information from the 2003
Medicare Current Beneficiary Survey
shows that approximately 80 percent of
fee-for service Medicare enrollees report
that they have supplemental coverage
that covers their Part B coinsurance
obligations. Although we are uncertain
of the level of coverage provided by
these plans, we believe this
supplemental coverage provides
significant financial protection to many
beneficiaries. However, we understand
that there will be instances where a
beneficiary may have difficulty in
meeting the deductible or coinsurance
payment. When this occurs under the
current payment system, the physician
often helps the beneficiary in finding
assistance to meet this obligation or
might choose not to pursue collection of
the cost-sharing if the physician has
made a good faith determination of
financial need or reasonable collection
efforts have failed.
In order to address these concerns, we
are modifying the program requirements
at § 414.914(g) to include a provision
requiring vendors to provide
information on sources of cost-sharing
assistance available to beneficiaries on
request. It is important to note that
routine waiver of deductibles and
coinsurance can violate the Federal antikickback statute, as well as the civil
prohibition on offering inducements to
beneficiaries at section 1128A(a)(5) of
the Act. However, cost-sharing waivers
are permitted under certain conditions
for beneficiaries who are experiencing
financial hardship. The assistance
offered by the vendor must take the
form of one of the following: a referral
to a bona fide and independent
charitable organization, implementation
of a reasonable payment plan, and/or a
full or partial waiver of the cost-sharing
amount based on the individual
financial need of the patient, provided
that the waiver meets all of the
requirements of paragraph (1) of 42 CFR
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
1003.101 (Definition of
‘‘Remuneration’’). The availability of
waivers may not be advertised or be
made as part of a solicitation; however,
vendors may inform beneficiaries
generally of the various categories of
assistance noted in the preceding
sentence. In no event may the vendor
include or make any statements or
representations that promise or
guarantee that beneficiaries will receive
cost-sharing waivers. We will evaluate
the procedures that applicant vendors
propose to implement to make costsharing assistance referrals as part of the
approved CAP vendor application
review process.
• Effect on approved CAP vendors.
With respect to concerns about the
potential impact on the approved CAP
vendors, we will not require an
approved CAP vendor to continue to
provide CAP drugs for beneficiaries who
do not pay their deductible or
coinsurance. As noted previously, under
the CAP contract, we are requiring
vendors to ship ordered drugs to
physicians in most situations. However,
in the case of a beneficiary who fails to
satisfy his or her cost-sharing
obligations for CAP drugs ordered by a
particular participating CAP physician,
we will allow the vendor to refuse to
make further shipments to that
physician for that beneficiary in
accordance with the provisions outlined
below. The vendor may refuse to ship
drugs to a physician for a beneficiary
who has not met his or her coinsurance
obligations, when the conditions
outlined below are met, until the earlier
of the end of the calendar year or the
beneficiary’s past due balance is paid in
full. We will require that after receiving
final payment by Medicare, the vendor
must first bill any applicable
supplemental insurance policy that the
beneficiary may have. If there is a
balance due after payment by the
supplemental insurer, or if the
beneficiary has no supplemental
insurance, the vendor may proceed with
billing the beneficiary.
As discussed previously, consistent
with the requirements of section
1128A(a)(5) of the Act and § 414.914(g),
at the time of billing, the vendor may
inform the beneficiary generally of the
types of cost-sharing assistance that may
be available. If the beneficiary is unable
to pay the coinsurance or deductible, he
or she may request assistance from the
vendor as described above. The vendor
has an obligation to provide the
information requested, and to take one
of the actions specified in § 414.914(g).
However, if the beneficiary has not
requested financial assistance and if
after a period of 45 days from the
PO 00000
Frm 00033
Fmt 4701
Sfmt 4700
39053
postmark date of the approved CAP
vendor’s bill to the beneficiary, the
beneficiary’s coinsurance obligation
remains unpaid, the vendor may refuse
to make further shipments of drugs to
the physician for that beneficiary. We
note that these provisions assume that
the vendor bills the beneficiary after
payment is received from Medicare and
his or her supplemental insurance
provider (if applicable.)
If the beneficiary requests cost-sharing
assistance and the vendor refers the
beneficiary to a bona fide independent
charitable organization for assistance or
offers a payment plan, the vendor must
wait an additional 15 days from the
postmark date of the approved CAP
vendor’s response to the beneficiary’s
request for cost-sharing assistance. If at
the end of the 15-day time period the
vendor has not received a cost-sharing
payment (either from the charitable
organization or from the beneficiary
under the payment plan), the vendor
may refuse to ship additional drugs to
the physician on behalf of that
beneficiary. Further, if the approved
CAP vendor implements a reasonable
payment plan, the vendor must
continue to ship CAP drugs for the
beneficiary, so long as the beneficiary
remains in compliance with the
payment plan.
Finally, if the vendor waives the costsharing in accordance with section
1128A(I)(6)(A) of the Act, 42 CFR
§ 1003.101, and § 414.914(g)(3) of these
regulations, the vendor may not refuse
to ship CAP drugs for the beneficiary. In
instances where a beneficiary has failed
to meet his or her obligation to pay
coinsurance or deductible for a drug and
the vendor has refused to continue
providing the drug, we will permit the
participating CAP physician to opt out
of that drug category for CAP. Note that
for the initial implementation of the
CAP, there is only one CAP drug
category. Thus, a physician exercising
this option will be opting out of the
entire CAP program until the next
opportunity to elect to participate. We
are amending the regulations at
§ 414.908(a)(5) to include this provision.
We seek comment on additional
provisions that we should use to define
these processes to protect the vendor
and the beneficiary.
• Clinical issues. With respect to
concerns raised that the inability of a
beneficiary to make the coinsurance
payment should not affect treatment, we
believe the modifications we are making
to require the vendor to provide
information on sources available to a
beneficiary who may be in need of
assistance with his or her coinsurance
payment as well as allowing the
E:\FR\FM\06JYR2.SGM
06JYR2
39054
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
physician to opt out of the CAP will
assist in ensuring that the treatment is
not affected.
Comment: One commenter questioned
what is required from physicians for
patients with Medigap or another type
of supplemental insurance coverage.
Response: A high percentage of
Medicare beneficiaries carry
supplemental insurance such as a
Medigap policy to cover deductible and
coinsurance amounts, and the physician
will provide this insurance information
to the approved CAP vendor. The
specific information that the physician
must provide is discussed earlier in this
section.
Comment: Another commenter
requested that we implement processes
to assist vendors in collecting
beneficiary coinsurance, especially if
the patient is deceased.
Response: We do not believe special
provisions need to be made in this rule
for beneficiaries who are deceased. If a
beneficiary has died after receiving the
CAP drug, but before he or she could
pay the coinsurance amount to the
vendor, the designated carrier would
still process the approved CAP vendor’s
drug claim in accordance with the
normal procedures outlined in these
regulations, and the approved CAP
vendor could bill the beneficiary’s estate
or the beneficiary’s alternative
insurance in accordance with CAP
requirements. However, we would
welcome further comments on this
issue.
Comment: Commenters questioned
whether vendors would be expected to
bill Medicaid for coinsurance and
deductible after billing Medicare in the
case of dual eligible beneficiaries and
the consequences to the beneficiary if
Medicaid did not pay the coinsurance.
Another commenter recommended that
we require any vendors awarded the
contracts to provide this prescription
benefit with a coinsurance structure no
higher than Medicaid.
Response: The CAP is an alternative
to the current system for paying for
Medicare Part B drugs. Because the
coinsurance is a part of the Medicare
total payment amount, we cannot
establish a limit for this amount based
on another payment system (that is,
Medicaid). We have no authority to set
coinsurance at anything other than 20
percent of the Medicare rate. If a
beneficiary has supplemental insurance,
the approved CAP vendor will bill the
insurance provided by the beneficiary
for the coinsurance amount. Medicaid
payment rates and policies for dual
eligibles will vary by State.
Comment: One commenter
recommended that we establish a policy
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
to reimburse vendors for part of the bad
debt they experience when they are
unable to collect in full the coinsurance
and deductibles, similar to provisions
for certain other providers.
Alternatively, the commenters believe
we should adjust the bid limit to take
this issue into account.
Response: The bad debt policy
referred to by the commenter is
established by statute and regulations
for specific provider types and is not
applicable to the CAP program. We do
not agree with the suggestion that we
should adjust the proposed bid limit to
account for the possibility that vendors
will be unable to collect all coinsurance.
Although the Medicare statute and
regulations provide specific provisions
to recognize and account for bad debt in
the context of payments to hospitals and
certain other provider types, there is no
such provision in relation to the CAP.
We therefore lack authority to provide
for explicit recognition of bad debt in
the mechanisms for bidding and
determining payment amounts under
the CAP.
Comment: One commenter stated that
the CAP could result in beneficiaries
returning to the physician’s office more
often and thus double the coinsurance
amount. For example, a beneficiary
undergoing chemotherapy may see the
physician and have his or her laboratory
results checked one day and, based on
changes to the prescription, the
physician will have to order a new drug
and the beneficiary will have to return
on another day to receive the drug.
Response: The statute and these
regulations provide for situations in
which a drug is needed immediately. If
the criteria outlined in § 414.906(e) are
met, the participating CAP physician
can submit a prescription order to the
approved CAP vendor to obtain a
replacement for a drug from his own
stock that was used to treat the
beneficiary. The participating CAP
physician is always free to do what is
best for the beneficiary, but under CAP
payment rules, payment is made for the
CAP drug only when it is ordered from
the vendor or the resupply or ‘‘furnish
as written’’ criteria are met.
3. Dispute Resolution
Section 1847B of the Act is generally
silent with regard to the treatment of
disputes surrounding the delivery of
drugs and the denial of drug claims.
However, section 1847B(b)(2)(A)(ii)(II)
of the Act does contain a reference to a
grievance process which is included
among the quality and service
requirements expected of vendors.
As explained in the March 4, 2005
proposed rule, we gave substantial
PO 00000
Frm 00034
Fmt 4701
Sfmt 4700
consideration to the applicability of the
Medicare Part B administrative appeals
process found at § 405.801 et seq. We
believe the traditional Part B appeals
process continues to be the appropriate
dispute resolution process for
beneficiaries and participating CAP
physicians seeking review of drug
administration claims that have been
denied by the local carrier for any of the
reasons described in § 405.803(a). Those
reasons include the following: (1)
Services were not a covered benefit; (2)
The deductible was not met; (3) No
evidence of acceptable payment; (4)
Charges for services were unreasonable;
and (5) Services furnished were not
reasonable and necessary.
We also outlined reasons that we
believed disputes raised by the
approved CAP vendor regarding the
nonpayment of a drug claim by the
designated carrier cannot be adjudicated
by application of the traditional Part B
appeals process. First, the designated
carrier’s denial is based on the lack of
a unique prescription ID number match
in the central claims processing system.
This reason does not meet any of the
appeal criteria in § 405.803(a). Second,
given the ministerial aspect of the
designated carrier’s prescription number
matching task, an informal process
focused on getting the underlying
participating CAP physician’s drug
administration claim properly filed and
adjudicated is a more effective remedy.
Finally, we believed application of the
proposed progressive alternative dispute
resolution process described in the
proposed rule represents a better use of
program administration resources.
We encourage participating CAP
physicians, beneficiaries, approved CAP
vendors and the designated carrier to
use informal communication to resolve
service-related administration issues
that occur in a delivery and payment
system of this complexity. However, we
recognized certain disputes will require
the intervention of a neutral third party
and established a proposed dispute
resolution process § 414.916 which is
summarized as follows.
a. Resolution of Vendor’s Claim Denial
The participating CAP physician has
control of the claim filed with the local
carrier for drug administration services.
In the proposed rule, we stated that the
approved CAP vendor would not be a
party to the appeal a physician may file
if his or her drug administration claim
is denied. We based this statement on
the fact that the approved CAP vendor
would possess little of the evidence
required to substantiate the medical
necessity requirements for
administration of the drug. However, we
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
wish to clarify that the approved CAP
vendor may appeal as a Medicare
supplier under the Part B appeals rules
at 42 CFR Part 405 and the online
Medicare Claims Processing Manual,
Chapter 29, §§ 20 and 60.4. Because the
local carrier’s initial determination
regarding the drug administration claim
is determinative of the CAP vendor’s
drug claim, we interpret that initial
determination to be an initial
determination regarding payment of the
CAP vendor’s drug claim for purposes of
the Part B appeals regulations at 42 CFR
405. Thus, the CAP vendor is a party to
any redetermination of the drug
administration claim by the local
carrier. In addition, any appeal from an
initial determination regarding a claim
for payment of a drug by the designated
carrier should be filed with the local
carrier. It is the local carrier, rather than
the designated carrier, that possesses all
information necessary to adjudicate an
appeal from a denial of a claim for
payment of a CAP drug. This
information includes local coverage
decisions, medical necessity
determinations, and information
regarding payment of drug
administration claims. Thus, all parties,
including the CAP vendor, will have
120 days from the date of receipt of an
initial determination by the designated
carrier regarding a claim for payment of
a drug in which to file a request for a
redetermination of that claim with the
local carrier.
Accordingly, we have expanded the
participating CAP physician’s
participation obligations to include
support of the approved CAP vendor’s
appeal with documentation and written
statements. Please see the comments
and responses below.
The approved CAP vendor’s drug
product claim may be denied by the
designated carrier if the participating
CAP physician’s drug administration
claim is denied. In that event, the
approved CAP vendor can not bill
Medicare for the cost of a drug and can
not bill the beneficiary for the
appropriate deductible or coinsurance.
The approved CAP vendor will track
its business with the individual
participating CAP physicians who order
drugs. We proposed that when an
approved CAP vendor is not paid and
the total dollar amount of the approved
CAP vendor’s loss exceeds an
acceptable threshold, then the approved
CAP vendor may ask the designated
carrier to counsel the participating CAP
physician on his or her obligation under
the CAP election agreement to file a
clean claim and pursue an
administrative appeal in accordance
with his or her CAP election agreement.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
We outlined the particulars of the
proposed participating CAP physician’s
CAP election agreement in
§ 414.908(a)(3) of our regulations and
we requested comment on the
appropriate amount for the CAP
vendor’s loss threshold.
If problems persist, we proposed that
the approved CAP vendor may request
the designated carrier to review the
situation and potentially recommend a
suspension of the participating CAP
physician’s CAP election agreement.
The designated carrier would gather and
review the relevant facts, and make a
recommendation to us on whether the
physician has been filing his or her CAP
administration claims in accordance
with the requirements for CAP
participation. We would review the
recommendation of the designated
carrier and, if necessary, gather
additional information before deciding
whether to suspend the participating
CAP physician’s election to participate
in the CAP.
We proposed the suspension would
last for a period not to exceed the end
of the following CAP election cycle.
Inasmuch as participating CAP
physicians can elect to enroll every year
for a 12-month period commencing in
January, the suspension would end on
one or another December thirty-first. We
are clarifying that the participating CAP
physician could enroll again a year from
the next January first. Upon
consideration of the situation where the
participating CAP physician is
suspended in the early months of the
year, we have determined that the
suspension may prove to be
unnecessarily long. Accordingly, we
have determined that a suspension
commencing before October 1 will
conclude on December 31 of the same
year. A suspension commencing on or
after October 1 will conclude on
December 31 of the next year. A
suspension of less than 2 months would
not have a meaningful impact. We
indicated that the physician would be
able to appeal our initial decision
through the process articulated in
proposed § 414.916.
Comment: Comments on the
appropriate loss threshold that an
approved CAP vendor would have to
bear before requesting suspension of the
participating CAP physician were
varied. The potential vendor community
indicated that it would prefer to have
authority to exclude participating CAP
physicians unilaterally. Physician
commenters indicated that they would
like a well-defined threshold with a
high dollar and occurrence level.
Response: Regardless of whether a
physician is participating in CAP, our
PO 00000
Frm 00035
Fmt 4701
Sfmt 4700
39055
primary concern is the welfare of the
beneficiary and the implications of
repeated drug administrations that are
not in accordance with Medicare
coverage policy. Our existing medical
review safeguards and provider
education efforts are as applicable to
drug administration when the drug is
provided by the approved CAP vendor
as when it is purchased by the
participating CAP physician. These
existing mechanisms help ensure that
our beneficiaries are receiving medically
reasonable and necessary services and,
as a consequence, will help ensure that
the approved CAP vendors are able to be
paid for drugs shipped to physicians.
We also note that physicians, as a
condition of participation in CAP, will
have agreed to the claims, appeals filing,
and CAP assignment requirements
described in section II.D.1, ‘‘Physician
Election,’’ of this interim final rule. This
will also help to ensure that the
approved CAP vendors are able to be
paid for drugs shipped to physicians.
We emphasize that we believe many
of the issues of concern raised by the
potential vendors can either be resolved
through cooperative interaction between
the approved CAP vendor and the
participating CAP physician or the
dispute resolution efforts of the
designated carrier without using the
formal process for removal of physician
from the CAP program. However, we
recognize the need for such a process in
the event the above efforts are
unsuccessful just as we recognize the
need to be able remove an approved
CAP vendor from the CAP program if
necessary.
We believe each CAP drug claim
denial will require individual analysis
to determine the cause. That review
focuses on the depth of consideration
the participating CAP physician gave to
the pertinent Medicare coverage policy.
If it turns out the physician knowingly
ordered and administered a drug that is
not covered, and the physician did not
file a claim, or filed a frivolous claim to
create the appearance of appropriate
consideration of the coverage
requirements, then the approved CAP
vendor’s request to initiate a suspension
investigation may be well founded.
Approved CAP vendors can not be
expected to have no recourse in the
event they are routinely shipping drugs
for which they do not receive payment.
However, participating CAP physicians
should not be removed from the CAP
program lightly. We think the ability of
the approved CAP vendor to raise these
issues to an independent party, the
designated carrier, for investigation and
a recommendation to us, provides a fair
opportunity for the participating CAP
E:\FR\FM\06JYR2.SGM
06JYR2
39056
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
physician and the approved CAP vendor
to submit evidence in support of
continued participation in CAP or
removal from the program. Our review
of the recommendation adds another
impartial step to the determination of
whether to remove the participating
CAP physician from the program. If we
determine that the participating CAP
physician should be removed from the
CAP program, the ability of the
participating CAP physician to request
reconsideration and the potential for the
involvement of an impartial hearing
officer provides yet another level of
safeguard against the improper removal
of a physician from the CAP program.
However, to take into account the
legitimate business needs of the
approved CAP vendor once a
determination by us has been made that
the participating CAP physician should
have his or her CAP participation
agreement suspended, the physician
will be able to obtain drugs and bill for
them under the ASP payment system
until a final reconsideration
determination is made. In response to
comments, we have removed the last
sentence of § 414.916(b)(3) which
indicated a participating CAP physician
could select another approved CAP
vendor while a reconsideration was
pending. The ability of the Director of
the Center for Medicare Management to
provide a final reconsideration of the
matter is yet a potential fourth level of
safeguard in this process. We believe
this process strikes an appropriate
balance between providing swift
recourse for approved CAP vendors and
the desire for a fixed threshold.
Given the impartial nature of the
process for removing physicians from
the CAP, and after consideration of all
the related comments, we believe that
institution of a fixed threshold would
run counter to the desired outcome. We
seek to have participating CAP
physicians give careful consideration to
Medicare coverage policy before
ordering drugs. There will be cases
when the cost of the denied drug is
high, but the participating CAP
physician researched and considered
the applicable coverage policy as
carefully as possible. Conversely, there
will be cases where the cost of the
denied drug is relatively low, but
coverage was denied because the
participating CAP physician did not
consider whether the applicable
coverage policy would support payment
for the drug and its administration
under the circumstances of the specific
case. The approved drug vendor must be
able to address a participating CAP
physician who flouts coverage policy
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
before a drug with a relatively high cost
is denied. We will monitor the data
trends carefully and may reexamine our
dispute resolution process as we gain
more experience under the CAP. Our
final process is codified in § 414.916(b).
Comment: Some potential physicians
commented and questioned the legal
authority for the designated contractor
to function in this capacity. One
commented that the designated carrier
is not qualified to make the
recommendation discussed in
§ 414.916(b)(2)(i) because the
recommendation amounts to a legal
determination, and the regulation states
no qualification for the individual
designated carrier employee who
develops that recommendation.
Response: As we noted in the
proposed rule, section 1847B of the Act
is generally silent with regard to the
treatment of disputes surrounding the
delivery of drugs and the denial of drug
claims. However, section
1847B(b)(2)(A)(ii)(II) of the Act does
contain reference to a grievance process
which is included among the quality
and service requirements expected of
vendors. We believe that section
1847B(b)(2)(A)(ii)(II) of the Act, at a
minimum, provides authority for this
function of the designated contractor.
We have a longstanding history of
working with contractors such as
carriers and fiscal intermediaries, that
employ individuals to make
recommendations with respect to
various operational and policy issues
related to the administration of the
Medicare program. The designated
carrier will meet all of the qualifications
that are applicable to our administrative
contractors generally.
Specialty carriers perform a variety of
functions to support programs that
deliver benefits in a new or unique
manner. As an example, the Durable
Medical Equipment Competitive
Acquisition demonstration carrier
performed an alternative dispute
resolution function similar to the
function the designated carrier will
perform here.
Therefore, we believe that both the
designated carrier and its employees
will be qualified to undertake the
activities called for in this regulation.
Comment: Some commenters
questioned the impartiality of the
designated carrier and indicated a
preference for the local carrier.
Response: We note that the designated
carrier is not making the removal
determination, but only providing a
recommendation to us. The designated
carrier has been selected from the pool
of existing Part B carriers though the
process used to select Title XVIII
PO 00000
Frm 00036
Fmt 4701
Sfmt 4700
contractors. We will closely monitor the
designated carrier’s dispute resolution
function with Government oversight
staff experienced with other contractors
that perform dispute resolution
functions in the Medicare program.
Although we believe either the
designated carrier or local carrier would
function impartially, the designated
carrier will have the most familiarity
with the CAP program and there are
administrative efficiencies that can be
realized from consolidating this
function. However, because the local
carrier will possess valuable
information to add to the process, the
designated carrier will work closely
with the local carrier as appropriate
before making a recommendation.
Comment: Some potential physician
commenters questioned the
qualifications and impartiality of the
hearing officer.
Response: We find the Director of the
CMS Center for Medicare Management,
the Center with oversight responsibility
for the CAP program, to be abundantly
qualified to make an appropriate
unbiased selection of a hearing officer.
Comment: One commenter
encouraged CMS to inform the
participating CAP physician community
that claims should be submitted timely
and in compliance with local medical
policies. This commenter suggested that
CMS supply approved CAP vendors
with coverage determination
information prior to delivery of the drug
and shift the financial risk to the
participating CAP physician. The
commenter also suggested that CMS
regularly post the CAP claim denial
rates of participating CAP physicians on
a Web site in an effort to encourage
participating CAP physicians to meet
their obligation to file claims and
appeals.
Response: As described earlier, the
participating CAP physicians’ claims
and appeals filing expectations are
described in section II.D.1, ‘‘Physician
Election,’’ of this interim final rule.
Approved CAP vendors should consult
with the local carrier Web sites to
familiarize themselves with LCDs. They
should also review NCDs posted on the
our Web site.
We do not believe it is appropriate to
publish the names and claim denial
rates of participating CAP physicians
because approved CAP vendors will not
have the authority to refuse to service
participating CAP physicians who select
them.
Comment: One commenter asked us
to create a more meaningful way for the
approved CAP vendor to appeal the
local carrier’s denial of the drug
administration claim.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Response: As noted above, we have
clarified that the approved CAP vendor
has an independent right to appeal
claims under existing Part B appeals
rules. To assist approved CAP vendors
in exercising these rights, we are
including a new obligation in the
participating CAP physician’s CAP
election agreement. The participating
CAP physician must reasonably
cooperate with the approved CAP
vendor if the vendor chooses to appeal
the local carrier’s denial. Reasonable
cooperation may include providing the
approved CAP vendor with access to or
copies of medical records, as
appropriate, and written statements.
Comment: Several commenters were
concerned that the process for
determining whether a participating
CAP physician should be removed from
the CAP program would allow approved
CAP vendors to pressure participating
CAP physicians to alter their prescribing
pattern and to intrude unacceptably on
the participating CAP physician’s
clinical decision making.
Response: Please note the approved
CAP vendor will be required under the
terms of its CAP contract to ship the
drug ordered by a participating CAP
physician in most cases. The designated
contractor will closely monitor the
activities of approved CAP vendors and
complaints from participating CAP
physicians to ensure that no such
inappropriate intrusion on physician
clinical decision making occurs.
Participating CAP physicians may
address concerns of this type through
the participating CAP physician/
approved CAP vendor dispute
resolution process described below and
in § 414.917.
Comment: Several commenters
suggested that, during the designated
carrier’s investigation into the
participating CAP physician’s
compliance with his or her CAP election
agreement, the designated carrier should
be explicitly required to gather
information from the participating CAP
physician.
Response: The designated carrier will
gather necessary information from the
local carrier, the participating CAP
physician and the approved CAP
vendor. Section 414.916(b)(2)(ii) has
been adjusted to explicitly include the
physician among the sources of
information the designated carrier must
query during the investigation.
Comment: A commenter from a
physician association believed that the
participating CAP physician should be
allowed to submit additional material to
the record during the phase described in
§ 414.916(b)(3) when CMS makes a
determination whether to suspend the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
participating CAP physician’s CAP
participation agreement.
Response: We agree. Section
414.916(b)(3) has been adjusted to
require us to gather additional material
from the participating CAP physician as
appropriate.
Comment: Several commenters have
suggested emphatically that CMS drop
from the final rule the requirement that
suspended physicians’ names be
published in the Federal Register.
These commenters also requested that
the final rule make clear that suspension
of a CAP election agreement for denial
of claims does not result in the
physician becoming listed on the
exclusion list under section 1128 of the
Act.
Response: A suspension of a
participating CAP physician’s CAP
election agreement or a termination of
an approved CAP vendor’s contract with
us does not result per se in either party
being excluded from participation in
any Federal health care program. Such
a decision only precludes the physician
or vendor from participation in the CAP.
Whether a participating CAP physician
or vendor is excluded from all Federal
health care programs under section
1128, 1128A, or any other exclusionary
authority given to the Secretary under
the Act, shall be based on a
determination made by the Office of
Inspector General of HHS, not by CMS
through the § 414.916 or § 414.917
processes. We agree with the
commenters’ recommendation that we
refrain from publishing the names of
suspended physicians in the Federal
Register, and this requirement has been
removed.
Comment: One potential vendor
suggested that vendors should not be
required to enroll or re-enroll
physicians who had been suspended
from CAP at the conclusion of the
suspension period.
Response: Physicians whose period of
suspension from the CAP program has
ended will be allowed to elect to
participate in the CAP as described
above, and could potentially select the
same vendor that generated the
suspension request. Section
1847B(a)(1)(A)(ii) of the Act states that
each physician is given the opportunity
annually to elect to obtain drugs under
the CAP.
b. Resolution of Physicians’ Drug
Quality and Service Complaints
The proposed rule discussed how the
participating CAP physician would use
the approved CAP vendor’s grievance
process for drug quality or approved
CAP vendor service issues and turn to
the designated carrier for assistance in
PO 00000
Frm 00037
Fmt 4701
Sfmt 4700
39057
developing solutions. Based on
comments from physicians, we have
added § 414.917. This new section sets
forth a process culminating in
termination of the approved CAP
vendor’s contract for serious quality or
service issues. It is described below in
the responses to comments.
Comment: Several commenters
suggested that CMS make approved CAP
vendors indemnify participating CAP
physicians for legal defense costs
connected with ‘‘adverse drug events’’
when the participating CAP physician is
ultimately exonerated.
Response: Individual participating
CAP physicians and approved CAP
vendors can seek legal advice from
someone competent to provide such
advice regarding the product liability
laws and other laws applicable to
financial liability associated with
adverse drug events. We believe that
addressing these complex issues is
beyond the scope of this rule.
Comment: Several commenters
requested that the final rule include a
more definitive process for participating
CAP physicians to employ for the
resolution of service and drug quality
issues. They requested a process that
would include suspension of the
vendor’s right to participate in the CAP
program.
Response: Issues connected with drug
quality and approved CAP vendor
service will be given a top priority. Both
the approved CAP vendor and the
designated carrier will be required to
have qualified staff available to address
drug quality and service complaints
upon their receipt. Egregious drug safety
issues should be brought to the
designated carrier right away. For
instance, evidence of counterfeit drugs
would generate an immediate referral to
the appropriate Federal, State, and local
authorities, including the Department of
Health and Human Services, Office of
the Inspector General. The ultimate
sanction for service and quality issues is
suspension and/or termination of the
approved CAP vendor’s contract upon
exhaustion of the reconsideration
process set forth in § 414.917. This
process is very similar to the process for
removing participating CAP physicians,
which is described above and in
§ 414.916.
When a participating CAP physician
is dissatisfied with the drug quality or
drug delivery performance of an
approved CAP vendor, we expect the
participating CAP physician to make a
meaningful effort to resolve the issue
with the approved CAP vendor
informally, and then to use the
approved CAP vendor’s grievance
procedure. The next step is to ask for
E:\FR\FM\06JYR2.SGM
06JYR2
39058
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
the designated carrier’s assistance in
developing a solution with cooperation
from both parties. Failing resolution
there, the participating CAP physician
may ask the designated carrier to
recommend to CMS that the approved
CAP vendor’s contract be suspended.
CMS will act on that recommendation
after gathering any necessary, additional
information from the participating CAP
physician and approved CAP vendor.
The vendor may appeal our initial
decision through the process articulated
in § 414.917.
In response to these comments, we
also believe that the process set forth in
§ 414.917 is the appropriate means for
approved CAP vendors to seek a review
of our suspension or termination of its
CAP contract under § 414.914(a). We are
specifying that this process will be
available to approved CAP vendors who
are dissatisfied with our determination
to suspend or terminate the CAP
contract for default. While the approved
CAP vendor’s appeal of our decision is
pending, the approved CAP vendor’s
participation in the CAP would be
suspended. We seek further comment
about this issue.
In summary, § 414.916 and § 414.917
present several dispute resolution
processes to treat program challenges
experienced by beneficiaries,
participating CAP physicians, and
approved CAP vendors. The framework
of the process for treating the approved
CAP vendor’s request to suspend the
participating CAP physician’s CAP
election agreement has been changed in
these ways:
• The participating CAP physician
may now offer information to the
designated carrier as it develops its
recommendation on whether CMS
should suspend the participating CAP
physician’s CAP election agreement;
• The participating CAP physician
may now offer information to CMS as it
makes its decision on whether to
suspend the participating CAP
physician’s CAP election agreement;
and
• CMS will not publish in the Federal
Register the names of physicians whose
CAP participation agreements have been
suspended.
Section 414.917 has been added to
create a process for termination of a
vendor’s CAP contract upon the request
of a physician when service and quality
issues cannot be resolved cooperatively.
We will ensure beneficiaries are
educated on the avenues available to
them to dispute billing issues.
Approved CAP vendors may use the
advance beneficiary notice (ABN)
process if the approved CAP vendor
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
reasonably expects its drug claims may
be denied.
c. Resolution of Beneficiary Billing
Issues
In the proposed rule, we specified
that the beneficiary would receive a
medical summary notice (MSN) from
the local carrier indicating whether the
physician’s drug administration claim
has been paid or denied. If the drug
administration claim has been denied,
the MSN would reflect a message
instructing the beneficiary that no
deductible or coinsurance may be
collected for the drug. If the beneficiary
receives a bill for coinsurance from the
vendor, the beneficiary may participate
in the approved CAP vendor’s grievance
process to request correction of the
approved CAP vendor’s file. If the
beneficiary is dissatisfied with the result
of the approved CAP vendor’s grievance
process, the beneficiary may request
intervention from the designated carrier.
The designated carrier would first
investigate the facts and then facilitate
correction to the appropriate claim
record and beneficiary file. If the
approved CAP vendor requires targeted
education on the subject of beneficiary
billing, the designated carrier would
initiate that effort.
Comment: Several commenters
requested that CMS require every CAP
MSN to include standard language
clearly explaining the beneficiary
grievance process and make clear that
the CAP physician is not involved with
billing for drug coinsurance amounts.
Response: We share the commenters’
concern that beneficiaries should be
provided with complete and timely
information about the approved CAP
vendor’s grievance process. We support
the commenters’ interest in giving the
beneficiary notice that the participating
CAP physician is independent from the
approved CAP vendor. We will consider
these comments as the educational
materials are finalized. All beneficiary
education materials are focus-group
tested to be certain they are
understandable and communicate the
intended message. We will require
approved CAP vendors to provide
participating CAP physicians with
information on how beneficiaries, and
participating CAP physicians, can each
use their respective grievance processes
when the approved vendors send
introductory materials to the
participating CAP physicians each
autumn. It is unlikely the Medicare
summary notice will be used to
communicate about the beneficiary
grievance process because there will
exist no billing dispute until the
approved CAP vendor actually bills the
PO 00000
Frm 00038
Fmt 4701
Sfmt 4700
beneficiary. Information on the
beneficiary grievance process will be
more appropriately included with any
bill the approved vendor may send to
the beneficiary. We also will require all
participating CAP physicians to
distribute the CMS developed fact sheet
to beneficiaries in the participating CAP
physician’s office. The fact sheet
presents a good medium for distribution
of information on the beneficiary
grievance process, and information
about the participating CAP physician’s
independence from the approved
vendor.
Comment: Several commenters have
requested that we describe whether and
how an approved CAP vendor could
deliver an ABN to a beneficiary.
Response: An ABN is the standard
mechanism for advising beneficiaries of
the cost of items and/or services for
which they will be financially
responsible. Generally, an ABN informs
the beneficiary that, even though the
service being delivered may be covered
by Medicare in some situations, the
issuer has reason to believe Medicare
coverage policy will not support
payment under the circumstances of the
present case. For instance, an approved
CAP vendor may reach the conclusion
that the drug it is providing to the
participating CAP physician for
administration to the beneficiary would
not be reasonable and necessary—and
therefore will not be paid for by
Medicare—after reviewing data on the
prescription order and having follow-up
communication with the participating
CAP physician. The approved CAP
vendor may request the participating
CAP physician to deliver an ABN. If the
participating CAP physician agrees to
do so, then the physician will describe
on the ABN both the administration
services and the drug product, together
with the estimated cost for each that the
beneficiary must pay if he or she
receives the drug.
If the participating CAP physician
will not deliver an ABN on behalf of the
requesting approved CAP vendor, then
the approved CAP vendor may issue an
ABN directly to the beneficiary before
the item(s) or service(s) is received. For
instructions and forms connected with
ABNs, please visit this Web site:
http//www.cms.hhs.gov/medicare/bni.
C. CAP Contracting Process
1. Quality and Product Integrity Aspects
Sections 1847B(b)(2), 1847B(b)(3), and
1847B(b)(4) of the Act address the issue
of quality under the competitive
acquisition process at both the product
and approved CAP vendor level. We
proposed to use the bid evaluation
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
process to ensure that these quality
aspects are met.
a. Information To Assess and Ensure
Quality
Sections 1847B(b)(2) and 1847B(b)(3)
of the Act specifically require that
approved CAP vendors meet financial
and quality of care requirements aimed
at assuring the stability and safety of the
CAP program. Section 1847B(b)(2)(A) of
the Act requires that approved CAP
vendors have sufficient capacity to
acquire and deliver drugs in a timely
manner within the geographic area, to
deliver drugs in emergency situations,
and to ship drugs at least 5 days each
week. This section also requires that
approved CAP vendors meet quality,
service, financial performance, and
solvency standards, which include
having procedures for dispute
resolution with physicians and
beneficiaries regarding product
shipment, and having an appeals
process for the resolution of disputes.
We proposed that CMS be allowed to
suspend or terminate an approved CAP
vendor’s contract if the vendor falls out
of compliance with any of these quality
requirements. Section 1847B(b)(2)(B) of
the Act states that the Secretary may
refuse to award a contract, and may
terminate a contract if the entity’s
license to distribute drugs (including
controlled substances) has been
suspended or revoked, or if the entity is
excluded from participation in the
Medicare or other Federal health care
program under section 1128 or 1128A of
the Act. In the proposed rule, we stated
this requirement is enforced through the
routine provider enrollment form
monitoring process. We also specified
that section 1847B(b)(3)(C) of the Act
states that the ability to ensure product
integrity must be included in the criteria
for awarding approved CAP vendor
contracts.
In the March 4, 2005 proposed rule,
we stated that at a minimum, we wanted
to define a set of overall financial and
quality standards to ensure that
reputable and experienced vendors are
chosen to participate in the CAP. We
believe that physicians would be
reluctant to participate in the CAP if
they had little confidence that the CAP
vendors would be reliable and provide
quality CAP products. We also stated
that approved CAP vendors would be
required to provide quality products in
a timely manner.
Section 1847B(b)(4)(C) of the Act
specifies that any contractor selected for
this program ‘‘shall (i) acquire all drugs
and biological products it distributes
directly from the manufacturer or from
a distributor that has acquired the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
products directly from the
manufacturer; and (ii) comply with any
product integrity safeguards as may be
determined to be appropriate by the
Secretary.’’ We proposed to include this
requirement in the contracts signed
between CMS and approved CAP
vendors who are providing drugs or
biologicals under this section. We
solicited comments on what records or
other evidence bidders would be
required to furnish and approved CAP
vendors would be required to maintain
during the contract period.
Comment: Several commenters raised
issues related to product integrity and
vendors’ distribution systems (for
example, shipping and storage
procedures). In addition, many
commenters, including physicians,
potential vendors, and a mix of other
affected groups, associated high quality
with appropriate access to care,
avoiding delays in therapy, and
beneficiary safety. Commenters did not
perceive new or additional product
integrity requirements as desirable, but
requested that we provide a more
specific description of product integrity
and other quality requirements. One
commenter noted that the criteria for
assessing the adequacy of retail
pharmacy networks under Tricare and
the Part D rule (68 FR 4194) that will be
implemented in 2006 exist and that
these guidelines could be used to
evaluate CAP vendors.
Response: The approved CAP
vendors’ ability to accurately furnish
drug products in a timely manner will
be vital to this program’s success.
Assessment of the bidding entity’s
ability to perform similar drug
distribution tasks and the entity’s
financial status will occur through the
Medicare Provider enrollment process
and through a separate CAP Vendor
Application. This form was made
available for public comment and is
pending OMB approval.
In an effort to ensure that the CAP
provides high quality service and to
protect the integrity of drugs furnished
under the CAP, we proposed that the
approved CAP vendor be a Medicare
provider or supplier, and we proposed
additional and more specific
requirements on licensing, product
integrity, and contract agreements. We
plan to implement these requirements
in this interim final rule. The proposed
regulation and corresponding changes to
sections § 414.908(b) and § 414.914(f) of
the proposed regulation reflect these
requirements. The Provider Enrollment
and Vendor Application form process
will collect the detailed information that
will be used to assess a potential CAP
vendor’s capacity to acquire drugs, and
PO 00000
Frm 00039
Fmt 4701
Sfmt 4700
39059
the ability to provide quality products
and service, timely and accurate
shipping, use of a compliance plan,
history of past experience, and evidence
of appropriate State licensure. We
believe that the requirements described
above will not be improved by
incorporating additional criteria
intended to assess retail pharmacy
networks because CAP vendors are
expected to operate differently than
retail pharmacy networks. In addition,
we have determined that the CAP
vendors will be considered suppliers for
Medicare purposes.
Comment: Several commenters stated
that in order to attract physician
participation, quality requirements
should be stringent, and approved CAP
vendors should be held to very high
standards for quality and performance.
These commenters agreed that
measures, up to and including contract
termination, were appropriate means of
dealing with failure to adhere to a
contractual agreement. One commenter
also requested that we clarify the
procedure physicians should follow to
obtain CAP drugs when an approved
CAP vendor is terminated from the
program.
Response: As mentioned earlier,
entities seeking a contract to furnish
CAP drugs will be required to submit
detailed information that will be used
during the bid evaluation. Ongoing
quality assessment will be conducted in
a variety of ways, including routine
Medicare provider enrollment
monitoring, carrier statistics, and
complaint monitoring. Approved CAP
vendors are also expected to maintain
appropriate licensure to furnish CAP
drugs in the States in which they are
supplying drugs and to maintain status
as a Medicare supplier through the
contract’s period of performance.
During the contract’s period of
performance, compliance with these
standards, as well as such other terms
and conditions as we may specify
consistent with section 1847B of the
Act, will be a contractual requirement.
The contract between CMS and an
approved CAP vendor shall provide for
contract termination for patterns of poor
performance, single serious breaches of
contract, or failure to comply with
applicable laws and regulations.
Methods to improve vendor
performance and to resolve disputes
between parties are discussed in the
dispute resolution section of this
interim final rule in section II.B.3. We
note that the process described in
§ 414.917 for reconsidering the
termination of a CAP vendor’s approved
status applies not only in cases where
the termination was the result of a drug
E:\FR\FM\06JYR2.SGM
06JYR2
39060
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
service or quality issue brought to our
attention by a participating CAP
physician, but also in cases where we
suspend the CAP contract for
noncompliance or terminate the CAP
contract for cause under § 414.914(a).
We believe that this process will
provide approved CAP vendors with an
adequate process to contest our decision
to suspend or terminate the contract. As
noted above, pending the final
determination under § 414.917, the
approved CAP vendor’s contract is
suspended. Finally, we note that we
consider the termination of the
approved CAP contract to be separate
and distinct from any determination
with respect to the approved CAP
vendor’s status as a Medicare supplier.
Therefore, the provisions of 42 CFR part
498 would not apply in the case of the
termination of a CAP contract.
Comment: One commenter stated that
the statutory requirement to make
payments to the vendor meant that
vendors would not be permitted to
subcontract with a local or State
licensed pharmacy, because the
pharmacy could not be reimbursed
directly. The commenter believes that
this would mean that an approved CAP
vendor would be required to obtain a
license in each State, and the overall
cost of the program would be increased.
Response: We do not agree that the
statutory requirement that states
payments be made directly to the
approved CAP vendor would preclude
the vendor from subcontracting with
another drug distributor or pharmacy. A
vendor could subcontract with another
entity as long as that entity met all of
our approved CAP vendor requirements
and the subcontracting arrangement was
divulged in the vendor’s CAP
application. A subcontractor’s
qualifications, including its history,
structure, ownership and measures used
to ensure product integrity must be
described on the application and will be
reviewed during the bidding process.
The applicant is also required to certify
that other aspects of a subcontractor’s
operation are in compliance with
licensing requirements, Federal and
State requirements, including
compliance with all applicable fraud
and abuse requirements, and that key
personnel have not been excluded from
participation in various Federal and
State health care programs, including
Medicare. It is the approved CAP
vendor’s responsibility to determine
that subcontractors remain compliant
with these standards. We intend that
subcontractors or other entities
associated with furnishing CAP drugs
under an approved CAP vendor’s
contract maintain the same standards as
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
the approved CAP vendor for the role
that they play in furnishing CAP drugs.
Section 414.914(f)(9) of the regulation
states subcontractors’ requirements.
The approved CAP vendor and the
subcontracted entity would need to
make arrangements between themselves,
so that even if the subcontractor
handled the billing in a particular area,
it would still be acting as an agent of the
vendor and identify itself as acting on
the vendor’s behalf. Medicare will only
make payment to the vendor, and the
vendor is responsible for payment to the
subcontractor. Payment from the vendor
to the subcontractor shall be consistent
with all applicable laws, including all
fraud and abuse laws such as the
physician self-referral (‘‘Stark’’)
prohibition (section 1877 of the Act)
and the Federal anti-kickback statute
(section 1128B(b) of the Act).
Comment: Several comments stated
that proven capacity, including specific
experience with Part B injectable drugs,
was a desirable quality for a vendor.
One commenter stated that evidence of
Pharmacy licensing would be a
sufficient measure as an alternative to
the requirement for 3-years of
experience furnishing Medicare Part B
drugs. Among commenters who
discussed a specific timeframe
associated with furnishing Part B drug
injectable drugs, 3 years was generally
acceptable, but some commenters
suggested that experience with the
drugs in a category would be a better
marker. One commenter asked if our 3year requirement for ‘‘furnishing’’ Part B
injectable drugs meant furnishing drugs
that would be used by physicians for
their Medicare beneficiaries under the
ASP system, specialty pharmacy, and
distribution experience. One commenter
also stated that the ability to ship on an
immediate basis was highly desirable.
Other commenters stated that 3 years of
experience furnishing Part B injectables
did not measure services expected in a
pharmacy dispensing model, and its
restrictive nature could decrease
competition. Another commenter
specifically recommended that we ask
for references that could describe the
entity’s customer service.
Response: Although pharmacy
licensing may indicate some vendors’
ability to meet certain standards and
may be required in some States, we
believe that 3 years’ experience in
furnishing Medicare Part B drugs serves
to demonstrate the approved CAP
vendors’ commitment to maintaining an
infrastructure required to acquire, store,
and handle these drugs, to ship them in
a timely manner, and also demonstrates
familiarity with these products at the
organizational level.
PO 00000
Frm 00040
Fmt 4701
Sfmt 4700
Information supplied during the
provider enrollment process and from
the Vendor Application Form addresses
the comments above. Although this
process does not specifically ask for
references, the process collects and
checks similar information, including
licensure, financial stability, and
business affiliations. In response to
these comments, we plan to amend the
Vendor Application form to include a
request for references from businesses or
organizations to which the bidding
entity has supplied significant volumes
of Medicare Part B injectables.
Comment: Several commenters raised
issues regarding licensure and its
relationship to quality. Although some
comments supported the inclusion of
pharmacists in the CAP order process,
others pointed out that the involvement
of additional professionals may not
guarantee product integrity.
Response: The issue of licensing is
discussed elsewhere in this IFC. We do
not seek to pre-empt State law, but we
also recognize that licensing
requirements may not always guarantee
quality. Approved CAP vendors will be
required to have and maintain licensure
that is required by the State(s) in which
they furnish drugs under the CAP. This
licensing requirement and additional
quality requirements included in the
vendor application process and
ultimately in the approved CAP
vendor’s contract are intended to ensure
that the CAP provides the highest
quality services.
b. Product Integrity
Section 1847B(b)(3)(C) of the Act
states that the Secretary must consider
the ability of the applicant to ensure
product integrity. We proposed that the
evaluation include, but not be limited
to, the applicants’ ability to assure that
products are not adulterated,
misbranded, spoiled, contaminated,
expired, or counterfeit. We stated that at
a minimum, all drugs and biologics
used in this program must be licensed
under section 351 of the Public Health
Service Act or approved under section
505 of the Federal Food, Drug, and
Cosmetic Act. We also indicated
approved CAP vendors would also be
required to comply with sections 501
and 502 of the Federal Food, Drug, and
Cosmetic Act concerning adulteration
and misbranding. We note drug
products furnished under CAP are
expected to comply with FDA
requirements including current good
manufacturing practices (See
501(a)(2)(B) of the Federal Food Drug
and Cosmetic Act; 21 CFR Parts 210 and
211 for finished pharmaceuticals).
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Additionally, we proposed that
applicants would be required to employ
trained personnel, have appropriate
physical facilities, and use adequate
security measures to assure that
processing, handling, storage, and
shipment of drugs and biologicals are
adequate to maintain product integrity.
Because Federal statutory and
regulatory requirements are designed to
meet the standards in the paragraph
above, we also proposed to require that
all applicants comply with State
licensing requirements and be in full
compliance with any State or Federal
requirements for wholesale distributors
of drugs or biologics in States where
they furnish drugs for the CAP.
Although we did not propose to
require applicants to employ measures
beyond those required for licensure and
regulatory compliance, we believe the
measures set a minimum standard, and
we requested that applicants discuss
any additional measures they have
taken to assure product integrity. We
suggested that applicants review the
report on counterfeit drugs issued by the
Food and Drug Administration (FDA),
‘‘Combating Counterfeit Drugs,’’
available on the FDA Web site https://
www.fda.gov/counterfeit. We proposed
that applicants describe measures taken
to ensure drug product integrity on the
CAP vendor application. We provided
examples of additional measures that
posed minimal burden, but enhance the
ability to detect adulterated, misbranded
or counterfeit drugs that included the
following:
• Complying with the
‘‘Recommended Guidelines for
Pharmaceutical Distribution System
Integrity’’ developed by the Healthcare
Distribution Management Association,
available at https://
www.healthcaredistribution.org.
• Cooperating with Federal and State
authorities in their investigations of
suspected counterfeit drugs.
• Establishing mechanisms to obtain
timely information about suspected
counterfeits in the marketplace and to
educate their employees on how to
identify them.
• Notifying appropriate State and
Federal authorities within 5 business
days of any suspected counterfeit
products discovered by the wholesaler.
Comment: A number of commenters
agreed that vendors must demonstrate
commitment to furnishing products that
were not adulterated, misbranded,
spoiled, contaminated, expired, or
otherwise counterfeit. Commenters also
supported CMS’ overall approach to
maintaining product integrity and
vendor contract requirements that
include the statutory requirement for
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
acquiring CAP drugs directly from the
manufacturer or from a distributor who
has acquired the drug from a
manufacturer. One commenter also
suggested that we require approved CAP
vendors to be in compliance with the
Prescription Drug Marketing Act
(PDMA) in addition to State and other
Federal requirements.
Response: The CAP vendor
application process, the maintenance of
appropriate licensure and Medicare
supplier status form the framework for
protecting product integrity. We believe
that these requirements address the
qualifications of personnel who may be
handling the drugs as well. The FDA,
not CMS, is the agency that is charged
with enforcing the PDMA, however
approved CAP vendors are still subject
to the PDMA’s requirements, including
the prohibition on the sale of drug
samples. Vendors should consult with
the FDA for further guidance on the
PDMA.
Comment: Another commenter stated
that distributors and vendors that
participated in the CAP supply chain
could verify a product’s origin and
avoid use of a paper pedigree (a
document that tracks the product’s
origin) by including simple language
with shipping materials. The language
would verify that CAP drugs were
obtained directly from the manufacturer
or from a distributor that acquired them
from the manufacturer. This commenter
also noted that a ‘‘paper pedigree’’
system was burdensome and subject to
forgery or other types of failure, and that
practical electronic pedigrees are a
future solution that is 2 to 4 years away.
Response: The statute does not
exempt CAP vendors from PDMA
requirements, therefore a CAP vendor
who makes a wholesale distribution of
prescription drugs for which it is not an
authorized distributor is required to
pass on a pedigree that complies with
PDMA and current regulations (see
U.S.C. 353(e)(1)(A). Since some CAP
drug shipments may not be classified as
drug distribution, we also require a
distributor who ships to an approved
CAP vendor or an approved CAP vendor
who ships to a physician’s office to
include language with shipping material
stating that the drug was acquired
directly from the manufacturer or that
the vendor possesses verification that
the drug was acquired directly from the
manufacturer and has been acquired in
a manner that is consistent with
statutory requirements. The approved
CAP vendor or the distributor must also
be able to immediately furnish evidence
to support that information if requested
by CMS, its contractors, law
enforcement, the designated carrier, or a
PO 00000
Frm 00041
Fmt 4701
Sfmt 4700
39061
physician’s office. We have modified
the regulation text at § 414.906(a)(4) and
§ 414.914(c)(1) to reflect the comments
above.
Comment: Some commenters
expressed concern that physicians could
not vouch for the quality of products
that were opened by the vendor for
repackaging, for mixing the drug with
other drugs or injectable fluids
(admixture), or for removing a part of
the contents in order to supply the exact
dose for a beneficiary. Therefore, these
commenters recommended that vendors
deliver their products in the same form
in which they are received from the
manufacturer, without opening
packaging or containers, mixing or
reconstituting vials, or repackaging.
Specific points of concern included the
capabilities of individuals who mix the
drug, as well as shipping conditions,
storage and stability.
Response: CAP is not intended to
require approved CAP vendors to
perform pharmacy admixture services,
(for example, to furnish reconstituted or
otherwise mixed drugs repackaged in IV
bags, syringes, or other containers that
are ready to be administered to a
patient) when furnishing CAP drugs.
Admixture services for injectable drugs
require specialized staff, training, and
equipment, and these services are
subject to standards such as United
States Pharmacopoeia Chapter 797,
Pharmaceutical Compounding—Sterile
Preparations. These requirements have
significant impact on drug shipping,
storage, and stability requirements as
well as system cost and complexity.
Approved CAP vendors are to ship CAP
drugs in unopened manufacturer’s
packaging. Packages containing multiple
individual units of one drug (like vial
trays) may be split into quantities that
are appropriate for a beneficiary’s
shipment, but individual vials must be
unopened and any packaging
surrounding the individual vial must be
left intact.
Comment: One commenter mentioned
that because approved CAP vendors
would obtain drugs directly from the
manufacturer or from a distributor who
had obtained the drugs directly from the
manufacturer, the Healthcare
Distribution Management Association
(HDMA) Recommended Guidelines for
Pharmaceutical Distribution System
Integrity would not apply. The
guidelines were not intended to be
applied to relationships between
distributors and manufacturers. Instead,
they had been developed for situations
when a distributor was planning to buy
drug products from another distributor,
or to establish trading partner
agreements. Because the document was
E:\FR\FM\06JYR2.SGM
06JYR2
39062
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
a guideline, the commenter urged CMS
to allow vendors to use the guidelines
to fit the individual vendor’s
circumstances.
Response: The HDMA Guidelines
were being used as an example of
measures that could be used or adapted
in order to decrease risk of product
integrity. We did not propose to require
applicants to employ further measures
beyond those required for licensure and
regulatory compliance. However, we
would like bidders to be aware of
specific additional measures, such as
the HDMA Guidelines, that may be used
to protect product integrity.
Comment: One commenter stated that
a formal compliance program to ensure
adherence to drug storage and handling
requirements should be required of
vendors and distributors, and that this
information should be a part of the bid.
Response: We believe that the vendor
application process we proposed will
adequately assess a bidding entity’s
compliance plan. The vendor
application form specifically requires
the applicant to submit a compliance
plan that describes written policies,
procedures, and standards of conduct
articulating the organization’s
commitment to abide by all applicable
Federal and State standards; the
designation of a compliance officer and
compliance committee accountable to
senior management. The compliance
plan is also required to establish
effective training and education of the
compliance officer, organization
employees, contractors, agents, and
directors; effective lines of
communication between the compliance
officer and organization employees,
contractors, agents and directors and
members of the compliance committee;
disciplinary standards; procedures for
internal monitoring and auditing; and
procedures for ensuring prompt
response to detected offenses and
development of corrective action
initiatives, relating to the applicant’s
contract as an approved CAP vendor.
In the application and under our
regulation at § 414.914(c)(6)), we also
recommend that applicants’ compliance
plans include provisions that require
the reporting of fraud and abuse to the
appropriate government authority.
Approved CAP vendors that self-report
violations will continue to receive the
benefits of voluntary self-reporting
found in the False Claims Act and
Federal sentencing guidelines.
As we mentioned elsewhere, in order
to monitor approved CAP vendor
quality, we plan to include routine
Medicare provider enrollment
monitoring, carrier statistics, and
complaint monitoring. Vendors are also
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
expected to maintain appropriate
licensure to furnish CAP drugs in the
States in which they are supplying
drugs.
Comment: For quality standards other
than product integrity, two commenters
suggested that we use the DMEPOS
Supplier Manual as a guideline.
Response: The CAP does not
encompass DME drugs and is intended
to furnish medications to a physician’s
office. Therefore, we do not believe that
the DMEPOS quality standards are an
exact match for the CAP. However, we
do note that our focus on product
integrity, accurate delivery and other
vendor qualifications, including
enrollment as a Medicare supplier are
similar to the DMEPOS standards.
Comment: Several comments
questioned how the effects of shipping
on product integrity would be addressed
and were especially concerned with
breakage, damage, and delays. One
commenter asked who would bear the
cost burden of shipping a damaged drug
or a drug whose integrity was in
question, and whether replacement
would be offered. Another suggested
that approved CAP vendors be
responsible for maintaining records of
product integrity from the time that the
vendor received the product until it
reached the physician’s office, including
situations where a third party shipper
transported the drug to the physician’s
office.
Response: Approved CAP vendors are
required to ship drugs in a manner that
will protect product integrity and a
manner that is consistent with the
definitions of the CAP delivery time
frames, contractual obligations under
the CAP, and drug stability
requirements. Approved CAP vendors
are also responsible for keeping records
of how and when a specific drug order
was shipped to the physician’s office.
Finally, vendors are financially
responsible for the shipping costs
associated with the return of drugs, and
the approved CAP vendor retains title to
the drug until it is administered.
However, as noted above, other issues
regarding product liability laws and
other laws applicable to financial
liability associated with adverse drug
events are beyond the scope of this rule.
Comment: Commenters suggested that
we provide specific guidance on how to
manage drug waste and returns.
Response: Although a variety of
situations may create quantities of
unused drugs at the place of
administration, we believe the unused
CAP drugs will come in 3 forms: an
unopened vial (and/or vial package) as
shipped by the approved CAP vendor,
an opened vial (that may or may not be
PO 00000
Frm 00042
Fmt 4701
Sfmt 4700
reconstituted or partly used), and a drug
that has been removed from a vial or
package and is in a syringe, IV bag, or
other device or container used for drug
administration. Unused quantities of a
drug may increase the risk of waste,
fraud and abuse, and attempts to use the
excess drug may violate pharmacy law
and may compromise product integrity.
We expect that approved CAP vendors
will furnish drugs in a manner that will
minimize unused drug. We also expect
that physicians and approved CAP
vendors will both make an effort to
label, ship, and store drugs in a manner
that will allow the legal reuse of an
unopened and intact container of a
drug. Returns of unused products
through a distribution system may be
acceptable, however many States
prohibit reusing drugs that have been
dispensed by a pharmacy (For further
information, see FDA CPG 460.300). We
are aware of situations when an
approved CAP vendor may label a
vendor-supplied outer container for
prescriptions to keep the actual
manufacturer’s packaging intact and
unlabelled. We further expect approved
CAP vendors to offer and ship units of
a drug that match the beneficiary’s
dosing requirements and HCPCS billing
amount as closely as practical. In this
way, a degree of waste will be
prevented. Specific details, including
how waste, returns, and their cost
burden are handled, will depend on
State law and regulation as well as the
individual situations. Approved CAP
vendors should establish policies on
these issues (making sure that they
comply with applicable laws and
regulations) and make the policies
available for physicians to review
during the election period and through
the CAP contract’s period of
performance.
Approved CAP vendors will furnish
drugs to physician’s offices in unopened
vials. However, in situations where a
drug is dosed by body weight or body
surface area, the amount of drug in vials
may not match the patient’s actual dose,
and the vendor will be forced to ship
excess drug. In certain States, pharmacy
law may prevent the use of excess CAP
drug for another beneficiary if the order
must be labeled as a prescription.
The return process is guided by the
following:
• Federal Law and guidelines (such
as the FDA’s CPG 460.300), State law,
Medicare requirements (such as the
Claims Processing Manual), drug
stability, and appropriate standards
(such as United States Pharmacopoeia
Chapter 797, Pharmaceutical
Compounding—Sterile Preparations)
will be used to determine how extra
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
drug product may be used for
subsequent dosing on the same
beneficiary or for use on another
beneficiary.
• If excess drug product remaining in
a vial shipped by an authorized CAP
vendor must be returned, the approved
CAP vendor is expected to accept excess
drugs for disposal and is expected to
pay for shipping. The physician is
responsible for appropriately packing
the drug. Consolidating shipping into
larger and less frequent packages by the
physician would be encouraged. We do
not intend for this requirement to be
used as a vehicle for routine disposal of
empty or nearly empty vials, disposal of
any drug product not shipped by an
authorized CAP vendor, or disposal of
drug mixed in IV bags, syringes,
associated needles and tubing, or other
devices used in the administration of
the drug product to a beneficiary.
• The vendor bills Medicare only for
the amount of drug administered to the
beneficiary and the beneficiary’s
coinsurance amount will be calculated
from the quantity of drug that is
administered. Since the CAP statute
authorizes us to pay the approved CAP
vendor only upon administration of the
drug, any discarded drug (or drug that
is considered waste) will not be eligible
for payment. We have modified the
proposed regulation at § 414.906(a)(5).
The CAP dispute resolution process
will be available to resolve any
associated disputes. This process is
described in the interim final rule at
section II.B.3.
Comment: Commenters also cited
‘‘brown-bagging’’ (that is, having a
beneficiary pick up a drug at a
pharmacy and bring it to the physician’s
office for administration) as a potential
threat to product integrity as well as an
inconvenience for the beneficiary.
Response: We agree that the practice
of brown bagging may jeopardize
product integrity by potentially
subjecting the drug to unknown storage
conditions and exposing the drug to
diversion. Brown bagging may also
create a further burden on the
beneficiary by requiring additional time
and travel to obtain the drug product
and then requiring appropriate storage
of the drug. Section 1847B(b)(4)(E) of
the Act indicates that drugs furnished
under the CAP must usually be shipped
directly to the physicians. The CAP is
being implemented in a manner
consistent with section 1847B(b)(4)(E) of
the Act; therefore, we do not expect
‘‘brown bagging’’ to occur.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
c. Financial Performance and Solvency
Standards
Section 1847B(b)(2) of the Act
discusses the financial performance and
solvency standards we must develop for
entities that seek to become approved
CAP vendors. We proposed to fold
integrity and internal control aspects of
fiscal responsibility into this analysis.
In the March 4, 2005 proposed rule,
we stated that while licensure by the
State to distribute drugs may assess
some degree of financial responsibility,
we believe the focus and depth of
financial capability evaluations
associated with licensure might vary
across States. To assess bidders’
financial solvency in a consistent
manner with appropriate scrutiny and
minimal burden on the bidders, we
proposed using criteria from the Federal
Acquisition Regulation (FAR) Section
9.104 and following standards for
‘‘responsible contractors’’ as a baseline
standard. The FAR standards also
contain nonfinancial components that
address areas such as integrity,
performance, and ethics. In addition, we
sought to add standards that would
demonstrate the following:
Overall Capitalization and Financial
Capability and Working Capital
We proposed that bidders furnish a
copy of their most recent year’s audited
financial statements. Specific items,
such as net worth, could be used in the
evaluation process. We requested
comments on the potential validity of
specific financial indicators for this
process and whether or not specific
thresholds would be applicable. We also
requested comment on this overall
requirement from potential bidders,
such as group purchasing organizations
Group Purchasing Organizations
(GPOs), who do not routinely take
possession of drug products.
We proposed to review the audited
financial statements to determine if the
bidder has adequate working capital to
meet contractual obligations. Ratios of
current assets to current liabilities, total
liabilities to net worth, and cash or cash
equivalents to current liabilities are
commonly used to assess financial
capability (see the form at FAR 53.301–
1407). Given the 3-year contract
duration, we requested comments
regarding the appropriateness of these
tests, and thresholds to apply for the
ratios.
Comment: Several commenters noted
that financial standards in the proposed
rule were not clearly defined. One
commenter agreed that financial
capability standards were important, but
cautioned against setting standards that
PO 00000
Frm 00043
Fmt 4701
Sfmt 4700
39063
could unfairly or inadvertently exclude
bidders due to insufficient
capitalization, while another suggested
that credit worthiness be evaluated in
cases where a bidder was seeking to
expand operations by participating as an
approved CAP vendor. Other
commenters suggested that vendors
have significant financial stability to
withstand the potential risk of
participating in CAP and that debt to
capital ratio be included in the
evaluation because the commenter
considered financial ratio to be
particularly useful in assessing a
prospective vendor’s financial stability.
Response: In the proposed rule we
stated that we sought to define a set of
overall financial standards that would
ensure that reputable and experienced
vendors are chosen to participate in the
CAP. As noted by several commenters,
the proposed rule was intended to
provide us with a framework to which
we could add details based on public
comment.
Financial data supplied by the
bidders is intended to demonstrate that
the entity is capitalized, generating sales
volume, and is not operating at a loss.
We also plan to use several simple
financial ratios from Standard Form (SF)
1407, Preaward Survey of Prospective
Contractor Financial Capability (see
FAR 53.301–1407) to determine whether
a contractor has financial resources to
perform a contract. We expect bidders to
have a current ratio (current assets :
current liability) of >1. However, many
bidders are expected to have significant
inventory, particularly if they are
engaged in drug distribution activities.
We will also apply the quick ratio (also
known as the acid test ratio, that is,
current assets minus inventory : current
liability). Comparison of the current and
quick ratios also gives a sense of the
relative amount of inventory that an
entity may possess The debt to equity
ratio (total liability : net worth) is
intended to gain a sense of the role that
creditors have in financing the entity’s
operations. These ratios will be used to
help assess whether the vendor can
meet obligations to deliver CAP drugs
on receipt of a prescription order. More
specific financial information, such as
audited annual financial statements,
will be used to confirm the general
findings above.
Bidding entities could be a diverse
group that could include single
organizations or groups. The entities
could have a variety of backgrounds
including drug distribution, specialty
pharmacy, or group purchasing.
Therefore, in an effort to minimize the
risk of having an absolute threshold
disqualify a potentially capable bidder,
E:\FR\FM\06JYR2.SGM
06JYR2
39064
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
we are avoiding using absolute
thresholds when possible. Instead, we
plan to compare data, especially the
financial ratios, and use the data to rank
bidders relative to one another. We will
rank the bidders on four basic financial
categories: Financial ratios, profitability,
capitalization, and total sales. These
rankings would then be used along with
quality information provided during the
bidding process and bid prices to select
vendors who will be offered a contract
to furnish drugs under CAP. A lower
financial ranking will not be an absolute
reason for exclusion from the bidding
process, but will be one of several
factors being evaluated.
Comment: One commenter stated that
requiring bidders to have Medicare sales
account for less than half of their total
predicted sales volume for the
upcoming year would demonstrate an
entity’s scale and would limit the
entity’s dependence on Medicare as a
means to ensure financial viability.
Response: Although we believe that
experience with Medicare Part B
injectable drugs is necessary for a
vendor, we do not believe that it would
be appropriate for us to set a limit in the
manner the commenter suggests because
it could interfere with the vendor’s
business planning and may have the
effect of excluding qualified bidders.
Comment: Group Purchasing
Organizations (GPOs) and similar
entities who do not routinely take
possession of drug products were
invited to comment on the assessment
of a bidder’s financial capability.
However, we received one comment
from a GPO expressing concern about
the significant financial risk of longterm receivables and low margins, but
GPOs did not comment specifically on
proposed financial indicators.
Response: We will use the financial
evaluation process outlined earlier. By
statute, payment for drugs furnished
under CAP is conditioned upon the
administration of a drug to the
beneficiary. This limits how soon a
vendor can be paid. We believe that
establishment of operations and the
opportunity for periodic price
adjustments will create an opportunity
for the vendors to achieve financial
stability while participating in the CAP.
Comment: Several commenters agreed
with deriving financial and solvency
standards from the FAR. Commenters
also suggested that FAR business
integrity and conflict of interest
standards be adopted. Finally,
commenters requested details on how
ongoing compliance would be
monitored, which parameters would
have to be reported, and penalties for
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
failing to report standards or missing the
standards.
Response: The proposed rule
mentions using FAR Section 9.104 as a
baseline for evaluating a prospective
contractor. We also adapted a form (FAR
53.301–1407) used for the preaward
financial evaluation of a contractor for
use in the Vendor Application.
However, the FAR does not contain
specific financial solvency standards.
We did not propose a competition
strictly based on FAR, nor do we plan
on implementing CAP in this manner in
this interim final rule. Business
integrity, conflict of interest,
compliance, and penalties are discussed
in section 2.B.2 of this interim final
rule.
Record of Integrity
We proposed that the bidders supply
us with applicable information on
whether any of the bidder’s Board of
Directors, employees, affiliated
companies, or subcontractors—
• Know they are under investigation
by any State, Federal, or Local
Government agency related to a fraud
issue; and
• Have escrowed money in
anticipation of, or entered into a
settlement agreement or corporate
integrity agreement with any State or
Federal Government agency related to a
fraud issue.
We also proposed that bidders
provide a conflict of interest mitigation
plan to address financial relationships
the bidder may have with manufacturers
of drugs or biologicals in the CAP.
We received no comments on this
topic. Therefore, we will finalize these
requirements as proposed. The vendor
application process, which includes
enrollment as a Medicare Supplier and
the completion of the Vendor
Application and Bid Form will provide
information related to a record of
integrity. Bidders will also be required
to submit a conflict of interest
mitigation plan as described above
during the vendor application process.
Conflict of interest and mitigation
strategies are described in section
II.2.C.3. in this interim final rule.
Internal Control
We proposed to review information
relating to the establishment and
effectiveness of the bidder’s internal
control system designed to provide
reasonable assurance of financial and
compliance objectives. We provided
examples of information that we might
review as evidence of the design and
effectiveness of a bidder’s internal
control system.
PO 00000
Frm 00044
Fmt 4701
Sfmt 4700
We proposed to set forth these
requirements in regulations at proposed
§ 414.908.We received no comments
about internal financial control.
Therefore, we will finalize these
requirements as proposed.
Deemed Compliance
In the proposed rule, we noted that
some vendor applicants may already be
subject to financial oversight by one or
more State or Federal regulators. The
vendor applicant’s current financial
reporting may satisfy one or more of the
above requirements. We proposed to
request documentation of this parallel
oversight together with contact
information for the regulator. We would
contact the regulator to inquire as to the
vendor applicant’s status and we may
deem certain portions of the above
requirements ‘‘met’’ at our discretion.
We received no comments on this topic.
Therefore, we will finalize these
requirements as proposed.
2. Bidding Entity Qualifications
a. Quality and Financial Information—
Vendor Application
In the March 4, 2005 proposed rule,
we stated that the vendor would be
responsible for completing and meeting
all criteria on both the Vendor
Application Form and the Provider/
Supplier Enrollment Application (Form
CMS 855B) (for the purpose of
completing these applications, vendors
will be considered suppliers) by the
established deadlines in order to be
considered as a potential vendor under
the CAP. For example, if a vendor has
been excluded from participation in a
Federal health program, or has been
convicted of a fraud-related crime, the
vendor must record that on the form
855B. We would treat these admissions
from vendors in the same manner as we
do for other suppliers. Both a draft copy
of the Vendor Application Form and the
Provider/Supplier Enrollment
Application (Form CMS 855B) are
available on the CMS Web site at the
following address: https://
www.cms.hhs.gov/providers/drugs/).
Both forms are needed to cover all
required vendor qualifications.
In the proposed rule, we stated that
we would require that the vendor be
prepared to offer complete information
in four major areas and complete a
certification statement. The vendor’s
business experience would be required
to be within the United States. In
addition, we proposed to require that
prospective vendor provide on the
Vendor Application Form, a complete
list of drugs that the vendor would
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
intend to bid by National Drug Code
(NDC) number.
Management and Operations
We proposed to require that the
vendor attest that adequate
administrative arrangements are in
place to ensure effective operations,
such as but not limited to, policies that
assure that business is conducted in the
best interest of the customer,
maintenance of fidelity bonds, and
insurance policies to cover losses.
General identifying information would
also be required such as business name,
address, taxpayer identification number,
contacts representing the organization,
and a description of the organization’s
structure. In addition, we proposed that
each subcontractor, subsidiary, or
business affiliate that is used by the
vendor under the CAP would be
required to provide the same
information.
Experience and Capabilities
In the proposed rule we stated that
the approved CAP vendor would be
required to:
• Maintain the operation of a
grievance process so that physician,
beneficiary, and beneficiary caregiver
complaints can be addressed;
• Provide a prompt response to any
inquiry as outlined in the vendor
application form;
• Maintain business hours on
weekdays and weekends with staff
available to provide customer assistance
for the disabled, including the hearing
impaired, and to Spanish speaking
inquirers; and
• Provide toll free emergency
assistance when the call center is
closed.
We emphasized that customer service
is a primary consideration, especially
the ability to respond on an emergency
basis to participating CAP physicians. In
addition, we stated that a working
telephone customer service number be
submitted for verification during the bid
evaluation process.
Section 1847B(b)(2)(A)(i)(II) of the Act
gives some guidance regarding
timeframes for routine and emergency
shipment; however, the statute does not
provide specific definitions of these
timeframes. Therefore, we requested
comment on how to define timely
delivery for routine and emergency drug
shipments. For the purposes of this
discussion, we proposed that the
delivery time period would begin when
a drug order is received by the vendor
and would end at the time of delivery
to the participating CAP physician’s
office or other intended setting. We
proposed that routine shipments of
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
drugs furnished under the CAP would
occur within a 1 to 2 business day time
period. However, the duration of the
delivery time period must not exceed
the drug’s stability in appropriate
shipping containers and packaging. We
requested comments on the feasibility of
requiring a shorter duration for routine
delivery of CAP drugs. This discussion
is included in section II.B. of this
interim final rule, ‘‘Operational Aspects
of the CAP.’’
We proposed to require that approved
CAP vendors maintain a formal
mechanism for responding to
complaints from participating CAP
physicians, beneficiaries, and their
caregivers (if applicable). In the
proposed rule, we stated that evidence
of this mechanism, in the form of any
complaint resolution manuals, agendas,
and minutes from complaint resolution
committee meetings, or other evidence
of complaints being resolved would be
submitted as part of the bid application.
In addition to providing an audited
financial statement as an attachment, we
proposed that the vendor be required to
present a standardized summary of
financial information on the collection
form. We also proposed that the vendor
must have been in the business of
furnishing Part B injectable drugs for at
least 3 years, and specifically requested
comment on whether the requirement of
3 tax reporting years of experience
would prevent newer vendors with
sufficient experience and resources from
being included in the program. We also
proposed that the vendor would be
prepared to offer and substantiate the
drug volume managed (in dollars and
units) for the immediate previous
calendar year and provide specific
personnel statistics such as the number
of staff assigned to various activities,
and its policy-making organizational
structure within the United States.
Finally, because selected approved
CAP vendors would be considered a
covered entity under the HIPAA
Administrative Simplification Rules, to
the extent that they conduct any of the
standard HIPAA transactions
electronically, these approved CAP
vendors would be required to comply
with the Administrative Simplification
rules, including the Privacy Rule.
Comment: Some commenters were
concerned with our proposed
requirement for a vendor to have been
in business for 3 years as one of the
thresholds for participation in the CAP.
These commenters argue that there is no
correlation between business longevity
and quality of care.
Response: The statute directs us to
select among qualified bidders based on,
among other things, past experience in
PO 00000
Frm 00045
Fmt 4701
Sfmt 4700
39065
the distribution of drugs and biologicals.
We believe that it is reasonable to
expect a vendor who seeks to participate
in the CAP to have been in the business
of furnishing Part B injectable drugs for
at least 3 years because that will provide
us with an appropriate amount of
information to assess the applicant’s
past experience. We believe that
requiring a potential vendor to prove 3
years of experience would allow us to
evaluate their ability to use resources
appropriately based on their past
performance. Vendors with less than 3
years of experience would not be in a
position to demonstrate any kind of a
track record that could be reviewed so
that we could be assured of their ability
to perform effectively and in an
acceptable manner under the CAP.
Finally, a vendor who meets all the
criteria except that it has not yet been
in the business of furnishing Part B
injectable drugs for the required 3-year
threshold is free to participate in the
CAP once it has met the 3-year
requirement.
Comment: Commenters suggested that
submitted bid information provided by
the vendor should be kept confidential
and protected from public disclosure.
Response: As we mentioned in the
proposed rule, we will follow HIPAA
standards to protect privacy. All cost
information will be confidential and not
made available for public display. In
accordance with section 1927(b)(3) of
the Act, bid prices will be kept
confidential.
Comment: Commenters suggested that
CMS collect additional information on
the vendor’s application forms.
Response: We believe that the vendor
information submitted on the Form
855B (the Medicare fee-for-service
physician/supplier enrollment form)
and the vendor application forms is
sufficient.
Licensure
We proposed that the vendor would
be required to maintain an appropriate
license in each State in which the drug
vendor seeks to operate under the CAP.
We also proposed to require that the
vendor certify that any subcontractor or
subsidiary also maintains a license that
complies with State regulations in every
applicable State.
Comment: Several commenters
believed that we should require a
vendor to be licensed to operate a
pharmacy as well as to be a licensed
wholesaler in the States in which the
vendor seeks to do business under the
CAP. These commenters stated that the
drug dispensing duties of a vendor
naturally require the experience and
E:\FR\FM\06JYR2.SGM
06JYR2
39066
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
expertise of a pharmacist, rather than a
general wholesaler.
Response: We believe that vendors
must operate as distributors in order to
participate in the CAP, and we
recognize that a natural outgrowth of
participating in this program may be
that those distributors also will need to
be licensed as a pharmacy. Regardless,
either the vendor, its sub-contractor
under the CAP, or both, must be
licensed appropriately by each State to
conduct its operations under the CAP.
Therefore, a vendor under the CAP
would be required to be licensed as a
pharmacy as well as a distributor if a
State requires it. Because our initial
competitive acquisition area is
nationwide, appropriate licensure in all
States would be required. We note that
by its terms, nothing in section 1847B
of the Act shall be construed as waiving
applicable State requirements relating to
the licensing of pharmacies.
Business Integrity
In the proposed rule, we stated that
the vendor would be responsible for
identifying and disclosing business
relationships and conflicts of interest as
well as potential conflicts of interest
with other organizations. We also stated
that the vendor would be required to
answer questions and provide
information about fraud investigations,
settlement agreements, and Federal
government exclusions.
Comment: We received several
comments supporting our strong
requirements related to vendor
qualifications, including management
and operations standards, operation of a
grievance process, experience, HIPAA
compliance, licensure, and business
integrity. Commenters believe that the
requirements were necessary to ensure
that only qualified entities were selected
as CAP vendors.
Response: In evaluating whether to
award a CAP vendor contract or renew
an approved CAP vendor contract, CMS
will take into account a bidder’s record
of corporate integrity and performance
and will review the bidder’s internal
integrity measures, which include at a
minimum, a compliance plan to prevent
fraud, waste and abuse. We appreciate
comments in support of our approach to
review these criteria as part of our
selection and renewal process. As a
result, we are retaining our
requirements for potential vendors
under the CAP. Additionally, in
response to comments we are including
language at § 414.908(c) that permits
CMS to refuse to award or terminate a
contract based on a potential CAP
vendor’s past violations or misconduct
related to the marketing, distribution, or
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
handling of drugs. This requirement
will strengthen CMS’ efforts to ensure
that entities granted the ability to
provide Medicare products or services
have a record of corporate integrity and
performance that reflects the provision
of scrupulous products and services.
Certification
We proposed that the vendor be
prepared to certify that all the
information in the Vendor Application
Form is true, accurate, and complete
and to certify to any other requirements
as specified by us. Failure to provide
correct and updated information when
it becomes available, if it affects the
information provided on the Vendor
Application Form, may be cause for
termination of the vendor’s contract
under the CAP. We believe that it is
vital to certify that the information
provided is accurate. We received no
comments on this issue, so, as a result,
we are finalizing that requirement in
this rule. In addition, we provide further
direction for vendor and subcontractor
conduct in the next two sections (Fraud
and Abuse as well as Conflicts of
Interest).
b. Specific Information Relating to
Prevention of Fraud and Abuse
Section 1847B(b)(4)(D)(ii) of the Act
requires that the approved CAP vendor
comply with all applicable provisions
relating to the prevention of fraud and
abuse. This includes compliance with
applicable guidelines of the Department
of Justice (DOJ) and the Office of the
Inspector General (OIG) of the DHHS.
In accordance with this statutory
authority, we proposed that each
approved CAP vendor develop and
maintain a compliance plan to control
program fraud, waste, and abuse, that
includes at a minimum, the
requirements proposed at § 414.914(c) of
our regulations. These requirements
already apply to many of the entities
participating in the Medicare program,
such as prescription drug plans
administering the prescription drug
benefit and Medicare Advantage
organizations. In addition, the OIG has
recommended these minimum elements
in published guidance.
We stated in our proposed rule that a
compliance plan should contain
policies and procedures that control
program fraud, waste and abuse. In
developing written policies, procedures,
and standards of conduct for detecting
and preventing waste, fraud and abuse,
we stated that approved CAP vendors
should consult a variety of sources
including applicable statutes and
regulations and compliance guidance
issued by CMS, our contractors,
PO 00000
Frm 00046
Fmt 4701
Sfmt 4700
Program Safeguard Contractors (PSCs),
and the OIG. We provided some
recommended sources for relevant
information. Approved CAP vendor
compliance plans must be submitted
with the CAP applications, and must be
available to us and our contractors for
periodic reviews.
We also proposed that approved CAP
vendors and entities that they contract
with establish effective training and
education programs related to fraud,
waste and abuse that address pertinent
laws related to fraud and abuse
including the physician self-referral
(‘‘Stark’’) prohibition (section 1877 of
the Act) and the Federal Anti-Kickback
statute (section 1128B(b) of the Act),
and the False Claims Act (31 U.S.C.
3729–3733). In addition, we proposed
that approved CAP vendors and entities
that they contract with be trained on
detecting and preventing common
fraudulent schemes in the
pharmaceutical industry, as identified
by CMS, the OIG, and/or the DOJ and
provided examples of some common
fraudulent or abusive problems within
the pharmaceutical industry.
To ensure successful internal
monitoring and auditing of fraud, waste,
and abuse under Part B, we proposed
that approved CAP vendors should
regularly monitor and audit their
processes and procedures to ensure that
they are in fact taking the steps
necessary to comply with all Federal
and State regulations and to mitigate the
potential for waste, fraud, and abuse
within their organizations. Establishing
procedures to ensure prompt responses
to potential fraud violations is an
important element in an effective fraud
and abuse plan. Approved CAP vendors
are responsible for monitoring and
identifying potentially fraudulent or
abusive activity. We further stated that
after an approved CAP vendor has
determined that any misconduct has
violated or may violate criminal, civil or
administrative law, the approved CAP
vendor should report the existence of
the misconduct to OIG or other
appropriate government authority
within a reasonable period, but no later
than 60 days after the determination
that a violation may have occurred. Selfreporting of fraud and abuse is a critical
element to an effective compliance plan,
and approved CAP vendors are strongly
encouraged to alert CMS, the PSCs, the
OIG, or law enforcement of any
potential fraud or misconduct relating to
the CAP. We investigate all cases
referred as potentially fraudulent and
then refer them to the appropriate law
enforcement agency as warranted.
Likewise, we expect that the approved
CAP vendors would fully cooperate in
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
any investigations related to fraud
identified in a particular approved CAP
vendor’s organization.
We are aware that there are many
possible approaches to developing an
effective compliance plan. Therefore,
we requested comments on the scope
and implementation of an effective
compliance plan.
Comment: There were some
operational comments regarding the
opportunity for fraud, waste and abuse.
One commenter pointed out that when
a drug product sent to a physicians’
office is unused and returned to the
approved CAP vendor, this transaction
could allow for the opportunity for
fraud and drug spoilage. Because CAP
drugs are kept in a separate inventory,
a commenter asked if inventory errors
would be subject to prosecution for
fraud and abuse.
Response: We discuss the design of
the inventory and return process in
section II.B.2 of this interim final rule
and the product integrity requirement in
section II.C.1 of this interim final rule.
We believe these processes, along with
the fraud, waste and abuse provisions
outlined above provide a framework for
ensuring the integrity of the product
delivery process. We note that the
return of a product must be in
accordance with applicable State and
Federal laws. The approved CAP vendor
is responsible for providing appropriate
drug product delivery to the
participating CAP physician’s office that
preserves that drug’s integrity. The
participating CAP physician is
responsible for not accepting delivery of
a drug product damaged during
shipment or whose integrity the
participating CAP physician believes
was compromised. It is also the
responsibility of the participating CAP
physician to store appropriately an
accepted product delivery to ensure its
continued integrity.
Typically, there must be intent to
commit fraud in order for the
government to subject a physician or
approved CAP vendor to prosecution for
fraud and abuse. Minor inventory errors
normally would not subject a
participating CAP physician or
approved CAP vendor to prosecution for
fraud and abuse. Approved CAP
vendors and participating CAP
physicians each are responsible for
complying with all laws and regulations
applicable to them that govern the
receipt, storage, and return of drug
products. Participating CAP Physicians
and approved CAP vendors may be held
accountable for failing to adhere to any
applicable requirements. We will
investigate all cases brought to our
attention as potentially fraudulent and
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
then, if warranted, refer them to the
appropriate law enforcement agency.
c. Conflicts of Interest
Section 1847B(b)(4)(D)(i)of the Act
requires that approved CAP vendors
participating in the CAP comply with a
code of conduct, specified or recognized
by the Secretary. The statute authorizes
us to require approved CAP vendors to
establish a code of conduct related to
conflicts of interest in bidding and
performance.
In the March 4, 2005 proposed rule,
we stated that a code of conduct should
function much like a constitution, that
is, it should be a document that details
the fundamental principles, values, and
framework for action within an
organization. We proposed that the code
of conduct for approved CAP vendors
articulate the approved CAP vendor’s
expectations of commitment to
compliance by management, employees,
and agents, and summarize the broad
ethical and legal principles under which
the company must operate.
Avoiding conflicts of interest and the
appearance of these conflicts is critical
to the operations of the CAP. In
accordance with our statutory authority
under the Act, we proposed to require
that each approved CAP vendor
establish and follow a code of conduct
that addresses its policies and
procedures for identifying and resolving
any conflict of interest. We stated that
a conflict of interest may occur where
an approved CAP vendor, its
representative, or contractor provides a
product or service for a Medicare
participating CAP physician or
beneficiary and the approved CAP
vendor, representative or contractor has
a relationship with another person,
entity, product or service that impairs or
appears to impair the approved CAP
vendor’s or contractor’s objectivity to
provide the Medicare-covered product
or service. Situations that compromise
or appear to compromise an approved
CAP vendor’s ability to avoid selfdealing when providing a Medicare
product or service create a conflict of
interest and must be resolved. Approved
CAP vendors should take steps to
identify and mitigate any conflict of
interest that may arise in the provision
of a product or service for a Medicare
participating CAP physician or
beneficiary.
We indicated the code of conduct
should communicate the need for all
management, board of directors,
employees, and agents to comply with
the approved CAP vendor’s code of
conduct and policies and procedures for
addressing and resolving conflicts of
interest. It also should reflect the
PO 00000
Frm 00047
Fmt 4701
Sfmt 4700
39067
approved CAP vendor’s commitment to
detect and resolve any conflict of
interest. The code of conduct should
establish procedures for determining
whether or not a conflict exists, and if
so, how the conflict will be resolved.
We proposed that the code of conduct
address issues such as whether or not
the offer or acceptance of some
remuneration to or from an approved
CAP vendor, physician, beneficiary, or
manufacturer would diminish, or
appear to diminish, the objectivity of
professional judgment; or whether or
not certain transactions raise patient
safety or quality of care concerns.
In addition, throughout the
solicitation of CAP contracts, we
proposed that approved CAP vendors
comply with the requirements of the
FAR organizational conflict of interest
guidance, found under 48 CFR Subpart
9.5, and the requirements and standards
contained in each individual contract
awarded to perform functions under
section 1847B of the Act. Consistent
with FAR 9.507–2, in making awards to
approved CAP vendors, we proposed
that each contract contain a conflict of
interest clause specific to the approved
CAP vendor for inclusion in the
contract.
We proposed fairly general conflict of
interest requirements because we
believe that individual contracts may be
a better venue to address specific
conflicts of interest. However, we
solicited comments regarding what may
or may not constitute a conflict of
interest in the CAP program and how
such conflicts might be identified and
mitigated.
We proposed to set forth our conflict
of interest policies and procedures in
regulations at proposed § 414.912.
Comment: One commenter suggested
that CMS require full disclosure of an
approved CAP vendor’s corporate
relationships during the bidding process
and take steps to prevent
monopolization by any one company
within the bidding or contract award
stages of the CAP program. This
includes adopting language that requires
corporate-structure disclosure and
specifically prohibits approved CAP
vendor subsidiaries from bidding
against their parent company or other
subsidiaries with the same parent
company. The commenter suggested
that CMS revise the language of
§ 414.908(e), ‘‘Multiple contracts for a
category and area,’’ § 414.910(a) on the
bidding process, and elsewhere, to
reflect this bidding and contract award
restriction. Another commenter
suggested that the final rule address
situations in which a company affiliated
with a potential approved CAP vendor
E:\FR\FM\06JYR2.SGM
06JYR2
39068
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
manages a physician or medical/nurse
practice. In these cases the physician
may have no effective choice of an
approved CAP vendor and non-affiliate
vendors may not have a meaningful
opportunity to compete for the business
of the practice. The commenter
recommended that the final rule include
explicit conflict of interest standards to
guard against preferential selection and
treatment of potential approved CAP
vendors that are affiliated with
physician and medical/nursing practice
management companies.
Response: The proposed rule stated
that the approved CAP vendor’s code of
conduct should communicate the need
for all management, board of directors,
employees, and agents to comply with
the approved CAP vendor’s code of
conduct and policies and procedures for
addressing and resolving conflicts of
interest. Also, consistent with FAR
9.507–2, in making awards to approved
CAP vendors, each contract will contain
a conflict of interest clause specific to
the approved CAP vendor for inclusion
in the contract. We believe this will
identify potential conflicts of interest
pertaining to participation in the CAP.
Approved CAP vendors that are
affiliated with a medical practice
management company do not create a
per se conflict of interest. However,
these relationships should be entered
into carefully and monitored closely for
the appearances of a conflict of interest.
There are a minimum of two and a
maximum of five approved CAP
vendors in each category in a given CAP
area. In the optimal situation, there will
be five approved CAP vendors for a
given drug category, and where a
conflict of interest is obvious between
one approved CAP vendor and a
physician’s practice, the physician’s
practice would have up to four other
approved CAP vendors to choose from,
and should choose one of those other
approved CAP vendors accordingly.
Based on the comments received and
data analysis discussed elsewhere in
this interim final rule with comment
period, there will be one extensive CAP
category of drugs covering one single
national area including all States, the
District of Columbia, and the U.S.
Territories. If there are only two
approved CAP vendors for a given drug
category and there is a potential conflict
of interest, the physician’s practice has
two options to consider. The physician’s
practice can choose to receive drug
products under the CAP program from
the approved CAP vendor with which it
does not have a conflict, or the
physician’s practice can choose not to
participate in the CAP program.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
Medical and utilization review
activities currently utilized by carriers
and CMS Program Integrity contractors
will be applied to the provision of drug
products through the CAP program.
These efforts will help to ensure the
medical necessity of the drugs provided
and to monitor for inappropriate
utilization that may stem from improper
preferential selection.
Comment: Some commenters were
concerned that the creation of
formularies could have the appearance
of conflicts of interest if their purpose
was to steer market share toward one
drug in a category over another in
response to contracting discounts and
rebates. Commenters believed this could
occur if physicians are required to
acquire drugs within categories as
defined by the approved CAP vendor,
and the approved CAP vendor offers
only a limited selection of the possible
drugs.
Another commenter suggested that
CMS prohibit approved CAP vendors
from offering physicians financial
incentives to stock preferred drugs
specifically for ‘‘re-supply’’ under the
CAP. This will help prevent approved
CAPs from enforcing preferred status in
the CAP by controlling which agents a
physician keeps in-stock (for example,
for their commercially insured patients).
Response: We believe that the code of
conduct should address issues such as
acceptance of remuneration to or from
an approved CAP vendor, participating
CAP physician, beneficiary, or
manufacturer that would diminish, or
appear to diminish, the objectivity of
professional judgment; or whether or
not certain transactions raise patient
safety or quality of care concerns.
Section II.A.2 of this interim final rule
describes the development of the drug
category. The drug category was
intended to be a list of HCPCS codes for
the Part B drugs and biologicals on
which a potential CAP vendor may bid.
It does not constitute a drug formulary.
We do not expect there to be creation of
a drug formulary. As discussed above,
there will be one extensive CAP drug
category. It will include many of the
HCPCS for drugs commonly used by
physicians’ offices, but not all of them.
Also, as discussed before, an NDC
number represents a specific drug
manufacturer’s product formulation and
package size for its drug product.
Currently there may be more than one
NDC number associated with a HCPCS
code if the drug is multi-source, is
available in multiple package sizes, or if
the drug is available in different
formulations. A participating CAP
physician, who has elected a CAP
vendor from whom he or she wishes to
PO 00000
Frm 00048
Fmt 4701
Sfmt 4700
order drugs, may find it medically
necessary to require a specific drug
represented by a specific NDC within a
given HCPCS code. If the CAP vendor
has contracted to provide a drug within
that HCPCS code but not the specific
NDC that the participating CAP
physician requires, then the
participating CAP physician may obtain
the drug through the ‘‘Furnish As
Written’’ option discussed in section
II.B.2 of this interim final rule. If the
participating CAP physician needs to
obtain a drug identified by a HCPCS
code that is not available from the CAP
vendor, the participating CAP physician
may continue to obtain the drug through
the normal ASP system.
In response to the re-supply comment,
section II.B.1 of this interim final rule
describes the conditions under which a
drug administered from the
participating CAP physician’s supply
may be replaced with a CAP drug. These
occurrences are expected to be few and
only in the event of an emergency. The
utilization of this option will be
monitored to detect patterns of abuse
through carrier and CMS Program
Integrity contractor oversight.
Comment: A commenter commended
CMS on the thorough code of conduct
language. The commenter stated that
they currently have an objective third
party that monitors and prevents
conflicts, and assures some equity
within the market.
Response: We believe the commenter
is indicating that it has a process in
place to monitor for and prevent
conflicts in the healthcare market. The
commenter seems to indicate that this
function should now be the
responsibility of the CAP. The CAP is
only a small part of the healthcare
market. Approved CAP vendors are
ultimately responsible for monitoring
and preventing conflicts of interest
related to only their participation in the
CAP. Our contracts with approved CAP
vendors will require that approved CAP
vendors adhere to a code of conduct that
establishes policies and procedures for
recognizing and resolving conflicts of
interest. We will also continue to apply
the medical and utilization review
activities currently used by carriers and
CMS Program Integrity contractors to
the provision of drugs through the CAP.
These monitoring efforts will help to
ensure the medical necessity of the
drugs provided and to monitor for
inappropriate utilization that may stem
from conflicts of interest. If an
undisclosed conflict is discovered
through one of our various reviews,
such as a Program Safeguard Contractor
audit, we will raise the issue with our
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Contracting department and inform law
enforcement where appropriate.
Physicians, suppliers, and approved
CAP vendors should be aware that we
expect all entities with whom we do
business to continue to comply with all
applicable conflict of interest rules,
including the Stark law and AntiKickback Statute. We also hope that all
entities involved in the CAP will
continue to take whatever measures
they believe necessary to assure the
prevention of conflicts of interest.
Comment: Commenters recommended
that CMS prohibit approved CAP
vendors from using, sharing or selling
patient information for any purpose
other than that which is strictly related
to fulfilling CAP orders.
Response: An approved CAP vendor
is a HIPAA covered entity and is subject
to the HIPAA Privacy Rule that governs
the use and disclosure of protected
health information. As covered entities,
approved CAP vendors also are subject
to the HIPAA Security Rule.
Record Retention
As in other regulations that apply to
entities that retain records of their
dealings with the Medicare program, we
believe approved CAP vendors should
be held to reasonable record retention
standards. We seek additional comment
on whether these requirements should
be further explicated in the final CAP
regulation.
After reviewing the comments, we are
finalizing § 414.912 with amendments
to the content of the code of conduct
which is submitted as part of the
application process.
3. CAP Bidding Process—Evaluation
and Selection
a. Evaluating Bid Prices by the
Composite Bid Price
In the March 4, 2005 proposed rule
we stated that in selecting vendors, the
statute requires consideration of both
price and non-price (for example,
quality of service and financial
qualifications) aspects of the bid. We
also stated that technical and financial
criteria for selecting CAP vendors would
be used to determine which bidders will
be awarded contracts to furnish drugs
under the CAP. Our ultimate choice of
an appropriate evaluation process will
take into account the final policies
concerning the drug categories, the
geographic areas for the program, and
comments on our proposed evaluation
process. We proposed a basic approach
to the evaluation and bidding selection
process and encouraged comments on
this proposal and recommendations for
alternative approaches.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
Comment: Several commenters
suggested that CMS continue to provide
interested parties with opportunities for
learning more about the CAP. One
commenter specifically suggested that a
pre-bid conference be held for potential
CAP vendors in order to provide
potential bidders with detailed
information that bidders could then use
to calculate their bid prices.
Response: We agree that
communicating information about the
CAP bidding process (as well as other
aspects of CAP) is necessary. Therefore,
we plan to use several methods to
communicate bidding requirements,
update existing information, provide
clarification, and answer questions.
While we may not have time to host a
formal pre-bid conference, these
methods may include a public
conference call with potential vendors.
We also may hold an open door forum.
We will also provide updates to the CAP
Web site, and other channels.
Comment: One comment asked for
clarification about whether the vendor
could provide services to manufacturers
for fees and whether this payment
would influence ASP calculations.
Response: Bona fide service fees that
are paid by a manufacturer to an entity,
that represent fair market value for an
actual service provided by the entity,
and that are not passed on in whole or
in part to a client or customer of an
entity, are not included in the
calculation of ASP because these fees
would not ultimately affect the price
realized by the manufacturer. ‘‘Bona
fide service fees’’ means expenses that
are for an itemized service actually
performed by an entity on behalf of the
manufacturer that would have generally
been paid for by the manufacturer at the
same rate had these services been
performed by other entities.
In the discussion of our proposal for
the bidding process as set forth in
§ 414.910, we assumed that we were
conducting competitive bidding for
some number of distinct drug categories.
We also assumed that bidders with
relatively large (including national)
distribution networks might also want
to submit bids for multiple acquisition
areas (depending upon the area
definitions that we adopted in the final
rule). We stated that these bidders
would be permitted either to submit the
same bid price for all areas in which
they wish to compete, or to submit
separate bid prices for each acquisition
area. The procedure for evaluating the
price component of the bids (and setting
payment rates) would be the same
regardless of the method for defining the
categories of drugs (HCPCS) adopted in
the final rule. Section 1847B(c)(6) of the
PO 00000
Frm 00049
Fmt 4701
Sfmt 4700
39069
Act requires that the submitted bid price
include all costs related to the delivery
of the drug to the selecting physician,
and the costs of dispensing (including
shipping) the drug and management
fees. Costs related to the administration
of the drug or wastage, spillage, or
spoilage may not be included in the
submitted bid. We proposed to specify
these requirements at § 414.910 of the
regulations.
As discussed in the proposed rule, the
purpose of requiring vendors to bid for
all drugs in a category would be to
identify a set of vendors that can supply
the range of drugs in that category at an
appropriate overall cost. Because a
vendor may have different discounts
that it can negotiate for a drug, a vendor
may be able to bid a lower price for one
drug, but not for another drug within a
category. We sought to identify a
selection process that, in the aggregate,
could provide drugs at reasonable cost
to the program while maintaining the
required quality standards.
We therefore proposed to employ a
‘‘composite bid,’’ constructed from the
bid prices for the individual drugs in
the CAP category, in the process of
selecting bidders for the CAP. The
composite bid would be constructed by
weighting each HCPCS bid by the
HCPCS code’s share of volume
(measured in HCPCS units) of drugs in
a particular drug category during the
prior year. Within each CAP category,
the drug weights would sum to one.
Based on data availability, the volume
data used for bids in the first CAP
bidding cycle (for supplying drugs
starting January 1, 2006) would be from
2004 because bidding is anticipated to
occur in mid-2005. (We noted that we
had not developed a method to weight
drugs introduced during and after 2004,
but invited public comment on methods
for consideration.) The calculated
composite bid would equal the average
price per HCPCS unit for drugs in that
category. In this way, the composite bid
would be proportional to the expected
cost to the program of acquiring drugs
from that vendor (based on the
assumption that the 2004 volume in
each HCPCS category is roughly
proportional to volume in 2006). If one
vendor has a lower composite bid than
another, it will also have a lower
expected cost of supplying all drugs in
the particular CAP category.
The statute requires consideration of
price and non-price (for example,
quality of service and financial
qualifications) aspects of the bid. In
order to implement this requirement, we
proposed a two-step bidder selection
process:
E:\FR\FM\06JYR2.SGM
06JYR2
39070
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
• First, all bidders must meet certain
quality and financial thresholds.
• Second, winning bidders would be
selected from those that meet the quality
and financial thresholds based on the
composite bids.
We considered several basic methods
for evaluating the composite bids. From
these alternatives, we proposed a
method that bases the selection of
winning bidders on a predetermined
threshold. Specifically, we proposed
that we would select, from all those
bidders that meet the quality and
financial thresholds, up to the five
lowest bidders for a drug category
within each area. However, we would
not select any bid for the category that
is higher than 106 percent of the
weighted ASP for the drugs in that
category. We believe that limiting the
maximum bid price that we would
accept is consistent with Congressional
intent that the CAP promote savings.
We proposed this method for
selecting bids because it is
straightforward and relatively easy to
implement. In addition, rejecting
composite bids that exceed the payment
level under the new ASP payment
methodology is consistent with one
major purpose of the new competitive
acquisition system, since it creates the
possibility of realizing savings to the
Medicare program. We believe this
method was preferable to other options
and provided a discussion of an
alternative method that could have been
used. This would have been to accept
any composite bid for a drug category
that is less than 106 percent of the
weighted ASP for the drugs in that
category. Under this alternative method,
it would be possible for every bidder to
submit a bid price just below ASP plus
6 percent, in the confidence that the bid
would be accepted. This alternative
method would thus limit the potential
for savings to the program, compared to
the bidding process that we proposed.
Under the process that we proposed,
bidders retain an incentive to submit the
best bid price that is possible for them.
Restricting the number of bids that
might be accepted provides for more
competition in the bidding process than
accepting all bidders under a designated
threshold. Thus, we proposed to accept
up to five composite bids, for a category
of drugs, but we proposed not to accept
any bid that exceeds a composite bid
threshold of 106 percent of ASP. We
would compute the composite bids, and
the 106 percent composite bid
threshold, in the manner described in
the example we provided in the
proposed rule (70 FR 10763).
We requested comments on this
proposed process, as well as
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
recommendations for alternative
approaches.
Comment: Several commenters
expressed general agreement with our
proposal to employ a composite bid to
compare bids. However, a number of
commenters objected to our proposal
not to accept any bid for a category that
is higher than 106 percent of the
weighted ASP of the drugs in a category.
Some of these commenters expressed
concern that such a limit would
discourage vendors from bidding, and
result in too few vendors participating
in the program. Some commenters
pointed out that the ASP system itself
is new, and that it remains to be
determined whether it provides
adequate reimbursement. Some
commenters pointed out that the statute
itself does not require a ceiling. Some
commenters also expressed concern that
the methodology would result in a ‘‘race
to the bottom,’’ as potential vendors
elect to bid only on drugs that can be
offered at a savings to the Medicare
program. Other commenters
recommended that we impose no ceiling
on the level of acceptable composite
bids; others advocated a higher ceiling
(120 percent of ASP). One commenter
suggested that the ceiling be waived if
it was necessary to do so in order to
approve at least 3 bidders in any
competitive acquisition area. Still other
commenters recommended the adoption
of methods such as risk corridors to
protect vendors against unexpected
losses in the early stages of the program
and simultaneously allow the program
to share in any savings that may be
realized from the CAP. One commenter
asked for confirmation that the bidding
threshold should be established on the
basis of ASP prices in effect during the
quarter in which the bids are generated.
A few commenters suggested not
announcing the composite bid
threshold.
Response: Although the statute does
not specifically require adopting a
ceiling on acceptable bids, we believe
that doing so is appropriate, as well as
consistent with the statute. Indeed, one
major purpose of the CAP is to create
the possibility of realizing savings to the
Medicare program. This is one reason
why the statute gives the Secretary the
authority (which we are not specifically
exercising with respect to our
determination of which competitively
biddable drugs are included in the
current drug category) to exclude from
the CAP drugs that are not likely to
result in significant savings (see section
1847B(a)(1)(D). The bid ceiling that we
proposed ensures that the CAP will be
no more costly to the Medicare program
than the alternative method of paying
PO 00000
Frm 00050
Fmt 4701
Sfmt 4700
for drugs at 106 percent of ASP. This
ceiling is thus consistent with the
possibility of realizing savings to the
Medicare program. It would also serve
to maintain a level of parity between the
two systems, preventing a situation in
which significant payment differentials
might skew incentives and choices. We
are therefore finalizing that provision in
this interim final rule. We are not
adopting some of the alternatives
recommended by some commenters (for
example, no ceiling, a higher ceiling,
waiver of ceiling under certain
circumstances) because the
recommendations would not preserve
the possibility of realizing some savings
to the Medicare program. We are not
adopting the recommendation for
establishing risk corridors because we
do not believe that such a provision
would be consistent with the statute.
Section 1847B(d)(1) of the Act
specifically requires that the Secretary
establish a ‘‘single payment amount for
each competitively biddable drug’’ in an
area. We do not believe that the
composite bid methodology we are
adopting will lead to a ‘‘race to the
bottom,’’ in which vendors bid only on
drugs that will yield savings to the
Medicare program. In the first place, we
are requiring potential vendors to bid on
all the drugs in the broad category of
Part B physician drugs that we are
establishing for this initial stage of
implementing the CAP. Vendors will
not be able to choose among the HCPCS
codes included in the drug category. In
addition, the methodology that we are
adopting does not require that the bid
for each drug be at or below the level
of 106 percent of ASP. Rather, it
requires only that weighted average of
the bids for all drugs in the category will
be less than or equal to 106 percent of
the weighted average of the ASPs for all
the drugs in a category. Under this
methodology, potential vendors can bid
more than 106 percent of ASP for some
drugs in the broad, single category that
we are establishing. In order to meet the
threshold requirement, bidders will
only have to bid below 106 percent of
ASP on enough drugs in our large single
drug category to produce composite bids
at or below 106 percent of the weighted
average of the ASPs for all the drugs in
a category. We believe that it is
reasonable to expect that potential
vendors will be able to realize sufficient
efficiency in obtaining and delivering
Part B drugs commonly administered
incident to a physician’s service to
produce a composite bid at or below
this threshold.
Finally, we are confirming that the
composite bid ceiling will be
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
determined on the basis of ASP prices
in effect during the quarter in which the
bids are generated. Specifically, we will
determine the threshold (106 percent of
the weighted ASP for the drugs
included in our single drug category) on
the basis of the ASP prices in effect at
the time of the bidding, which will be
conducted during the second quarter of
calendar year 2005. Potential vendors
will be able to find the ASP pricing file
on our Web site at https://
www.cms.hhs.gov/providers/drugs/
asp.asp. We will provide potential
vendors with the ceiling in time for
consideration in developing bids.
Vendors will also be able to compute
the ceiling from the weighting factors in
Addendum A of this interim final rule
with comment period and the ASP
prices in effect for the second quarter of
calendar year 2005.
We also note that we have revised
§ 414.910(b) of our proposed regulations
to clarify that the amount of a bid for
any CAP drug must be uniform for all
portions of a specific competitive
acquisition area.
Comment: Several commenters
expressed concern about the lag in the
utilization data that would be employed
in weighting the bid prices under the
composite bid methodology. Even the
most recent available utilization data
may not reflect utilization patterns in
the payment year, creating a potential
vulnerability for vendors if physicians
increase their utilization of more costly
drugs.
Response: We will always employ the
most recent available utilization data to
compute the weights that will be
employed in computing composite bids.
In this interim final rule, we are
employing utilization data from FY
2003 and FY 2004 for this purpose. (We
describe the utilization data used to
construct the weights in section II.A.2 of
this interim final rule. We display the
weights that we computed on the basis
of these data in our table of the drugs
that we are including in our single drug
category. See Addendum A of this
interim final rule with comment
period.) At the same time, we do not
believe that the composite bid
methodology creates the vulnerability
described by the commenters. It is
important to keep in mind that while it
is necessary to employ a prior year’s
utilization data in the computation and
evaluation of composite bids, the
composite bids themselves do not
determine the single payment price for
each drug. Rather, as we describe below
in section 3.b. of this interim final rule,
the single price for a drug is a function
of the bids submitted for that drug by
the winning bidders: specifically, we are
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
setting the single price for each drug at
the median of the bids of the winning
bidders for that drug. The utilization
data will play a role in determining
acceptable composite bids (those
composite bids that are no greater than
106 percent of the weighted average of
the ASPs for all the drugs in the
category) and the winning bids (up to
the five lowest composite bids below
the threshold in our nationwide
competitive acquisition area, from
qualified applicants). However, once the
winning bidders have been determined,
only those bidders’ specific bids for
each HCPCS code are used to set the
single price. Utilization data from a
prior year has no effect on the single
price for any drug under this
methodology.
Comment: Several commenters
recommended that, in order to provide
greater choice among vendors, we
should accept all bidders with
composite bids at or below 106 percent
of the weighted average of the ASPs for
all the drugs in a category. These
commenters therefore requested that we
drop our proposal to accept up to the
five lowest bids.
Response: As we discussed in the
proposed rule (70 FR 10763), we had
considered this alternative to our
proposal that we accept the five lowest
bids in any area with composite bids at
or below 106 percent of the weighted
average of the ASPs for all drugs in the
category. We stated in that discussion
that one alternative to the method we
proposed is simply to accept any
composite bid for a drug category that
is less than 106 percent of the weighted
ASP for the drugs in that category.
Under this method, it would be possible
for every bidder to submit a bid price
just below ASP plus 6 percent, in the
confidence that the bid would be
accepted. This method would thus limit
the potential for savings to the program,
compared to the bidding process that we
proposed. Under the process that we
proposed, bidders retain an incentive to
submit the best bid price that is possible
for them. Thus, restricting the number
of bidders that might be accepted
provides for more competition in the
bidding process than accepting all
bidders under a designated threshold.
We continue to find this rationale
persuasive. Therefore, in order to
promote competition among vendors
and the possibility of realizing some
savings for the Medicare program, we
are finalizing our proposal to select,
from all those bidders that meet the
quality and financial thresholds, up to
the five lowest bids for a drug category
in our nationwide competitive
acquisition area. However, we would
PO 00000
Frm 00051
Fmt 4701
Sfmt 4700
39071
not select any bid that is higher than
106 percent of the weighted ASP for the
drugs in our single drug category.
Comment: One comment suggested
that the vendor be allowed to include
costs of spoilage and breakage in the
bid. Another commenter suggested that
vendors be paid for patient and provider
education, counseling and compliance
checks.
Response: The costs that a bidding
entity may include in their bid price are
described in section 1847B(c)(6) of the
Act. The statute requires that the
submitted bid price include ‘‘all costs
related to the delivery of the drug or
biological to the selecting physician’’
and ‘‘the costs of dispensing (including
shipping) of such drug or biological and
management fees.’’ The statute
specifically prohibits including ‘‘any
costs related to the administration of the
drug or biological, or wastage, spillage,
or spoilage.’’ We therefore do not have
the statutory authority to allow
inclusion of costs for spoilage and
breakage in the bid. We also do not have
the authority to provide separate
payment to vendors for patient and
provider education, counseling, and
compliance checks.
Comment: One comment stated that
the method for determining the bid
price for multiple source drugs was not
clear and suggested that it should be the
same method that is used for single
source drugs. Another comment
suggested that using a pre-MMA fee
schedule as the threshold was more
appropriate.
Response: We assume that the
commenter is referring to the drug
prices established under the AWP
methodology in effect prior to the MMA.
We do not believe that employing the
prices determined under that
methodology as a benchmark would be
appropriate, because Congress has
specifically replaced that methodology
with the ASP system for most Part B
drugs. Under the composite bidding
methodology that we have adopted,
bidders must submit bid prices for each
HCPCS code included in our broad
category of drugs. As we note in section
A.2 of this rule, HCPCS codes can often
describe products represented by
multiple National Drug Codes (NDCs).
We are requiring vendors to submit bids
for each HCPCS code within a category,
and to provide at least one drug within
each code. Vendors will also be required
to provide potential physician
participants in the competitive
acquisition program the specific NDCs
within each HCPCS code that they will
be able to provide to the physician. In
constructing their bids for each code,
vendors will need to take into account
E:\FR\FM\06JYR2.SGM
06JYR2
39072
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
which specific drug(s) they intend to
provide within that code. In
constructing their bids, it will also be
important for potential vendors to
consider whether the drug or drugs
within a specific code are multiple
source or single source, and the prices
at which they may be able to obtain
these drugs from the respective
manufacturers. However, it is neither
necessary nor advisable for us to
prescribe the manner in which vendors
should take these considerations into
account in developing the bid price for
each specific code. Rather, we believe
that the CAP will function most
efficiently in this respect if bidders have
the flexibility to construct their bids in
the light of their own business goals and
cost analysis within the statutory and
regulatory parameters (that bid prices
may not include any costs related to
wastage, spillage, or spoilage).
As discussed above, our method for
computing composite bids requires us to
weigh the bids for the specific drugs in
our single drug category. We proposed
to employ volume data, specifically
each HCPCS code’s share of volume
(measured in HCPCS units) for the prior
year. In the proposed rule, we invited
public comment on methods for
weighting drugs introduced during and
after 2004 within the composite bidding
methodology (70 FR 10762).
Comment: Many commenters urged
us to provide for inclusion of newer
drugs within the drug categories that we
adopt. Commenters did not offer
specific proposals for developing
weights for these drugs in order to
provide for considering them with the
composite bidding methodology.
Commenters generally suggested using
the new ASP system as a basis of
bidding and payment for these drugs
within the CAP, or allowing for
payment based on a vendor’s actual
costs for acquiring these drugs.
Response: We agree with the
commenters that it is important to
include newer drugs within the CAP as
quickly as possible. In the case of drugs
that have been introduced during and
after 2003 (but in time for consideration
in developing this interim final rule),
we have decided upon the following
methodology. We have developed a list
of drugs that have been introduced
during and after 2003 and that are
appropriate for inclusion within the
established category of Part B drugs that
are commonly administered incident to
a physician’s services. We have
included in this list only those drugs
that meet a minimum threshold in
allowed charges ($50,000) in our billing
data from the first quarter of CY 2005.
The drugs on this list include important
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
new therapies such as risperidone. The
complete list of these drugs is shown in
Addendum B of this interim final rule
with comment period. We will require
that prospective vendors include bids
for these drugs in their submissions and
provide these drugs to physicians who
elect to participate in the CAP.
However, we will not incorporate the
bids for these drugs into the composite
bid methodology, because we lack
sufficient utilization data to compute
appropriate weights for these drugs.
Instead, we will consider these bids
separately from, but parallel to,
evaluation of the composite bid for the
other drugs for which we have adequate
utilization data. Specifically, we will
require bidders to submit a separate bid
for each drug in the list. We will also
impose a ceiling on acceptable bids. As
in the case of the composite bids, that
ceiling will be tied to the ASP payment
methodology. Specifically, we will not
accept any bid for a new drug that is
higher than 106 percent of the ASP for
that drug (as determined at the time
when the bidding begins, which will be
the second quarter of calendar year
2005). Vendors will be able to locate the
appropriate prices for that quarter on
our Web site at https://www.cms.hhs.gov/
providers/drugs/asp.asp. In order to be
selected as a CAP vendor, a bidder must
submit acceptable bids on each of the
new drugs listed in Addendum B of this
interim final rule with comment period.
In order to be selected as a vendor,
then, a bidder must meet three
conditions. First, a bidder must submit
a composite bid on the single drug
category that is less than or equal to the
106 percent of the weighted ASP for the
drugs in that category (based on the ASP
prices in effect during the second
quarter of CY 2005, during which the
bidding will begin). Second, a bidder
must submit one of the five lowest bids
for the single drug category in our
nationwide competitive acquisition
area. Third, a bidder must also submit
acceptable bids on each of the new
drugs listed in Addendum B of this
interim final rule with comment period.
An acceptable bid on one of these new
drugs is less than or equal to 106
percent of the ASP for that drug (as
determined at the time of the bidding,
which will begin during the second
quarter of CY 2005).
In this interim final rule, we are
therefore finalizing our proposal to
employ a ‘‘composite bid,’’ constructed
from the bid prices for the individual
drugs in the CAP category, in the
process of selected bidders for the CAP.
The composite bid will be constructed
by weighting each HCPCS bid by the
HCPCS code’s share of volume
PO 00000
Frm 00052
Fmt 4701
Sfmt 4700
(measured in HCPCS units) of drugs in
our single drug category during the prior
year. Within the single category, the
drug weights will thus sum to one.
Based on data availability, the volume
data used for bids in the first CAP
bidding cycle (for supplying drugs
starting January 1, 2006) will from FY
2004. The calculated composite bid will
be equal to the average price per HCPCS
unit for drugs in that category. In this
way, the composite bid will be
proportional to the expected cost to the
program of acquiring drugs from that
vendor (based on the assumption that
the 2004 volume is roughly proportional
to volume in 2006). If one vendor has
a lower composite bid than another, it
will also have a lower expected cost of
supplying all drugs in the CAP category.
Also, as a point of clarification,
although it will not impact the initial
implementation of CAP since it is one
area, we are revising § 414.910 to clarify
in the case of multiple areas, entities
can bid on one or more areas.
To illustrate how the composite bid
will be calculated, we are providing the
following example. Suppose that there
are four drugs in a CAP drug category
(Drug A, Drug B, Drug C, and Drug D).
The first column of Table 3 below
provides the total volume (HCPCS units)
of these drugs administered in 2004 for
this hypothetical drug category.
TABLE 3.—EXAMPLE DRUG VOLUMES
AND RELATIVE VOLUMES, 2004
Total HCPCS
units
Relative volume
..........
..........
..........
..........
1,452,472
988,586
1,671,567
14,302
0.3520
0.2395
0.4050
0.0035
Total .......
4,126,927
1.0000
Drug
Drug
Drug
Drug
Drug
A
B
C
D
Three drugs (Drugs A, B, and C) have
volumes (total HCPCS units) much
greater than that of the fourth (Drug D).
The second column of Table 3 gives the
relative volumes, computed by dividing
the volumes of the individual
components of this CAP category by the
total volume of HCPCS units for drugs
in this category. These relative volumes
are the weights used to construct the
composite bids.
The computation of the composite
bids for these four bidders is shown in
Table 4. The composite bid for Bidder
1 is computed as the weighted sum of
the bids for the four drugs: ($520 ×
0.3520) + ($400 × 0.2395) + ($135 ×
0.4050) + ($4,780 × 0.0035), which is
equal to $350.25. The composite bids for
the other three bidders are computed
similarly.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
39073
TABLE 4.—EXAMPLE COMPOSITE BID COMPUTATION
Drug
Weight
Drug A ..............................................................................
Drug B ..............................................................................
Drug C ..............................................................................
Drug D ..............................................................................
Composite Bid ..................................................................
0.3520
0.2395
0.4050
0.0035
....................
As Table 4 illustrates, it is possible for
a bidder to submit the lowest bid on
more individual drugs than other
bidders (such as, Bidder 3 has submitted
the lowest bids for Drug B and Drug D),
but have the highest composite bid. This
is because Bidder 3 submitted relatively
high bids for Drug A and Drug C, which
have the largest volumes (in HCPCS
units). Also note that although Bidder 4
did not submit the lowest bid for any of
the four drugs, its composite bid is the
second lowest.
As we have discussed above, we have
decided to adopt a method that bases
Bidder 1
$520
400
135
4,780
$350.25
Bidder 2
$530
410
105
4,830
$344.19
the selection of winning bidders on
applying a predetermined ceiling on the
composite bid. Specifically, under the
method we are adopting, we will select,
from all those bidders that meet the
quality and financial thresholds, up to
the five lowest bidders for the single
drug category in our nationwide
competitive acquisition area. However,
we will not select any bid for the
category that is higher than 106 percent
of the weighted ASP for the drugs in
that category. As we have also
discussed, we believe that limiting the
maximum bid price we would accept is
Bidder 3
$550
380
135
4,430
$354.79
Bidder 4
Low bidder
$530
390
120
4,800
$345.37
1
3
2
3
2
consistent with Congressional intent
that the CAP promote savings.
As an example of this computation,
suppose that the ASPs for four drugs in
the composite bid example above (see
Table 4) are as follows: $516 for Drug A,
$376 for Drug B, $111 for Drug C, and
$4,831 for Drug D. Using the relative
weights in Table 4, we would compute
the composite bid threshold as 1.06 ×
($516 × 0.3520 + $376 × 0.2395 + $111
× 0.4050 + $4,831 × 0.0035), which is
equal to $353.56. In this example, three
bidders (Bidder 1, 2 and 4) would be
selected as CAP vendors. (See Table 5.)
TABLE 5.—EXAMPLE: PROPOSED COMPOSITE BID SELECTION METHOD
Drug
Weight
Drug A ..............................................................................
Drug B ..............................................................................
Drug C ..............................................................................
Drug D ..............................................................................
Composite Bid ..................................................................
Maximum Bid ...................................................................
0.3520
0.2395
0.4050
0.0035
....................
....................
b. Determining the Single Price for a
Category of Drugs
Once the winning bidders have been
identified, section 1847B(d)(1) of the
Act requires that a single price must be
determined for each drug in a
competitive acquisition area, ‘‘based on
bids submitted and accepted.’’ We
considered a number of options for
determining this single price on the
basis of the accepted bid prices. In the
proposed rule at § 414.906(c)(1), (which
describes the computation of the
payment amount), we proposed to
establish a single price for each drug in
a competitive acquisition area, based on
the median bid of the winning bidders
if there is an odd number of vendors (3
or 5). If there are four vendors, we will
employ the median through averaging of
the bids of the second and third highest
bidders on each drug to set the price for
the drugs. If only two bidders are
selected, we would use the median, in
this case also the average, of the two
bids for the drug to set the price for that
drug. [Note the mean (or average) is the
median of the two middle bids or the
straight average if there are only two
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
Bidder 1
$520
400
135
4,780
$350.25
$353.56
Bidder 2
$530
410
105
4,830
$344.19
$353.56
bids.] The qualified vendors would be
made aware of the established price set
for the CAP drugs before he or she signs
the contract to be an approved vendor.
We proposed to employ the median
bid for several reasons. First, this
method is straightforward and relatively
easy to implement. The median bid is
an obvious statistical method to
determine a single price based on using
the information provided by bids, as
required by the statute. In addition, this
method could realize some savings to
the Medicare program: Unless the bids
for a given drug of all selected bidders
are at or above the level of the
maximum allowable bid (106 percent of
ASP), this method for determining the
single price would yield savings to the
program.
In cases where there are four winning
bidders for a drug category in an area,
we proposed to employ the average of
the bids of the second and third highest
bidders on each drug to set the price for
the drug. If there are only two bidders,
we would use the average of the two
bids for the drug to set the price for that
drug. We noted that the qualified
PO 00000
Frm 00053
Fmt 4701
Sfmt 4700
Bidder 3
$550
380
135
4,430
$354.79
$353.56
Bidder 4
$530
390
120
4,800
$345.37
$353.56
Bids selected
....................
....................
....................
....................
....................
1, 2, 4
vendors would be made aware of the
established price set for the CAP drugs
before they sign the contract to be an
approved vendor. As we stated in the
proposed rule (70 FR 10763), qualified
vendors will be made aware of the
established price set for the CAP drugs
before he or she signs the contract to be
an approved vendor.
We requested comments on our
proposed approach for determining the
price of the drug under the CAP and any
alternative approaches that might be
utilized.
Comment: One commenter suggested
that vendor-specific payment be
considered, but also acknowledged that
this would require a change to the
statute. Some commenters also
recommended that we pay each vendor
the actual bid amount rather than pay a
median of the bids of all the winning
vendors.
Response: We agree with the
commenter who acknowledged that
statutory change would be necessary to
adopt vendor-specific payment. The
statute specifically requires
establishment of a ‘‘single payment
amount for each competitively biddable
E:\FR\FM\06JYR2.SGM
06JYR2
39074
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
drug or biological’’ in an area (section
1847B((d)(1) of the Act). It is not
possible to establish a single price for
each drug in the nationwide competitive
acquisition area and simultaneously to
provide for vendor-specific payment.
Because paying each vendor the actual
bid amount would essentially establish
a vendor-specific payment, that method
also is not permitted by the statute.
Comment: One commenter expressed
concern that one expensive and heavily
utilized HCPCS code in a category could
have a significant impact on the entire
category’s price.
Response: We do not believe that our
proposed method for using bids to
determine single prices for drugs will
lead to this result. In particular, we did
not propose establishing a price for an
entire category. Rather, we proposed
using the bids, for each specific HCPCS
code, of the successful bidders to set the
price for the drug. In addition, we
proposed that the single price for a drug
would be the median of those bids (or
in the cases of even numbers of
accepted bidders, averages of the bids,
as previously described). The weighting
of heavily utilized drugs will thus have
an effect on the calculation of composite
bids and the determination of successful
bids. However, our decision to establish
one large category with a large number
of HCPCS codes will minimize the effect
of any one drug or one manufacturer on
the composite bids as a whole. In
addition, using the median to determine
the single price limits the effects of any
one highly expensive drug in a HCPCS
code on the determination of the single
price for that code.
Comment: Several comments asked us
to confirm which ASP quarter would be
used to evaluate bid prices. Some
commenters also requested that we
provide some allowance for price
increases from that quarter until the
contract period during which the single
drug prices would be in effect. One
commenter suggested using the
Producer Price Index for this purpose.
Other commenters suggested tying
single price updates to changes in ASP
prices.
Response: As we discussed in section
3.a above, the composite bid ceiling will
be determined on the basis of ASP
prices in effect during the quarter in
which the bids are generated.
Specifically, we will determine the
threshold (106 percent of the weighted
ASP for the drugs included in our single
drug category) on the basis of the ASP
prices in effect at the time when the
bidding begins, which will be during
the second quarter of calendar year
2005.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
We agree with the commenters that
adopting some mechanism for updating
prices from the period in which bidding
begins (the second quarter of calendar
year 2005) to the period in which the
single prices will actually be in effect
(calendar year 2006) is appropriate. We
also agree with the suggestion of some
commenters that the most appropriate
mechanism for doing so is to employ the
changes in the Producer Price Index
(PPI) for prescription preparations over
the same period. Therefore, in this
interim final rule, we are providing that
the single price for each drug (HCPCS
code) will be initially determined on the
basis of the median of the bids
submitted during the second quarter of
calendar year 2005 for that drug. The
price of each drug will then be updated
to the mid-point of calendar year 2006
(five quarter increase) PPI for
prescription preparations. The PPI for
prescription preparations is released
monthly by the Bureau of Labor
Statistics, and reflects price changes at
the wholesale or manufacturer stage. By
comparison, the Consumer Price Index
(CPI) reflects price changes at the retail
stage. Because the CAP drugs are
purchased direct from the manufacturer
or wholesaler, this is an appropriate
price index to use. In addition, the PPI
for prescription drugs is the measure
used in various market baskets that
update Medicare payments to hospitals,
physicians, skilled nursing facilities and
home health agencies. We will be using
the most up to date forecast data
available from Global Insight Inc. at the
time of contract award to determine the
PPI. We feel that the use of an
independent forecast, in this case from
Global Insight, Inc. is superior to using
the National Health Expenditure
Projections for drug prices (which is the
CPI for prescription drugs) and is
consistent with the methodology used
in projecting market basket increases in
Medicare prospective payment systems.
Currently, we do not believe there has
been enough experience with the ASP
payment methodology to update the
bids based on growth in the ASP. We
are only in the second quarter of using
ASP as a payment, and we do not have
enough data to make reliable projections
in growth. However, we will continue to
analyze the ASP data and will revisit
this issue in the future. We welcome
comments on this method of updating
the single drugs prices to the payment
year, and will consider those comments
as we develop and refine the CAP.
Under our approach of updating to
the mid-point of 2006, it is also
important to note that the CAP prices
may be somewhat higher than the ASP
prices during the first half of calendar
PO 00000
Frm 00054
Fmt 4701
Sfmt 4700
year 2006. We have chosen to update to
the mid-point of the year to most
accurately reflect the increase in prices
that will occur over the course of the
year. ASP prices are updated on a
quarterly basis so there is no need to
make projections under that payment
system. On balance and over the entire
year, CAP and ASP prices should be
equivalent. We welcome comments on
this method of updating the single drugs
prices to the payment year, and will
consider those comments as we develop
and refine the CAP in subsequent
regulations.
Section 1847B(d)(2) of the Act
requires the Secretary to ‘‘establish rules
regarding the use * * * of the
alternative payment amount provided
under section 1847A of the Act’’ for
payment of a new drug or biological
under the CAP. Section 1847A of the
Act establishes the average sales price
methodology for most drugs paid under
Part B of the Medicare program. Section
1847A(c)(4) of the Act further provides
alternatives for the Secretary to
determine the amount payable for new
drugs during an initial period. In
accordance with the requirement at
section 1847B(d)(2) of the Act, we
proposed to apply the payment amount
that we establish under section 1847A
of the Act in the case of any drug or
biological for which we determine
that—(1) the drug or biological is
properly assigned to a category
established under the CAP; and (2)
issuance of a new HCPCS code is
required for the drug or biological. We
also stated we would employ the
payment amount determined in
accordance with the methodology
provided under section 1847A(c)(4) of
the Act until the next annual update of
the single price amounts.
Comment: Many commenters asked
us to clarify whether and how we would
pay for new drugs. Many of these
commenters recommended that vendors
be required to provide new drugs, so
that beneficiaries will have access
through the CAP to the most recent
therapies available. These commenters
variously recommended that vendors be
reimbursed at the ASP price or at cost
for providing these new drugs.
Alternatively, some commenters asked
us to clarify that physicians who elect
to obtain their drugs through a CAP
vendor may still obtain drugs that are
not available through the vendor, such
as new drugs or drugs not included in
the drug category provided under the
CAP contract, from other sources and
receive payment under the ASP system.
Another comment recommended that
new drugs be added to CAP no later
than 2 quarters after introduction.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Response: It is important to
distinguish two categories of new drugs
in relation to the CAP. The first category
consists of drugs that have been released
in the period just prior to the bidding in
a given year, have been assigned codes,
and have established prices under the
ASP system. In these cases, we
sometimes do not have sufficient data
on volume to include these drugs in the
composite bidding methodology. As we
discuss in section 3.a above, we have
decided to include a select list of drugs
that have been introduced during and
after 2004 within the single drug
category that we are adopting. We will
also require that prospective vendors
include bids for these drugs in their
submissions and provide these drugs to
physicians who elect to participate in
the CAP. However, we will not
incorporate the bids for these drugs into
the composite bid methodology, but
rather consider these bids separately,
imposing a ceiling tied to the ASP
payment methodology on acceptable
bids. That is, the bids for each drug on
the list must not exceed the payment
level determined under section 1847A
of the Act.
The second category of new drugs
consists of those that are introduced too
late even to be incorporated under this
special methodology. These drugs may
have been introduced prior to the
bidding period, but too late to obtain
HCPCS codes and/or ASP prices. Other
such new drugs may not be introduced
until after the bidding period, even in
the second or third years of the vendor
contracts under the CAP. We agree with
the commenters that it is important to
provide beneficiaries with access to
these drugs as quickly and effectively as
possible. However, we do not agree that
it is appropriate, especially during the
initial stages of implementing the CAP,
to impose a requirement on vendors to
include all new drugs introduced too
late to be taken into consideration
during the bidding period. Such a
requirement may impose unpredictable,
and sometimes difficult or impossible,
burdens on some vendors. Vendors may
not be able to make the acquisition
arrangements necessary to obtain some
new drugs, or at least to obtain them at
a reasonable price. It would also be
difficult to develop the administrative
mechanisms necessary to identify new
drugs that should be included within
the CAP, to advise vendors that they
must begin providing specific new
drugs, to monitor vendor compliance,
and to enforce these requirements
(where necessary) in a timely fashion.
Therefore, we are not adopting such a
requirement at this time. It is important
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
to note that physicians who have
elected to participate in CAP are
expected to order all of the CAP drugs
they use through the CAP vendor except
when a CAP physician is utilizing the
‘‘furnish as written’’ exception. If a
physician obtains a CAP drug
elsewhere, the drug will not be covered.
When a participating CAP physician is
purchasing a drug under the ‘‘furnish as
written’’ exception or is purchasing a
drug that is not available under the
CAP, he or she can receive payment for
those drugs through the ASP system and
would be expected to bill Medicare
directly for the drugs. At the same time,
we certainly encourage vendors to add
such new drugs as they are introduced.
We are therefore adopting the
mechanism we proposed in order to
make it possible for vendors to do so. In
accordance with the requirement at
section 1847B(d)(2) of the Act and
§ 414.906(c)(2), we will apply the
payment amount that we establish
under section 1847A of the Act in the
case of any drug or biological for which
we determine that—(1) The drug or
biological would be properly assigned to
the single drug category that we are
establishing for this initial stage of
implementation under the CAP; and (2)
issuance of a new HCPCS code is
required for the drug or biological and
will revise the regulation at
§ 414.906(c)(2) to ensure that it is
explicit. We will provide for payment to
CAP vendors for these new drugs at the
time of the next quarterly update after
the drug receives a code. Vendors may
contact CMS in order to propose adding
a new drug to their approved list. If we
determine that the new drug is
appropriate for inclusion on the
approved CAP vendor’s approved list,
we will approve the vendor’s request to
add the drug under the CAP contract
and provide for payment at the next
quarterly update. The new drug will be
considered a CAP drug for purposes of
the CAP program, and the coverage
rules described above will apply (that is,
the physician must obtain the drug from
the approved CAP vendor in order for
payment to be made for the drug, unless
the ‘‘furnish as written’’ exception
applies). We will not formally revise the
CAP categories in order to accommodate
vendor requests to add new drugs, since
such additions will not be mandatory. If
there are any further annual updates
during the period of a vendor’s contract
after we initially provide for payment of
a new drug that the vendor is providing,
we will employ the mechanism for
annual updates of single price amounts
that we describe below.
PO 00000
Frm 00055
Fmt 4701
Sfmt 4700
39075
Section 1847B(b)(4)(B) of the Act
provides that contracts for the
acquisition of competitively biddable
drugs under the CAP must be for a
period of 3 years. Therefore, it is
necessary to determine some
mechanism for setting the single price
for each category of drugs in the second
and third years of this 3-year contract.
We proposed to employ the mechanisms
provided under section 1847B(c)(7) of
the Act for this purpose. Specifically,
that section requires that each contract
must provide for disclosure to the
Secretary of the vendor’s ‘‘reasonable,
net acquisition costs’’ on a regular basis
(not more often than quarterly). It
further requires that contracts must
provide for ‘‘appropriate price
adjustments over the period of the
contract to reflect significant increases
or decreases in a vendor’s reasonable,
net acquisition costs, as so disclosed.’’
Therefore we proposed at
§ 414.906(c)(1) to update the CAP prices
for each drug in a category in year 2 and
year 3 based on the vendor’s
‘‘reasonable, net acquisition costs’’ for
that category as determined by CMS
based, in part, on information disclosed
to the Secretary and limited by the
weighted payment amount established
under 1847A of the Act across all drugs
in that category.
Section 1847B(c)(7) of the Act gives
the Secretary the discretion to establish
an appropriate schedule for the CAP
vendor’s disclosure of this cost
information to us, provided that
disclosure is not required more
frequently than quarterly. We proposed
to require that each vendor disclose to
the Secretary its reasonable, net
acquisition costs for the drugs covered
under the contract annually during the
period of its contract. Annual disclosure
imposes the minimal burden on vendors
consistent with employing this
provision to determine the single price
for drugs in the second and third years
of a contract. More frequent disclosure
(for example, quarterly) is, of course,
also consistent with this purpose. We
anticipate that the annual disclosure
would be required in or around October
of each year, to provide sufficient time
to determine what, if any, update in
drug prices would be appropriate for the
following year. We invited comments
regarding an appropriate disclosure
schedule under section 1847B(c)(7) of
the Act for this purpose.
Comment: Several commenters stated
that yearly cost disclosure and price
adjustments would be sufficient. One
commenter favored yearly adjustment
because more frequent adjustment may
cause vendors to leave the program if
rates are not adjusted in their favor.
E:\FR\FM\06JYR2.SGM
06JYR2
39076
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Many other commenters recommended
more frequent reporting and updates.
Some of these commenters
recommended a biannual process, but
most preferred quarterly updates. Some
comments acknowledged that more
frequent acquisition cost reporting
could be a burden for vendors, but many
commenters noted that increasing the
frequency of acquisition cost reporting
and price adjustments would provide
for greater consistency between CAP
and ASP systems, minimize the
payment difference between CAP and
ASP, and would be less financially risky
for vendors.
Response: We appreciate the concerns
of the commenters who recommended
more frequent (biannual or quarterly)
updates. However, we continue to
believe that annual reporting and
payment updates provide the most
appropriate balance between vendor
and CMS administrative burden and
paying for CAP drugs based upon the
most timely data, at least during this
initial stage of implementing the CAP.
Specifically, we remain concerned that
more frequent updates would also
require more frequent reporting. We are
reluctant to impose the burden of
semiannual or quarterly reporting at this
time. When the administrative
mechanisms of the CAP are operational
and vendors have more experience
under the program, we will consider
whether more frequent reporting would
be appropriate.
We proposed the following
methodology for developing an
appropriate adjustment on the basis of
the net reasonable cost information
disclosed by vendors. We would employ
the net reasonable cost information
disclosed by each vendor to determine
whether the vendor has experienced
significant increases or decreases in the
reasonable, net acquisition costs across
a category of drugs. For this purpose, we
stated that we were considering
establishing a threshold percentage
change in these costs, to determine
whether the changes warrant computing
an adjustment to the single prices for
the drugs in that category. If the change
in the costs reported by a particular
vendor meet this threshold, we would
use a two-step process to recompute the
single price for each drug in that class.
First, we would adjust the bid price that
the vendor originally submitted by the
percentage change indicated in the
information that the vendor disclosed.
Next, we would recompute the single
price for the drug as the median of these
adjusted bid prices. We noted that this
mechanism would apply in the case of
any significant change in reasonable, net
acquisition costs, whether those changes
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
reflect increase or decreases in costs. It
is therefore possible that the single price
for a drug could decrease in the second
or third year of a contract where, for
example, acquisition costs for the drug
have decreased because of the
introduction of a generic equivalent.
Comment: A number of commenters
recommended that we apply no
threshold test in determining whether
price adjustments should occur. One
commenter supported using a rolling 12
month ASP as the basis of price
adjustments in order to smooth out the
influence of price spikes. Another
comment recommended that price
changes from manufacturers should be
automatically reflected in an update.
Comments asked for more specific
information about how the threshold
would be calculated, specifically, which
quarter’s data would be used to
calculate an adjustment, noting that the
‘‘lag’’ period between the time of
adjustment and the time that financial
information was collected should be
minimal.
Response: We agree with the
commenters who recommended that we
not employ a threshold for determining
whether a change in costs warranted an
update in the single prices for drugs.
Rather, we will adopt the mechanism
that we described in the proposed rule
without applying any threshold.
Specifically, we will employ the net
reasonable cost information disclosed
by each vendor to determine whether
the vendor has experienced changes in
the reasonable, net acquisition costs for
the drugs included in our single
category of drugs. If there is a change in
the costs reported by a particular
vendor, we would use a two-step
process to recompute the single price for
each drug in the single drug category.
First, we would adjust the bid price that
the vendor originally submitted by the
percentage change indicated in the
information that the vendor disclosed.
Next, we would recompute the single
price for the drug as the median of all
of these adjusted bid prices. We would
then notify all of the vendors of the
single price that we would be paying for
the particular drugs in the following
year. As we noted in the notice of
proposed rulemaking, this mechanism
would apply in the case of any change
in reasonable, net acquisition costs,
whether those changes reflect increase
or decreases in costs. It is therefore
possible that the single price for a drug
could decrease in the second or third
year of a contract where, for example,
acquisition costs for the drug have
decreased because of the introduction of
a generic equivalent. It is also possible
that one vendor would report large
PO 00000
Frm 00056
Fmt 4701
Sfmt 4700
increases while the other vendors report
price decreases or vice versa. In this
situation, we would follow the same
two step process for updating the single
price. As noted in the proposed rule, we
will limit the annual update by the
weighted payment amount established
under section 1847A of the Act across
all drugs in the category. We will
require submission of net reasonable
cost information by each vendor at the
beginning of the fourth quarter in each
year of the contract, in order to provide
sufficient time to determine any update
in drug prices for the following calendar
year. We believe that this reporting
deadline reduces the inevitable lag
between the reporting of financial
information and the time of adjustment
to an acceptable, minimal level.
We indicated in the proposed rule
that we would consider ‘‘reasonable, net
acquisition costs’’ to be those costs
actually incurred by the vendor that are
necessary and proper for acquiring the
drugs that the vendor is obligated to
provide under a CAP contract. Actual
acquisition costs are net of all discounts
and rebates provided by the vendor’s
own suppliers. We would require full
disclosure of the vendor’s acquisition
costs for drugs included in the CAP
contract. We proposed that this
disclosure would reflect the vendor’s
purchases of these drugs from all
manufacturers, and the total number of
units purchased from each
manufacturer. The vendor would be
required to submit full documentation
reflecting actual purchase prices. This
documentation would include all
records reflecting discounts that result
in a reduction of actual cost to the
vendor. (Such discounts would include
volume discounts, prompt pay
discounts, cash discounts, free goods
that are contingent on any purchase
requirement, chargebacks, rebates,
refunds, and other price concessions
regardless of when they are recognized.)
Comment: One commenter
recommended that all costs related to
drug delivery and dispensing be
included in the report and that all
factors be considered in determining the
price adjustment. Other commenters
stated that only CAP program prices be
used in the price determination.
Another commenter stated that prompt
pay discounts should be excluded for
the net acquisition cost, since the
discount actually occurs as a term of
financing.
Response: We do not agree with the
recommendation to exclude prompt pay
discounts from the determination of
reasonable, net acquisition costs for
purposes of Section 1847B(c)(7) of the
Act. It is not obvious to us that this
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
discount occurs exclusively as a term of
financing, nor that it should be
excluded from consideration even if that
is the case. We do not see how prompt
pay discounts are any different from
other types of price concessions and
why they would need to be treated
differently for purposes of the CAP. We
are interested in learning more about
how these discounts are arranged and
whether they are indeed different from
other price concessions and discount
arrangements. We appreciate the
comment that only CAP program prices
be used in the determination of whether
acquisition costs have increased.
However, we are concerned that it may
be administratively difficult for
approved CAP vendors to distinguish
their acquisition costs for provision of
drugs under the CAP program from
acquisition costs for drugs generally. We
are therefore not adopting the
recommendation at this time. Finally,
we cannot adopt the recommendation
that all costs related to drug delivery
and dispensing be included in the
report. Section 1847B(c)(7) of the Act
provides only for the disclosure of
contractor’s ‘‘reasonable, net acquisition
costs’’ to the Secretary, and for basing
price adjustments under the CAP on
‘‘significant increases or decreases’’ in
those costs. Therefore, only net
acquisition costs that meet these criteria
may be included. We would also note
that we are not adopting any specific
definition of ‘‘significant’’ at this time.
In this initial stage of the program, we
will treat all cost increases and
decreases as significant.
Comment: Two commenters
expressed concern about whether price
information could be made exempt from
Freedom of Information Act requests
and suggested that vendors certify the
accuracy of CAP drug price information
in a manner similar to ASP pricing
certification. Another commenter
mentioned confidentiality provisions of
the Trade Secrets Act. These
commenters requested details about
how confidentiality of manufacturer’s
pricing information would be handled.
Two commenters stated that the pricing
information is proprietary and should
be treated as such. Several comments
noted that price data provided to CMS
should be afforded the same protection
as ASP data and data submitted to
Medicaid.
Response: Section 1847B(a)(1)(C) of
the Act provides that, in implementing
the CAP, the Secretary may waive
provisions of the Federal Acquisition
Regulation (FAR), ‘‘other than
provisions relating to the confidentiality
of information.’’ The confidentiality
provisions of the FAR thus apply to the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
data submitted by bidders and vendors
under the CAP. Generally, the FAR
requires contractors and bidders to
clearly mark all information they seek to
protect, and generally, a bidder’s
confidential business strategies and unit
prices are protected as confidential.
However, what is confidential for FAR
purposes may not necessarily be
protected under the provisions of the
Freedom of Information Act (FOIA). In
the event that CMS receives a FOIA
request for pricing information, the CMS
FOIA officer will process the request in
accordance with 5 U.S.C 552 and 5 CFR
part 5, and determine whether any of
the FOIA’s exemptions to mandatory
disclosure may apply to protect the
information. In addition, under section
1847B(c)(5) of the Act, the Medicaid
drug rebate confidentiality provisions of
section 1927(b)(3)(D)of the Act apply to
periods during which a bid is submitted
with respect to a CAP drug in the same
manner as it applies to information
disclosed under the Medicaid drug
rebate statute. We also require that
vendors certify the accuracy of their
CAP drug pricing information on the
vendor application form.
We also proposed to make more
frequent adjustments (but not more
often than quarterly) in three cases:
introduction of a new drug, expiration
of a drug patent, or a material shortage
that results in a significant price
increase for a drug. We may restrict the
circumstances in which we would make
adjustments to account for shortages to
those in which the Secretary has
declared a public health emergency
under section 319 of the Public Health
Service Act. We invited comments on
this approach.
Comment: We received no comments
addressing our specific proposal for
more frequent updates in these cases.
However, several commenters asked for
clarification about the obligations of
vendors when a drug offered under the
CAP becomes unavailable (such as in
the case of a recall). Some of these
commenters recommended that the
vendor be allowed to add a new drug to
its list to replace or complement the
drug that is no longer available. One
commenter recommended that vendors
should be allowed to remove drugs from
the list of CAP drugs only when it is
necessary to address safety concerns or
when the drug has been removed from
the market.
Response: We agree with the
recommendation that vendors should be
allowed to remove drugs from their lists
in cases of withdrawals from the market.
We also agree that vendors should be
allowed to replace such drugs where it
is possible to do so. Therefore, we are
PO 00000
Frm 00057
Fmt 4701
Sfmt 4700
39077
providing in § 414.906(c)(1)(iv) of this
interim final rule with comment period
that, in cases where drugs are
withdrawn from the market, vendors
may substitute another drug if one is
available (for example, another drug
within a HCPCS code that contains
multiple NDCs). In order to make such
substitutions more feasible for vendors,
we will also expand our proposal for
more frequent updates (restricted in the
proposed rule to introduction of a new
drug, expiration of a drug patent, or a
material shortage) to include this case.
This mechanism will not, of course, be
available if no replacement (another
available NDC within the HCPCS) is
available. Until we have the opportunity
to update the drug price, we will pay for
these substitutions at the price
previously established for the drug
code.
Comment: Many commenters also
requested clarification about whether
the prices determined under CAP will
be taken into account in computing the
average sales price (ASP) under section
1847A of the statute. Most of these
commenters recommended exclusion of
CAP prices from the ASP calculation.
Some of these commenters pointed out
that inclusion of CAP prices in the ASP
computation may discourage
manufacturers from offering price
concessions to CAP vendors. A
congressional commenter supported
exclusion of CAP prices from the ASP
computation, stating that it was the
intent of Congress that these two
programs should not interact, and that
prices developed under the CAP should
not be incorporated into ASP
calculations. Another commenter noted,
however, that section 1847A(c)(2) of the
Act contains a specific list of sales that
are exempt from the ASP calculation,
and sales to vendors operating under
CAP are not included on that list. This
commenter therefore contended that
manufacturer prices offered under the
CAP must be included in ASP
calculations.
Response: We do not believe that we
have the statutory authority to exclude
prices determined under the CAP from
the computation of ASP under section
1847A of the Act. Section 1847A(c)(2) of
the Act contains a specific list of sales
that are exempt from the ASP
calculation, and sales to vendors
operating under CAP are not included
on that list. Prices offered under the
CAP must therefore be included in ASP
calculations.
In this interim final rule, we are
therefore establishing the following
policies and procedures for establishing
single prices for drugs under the CAP,
and updating those prices as
E:\FR\FM\06JYR2.SGM
06JYR2
39078
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
appropriate. Once the winning bidders
have been identified, section
1847B(d)(1) of the Act requires that a
single price must be determined for
each drug in a competitive acquisition
area, ‘‘based on bids submitted and
accepted.’’ Consistent with that
requirement, we calculate a single price,
for each drug in a competitive
acquisition area, based on the median of
the bids for that drug submitted by the
winning bidders. (In case there are four
winning bidders, we will employ the
average of the bids of the second and
third highest bidders on each drug to set
the median price for the drug. If there
are only two winning bidders, we would
use the average of the two bids for the
drug to set the median price for that
drug.)
We will also update the single prices
from the period in which bidding is
conducted (the second quarter of
calendar year 2005) to the period in
which the single prices will actually be
in effect (calendar year 2006).
Specifically, the price of each drug will
be updated to the mid-point of calendar
year 2006 on the basis of projecting the
overall change in PPI prices for
prescription preparations.
Section 1847B(d)(2) of the Act
requires the Secretary to ‘‘establish rules
regarding the use ‘‘of the alternative
payment amount provided under
section 1847A of the Act’’ for payment
of a new drug or biological under the
CAP. Section 1847A of the Act
establishes the average sales price
methodology for most drugs paid under
Part B of the Medicare program. In
accordance with this requirement and as
established in § 414.906(c)(2), we will
apply the payment amount that we
establish under section 1847A of the Act
in the case of any drug or biological for
which we determine that—(1) the drug
or biological is properly assigned to a
category established under the CAP; and
(2) issuance of a new HCPCS code is
required for the drug or biological. We
are encouraging vendors to add such
drugs that are introduced too late to be
incorporated into the bidding process to
the lists of the drugs provided under
CAP. However, due to systems
limitations during this initial stage of
the CAP, we will only be able to provide
for payment to CAP vendors at the time
of the next quarterly update of the CAP
prices. If there are any further annual
updates during the period of a vendor’s
contract after we initially provide for
payment of a new drug that the vendor
is providing, we would employ the
mechanism for annual updates of single
price amounts that we describe below.
As noted above, participating CAP
physicians are expected to order all of
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
the CAP drugs they use through the CAP
vendor except when the ‘‘furnish as
written’’ exception applies. If a
physician obtains a CAP drug
elsewhere, the drug will not be covered.
When a participating CAP physician is
purchasing a drug under the ‘‘furnish as
written’’ exception or is purchasing a
drug that is not available under the
CAP, he or she can bill for those drugs
under the ASP system.
Section 1847B(b)(4)(B) of the Act
provides that contracts for the
acquisition of competitively biddable
drugs under the CAP must be for a
period of 3 years. Therefore, it is
necessary to determine some
mechanism for setting the single price
for each category of drugs in the second
and third years of this 3-year contract.
We will employ the mechanisms
provided under section 1847B(c)(7) of
the Act for this purpose. Specifically,
that section requires that each contract
must provide for disclosure to the
Secretary of the vendor’s ‘‘reasonable,
net acquisition costs’’ on a regular basis
(not more often than quarterly). It
further requires that contracts must
provide for ‘‘appropriate price
adjustments over the period of the
contract to reflect significant increases
or decreases in a vendor’s reasonable,
net acquisition costs, as so disclosed.’’
In this interim final rule, we are
providing in § 414.906(c)that we will
employ the net reasonable cost
information disclosed by each vendor to
determine whether the vendor has
experienced changes in the reasonable,
net acquisition costs for the drugs
included in our single category of drugs.
Such disclosure will be required
annually, at the beginning of the fourth
quarter of each calendar year of the
contract. If there is a change in the costs
reported by a particular vendor, we will
use a two-step process to recompute the
single price for each drug in the single
category for all vendors. First, we will
adjust the bid price that the vendor
originally submitted by the percentage
change indicated in the information that
the vendor disclosed. Next, we would
recompute the single price for the drug
as the median of these adjusted bid
prices. This mechanism would apply in
the case of any change in reasonable, net
acquisition costs, whether those changes
reflect increase or decreases in costs.
We will also make more frequent
adjustments (but not more often than
quarterly) in four cases: introduction of
a new drug, expiration of a drug patent,
substitution of a drug for a drug
withdrawn from the market, or a
material shortage that results in a
significant price increase for a drug.
PO 00000
Frm 00058
Fmt 4701
Sfmt 4700
4. Contract Requirements
Section 1847B(b)(4) of the Act
discusses items to be incorporated in
the contract entered into with an
approved CAP vendor. These include
the following:
• The length of the contract.
• Assurance of the integrity of the
drug distribution system.
• A pledge to comply with code of
conduct and fraud and abuse rules.
• Assurance that drugs are only
supplied directly to CAP physicians,
with limited exceptions, upon receipt of
a prescription and other necessary data.
We set forth the contract terms
between CMS and the approved CAP
vendor as well as approved CAP vendor
responsibilities in proposed § 414.914.
Comment: A potential vendor
commented that a vendor should be
allowed to withdraw from the CAP at
any time upon a showing of financial
hardship or if the vendor can
demonstrate it cannot acquire product
directly from the manufacturer for less
than the reimbursed amount.
Response: We appreciate the potential
vendor’s comment on the duration of
the approved CAP vendor’s contract.
Given the statutory requirement that the
term of the contracts are for 3 years, we
are specifying at § 414.914(a)(2) that an
approved CAP vendor may terminate
the contract in the absence of a contract
violation, if the approved CAP vendor
provides notice to us by June 30 for an
effective date of termination of
December 31 of the same year. We
believe that to allow for a mid-year
termination, except where we terminate
the contract as provided in § 414.914(a)
or § 414.917, including in cases of
quality problems, would be
unnecessarily disruptive to services
being provided and to the operation of
the CAP.
Contract terms between CMS and the
approved CAP vendor, as well as
approved CAP vendor responsibilities,
will be addressed at § 414.914 as
proposed; however, modifications have
been made to incorporate revisions
based on issues discussed elsewhere in
this preamble.
5. Judicial Review
Provisions of section 1847(B)(g) of the
Act concerning administrative and
judicial review are set forth in
regulations at proposed § 414.920. This
section of the Act specifies aspects of
the CAP that are not subject to
administrative or judicial review.
We received no specific comments on
requirements proposed under § 414.920
concerning administrative and judicial
reviews, so we are finalizing this section
as proposed.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
D. Implementation of the CAP
1. Participating CAP Physician Election
Process
Section 1847B(a)(1)(A) of the Act
specifies that each physician be given
the opportunity annually to elect to
participate in the CAP. Physicians who
do not elect to participate in the CAP
would continue to buy the drugs they
provide to beneficiaries incident to a
physician’s service and bill the
Medicare program for them under
section 1847A of the Act, the ASP
system.
Section 1847B(a)(5)(A) of the Act
requires that we develop a process that
physicians who wish to participate in
the CAP may use on an annual basis to
select the approved CAP vendor from
whom they wish to obtain the categories
of drugs they wish to obtain under the
CAP program. The statute also requires
that we coordinate the physician’s
election to participate in the CAP with
the Medicare Participating Physician
Process described in section 1842(h) of
the Act. To inform physicians about the
choices of drugs and approved CAP
vendors available to them under the
CAP, we are required to post a directory
on our Web site or to make such a
directory available to interested
physicians on an ongoing basis.
In the proposed rule, we specified
that physicians who elect to participate
in the CAP would remain in the
program for at least 1 calendar year. As
described in more detail later in this
section, physicians who elect to
participate in the CAP would be
required to complete a CAP election
agreement. By completing this
participating CAP physician election
agreement, the participating CAP
physician would select the approved
CAP vendor that he or she would use
under the CAP and would agree to the
participating CAP physician
requirements. As described in further
detail in this section and the
regulations, a participating CAP
physician agrees to—
• Share information with the
approved CAP vendor to facilitate the
collection of applicable deductible and
coinsurance.
• Promptly file drug administration
claims.
• Timely and appropriately pursue
claims that are denied because of
medical necessity issues.
• Accept assignment for CAP drug
administration claims.
• Notify the approved CAP vendor
when a drug is not administered.
• Agree to comply with emergency
drug replacement rules.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
• Agree to requirements for using the
‘‘furnish as written’’ provision.
• Maintain an inventory for each CAP
drug he or she obtains.
• Provide support to the approved
CAP vendor on an administrative appeal
of the drug administration claim denial.
Such support may include medical
records and written statements.
If we find it necessary, we could
suspend the physician’s election to
participate in the CAP if the
participating CAP physician fails to
abide by the participating CAP
physician election agreement.
We proposed to initiate an annual
participating CAP physician election
process and modeled this proposed
process after the existing Medicare
Participating Physician Process to the
extent possible. In addition, we
communicated information to
physicians about the upcoming CAP
through the fact sheet that accompanied
the 2005 Participating Physician
Mailing, and proposed to continue to
use that vehicle to communicate
information about CAP to physicians in
future years. However, we noted that the
annual physician participation election
process for accepting assignment runs
from November 14 to December 31 of
each year. Waiting until December 31 to
receive information about physicians’
CAP election choices would not provide
sufficient time for us and our claims
processing contractors to record
information about participating CAP
physicians and their approved CAP
vendor selections, update claims
processing files, perform testing, and
inform approved CAP vendors so that
we are ready to pay CAP claims on
January 1, 2006. For this 3-year contract
cycle for the approved CAP vendors,
there will be one drug category. In the
future, as more CAP drug categories are
developed, the collection of information
on the selection of the approved CAP
vendor and drug category will be more
complicated. In addition, a deadline of
December 31 would not allow sufficient
time for approved CAP vendors to meet
the operational timeframe of January 1.
Therefore, we proposed that the
participating CAP physician election
process would run from October 1 to
November 15 of each calendar year. We
proposed that participating CAP
physicians who intend to continue into
subsequent years may signal that
preference by executing an abbreviated
participating CAP physician election
agreement. The abbreviated agreement
would be used to indicate a preference
to change approved CAP vendors or, as
applicable, drug categories from year to
year. We proposed that a physician who
PO 00000
Frm 00059
Fmt 4701
Sfmt 4700
39079
has elected to participate in the CAP
would select an approved CAP vendor
outside the annual election process if
the previously selected approved CAP
vendor’s contract is terminated, or if the
participating CAP physician leaves the
group practice that had selected the
given approved CAP vendor or relocates
to another competitive area once
multiple CAP competitive areas are
developed. We proposed to set forth the
exceptions to the annual selection
process at § 414.908(a)(2) of our
regulations.
We requested comments on the
potential options available to affected
participating CAP physicians when an
approved CAP vendor’s contract is
terminated during the middle of the
CAP year. The proposed participating
CAP physician options included leaving
the CAP or selecting another approved
CAP vendor as presented in the
proposed participating CAP physician
election agreement for the physician to
participate in the CAP.
Comment: One commenter expressed
concern that for this first year in 2005
participating CAP physician election
agreements must be postmarked by
November 15 but that the carrier is not
expected to be ready to pay claims until
January 1, 2006. This meant that the
earlier a physician elects CAP and
acquires drugs from CAP, the longer the
physician will wait for reimbursement
for drug administration. The commenter
expressed concern that the time lag
would be more than 3 months for those
who elect early. The commenter
suggested that we permit physicians to
complete the participating CAP
physician election process, with the
agreement effective as of January 1,
2006, and allow them to use the ASP
system until then.
Response: Although the participating
CAP physician election period ends on
November 15, 2005, the CAP does not
begin until January 1, 2006. Physicians
who elect to participate in the CAP are
to continue to use the ASP system
through December 31, 2005. On January
1, 2006, physicians who have elected to
participate in the CAP should order
drugs from the approved CAP vendor
they have selected. The early selection
process is necessary so that the local
carrier and the designated carrier can
begin system testing to be ready to pay
claims. This is consistent with the
statute, which requires that the CAP be
phased in beginning in 2006.
Comment: Commenters opposed the
election period of October 1 to
November 15 for physicians to elect to
participate in the CAP. They asserted
that this deadline would confuse
physicians because it is different from
E:\FR\FM\06JYR2.SGM
06JYR2
39080
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
the Medicare participation agreement
timeline. They proposed that the
deadline coincide with the participation
agreement election period (November 14
through December 31) and that although
notification of enrollment may occur
after December 31, physicians could bill
for drugs under the ASP system until
the vendor had processed and
acknowledged approval of the physician
application. A commenter suggested
that we should provide vendor
notification of selection by a physician.
Response: We believe that an election
period that is earlier than the
participating physician enrollment
process is necessary to allow both the
approved CAP vendors and us to
prepare for the CAP and to be ready to
ship drugs and pay claims on January 1,
2006. Waiting until December 31 to
receive information about physicians’
CAP election choices will not provide
sufficient time for the approved CAP
vendors to acquire the necessary volume
of drugs and make introductions with
participating CAP physicians who have
selected them in order to meet the
operational timeframe of January 1,
2006. Further, waiting until December
31 will not allow for us and our claims
processing contractors to record
information about participating CAP
physicians and their selected approved
CAP vendor, update the Web site with
CAP information, update the claims
processing files, perform testing, and
inform approved CAP vendors so that
we are ready to pay CAP claims on
January 1, 2006. For this 3-year contract
for the approved CAP vendors, there
will be one drug category. In the future,
as more CAP drug categories are
developed, the collection of information
on the election of the approved CAP
vendor and drug category will be more
complicated.
Comment: Several commenters
asserted that physicians should have the
ability to elect into the system more
than once per year. Commenters
suggested election options that ranged
from the ability to disenroll or switch
vendors at any time, to the adoption of
a transition period ranging anywhere
from 3 to 24 months during which there
would be greater flexibility to opt in or
out of the CAP. Commenters were
concerned that the 1-year enrollment
period would commit them to a poor
performing vendor with no recourse
available to them. In particular,
commenters were concerned with the
quality of the products, timely delivery
of drugs, overall performance of the
vendor, and the physician’s financial
situation if he or she chooses the CAP
versus the ASP system. Other
commenters asserted that although the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
statute does provide for an annual
election, nothing in the statute requires
or supports the use of a ‘‘lock-in’’
period. Still other commenters
requested that we provide more
flexibility within the CAP enrollment
period to be able to evaluate the impact
on a practice’s financial situation by
being able to asses the most current ASP
payment rates, published quarterly, and
then determining whether to elect to
participate in the CAP.
Response: Section 1847B(a)(1)(A)(ii)
and section 1847B(a)(5)(A)(ii) of the Act
require that each physician be given the
opportunity annually to elect to obtain
drugs and biologicals through the CAP
and to select an approved CAP vendor.
Furthermore, section 1847B(a)(5)(A)(i)
of the Act allows for selection of another
approved CAP vendor more frequently
than annually in exigent circumstances
as defined by CMS. As discussed above,
we proposed that a participating CAP
physician would select an approved
CAP vendor outside the annual election
process if the previously selected
approved CAP vendor’s contract is
terminated, or if the participating CAP
physician leaves the group practice that
had selected the given approved CAP
vendor, or the participating CAP
physician relocates to another
competitive area (once multiple CAP
competitive areas are developed).
Physicians will need to carefully
consider their options because the CAP
election agreement will be binding for 1
calendar year. We proposed to set forth
the exceptions to the annual selection
process at § 414.908(a)(2) of our
regulations.
It is typical for Government and
private sector programs to operate on a
1-year basis. However, we have built in
safeguards in the CAP that participating
CAP physicians may use in addressing
operational issues that arise in addition
to communicating their program issues
to their local carrier. These include the
dispute resolution option that
participating CAP physicians may use to
address operational and quality issues
(see section II.B.3 of this interim final
rule on dispute resolution). If approved
CAP vendor quality issues cannot be
resolved, we may terminate the
approved CAP vendor’s contract. The
participating CAP physician would then
have the option to elect a new approved
CAP vendor mid-cycle. We also believe
that by the time physicians are given the
option to elect the CAP, they will have
had almost 1 year of experience in the
ASP system and will be able to choose
which option is best for their practice.
However, in response to comments, we
have modified § 414.908(a)(2), to allow
a participating CAP physician to either
PO 00000
Frm 00060
Fmt 4701
Sfmt 4700
select an approved CAP vendor outside
of the annual selection process or opt
out of the CAP for the remainder of the
annual selection period when one of the
conditions specified in § 414.908(a)(2) is
met.
Comment: Commenters urged us to
assure physicians that vendors will be
required to accept all physicians who
elect to participate in the CAP. A few
commenters also requested assurance
that vendors not be allowed to terminate
the ‘‘contract’’ with a physician because
the beneficiaries are not making their
coinsurance payments.
Response: As noted above in section
II.B.2 of this preamble, this interim final
rule does not prohibit CAP vendors and
physicians from entering into a contract
or agreement governing their
arrangements for the provision of CAP
drugs or other items or services.
However, we will not require contracts
between participating CAP physicians
and the approved CAP vendor they
select. Instead, there will be 3-year
contracts between CMS and the
approved CAP vendors, and
participating CAP physicians will sign
annual participating CAP physician
election agreements with CMS.
Discussed elsewhere in this interim
final rule are the criteria for the
selection of the approved CAP vendor
and the content of the approved CAP
vendor contracts. We will include a
provision in the approved CAP vendor
contract that requires an approved CAP
vendor to accept all physicians who
elect to participate in the annual CAP
election process. In addition, the
contract will specify that approved CAP
vendors may not unilaterally drop
participating CAP physicians. Rather,
the approved CAP vendor may ask the
designated carrier to intervene under
the dispute resolution process described
elsewhere in this preamble.
As noted above, in addition to the 3year approved CAP vendor contract
there will be an initial participating
CAP physician election agreement, and
an abbreviated participating CAP
physician agreement for subsequent
years, that participating CAP physicians
will sign to notify us of their intent to
elect the CAP and agree to the terms and
conditions of the CAP participation. We
are clarifying the definition of the
participating CAP physician election
agreement at § 414.902 to codify that
participating CAP physicians must sign
this agreement to notify us of their
participation in CAP and to agree to the
terms and conditions of CAP
participation as set forth in these
regulations.
A physician may elect to participate
in the CAP independently of his or her
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
choice to participate in Medicare.
Participation in Medicare is not a
requirement for participation in the
CAP. However, as noted below, all
participating CAP physicians must be
enrolled in Medicare.
Participating CAP physicians will
select the approved CAP vendor to
provide them with drugs for their
Medicare patients on an annual basis.
We previously described the
circumstances, listed in § 414.908(a)(2),
under which a physician who has
elected to participate in the CAP would
select an approved CAP vendor outside
the annual election process. In addition
to those circumstances, for the specific
circumstance that the beneficiary does
not pay their coinsurance, we will allow
a participating CAP physician the
opportunity to opt out of that drug
category; and while there is only one
drug category for CAP, the participating
CAP physician would be allowed to optout of the CAP altogether. The opt-out
would be effective until the next
election cycle begins at which time the
physician can elect a new approved
CAP vendor, that same approved CAP
vendor or leave CAP. We are amending
our regulations at § 414.908 to include
this provision.
Comment: Commenters questioned
whether information for the CAP
election would be available timely. One
commenter stated that targeting to
complete the following steps by Fall
2005 appeared to be an unrealistic
timeframe: Bidding and finalizing
vendors, having materials sent to
physicians, notifying beneficiaries, and
allowing physicians time to evaluate the
specific NDCs. Another commenter
would like to see the list of approved
CAP vendors within a sufficient amount
of time to be able to make a decision on
whether to select a CAP vendor or the
ASP system.
Response: We stated in the proposed
rule that we would prepare a posting on
our Web site approximately on October
1, describing the approved CAP vendors
we have selected for CAP, their
categories of drugs, and the geographic
areas within which they would operate.
We stated that we would publicize the
participating CAP physician election
information on our Web site via our
physicians’ listservs, and through our
Medicare fee-for-service contractors’
Web sites and newsletters. We would
also coordinate with physician specialty
organizations to inform their members
that the participating CAP physician
election information is available.
We agree that this is an ambitious
timeline and intend to provide timely
communication about the CAP. The
CAP fact sheet is scheduled for
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
completion this summer so that the
carriers can disseminate it to their
physicians by September 1, 2005. Before
October 1 2005, there will be an
education campaign to inform
physicians about the CAP Web site and
the election process. By October 1, 2005,
we will make available, on our Web site,
information on the CAP, a directory of
the approved CAP vendors and the
specific NDC numbers the approved
CAP vendors will be providing, and the
participating CAP physician election
agreement forms. We will continue to
update the approved CAP vendor
directory on our Web site or make the
directory available to interested
physicians on an ongoing basis, as
required under the statute.
Physicians will be asked to access the
participating CAP physician election
agreement on our Web site and
determine whether they would like to
elect to participate in the program. They
will have 6 weeks in which to evaluate
the information, download and
complete the election forms and mail
them to their carrier. Physicians who
elect to participate will be asked to
download, complete, and sign the CAP
election agreement. The participating
CAP physician election agreement will
require that they select the approved
CAP vendor(s) in their area from which
they would like to obtain drugs and the
categories of drugs they wish to obtain
through the program when multiple
categories of drugs become available.
For this 3-year contract-cycle with the
approved CAP vendor, there will only
be one category of drugs.
Physicians will be instructed to return
the completed participating CAP
physician election agreement to their
local carrier. The participating CAP
physician election agreement must be
postmarked by November 15. The local
carrier will note the physician’s
decision to participate in the CAP, and
the approved CAP vendor and
categories of drugs selected when
multiple categories of drugs become
available. The local carrier will forward
information from the participating CAP
physician election agreement to the CAP
designated carrier. The designated
carrier will compile a master list of all
participating CAP physicians’ approved
CAP vendor and drug category
selections. In addition, the designated
carrier will notify each approved CAP
vendor of the participating CAP
physicians who have elected to enroll
with that approved CAP vendor.
Comment: One commenter urged us
to modify the proposed
§ 414.908(a)(2)(ii) to remove the
example of ‘‘physician relocates to
another competitive area’’ as an exigent
PO 00000
Frm 00061
Fmt 4701
Sfmt 4700
39081
circumstance that would permit a
physician to choose another vendor.
The commenter believes that it would
not be necessary for a nationally based
acquisition area program.
Response: For a nationally based
approved CAP vendor, it would not be
necessary for a relocating participating
CAP physician to choose another
approved CAP vendor. This would be
the case for this first round of
competitive acquisition. In the future,
when we create other competitive
acquisition areas, we believe
participating CAP physicians who are
relocating to another competitive
acquisition area will need to be able to
select a different approved CAP vendor.
Therefore, we retain this provision in
the regulation.
Comment: Commenters suggested that
if a vendor leaves the program mid-year,
the physician should have the option to
either leave the program or choose
another vendor. In particular, one
commenter suggested that physicians
might choose to be in the CAP based on
the specific brand-name drugs a vendor
would supply. In that case, the
commenter believes, if that vendor
leaves the program mid-cycle, the
physician should be given the option to
choose another vendor or return to the
ASP system. However, another
commenter indicated that because
physicians are accustomed to changing
suppliers on a frequent basis, it should
not be problematic for them to select a
different CAP vendor.
Response: We previously described
the circumstances, listed in
§ 414.908(a)(2), under which a
physician who has elected to participate
in the CAP would select an approved
CAP vendor outside the annual election
process. These were if the selected
approved CAP vendor’s contract is
terminated, or if the participating CAP
physician leaves the group practice that
had selected the given approved CAP
vendor, or the participating CAP
physician relocates to another
competitive acquisition area, once
multiple CAP competitive areas are
developed, or other exigent
circumstances defined by CMS.
However, under these specific
circumstances, the participating CAP
physician may also opt out of CAP. We
have revised the regulation accordingly.
Requirements for Group Practices
We specified in the proposed rule
that, consistent with the Medicare
Participating Physician Process, if
members of a group practice elect to
participate in the CAP, the entire
practice would participate. Physician
groups that elect to participate in the
E:\FR\FM\06JYR2.SGM
06JYR2
39082
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
CAP would be paid for drug
administration based on the group PIN
number that they place on their claim.
We proposed that when a physician
bills as a member of a group using the
group PIN, he or she must follow the
group’s election to participate or not to
participate in the CAP. However, we
also proposed that if a group practice
physician maintains a separate solo
practice, he or she could make a
different determination to participate or
not to participate in the CAP with
respect to the solo practice if using his
or her individual PIN.
Comment: Commenters asserted that
requiring a single CAP election for an
entire physician group practice is
contrary to the statute. Some of these
commenters suggested that we allow
physicians that practice in groups to
elect to participate in CAP on an
individual or on a specialty basis. This
flexibility would allow a specialty
having difficulty obtaining its drugs to
elect CAP while not affecting another
specialty within the same group that is
satisfied with ‘‘buy and bill.’’ The
commenters asserted that, without such
flexibility multi-specialty groups may
break up into separate practices.
Alternatively, the commenters suggested
that physicians might provide care at
other sites operated by the group,
thereby potentially decreasing patient
access to care in order to comply with
the group election provision.
In contrast, other commenters
supported the recommendation that all
physicians in a group practice who
enroll in the CAP program under the
group number must adhere to the
participation decision of the group
because it simplifies the need to enroll
all group practice physicians in the CAP
program. One commenter requested that
the group CAP election apply across
group and private practice affiliations.
They recommended that we require
group practices to submit both group
and individual unique provider
identification number (UPIN) numbers
upon application to avoid the
possibility of allowing physicians to
‘‘cherry pick’’ medications to administer
in their private practice, thereby
requiring approved CAP vendors to
supply a disproportionate share of the
unprofitable drugs. Another commenter
asserted that there is a possibility that
a group practice may channel different
purchases through different physicians,
allowing the group to choose on a per
drug basis whether to use the CAP or
the ASP system. The commenter
suggested that to avoid such abuses,
group practices (including any entities
controlled by a group practice) should
be required to choose, as a group, to
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
participate in the CAP and that
physicians who are part of the group
practice should not be permitted to bill
separately for drugs covered under the
CAP.
A commenter requested that we
clarify whether an individual physician
in a group practice would be allowed to
enroll in the CAP program under his or
her own individual number; in
particular, the commenter questioned
whether the group would be held
accountable to the individual’s decision.
Commenters asserted that it would be
the individual physician’s choice to
participate in the CAP and it should not
be attributed to the whole group, unless
the business as a whole enrolls the
entire group under its number in the
program.
Response: We do not believe that CAP
elections on a group basis violate the
statutory provision requiring each
physician to be given an opportunity to
elect to obtain drugs under the CAP
program. The statute requires us to
coordinate the selection of the approved
CAP vendor with agreements entered
into under section 1842(h) of the Act
(agreements to become a Medicare
participating physician). The
participating physician enrollment
process coordinates the participation
election of, and claims processing for,
physicians, including those who work
in one or more group practices.
Consistent with the rules for Medicare
participation agreements under section
1842(h) of the Act, CAP elections are
linked to the billing number under
which an individual physician bills.
Accordingly, if a physician in a group
practice chooses to bill for his or her
professional services through a billing
number assigned to a group, he or she
has chosen to delegate the CAP election
to the group. If a physician practices in
a group that has elected to participate in
CAP, but the physician wants to ‘‘buy
and bill,’’ the physician may avoid
participating in CAP by billing all of his
or her professional services under his or
her own billing number instead of under
a billing number assigned to the group
(this would require the physician to
revoke his or her reassignment
agreement with the group in accordance
with applicable Medicare procedures).
Thus, a physician in a group practice
may not participate in the two payment
systems (ASP and CAP) at the same time
in the same practice. However, if a
physician renders professional services
in more than one group practice (or in
a group practice and in a separate solo
practice), the CAP elections of the
different groups or practices need not be
the same. We believe that our
interpretation will preserve each
PO 00000
Frm 00062
Fmt 4701
Sfmt 4700
physicians’ choice while simplifying the
election process, assuring that election
into the CAP is correctly identified for
billing purposes, and minimizing the
potential for program abuse.
With respect to the comment that the
group CAP election apply across group
and private practice affiliations, we
believe the commenter is recommending
not allowing a physician in a group and
a solo practice in another location
separately to determine whether to
participate in the CAP. In the proposed
rule, we noted that if a physician has a
solo practice in another location, he or
she will be able to make a separate
determination about whether to
participate in the CAP. To assist the
approved CAP vendor in identifying for
which practice a physician has elected
CAP, we will be requiring collecting on
the participating CAP physician election
form the participating CAP physician’s
UPIN and the PIN or Group PIN, or
both, for each practice that has elected
the CAP. We believe this information
will avert the unethical practices that
were of concern to the commenter.
Comment: Some commenters stated
that groups whose physicians cannot
agree on whether to elect CAP
participation will dissolve or break up.
The commenters asserted that the
dissolution or breakup of group
practices had implications under the
physician self-referral prohibition (also
known as the ‘‘Stark law’’) in section
1877 of the Act. Specifically, the
commenter feared that groups suffering
a partial breakaway of group members
might be unable to satisfy the
‘‘substantially all test’’ under the Stark
definition of a ‘‘group practice’’
(§ 411.352), which in turn would
jeopardize the group’s ability to rely on
the Stark exception for in-office
ancillary services.
Response: We think it is unlikely that
CAP will cause a significant number of
group practices to dissolve because a
group physician may still ‘‘buy and
bill,’’ even though the group has elected
to participate in CAP, as long as the
physician bills all of his or her
professional services rendered to group
patients under his or her own
individual PIN. Moreover, we believe
that physicians choose to practice in a
group for many reasons having nothing
to do with whether or not a vendor
furnishes a particular item or service to
patients served by the group (for
example, the ability to share overhead
costs, coverage duties, and expertise).
Under the ‘‘substantially all test’’
referenced by the commenter,
substantially all of the patient care
services of the physicians who are
members of the group must be furnished
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
through the group and billed under a
billing number assigned to the group,
and the amounts received must be
treated as receipts of the group. We see
no reason why the resignation of one or
more physician members of a group
would cause the remaining group
members to be unable to satisfy the
‘‘substantially all test.’’ On the other
hand, depending on the circumstances,
it is possible that the decision of some
group members to bill individually and
not through a number assigned to the
group could cause the group to fail the
‘‘substantially all test.’’ Accordingly,
physicians and their group practices
will have to consider the Stark law
implications of their CAP elections and
exercise their choice in a manner that
will ensure compliance with Stark.
CAP Election Agreement
Consistent with the Medicare
participating physician enrollment
process, we will give physicians who
are newly enrolled in Medicare 90 days
in which to decide to elect to participate
in the CAP. We will provide
information about the CAP when they
enroll in Medicare and will be
instructed how to find the election
information and forms on our Web site.
If they elect to participate in the CAP,
they will download the participating
CAP physician election agreement and
submit it to their Medicare carrier.
The final election process is
summarized as follows:
(1) We will prepare a posting on our
Web site approximately on October 1,
describing the approved CAP vendors,
the categories of drugs they will be
providing, and the geographic areas
within which each approved CAP
vendor will operate.
(2) We will publicize the availability
of the participating CAP physician
election information on our Web site via
our physicians’ listservs, and our
Medicare fee-for-service contractors’
Web sites and newsletters. We will also
coordinate with physician specialty
organizations to enlist their assistance
in informing their members that the
physician election information is
available.
(3) Physicians will be asked to access
the participating CAP physician election
agreement on our Web site and
determine whether they would like to
elect to participate in the program.
(4) Physicians who elect to participate
will be asked to download, complete
and sign the participating CAP
physician election agreement. The
participating CAP physician election
agreement will require that they select
the approved CAP vendor(s) in their
area from which they would like to
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
obtain drugs and the categories of drugs
they wish to obtain through the program
(when multiple categories of drugs
become available). For this 3-year
contract-cycle with the approved CAP
vendors, there will only be one category
of drugs.
(5) Physicians will be instructed to
return the completed participating CAP
physician election agreement to their
local carrier. The participating CAP
physician election agreement must be
postmarked by November 15 for
participation in the CAP beginning
January 1 of the following year.
(6) The local carrier will note the
physician’s decision to participate in
the CAP, and the approved CAP vendor
and categories of drugs selected (when
multiple categories of drugs become
available). For this 3-year contract-cycle
with the approved CAP vendor, there
will only be one category of drugs.
(7) The local carrier will forward
information from the CAP election
agreement to the CAP designated
carrier.
(8) The designated carrier will
compile a master list of all participating
CAP physicians’ approved CAP vendor
and drug category selections. In
addition, the designated carrier will
notify each approved CAP vendor of the
participating CAP physicians who have
selected that approved CAP vendor.
(9) After the necessary claims
processing files are prepared, the local
carrier and the designated carrier will
begin system testing to be ready to pay
claims by January 1, 2006.
The requirements concerning a
physician’s election to participate in the
CAP are set forth in § 414.908(a).
Comment: Commenters requested
clarification as to whether a physician
must participate in Medicare in order to
participate in the CAP.
Response: We believe that the
commenter is asking if the physician
must agree to accept assignment for all
Medicare covered services, not if a
physician must be enrolled in the
Medicare program. A physician is
required to be enrolled into the
Medicare program as a supplier in order
to receive a Medicare billing number.
Physicians who participate in Medicare
must accept assignment, but nonparticipating physicians are not
required to accept assignment. A
physician can be in the CAP and have
a CAP election agreement if he or she is
enrolled in the Medicare program, but is
not required to be a Medicare
participating physician who has elected
to accept assignment of all Medicare
covered services. However, as we have
implemented the CAP, participating
CAP physicians must appeal drug
PO 00000
Frm 00063
Fmt 4701
Sfmt 4700
39083
administration claim denials. Therefore,
non-participating physicians who elect
to join the CAP will need to accept
assignment for CAP drug administration
claims on a case-by-case basis in order
to be in compliance with their CAP
election agreements. We are revising the
definition of participating CAP
physician to address this issue at
§ 414.902.
Toward the end of each calendar year
(generally in November), all Medicare
carriers have an open enrollment
period. Also toward the end of each
calendar year (generally in October), we
will be making available to physicians
the option to participate in the CAP. As
noted above, a physician who is newly
enrolled in Medicare will have the
opportunity to elect to join the CAP.
Comment: One commenter requested
that we clarify whether physicians will
be penalized if they do not elect to
participate in the CAP in the first year.
Another commenter requested that we
clarify the definition of ‘‘new
physician’’ for the purposes of the CAP
program and the triggering event for the
90 days notification timeline.
Response: We will not penalize
physicians if they choose not to
participate in the CAP in the first year.
If a physician chooses not to enroll the
first year, there will be an annual
process for physicians to participate in
CAP, and the physician may enroll
during the next available period.
However, if the reason for not electing
to participate in the first year of the CAP
was that the physician was newly
enrolled in Medicare, he or she may
elect to participate within 90 days of his
or her billing number activation, and his
or her initial CAP election agreement
will continue through December 31 of
the calendar year. The date that the
billing number is activated is the
triggering event of the 90-day election
time-period. This is consistent with the
process for new physicians to choose to
participate in Medicare and accept
assignment.
We will finalize the requirements at
§ 414.908 with modification. At
§ 414.908(a)(2), we set forth the
exceptions to the annual selection
process. At § 414.908(a)(5), we amend
the provision to include the option for
a physician to opt out of that drug
category; and while there is only one
drug category for CAP, the physician
would be allowed to opt-out of the CAP
altogether for the remainder of the year.
At § 414.902, we are clarifying the
definition of the participating CAP
physician election agreement.
E:\FR\FM\06JYR2.SGM
06JYR2
39084
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
2. Vendor or Physician Education
3. Beneficiary Education
To ensure that vendors and
physicians have timely access to
accurate Medicare program information
regarding the CAP, in the proposed rule,
we indicated we would instruct the CAP
designated carrier to use various
communication channels at the local
and national levels to disseminate
information about the CAP and assist
vendors and physicians in
understanding the Medicare program’s
operations, policy, and billing and
administration procedures regarding the
CAP. The CAP designated carrier would
be instructed to use data analyses in
tailoring its outreach and educational
efforts for vendors and physicians
regarding identified areas of confusion
about the CAP. Additionally, we
specified that the CAP designated
carrier would be instructed to use mass
media, as well as educational and
outreach products, services, forums, and
partnerships in an effort to disseminate
information about, and provide
assistance regarding, the CAP to the
vendor and healthcare practitioner
communities. The fundamental goal of
our outreach and education
requirements of the CAP designated
carrier would be to ensure that those
who provide services to beneficiaries
receive the information they need to
understand the Medicare program so
that it is administered appropriately and
billed correctly. As such, we would be
involved in oversight of, and
partnership with, the CAP designated
carrier’s vendor and physician outreach
and educational program regarding the
CAP.
Comment: Commenters were
supportive of our proposal to utilize
numerous outreach and educational
activities to disseminate information
about the CAP and emphasized that
education is paramount to successful
implementation of the CAP program.
Commenters also stressed that
information provided by the CAP
designated carrier must be correct and
timely and that CMS stay actively
involved in the process.
Response: We also believe that
education will be vital to the success of
the CAP and will be ensuring that the
CAP designated contractor fulfills the
responsibility of providing timely and
accurate information on the CAP.
As proposed we will have the CAP
designated carrier utilize a variety of
communication channels at the local
and national levels to disseminate
information about the CAP and assist
approved CAP vendors and physicians
in understanding this new program.
The CAP will have an impact on
beneficiaries who receive physicianadministered drugs. As discussed in the
March 4, 2005 proposed rule, if a
physician elects to participate in the
CAP, beneficiaries receiving services
from this physician would receive a
separate medical summary notice (MSN)
from the designated carrier that
processes invoices for the approved
CAP vendor as well as a bill from the
approved CAP vendor for the
coinsurance of the drug. This could
cause confusion for the beneficiary
because he or she would only know that
the drugs were administered by a
physician. In addition, because the
activity of the approved CAP vendor
would be transparent to the
beneficiaries, they may question why
they are receiving a bill from an
unknown entity.
To educate beneficiaries in a
proactive fashion, we proposed to
develop a beneficiary-focused fact sheet
and to update existing related
educational materials to reflect these
changes. The fact sheet would be
available for physicians who elect to
participate in the CAP to provide to
beneficiaries at the time of service. It
would explain the CAP and its impact
on the beneficiary. We would also make
this fact sheet available at 1–800–
MEDICARE, as well as on the https://
www.medicare.gov Web site. Although
we did not propose to require
participating CAP physicians to provide
beneficiaries with the fact sheet, we
requested comments on the
administrative burden associated with
this activity. In addition, although we
did not propose to require any
additional options for specific outreach,
we requested comments on other
mechanisms that might be used to
inform the beneficiary of services
provided as part of the CAP and the
burden that would be associated with
this mechanism.
We also proposed to provide
information about the CAP in the 2006
versions of the Medicare & You
handbook and Your Medicare Benefits.
The handbook is mailed annually to
each beneficiary household. Your
Medicare Benefits is available upon
request at 1–800–MEDICARE, as well as
on the https://www.medicare.gov Web
site. We also proposed to provide
information to the 1–800–MEDICARE
helpline so that operators can answer
CAP-related questions. The https://
www.medicare.gov Web site would also
have consumer-friendly information
available about the CAP.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
PO 00000
Frm 00064
Fmt 4701
Sfmt 4700
Comment: Several commenters were
pleased with the proposals to create and
distribute material on CAP to educate
stakeholders while one commenter
believed that a fact sheet was not
sufficient. Some commenters indicated
that the physician should be required to
provide information about the CAP to
the beneficiary. However, one
commenter stated that proactive
communication for services that they
may never receive will increase costs to
CMS and physicians for a program not
applicable to all beneficiaries, while
another commenter recommended the
fact sheet be developed as a template
with sections that could be customized
by each CAP physician so information
relevant to a specific beneficiary could
be added (for example, CAP drugs being
procured, name of vendor).
Other commenters opposed a mandate
to require physicians to distribute
outreach materials to beneficiaries. One
of these commenters stated it was not
the physician’s responsibility to make
this information available to their
patients, while another stated practice
management systems cannot easily
identify patients who are participating
in a subprogram of an individual health
insurance product. Other commenters,
while agreeing this information is
important, believed that this
information should come from CMS and
added that the physician and the CAP
vendor should not be required to
educate the beneficiary directly as this
is outside their role.
One commenter also encouraged us to
have the CAP vendors supply fact sheets
or introductory letters to the CAP
physicians who contract with them that
the physician can provide to
beneficiaries.
Response: We agree that the education
of the stakeholders in the CAP is
extremely important and we will be
providing information on the CAP as
discussed in the proposed rule. Because
we are aware that the CAP may not
impact all beneficiaries, we will not
provide specific information on the CAP
to all Medicare beneficiaries. However,
we will provide some general
information about the CAP in the
Medicare & You booklet so that
beneficiaries will be aware of this
program. Although a few commenters
recommended that the participating
CAP physician should not be required
to provide a fact sheet to beneficiaries,
we believe that it is important that
beneficiaries understand that their
physician has elected to participate in
the CAP and what this will mean to the
beneficiary. Therefore, we will require
the physician to provide the fact sheet
developed by us during the beneficiary’s
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
first visit to the office subsequent to the
physician enrolling in the CAP.
This fact sheet detailing the CAP
program in plain language will also be
available to beneficiaries via 1–800–
MEDICARE (1–800–633–4227) and
https://www.medicare.gov. When
distributing the fact sheet, physicians
may include additional information
specific to the beneficiary. We believe
that this approach will allow the
participating CAP physician to address
the specific needs of the beneficiary and
minimize the burden on the
participating CAP physician. As
commenters suggested, we will also
encourage the approved CAP vendors to
provide introductory information about
themselves and the CAP program that
could be shared with beneficiaries. As
discussed in section II.B.3 of this
interim final rule, we will also have the
approved CAP vendor include
information on the beneficiary grievance
process with any bill that is sent to the
beneficiary. As a final point, as part of
the vendor application process, we have
stated that customer service is of
primary importance and approved CAP
vendors must demonstrate the ability to
respond to inquiries on both weekdays
and weekends.
Because we recognize the impact the
CAP will have on Medicare
beneficiaries, we will use a multi-tiered
educational approach to provide
information that will increase
beneficiary awareness of the issues
related to the CAP. The outreach efforts
will include the following:
• A plain language fact sheet to be
distributed by participating CAP
physicians and available upon request
via 1–800–MEDICARE (1–800–633–
4227) and https://www.medicare.gov.
• New language in the existing
Medicare & You and Your Medicare
Benefits booklets. The Medicare & You
booklet is mailed each fall to every
beneficiary household. Your Medicare
Benefits is available through 1–800–
MEDICARE (1–800–633–4227) and
https://www.medicare.gov.
• CAP related scripts for the customer
service representatives at 1–800–
MEDICARE (1–800–633–4227).
• Frequently asked questions and
answers in consumer friendly language
regarding the CAP available at
https://www.medicare.gov on the Web.
III. Provisions of the Interim Final Rule
[If you choose to comment on issues in this
section, please include the caption
‘‘Provisions to the Interim Final Rule’’ at the
beginning of your comments.]
For the most part, this interim final
rule incorporates the provisions of the
March 4, 2005 proposed rule. Those
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
provisions of this interim final rule that
differ from the proposed rule follow.
Under § 414.902, we are revising our
definitions section to revise current
definitions set forth in the proposed rule
and to add new definitions:
We are making a conforming change
to revise ‘‘approved vendor’’ to read
‘‘approved CAP vendor.’’ In § 414.902,
we are also making a technical
clarifying revision to the definition of an
‘‘approved CAP vendor’’ to specify that
this vendor is one that has been
approved by CMS to participate in the
CAP program under ‘‘1847B of the Act’’
to avoid confusion with the competitive
acquisition program for DME provided
for under section 1847 of the Act. We
are also revising the definition of
‘‘participating CAP physician’’ to clarify
that physicians who do not participate
in Medicare but elect to participate in
the CAP agree to accept assignment for
CAP drug administration services.
We are adding a definition of ‘‘CAP
drug’’ to mean a physician-administered
drug or biological furnished on or after
January 1, 2006 described in section
1842(o)(1)(C) of the Act and supplied by
an approved CAP vendor under the CAP
as provided in this subpart.
• Under § 414.902, we are adding the
definition of emergency delivery to
mean the delivery of a CAP drug within
one business day in appropriate
shipping and packaging, in all areas of
the United States and its territories,
with the exception of the Pacific
Territories. In the Pacific Territories,
emergency delivery means delivery of a
CAP drug within 5 business days in
appropriate shipping and packaging. We
are also adding that this timeframe may
be reduced if product stability requires
it, meaning that the manufacturer’s
labeling instructions, drug compendia,
or specialized drug stability references
indicate that a shorter delivery
timeframe is necessary to avoid
adversely affecting the product’s
integrity, safety, or efficacy.
• We are adding the definition of an
emergency situation to mean an
unforeseen occurrence or situation
determined by the participating CAP
physician, in his or her clinical
judgment, to require prompt action or
attention for the purposes of permitting
the participating CAP physician to use
a drug from his or her own stock, if the
other requirements for the CAP under
§ 414.906 are met.
• We are adding a definition ‘‘Pacific
territories’’ to mean, for purposes of the
CAP, American Samoa, Guam, or the
Northern Mariana Islands.
• We are making a conforming change
to revise ‘‘CAP election agreement’’ to
read ‘‘Participating CAP physician
PO 00000
Frm 00065
Fmt 4701
Sfmt 4700
39085
election agreement.’’ In addition, we are
revising the definition to clarify that this
is an agreement the physician signs to
notify CMS of the physician’s election
to participate in the CAP and to agree
to the terms and conditions of CAP
participation as set forth in our
regulations.
• We are adding a definition for
prescription order. We are defining a
prescription order as a written order
submitted by the participating CAP
physician to the approved CAP vendor
that meets the requirements of part 414,
subpart K.
• Under § 414.902, we are adding the
definition of routine delivery to mean
the delivery of a drug within 2 business
days in appropriate shipping and
packaging, in all areas of the United
States and its territories, with the
exception of the Pacific Territories. In
the Pacific Territories, routine delivery
of drug means delivery of a CAP drug
within 7 business days in appropriate
shipping and packaging. This timeframe
will be reduced if product stability
requires it, meaning that the
manufacturer’s labeling instructions,
drug compendia, or specialized drug
stability references indicate that a
shorter delivery timeframe is necessary
to avoid adversely affecting the
product’s integrity, safety, or efficacy.
• Under § 414.902, we are adding the
definition of ‘‘timely delivery’’ to mean
the delivery of a CAP drug within the
defined routine and emergency delivery
timeframes. Compliance with timely
delivery standards is also a factor for
evaluation of potential and approved
CAP vendors.
• We are also making additional
conforming changes to terms under our
definitions section to include revising
‘‘competitive area’’ to read ‘‘competitive
acquisition area.’’
We are revising § 414.906(a)(4) to
specify that when the approved CAP
vendor delivers the drugs directly to the
participating CAP physician, the drugs
must be in unopened vials or other
original container as supplied by the
manufacturer or from a distributor that
has acquired the products directly from
the manufacturer, and the shipping
material must include language stating
that the drug was acquired in a manner
that is consistent with statutory
requirements. In addition, we are
providing the process that the approved
CAP vendor must follow if the approved
CAP vendor opts to split shipments. We
are revising § 414.906(a)(5) to specify
that the approved CAP vendor bills
Medicare only for the amount of the
drug that the participating CAP
physician has administered to the
patient, and the beneficiary’s
E:\FR\FM\06JYR2.SGM
06JYR2
39086
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
coinsurance will be calculated from the
quantity of the drugs that is
administered.
We are making revisions under
§ 414.906(c)(1) to clarify the payment
methodology for CAP drugs.
We are making revisions under
§ 414.906(c)(2) regarding those
circumstances under which the
alternative payment amount established
under section 1847A of the Act may be
used to establish payment for a
competitively biddable drug. At
§ 414.906(c)(2)(i) and (ii), we are
clarifying that this alternative payment
amount may be allowed if the drug is
properly assigned to a category
established under the CAP and if a
HCPCS code must be established for the
drug.
We are adding § 414.906(f) to specify
the process the approved CAP vendor
must follow if the approved CAP vendor
substitutes a CAP drug.
We are revising § 414.908(a)(2) to
clarify that under certain circumstances,
the participating CAP physician not
only has the option to choose another
approved CAP vendor outside of the
annual selection process but also the
option to ‘‘opt out’’ of the CAP for the
remainder of the annual selection
period. The circumstances may include
when the approved CAP vendor ceases
to participate in the CAP; the
participating CAP physician leaves a
group practice participating in CAP; the
participating CAP physician relocates to
another competitive acquisition area; or
other exigent circumstances defined by
CMS.
We are revising § 414.908(a)(3)(iii) to
specify that the participating CAP
physician will submit a ‘‘prescription
order’’ to the approved CAP vendor
with complete patient information for
the initial orders or when the
information changes. In addition, we are
specifying how and when abbreviated
information may be used and we are
also adding that the participating CAP
physician may initiate the prescription
orders by telephone with a follow-up
written order within a specified period
of time.
We are revising § 414.908(a)(3)(v) to
set forth the specific information that
the participating CAP physician must
provide to the approved CAP vendor to
facilitate collection of applicable
deductible and coinsurance (except
where applicable State pharmacy law
prohibits it).
We are adding new § 414.908(a)(3)(vi)
to specify that the participating CAP
physician must also notify the approved
CAP vendor when a drug is not
administered, or when he or she
administers a smaller amount of the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
drug than was originally ordered. The
participating CAP physician and the
approved CAP vendor will agree on how
to handle the unused CAP drug. We
outlined the procedures the
participating CAP physician follows if
an agreement is reached for this
physician to maintain the CAP drug in
his or her inventory to be administered
later.
We are adding new § 414.908(a)(3)(x)
to state that the physician participating
in the CAP agrees not to transport CAP
drugs from one practice location (place
of service) to another location.
We are adding new § 414.908(a)(3)(xi)
to specify that the physician
participating in the CAP agrees to
provide the CMS-developed CAP fact
sheet to beneficiaries.
We are adding a new
§ 414.908(a)(3)(xii) to specify that the
participating CAP physician may
receive payment under the ASP system
when medical necessity requires a
certain brand or formulation of a drug
that the approved CAP vendor has not
been contracted to furnish under the
CAP.
We are adding a new § 414.908(a)(5)
to set forth the opt out provision for
participating CAP physicians that is in
addition to the circumstances described
under § 414.908(a)(2). We specify that if
the approved CAP vendor refuses to
ship to the participating CAP physician
because the conditions of § 414.914
have been met, the physician can
withdraw from CAP for the remainder of
the year immediately upon notice to us
and the approved CAP vendor.
We are revising § 414.908(b)(1)(i) to
specify that competing bidders and
vendors will submit the bid prices
‘‘using the OMB Approved Vendor
Application and Bid Form’’ for
competitively biddable drugs within the
category and competitive acquisition
area.
Under § 414.908(b)(1), we specify the
criteria we use to select an approved
bidder. We are adding additional
criteria. We are revising
§ 414.908(b)(1)(iii) to add that the
potential vendor’s ‘‘grievance process’’
is considered when we select a bidder.
We are also adding a new
§ 414.908(b)(1)(ix) to include that the
approved CAP vendor must maintain
appropriate licensure to supply CAP
drugs in States in which the approved
CAP vendor supplies the drugs as well
as new § 414.908(b)(1)(x) to indicate that
the approved CAP vendor must provide
cost-sharing assistance. We are
redesignating proposed
§ 414.908(b)(1)(ix) as § 414.908(b)(1)(xi)
with minor editorial revisions.
PO 00000
Frm 00066
Fmt 4701
Sfmt 4700
At § 414.908(c)(3), we are adding
language indicating that CMS may
refuse to award a contract or terminate
an approved CAP vendor contract for
past violations or misconduct related to
the pricing, marketing, distribution, or
handling of drugs provided incident to
a physician’s service.
At § 414.914(a), we are making
revisions to clarify that the term of the
contract between the approved CAP
vendor and us is 3 years, ‘‘unless
terminated or suspended earlier as
provided in this section or § 414.917.’’
At § 414.914(c)(1), we describe the
elements of the approved CAP vendor’s
compliance plan. We indicated in the
proposed rule that the approved CAP
vendor must comply with all applicable
Federal and State laws, regulations, and
guidance and we have added that this
also includes, but is not limited to,
compliance with the Prescription Drug
Marketing Act, the physician selfreferral (‘‘Stark’’) prohibition, the AntiKickback statute, and the False Claims
Act.
Under 414.914(f)(2), we are clarifying
that the approved CAP vendor must
have arrangements for shipment at least
5 ‘‘weekdays’’ each week of CAP drugs
under the contact.
Under § 414.914(f)(7), we are
clarifying that the terms of the contract
for the approved CAP vendor must also
specify that the approved CAP vendor
comply with all ‘‘applicable Federal and
State laws, regulations, and guidance’’
related to the prevention of fraud and
abuse.
• Under § 414.914, we are adding
additional conditions under the terms of
the contract between the approved CAP
vendor and us under new
§ 414.914(f)(8), (f)(9), (f)(10), and (f)(11).
We are adding a new § 414.914(g) to
include additional vendor requirements
under the contract. These terms specify
that the approved CAP vendor must
provide appropriate assistance to
patients experiencing financial
difficulty in paying their cost-sharing
amounts through any one or all of the
following:
• Referral to a bona fide and
independent charitable organization.
• Implementation of a reasonable
payment plan.
• A full or partial waiver of the costsharing amount after determining in
good faith that the individual is in
financial need or the failure of
reasonable collection efforts, provided
that the waiver meets all of the
requirements of section 1128A(i)(6)(A)
of the Act and the corresponding
regulations at paragraph (1) of the
definition of ‘‘Remuneration’’ in
§ 1003.101 of this title. The availability
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
of waivers may not be advertised or be
made as part of a solicitation. Approved
CAP vendors may inform beneficiaries
that they generally make available the
categories of assistance described in
paragraphs (g)(1), (g)(2), and (g)(3) of
this section. In no event may the
approved CAP vendor include or make
any statements or representations that
promise or guarantee that beneficiaries
will receive cost-sharing waivers.
We are adding a new § 414.914(h) to
specify the procedures that the
approved CAP vendor must comply
with before it may refuse to make
further shipment of CAP drugs to a
participating CAP physician on behalf
of a specific beneficiary.
We are revising the heading of
§ 414.916 to read ‘‘Dispute resolution
process for vendors and beneficiaries.’’
Under § 414.916, regarding the
responsibilities of the designated
carrier, we are removing paragraph
(b)(2)(i) under this section that stated
that the designated carrier will
investigate and make a recommendation
to us on whether the participating CAP
physician has been meeting the claims
and appeals obligations in his or her
CAP election agreement. We are also
redesignating paragraphs (b)(2)(ii) and
(b)(2)(iii) as paragraphs (b)(2)(i) and
(b)(2)(ii), respectively.
Upon receiving the designated
carrier’s recommendation, we will make
a determination regarding suspension of
the participating CAP physician’s
election agreement. Specifically, we are
revising § 414.916(b)(3) to clarify the
suspension period for participating CAP
physicians. We are adding that a
suspension commencing before October
1 will conclude on December 31 of the
same year. A suspension commencing
on or after October 1 will conclude on
December 31 of the next year. We are
removing the last sentence in
§ 414.916(b)(3), which indicated a
participating CAP physician could
select another approved CAP vendor
while a reconsideration was pending.
Under § 414.916(c)(8) regarding the
findings of the hearing officer, we are
clarifying that if the hearing officer
decides to conduct an in-person or
telephone hearing, the hearing officer
will send a hearing notice to the
participating CAP physician ‘‘within 10
days of receipt of the hearing request.’’
Under § 414.916(c)(9), we are
clarifying our language regarding the
final reconsideration determination.
Under § 414.916(c)(9)(i) we are
clarifying that if the decision is
favorable to the participating CAP
physician, the participating CAP
physician may resume participation in
the CAP. We are also adding that the
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
hearing officer and the CMS official may
review decisions that are favorable or
unfavorable to the participating CAP
physician. Under § 414.916(c)(9)(iv), we
are clarifying that if our decision is
unfavorable to the participating CAP
physician, the participating CAP
physician’s CAP election agreement is
terminated.
We are removing proposed
§ 414.916(d) that stated the following:
‘‘The approved CAP vendor treats
quality and service issues through its
grievance process. If the approved CAP
vendor does not resolve a quality issue
to the participating CAP physician’s
satisfaction, the participating CAP
physician may escalate the matter to the
designated carrier. The designated
carrier attempts to develop solutions
that satisfy program requirements and
the needs of both the participating CAP
physician and the approved CAP
vendor.’’ This language has been
incorporated into new § 414.917. We are
also redesignating the proposed
paragraph (e) as new (d) under this
section.
We are adding a new § 414.917 to set
forth the process and responsibilities for
the dispute resolution for participating
CAP physicians and for suspension or
termination of an approved CAP
vendor’s CAP contract. We believe that
moving this language to a separate
section more clearly presents the
process and the responsibilities of the
particular parties.
Under the dispute resolution process
set forth under § 414.916 and § 414.917,
we are adding that the designated
carrier will include in its
recommendation to us, ‘‘numbered
findings of fact’’ when it makes a
recommendation whether the
participating CAP physician has been
filing his or her drug administration
claims in accordance with the
requirements of physician participation
in the CAP.
In addition, we are making editorial
and technical revisions as well as
necessary conforming changes.
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
PO 00000
Frm 00067
Fmt 4701
Sfmt 4700
39087
V. Waiver of Delayed Effective Date
[If you choose to comment on issues in this
section, please include the caption ‘‘Waiver
of Delayed Effective Date’’ at the beginning
of your comments.]
We also ordinarily provide a 60-day
delay in the effective date of the
provisions of a rule in accordance with
the Administrative Procedure Act (APA)
(5 U.S.C. 553(d), which requires a 30day delayed effective date, and the
Congressional Review Act (5 U.S.C.
801(a)(3), which requires a 60-day
delayed effective date for major rules.
However, we can waive the delay in
effective date if the Secretary finds, for
good cause, that such delay is
impracticable, unnecessary, or contrary
to the public interest, and incorporates
a statement of the finding and the
reasons in the rule issued. 5 U.S.C.
553(d)(3); 5 U.S.C. 808(2).
The Secretary finds that good cause
exists to implement the requirements
related to the selection process for
approved CAP vendors immediately
upon publication in the Federal
Register. Under section 1847B of the
Act, we are required to phase in the
CAP beginning in 2006. In addition,
section 1847B(a)(5)(A)(ii) of the Act
requires that the physicians’ annual
selection of approved CAP vendors be
coordinated with the Medicare
participating physician described in the
(PARDOC) process under section
1842(h) of the Act, which occurs in
November and December each year. To
comply with that statutory mandate, it
will be necessary for us to have
contracts in place with approved CAP
vendors in time to give physicians a
meaningful opportunity to review and
select an available approved CAP
vendor in their competitive acquisition
areas. If contracts with vendors are not
in place by that time, the next available
physician selection period would be at
the end of 2006 for a CAP
implementation date of January 1, 2007.
Such a delay would not be consistent
with the statutory mandate that the CAP
be phased-in beginning in 2006.
Therefore, the Secretary has determined
that it would be impractical and
contrary to the public interest to delay
the effective date of the provisions that
apply to the vendor application and
bidding process would be impracticable
and contrary to the public interest. An
effective date of July 6, 2005, for the
requirements related to the selection
process for approved CAP vendors will
ensure that the selection of approved
CAP vendors can proceed and will
afford the approved CAP vendors
needed time to prepare for the
enrollment of physicians and education
E:\FR\FM\06JYR2.SGM
06JYR2
39088
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
of beneficiaries concerning the CAP
program.
We note that only the provisions
associated with the selection process for
approved CAP vendors will be
implemented within 60 days of the date
of publication of this rule. There will be
at least 60 days between publication of
this rule and the implementation of
other provisions of this rule, including
the provisions related to physician
selection and operation of the CAP
program.
For all these reasons, we believe that
a 60-day delay in the effective date of
the provisions that apply to the vendor
application and bidding process would
be impracticable and contrary to the
public interest. We therefore find good
cause for waiving the 60-day delay in
the effective date for the requirements
related to the selection process for
approved CAP vendors.
VI. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 30day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
should be approved by OMB, section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we
solicit comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We are soliciting public comment on
each of these issues for the following
sections of this document that contain
information collection requirements:
Competitive acquisition program as
the basis for payment (§ 414.906). A
physician who elects to participate in
the program and has selected an
approved CAP vendor, must provide
information to the approved CAP
vendor to facilitate collection of
applicable deductible and coinsurance
as described in § 414.906(a)(2).
The burden associated with this
requirement is the time and effort
necessary for the participating CAP
physician to provide the information to
the approved CAP vendor to facilitate
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
collection of applicable deductible and
coinsurance.
We estimate the burden to be
approximately 29167 hours. We believe
there will be 500,000 claims and it will
take five minutes for the initial claim
per beneficiary and three minutes for
subsequent beneficiary claims. The
collection of information for the initial
claim is estimated to take five minutes
and subsequent claims will take
approximately three minutes. We
estimate 25 percent of claims to be
initial and 75 percent to be subsequent.
Competitive acquisition program
(§ 414.908). A physician is provided an
application process for the selection of
an approved CAP vendor on an annual
basis. The CAP election agreement will
facilitate physician enrollment and
designation of their approved CAP
vendor and agreement to abide by the
CAP program requirements.
In addition, physicians participating
in the CAP must elect to use an
approved CAP vendor for the drug
category area as discussed in
§ 414.904(a)(1); submit a written order
or prescription to the approved CAP
vendor; not receive payment for the
competitively biddable drug except as
described in § 414.906(c)(2)(ii); provide
information to the approved CAP
vendor to facilitate collection of
applicable deductible and coinsurance
as described in § 414.906(a)(3); notify
the approved CAP vendor when a drug
is not administered; maintain a separate
electronic or paper inventory for each
CAP drug obtained; agree to file the
Medicare claim when the drug is
administered.
The revised burden associated with
this requirement is the time and effort
necessary for the participating CAP
physician to provide and/or maintain
the information required as discussed
above. We revised our original estimate
to reflect new estimates on how many
physicians may participate in CAP and
the time required to fill out the most
current revision of the Physician
election form. For these burden
purposes, we estimate that there will be
10,000 physicians who fill out an
application and it will take the
physician 2 hours to complete the
application. Therefore, the burden
estimate is 20,000 hours.
Bidding process (§ 414.910). Vendors
may bid to furnish competitively
biddable drugs in all areas of the United
States, or a specific region that meets
the requirements of this section.
The burden associated with these
requirements is the time and effort
necessary to submit the bid application,
supporting documentation, and
maintain necessary documentation
PO 00000
Frm 00068
Fmt 4701
Sfmt 4700
demonstrating that the requirements set
forth in the contract have been or will
be met.
We currently estimate that it will
require 12 bid applicants 40 hours each
to meet the bidding and contract
requirements. This revised estimate is
based on data from the CAP RFI that
concluded in January and the policies
outlined in this IFC. The estimate of
hours required for one bidder to meet
this burden is unchanged.
Terms of contract (§ 414.914). The
terms of the contract between CMS and
the approved CAP vendor will be for a
term of 3 years. During the contract
period the approved CAP vendor must
disclosure to CMS or its agent, the
approved CAP vendor’s reasonable, net
acquisition costs for a specified period
of time, on at least an annual basis.
The burden associated with these
requirements is the time and effort
necessary for the approved CAP vendor
to submit to CMS or its agent, the
approved CAP vendor’s reasonable, net
acquisition costs for a specified period
of time, at least on an annual basis.
We estimate that it will require each
of the five vendors 8 hours on an annual
basis to submit the necessary
information, for total annual burden of
8 hours per vendor. The estimate was
revised to reflect a maximum of five
approved CAP vendors for one national
area.
Dispute resolution for vendors and
beneficiaries. Dispute resolution
(§ 414.916). Cases of an approved CAP
vendor’s dissatisfaction with denied
drug claims are resolved through a
voluntary alternative dispute resolution
process.
The dispute resolution process may
involve the gathering of information,
however, since the requirements set
forth in this section are in accordance
with administrative action, audit, or
investigation, the requirements of this
section are exempt from the PRA as
stipulated under 5 CFR 1320.4(a)(2).
Dispute resolution and process for
suspension or termination of an
approved CAP vendor (§ 414.917). If a
participating CAP physician finds an
approved CAP vendor’s service, or the
quality of a CAP drug to be
dissatisfactory, then the participating
CAP physician may treat the issue first
through the approved CAP vendor’s
grievance process, and second through
an alternative dispute resolution process
administered by the designated carrier
and CMS. In addition, if CMS suspends
or terminates an approved CAP vendor’s
CAP contract for cause, the approved
CAP vendor may request a
reconsideration of this decision.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
This process may involve the
gathering of information, however, since
the requirements set forth in this section
are in accordance with administrative
action, audit, or investigation, the
requirements of this section are exempt
from the PRA as stipulated under 5 CFR
1320.4(a)(2).
If you comment on these information
collection and recordkeeping
requirements, please mail copies
directly to the following:
Centers for Medicare & Medicaid
Services, Office of Strategic
Operations and Regulatory Affairs,
Regulations Development Group,
Attn: Jim Wickliffe, CMS–1325–IFC,
Room C5–13–28, 7500 Security
Boulevard, Baltimore, MD 21244–
1850; and
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Room 10235, New Executive
Office Building, Washington, DC
20503, Attn: Christopher Martin, CMS
Desk Officer, CMS–1325–P,
Christopher Martin@omb.eop.gov. Fax
(202) 395–6974.
Comments Related to the Collection of
Information Requirements
Comment: One commenter suggested
that CMS revise its estimate for
completing the physician application
for CAP election to reflect the additional
time it will take for physicians to
evaluate the CAP.
Response: While we understand this
concern, paperwork burden estimates
generally do not include the time
necessary to evaluate or consider taking
a specific action. Paperwork burden
estimates generally the time to complete
the information collection, including
the time to review instructions, search
existing data resources, gather the
needed data, and complete and review
the information collection. Accordingly,
CMS is not adopting this
recommendation.
Comment: Several commenters
recommended that CMS closely monitor
physician clerical and inventory
resources associated with the CAP
during the initial years of the program,
and if appropriate, consider making
additional payment to physicians to
cover the administrative costs
associated with CAP.
Response: CMS will monitor the
impact of the CAP program on
physicians, patients, and on Part B drug
prices closely. CMS will monitor its
implementation approach and, if
necessary, make adjustments to ensure
patient access and reduce the
administrative costs for providers.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
VII. Regulatory Impact Analysis
[If you choose to comment on issues in this
section, please include the caption
‘‘Regulatory Impact Analysis’’ at the
beginning of your comments.]
A. Overall Impact
We have examined the impacts of this
rule as required by Executive Order
12866 (September 1993, Regulatory
Planning and Review), the Regulatory
Flexibility Act (RFA) (September 19,
1980, Pub. L. 96–354), section 1102(b) of
the Social Security Act, the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4), and Executive Order 13132.
Executive Order 12866 (as amended
by Executive Order 13258, which
merely reassigns responsibility of
duties) directs agencies to assess all
costs and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
(RIA) must be prepared for major rules
with economically significant effects
(that is, a final rule that would have an
annual effect on the economy of $100
million or more in any 1 year, or would
adversely affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or tribal governments or
communities).
We indicated in the March 4, 2005
proposed rule that we were considering
this to be a major rule, but at that time
we had not yet defined geographic
area(s) and category(ies) of CAP drugs.
Based on the establishment of the CAP
initially as a national program with one
drug category, we continue to believe
that this rule is a major rule, and we
anticipate more than $100 million will
pass through the CAP payment system
in 2006. Therefore, we have prepared a
regulatory impact analysis (RIA).
However, as previously discussed in the
preamble, certain sections of this rule
will be effective immediately.
Specifically, the provisions related to
the vendor bidding process will not be
subject to the 60-day delay in effective
date applicable to major rules under the
Congressional Review Act (5 U.S.C. 801
et seq.) because of the need to meet the
statutory requirement to coordinate the
physicians’ election to participate in the
CAP with the Medicare Participating
Physician Process described in section
1842(h) of the Act. We can only meet
this statutory requirement if the delay in
effective date for these particular
portions of the rule are waived. We note
PO 00000
Frm 00069
Fmt 4701
Sfmt 4700
39089
that although the vendor bidding
process will begin immediately, vendors
will not be required to sign contracts
with Medicare until after the effective
date of all of the provisions of this rule.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of less than $6 million to $29 million in
any 1 year. We prepare an initial or final
regulatory flexibility analysis unless we
certify that a rule will not have a
significant economic impact on a
substantial number of small entities.
The analysis must include a justification
concerning the reason the action is
being taken, the kinds and number of
small entities the rule affects, and an
explanation of any meaningful options
that achieve the objectives with less
significant adverse economic impact on
the small entities. Individuals and
States are not included in the definition
of a small entity. For the reasons
described in the section on ‘‘Anticipated
Effects,’’ we certify that this rule will
not have a significant economic impact
on a substantial number of small
entities.
For purposes of the RFA, physicians
and non-physician practitioners are
considered small businesses if they
generate revenues of $8.5 million or
less. Approximately 96 percent of
physicians in private practice are
considered to be small entities. There
are in excess of 20,000 physicians and
other practitioners that receive Medicare
payment for drugs. These physicians are
more concentrated in the specialties of
oncology, urology, and rheumatology.
Of the physicians in these specialties,
approximately 40 percent are in
oncology and 45 percent in urology.
The impact of this interim final rule
on an individual physician is dependent
on the drugs they provide to Medicare
beneficiaries and whether these drugs
are included in the category of ‘‘incident
to’’ drugs identified in the preamble for
competitive acquisition and whether the
physician chooses to obtain drugs
administered to Medicare beneficiaries
through the CAP.
In addition, this interim final rule will
have a potential impact on entities,
either existing or formed specifically for
this purpose, that are involved in the
dispensing or distribution of drugs. This
aspect was dependent on our
determination of the particular category/
categories of drugs to be included in the
CAP and the geographic areas in which
E:\FR\FM\06JYR2.SGM
06JYR2
39090
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
it is to take place. It also depends on the
ability of potential vendors to
successfully compete and receive
approval as a vendor under the CAP. As
previously discussed, the CAP will be a
national program, and an approved CAP
vendor must be able to furnish all the
drugs in the established CAP category of
drugs.
Comment: At least one commenter
believed that the initial regulatory
flexibility analysis was not sufficient to
allow small vendors sufficient notice
that the CAP could have an impact on
them.
Response: We believe that small
businesses received ample notice that
this rule could have an impact on them.
We provided detailed explanations of
the options for the areas and categories
in the preamble to the proposed rule,
and indicated that the impact on small
entities would depend on how those
choices played out. We received more
than 500 comments from a variety of
sources, including potential CAP
vendors and individual physicians. We
believe that all possibly affected
entities, including small vendors, had
an opportunity to comment.
Also, section 1102(b) of the Social
Security Act requires us to prepare an
initial and final regulatory flexibility
analysis if a rule has a significant
impact on the operations of a substantial
number of small rural hospitals. This
analysis must conform to the provisions
of section 604 of the RFA. For purposes
of section 1102(b) of the Act, we define
a small rural hospital as a hospital that
is located outside of a Metropolitan
Statistical Area and has fewer than 100
beds. We have determined that this
interim final rule will have no
significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule that mandates
expenditures in any 1 year by State,
local, or tribal governments, in the
aggregate, or by the private sector, of
$110 million. Executive Order 13132
establishes certain requirements that an
agency must meet when it promulgates
a final rule that imposes substantial
direct requirement costs on State and
local governments, preempts State law,
or otherwise has Federalism
implications. We have examined this
interim final rule in accordance with
Executive Order 13132 and UMRA and
have determined that this regulation
will have no consequential effect on the
rights, roles, or responsibilities of State,
local, or tribal governments, or impose
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
direct costs on State, local, or tribal
governments. Nor does the rule mandate
direct costs on the private sector.
Comment: Several commenters
believe that, should CMS include
oncologists and oncology drugs in the
CAP, more Medicare beneficiaries will
require hospital treatment due to
delayed access to necessary drugs for
their treatment programs and this will
potentially impact small hospitals.
Response: Based on the comments
received and the results of our data
analysis, we will be including certain
oncology drugs in the CAP, and we
anticipate that some oncologists may
elect to participate in the CAP.
However, participation under the CAP
is voluntary, and we would not expect
these physicians to participate if this
would result in adverse consequences
for their Medicare beneficiary patients.
Moreover, we believe that we have built
into the program various safeguards that
will preserve beneficiary access and
prevent treatment delays or unnecessary
hospital referrals, as discussed
elsewhere in the preamble: For example,
the provisions related to ‘‘furnish as
written’’ and the resupply of inventories
for drugs administered in an emergency
situation will help ensure that Medicare
beneficiaries will receive their
treatments timely within their
physicians’ offices. Finally, the likely
effects on physicians and Medicare
beneficiary patients are discussed at
greater length in the discussion of
‘‘Anticipated Effects’’ below.
B. Anticipated Effects
We have prepared the following
analysis related to the assessment
requirements. It explains the rationale
for, and purposes of, the rule, details the
costs and benefits of the rule, analyzes
alternatives, and presents the measures
we are using to minimize the burden on
small entities. As indicated elsewhere in
this rule, this program provides an
alternative to the method that
physicians currently use to obtain and
pay for certain Medicare drugs in
response to the requirements of section
1847B of the Act. The provisions of this
rule discuss how this option will be
offered to physicians. The CAP process
is an alternative payment system for
Part B drugs and biologicals. This rule
does not impose reporting,
recordkeeping, and other compliance
requirements except as described in
sections II.B, II.C and II.D. of the
preamble. We are not aware of any
relevant Federal rules that duplicate,
overlap, or conflict with this rule.
Comment: Several commenters
expressed concern that there would be
a significant administrative as well as a
PO 00000
Frm 00070
Fmt 4701
Sfmt 4700
financial impact on physicians. These
commenters claimed that physicians
who elect to participate in the CAP will
not be appropriately compensated for
additional costs such as maintaining
separate drug storage for CAP
medications, hiring additional
personnel to order and keep track of
CAP medications, and the additional
time required to adequately track the
actual drug administrations.
Response: Although we recognize that
electing to participate in the CAP
imposes certain new burdens on
physicians who choose to participate,
we believe these are offset by the
decrease in burden associated with no
longer having to buy most Part B drugs
and bill the Medicare program for them.
The administrative payment burdens
that are relieved or reduced include
collecting the applicable deductible and
coinsurance from the beneficiary or
other supplemental insurer and the time
and cost of assuming legal ownership of
the drugs covered under the CAP. As
the physician does not assume legal
ownership of the drug under the CAP
(ownership remains with the approved
CAP vendor), this removes the burden
of negotiating with drug suppliers for
the best price. Further, it is possible that
the time and effort involved in
generating the drug in a quantity other
than that in which it was received also
could be removed from the physician.
Receiving drugs in the proper
administration dosage, where possible,
saves the physician time and effort. We
note that the CAP is an option offered
to physicians who believe that it is a
viable alternative to the buy and bill
system, especially when dealing with
extremely expensive drugs. Physicians
who believe the CAP burden would be
too onerous for their practice always
will have the option of electing not to
participate in the CAP and continue to
be paid under the ASP payment system
for the medically necessary drugs that
they obtain and administer under
Medicare. We remain committed to
working with members of the health
care community to assist them in
identifying the most appropriate
payment scenarios for providers as well
as the highest quality of care for
beneficiaries.
Comment: Several commenters were
concerned that if CMS selected a
national geographic area, then approved
CAP vendors who participate in the
CAP would be asked to handle business
on a national level. Small vendors who
want to operate under the CAP in a
specific area for a small number of local
physicians believe that in such an event,
they will have been excluded from the
CAP out of hand.
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Response: Initially, we believe that, in
order to get the program started, the
CAP needs to be administered on a
national level. Most of the comments we
received indicated that small vendors
were not limited geographically but,
instead, by drug specialty. The CAP
requirements are in place to facilitate
access to care for Medicare beneficiaries
and to maintain quality of care in the
treatment programs of these
beneficiaries. However, that does not
mean that larger vendors cannot
contract with smaller vendors under the
CAP to provide drugs to smaller
geographic areas of the country or
specific physicians, as long as all other
criteria can be met by the sub-contracted
vendor. Furthermore, there is nothing
that precludes a relatively small firm
from providing services on a national
basis. In this way, every qualified
vendor has the opportunity to
participate, even though it may not be
in a direct way. In the future, we will
establish additional or alternative
competitive acquisition areas and drug
categories and solicit comments on
those additions or alternatives, as
necessary.
The effect of this interim final rule on
an individual physician will be
dependent on the drugs he or she
provides to Medicare beneficiaries and
whether the drugs he or she furnishes
are included in the category of drugs
considered for the CAP. For example, a
physician may (1) determine the cost
associated with acquiring drugs through
the competitive acquisition program; (2)
determine the cost associated with
acquiring drugs through traditional
means and billing Medicare under the
ASP payment system methodology; and
(3) determine whether there is a cost
savings to them associated with either
program. Different outcomes may result
from these calculations depending on
the drug mix, overhead cost, and
Medicare beneficiary patient mix.
A physician who elects to participate
in the program would obtain all of his
or her Medicare-related drugs included
in the category through an approved
CAP vendor. The approved CAP vendor
will collect applicable deductibles and
coinsurance from the beneficiary. Under
this option, the participating CAP
physician will never take legal
ownership of the drug and will
eliminate the cost associated with
collecting deductibles and coinsurance.
Because the drug remains the property
of the approved CAP vendor until the
time of administration, the participating
CAP physician also may be able to
reduce the cost associated with storage
and individual drug supplier
negotiations. The CAP may also save
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
participating CAP physicians money
because they will not be in the drug
purchasing and procurement business
and will not have to collect coinsurance
for those drugs from beneficiaries.
Comment: Several commenters were
concerned about increased drug waste
by physicians who participate in the
CAP because, in their view, the
physician will not be able to return the
unused drug to the approved CAP
vendor or to use the drug when a
beneficiary’s treatment plan changes on
short notice. These commenters further
cited problems with redirecting these
unused medications to alternative
beneficiaries due to State regulations in
some instances.
Response: If it becomes apparent that
there is a problem with excessive waste
under the CAP, then we will examine
ways to specifically address the issue.
One question would concern whether
some types of physician practices may
be affected because drugs they use are
more prone to wastage for particular
reasons, or if waste is more of a random
problem that would lead us to deal with
the issue on an individual basis.
This rule also establishes rules
whereby drugs administered by the
participating CAP physician in
emergency situations that were not
originally acquired through a Medicareapproved CAP vendor may be
resupplied through the Medicareapproved CAP vendor, as described
elsewhere in the preamble.
C. Impact of Establishment of a
Competitive Acquisition Program
The purpose of the CAP program is to
potentially achieve budgetary savings to
Medicare and beneficiaries through a
competitive bidding approach to
determining Medicare payment rates for
selected drugs and to provide
physicians with an alternative way to
obtain these selected drugs that they use
for treating their Medicare beneficiaries
in their offices. We have estimated the
impact of the costs of furnishing or
administering drugs through the CAP on
the Medicare program and expect it to
be negligible, at least during the
beginning until participating CAP
physicians, approved CAP vendors and
CMS gain more experience with the
program. During the first year, we
anticipate no significant additional cost
savings or increases associated with the
CAP, particularly relative to the ASP
payment system. The CAP program will
provide alternatives to physicians who
do not wish to be in the drug purchasing
and coinsurance collection business. We
will further refine theses impacts as
participating CAP physicians, approved
PO 00000
Frm 00071
Fmt 4701
Sfmt 4700
39091
CAP vendors, and CMS gain experience
with this new program.
D. Alternatives Considered
As we developed the CAP, we
considered whether to break the country
into smaller geographic regional or State
areas as opposed to one national
competitive acquisitions area (the 50
United States, the District of Columbia
and the U.S. territories). We also
considered whether to include all drugs
available under the CAP in one category
as opposed to breaking the drugs out
into different categories such as
oncology drugs, non-oncology drugs,
and crossover drugs. We also considered
variations of these options such as
breaking down the drug categories at the
national level versus offering one drug
category at the regional or State level. In
reference to these options, we did not
receive any comments about
administering the CAP in specific
regions of the country or specific States
or any data to support such a
conclusion. As we stated earlier in this
section, vendors who wish to be
approved CAP vendors and who also
wish to operate in certain States,
regions, or areas of the country, as
opposed to nationally, are free to seek
out vendors who plan to participate in
the CAP at the national level to see
whether their services can be used at the
sub-contractor level. We do not intend
to direct such an arrangement other than
to reiterate that our criteria for
participation in the CAP must be met by
any and all potential approved CAP
vendors; however, we encourage this
communication between potential CAP
vendors as we believe that it will
enhance the opportunities for approved
CAP vendors as well as participating
CAP physicians under the CAP.
We also considered whether or not to
split drugs into more than one category
as well as several options for defining
drug categories across a wide spectrum
of physician Part B drugs, as described
in the preamble. Commenters on the
proposed rule were divided about
whether to employ broadly defined or
narrowly defined categories of drugs.
We are persuaded that more broadly
defined categories would better serve
the purposes of the program, at least in
the initial stage. This approach would
make it more feasible for participating
CAP physicians to obtain all, or almost
all, of their Part B drugs from one
approved CAP vendor. We expect that
the approved CAP vendors participating
on a nationwide scale will be able to
provide the broad spectrum of drugs
without appreciably more difficulty, if
any, than narrower sets of drugs. In
accordance with the statute, we will
E:\FR\FM\06JYR2.SGM
06JYR2
39092
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
develop more narrowly defined
categories if it seems advisable at a later
stage.
In this interim final rule, based on the
comments and our data analysis, we are
implementing the CAP with one
extensive category as it provides the
most expansive category of drugs and it
is the most simple in terms of
operationalization. We believe that this
option will encourage the highest
number of approved CAP vendors to
participate under the CAP due to the
potential for larger market share and the
opportunity for smaller vendors to
contract with the larger vendors. We
also believe that this option will
encourage the highest number of
physicians to participate under the CAP
due to the potential for acquiring a large
portion of the drugs administered to
their Medicare beneficiaries from a
single approved CAP vendor.
However, we will monitor the
program carefully, assessing all the
issues discussed above, and make
appropriate program adjustments if
these seem warranted. We welcome
input on any and all issues.
E. Impact on Beneficiaries
We have estimated the potential
changes in beneficiary coinsurance for
drugs and related changes in beneficiary
Part B premium payments resulting
from the implementation of the CAP for
Part B drugs. We do not expect, during
the first year of the program, that there
will be an appreciable difference to the
beneficiaries if their drugs were to be
administered by a physician
participating in the CAP or purchasing
them and being reimbursed for them
within the ASP payment system. At
least initially, until approved CAP
vendors, participating CAP physicians,
and CMS gain more experience with
this new program, we do not anticipate
there would be any significant
additional costs or savings to a
beneficiary whose physician
participates in the CAP. The CAP
should be largely transparent to the
beneficiary population. The only change
should be the entity that bills the
beneficiary for the coinsurance.
We do not believe that beneficiaries
would experience drug access issues as
a result of implementation of the CAP.
However, we intend to monitor
beneficiary access closely and may
propose additional changes to our
payment system in the future, if
necessary.
We intend to develop educational
material to distribute to beneficiaries,
such as pamphlets and a discussion in
The Medicare & You Handbook, to help
explain the CAP and the changes they
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
will see on their Medicare summary
notices. Specifically, under the CAP,
beneficiaries will now pay their
coinsurance and deductibles to their
approved CAP vendor instead of the
administering participating CAP
physician.
Comment: Several commenters
believed that beneficiary access to a
drug or drugs associated with the
beneficiary’s specific treatment program
will be compromised under the CAP,
resulting in multiple trips to the
physician’s office by not only the
beneficiary, but the beneficiary’s family
members, for a single treatment. Also,
these commenters believe that the
beneficiary’s condition may be
compromised and, in fact, may decline,
resulting in a hospital admission,
because treatment was delayed in these
circumstances. The commenters stated
that, often, a beneficiary’s treatment
program is altered on short notice. A
participating CAP physician that
stocked his or her own drugs would,
presumably, be able to accommodate
these treatment changes onsite, rather
than having to plan a subsequent visit
while an alternative drug prescription
order is filled.
Response: We appreciate the concerns
of these commenters, and we will
monitor beneficiary access under the
CAP. We believe that the construct of
the CAP will enhance beneficiary access
in several ways. The participating CAP
physician will have access to a category
of drugs that he or she can order to meet
the beneficiary’s needs. If the approved
CAP vendor does not offer a particular
drug that is medically necessary for a
beneficiary’s treatment plan, then the
participating CAP physician may use
the ‘‘furnish as written’’ option and
access the specific drug through this
channel. Further, if a beneficiary
presents in a condition that requires the
participating CAP physician to alter his
or her treatment plan, and the
participating CAP physician determines
it is an emergency, and the other criteria
under the resupply provision are met
such as, that the need is unanticipated
and the vendor cannot provide the drug
in time, then the participating CAP
physician could immediately administer
a drug out of his or her own stock and
then order a replacement from the
approved CAP vendor. Although we
cannot say that a situation would never
occur wherein a beneficiary would need
a drug that is not immediately available,
this could also occur under the current
ASP payment system.
Comment: Some commenters pointed
out that beneficiaries may be
disadvantaged if an approved CAP
vendor cannot react expeditiously when
PO 00000
Frm 00072
Fmt 4701
Sfmt 4700
new drugs are introduced or patents
expire due to the restrictions of the
CAP. An approved CAP vendor is
limited to offering drugs within a
certain category while the participating
CAP physician can act outside the CAP
for drugs that are different or new.
Response: We appreciate the fact that
new drugs may become available
through the FDA drug or biological
approval process, or alternatively that
previously approved drugs may be
discontinued on an ongoing basis. New
drugs may be included in the CAP once
they are assigned a permanent HCPCS
code, as described elsewhere in this
preamble. If a new drug or biological is
not offered by the participating CAP
physician’s approved CAP vendor,
participating CAP physician can
purchase it and bill for it through the
ASP payment system.
A drug approved by the FDA as a
generic for an existing drug with a
HCPCS code may not be available
within the CAP because for multiple
source drugs, the approved CAP vendor
is required to provide only one NDC
within a HCPCS code (although the
approved CAP vendor is free to bid to
provide multiple NDCs within a HCPCS
code). If a participating CAP physician
finds it medically necessary to prescribe
a new drug that is within an existing
HCPCS code in the CAP drug category,
but that his or her selected approved
CAP vendor has not contracted to
provide, he or she can obtain it and bill
for it under the ASP payment system
using the ‘‘furnish as written’’
provision.
Comment: A large number of
commenters involved in the mental
health arena stated that the inclusion of
psychiatric drugs under the CAP would
enable more patients in need of valuable
mental health medications to have
access to them, especially in rural areas,
and, as a result, bring new psychiatric
therapies into wider use. In the view of
these commenters, the current ASP
payment system presents them with
barriers to care for their patients because
of the administrative burden of locating
new mental health therapies and then
billing Medicare and tracking the
claims, which often are only partly paid.
If psychiatric drugs were included as an
available category, then this burden
would be removed.
Response: We appreciate the positive
response from the mental health
community for the CAP. We are working
to ensure the availability of the most
effective treatments to enable at-risk
individuals to live productive lives in
the least restrictive environments. As
previously stated, several mental health
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
drugs are included in the drug category
we have established for the CAP.
Comment: Several commenters
believe that Medicare beneficiaries will
have a difficult time understanding why
they receive two statements (one from
the participating CAP physician for the
administration of the drug and one from
the approved CAP vendor for the
coinsurance and deductible payments)
about each episode of treatment.
Response: We have built extensive
educational tools into the CAP for
beneficiaries, as described elsewhere in
the preamble. Beneficiaries will receive
information on the implementation of
the CAP and how it will affect them and
what they see as far as Medicare billing
is concerned. They will also be
provided with access to a help line for
the questions about their bills as well as
written information that they can
reference. Of course, regardless of which
option they select, we would expect
most participating CAP physicians to
explain to their Medicare beneficiaries
the process by which they will be billed.
Comment: Some commenters were
concerned that beneficiaries who were
financially burdened would be
adversely affected by the CAP because
they would be removed from dealing
directly with their physicians in
working out payment options for their
deductibles and copayments because
the approved CAP vendor would be
responsible for billing the beneficiaries
for these items.
Response: Beneficiaries are legally
responsible for paying their
coinsurance, and providers, including
participating CAP physicians and other
suppliers such as the approved CAP
vendors, are required to make an effort
to collect it. We address above in this
preamble measures that the approved
CAP vendor may take to address this
issue. We encourage beneficiaries to talk
to the approved CAP vendor in these
circumstances and encourage the
approved CAP vendor to provide
beneficiaries information about patient
assistance programs. Again, we will be
monitoring beneficiary access under the
CAP. In addition, approximately 80
percent of Medicare beneficiaries have
some type of supplemental coverage for
Part B that will pay their deductible and
coinsurance amounts either in whole or
in part.
F. Conclusion
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
List of Subjects in 42 CFR Part 414
Administrative practice and
procedure, Health facilities, Health
professions, Kidney diseases, Medicare,
Reporting and recordkeeping
requirements.
I For the reasons set forth in this
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
1. The authority citation for part 414
continues to read as follows:
I
Authority: Secs. 1102, 1871, and 1881(b)(1)
of the Social Security Act (42 U.S.C. 1302,
1395hh, and 1395rr(b)(1)).
Subpart K—Payment for Drugs and
Biologicals Under Part B
2. Revise the heading of subpart K to
read as set forth above.
I 3. Amend § 414.900 by—
I A. Revising the section heading.
I B. Revising paragraph (a).
I C. Revising paragraph (b)(3)(ii).
The revisions read as follows:
I
§ 414.900
Basis and scope.
(a) This subpart implements sections
1842(o), 1847A, and 1847B of the Act
and outlines two payment
methodologies applicable to drugs and
biologicals covered under Medicare Part
B that are not paid on a cost or
prospective payment system basis.
(b) * * *
(3) * * *
(ii) Pneumococcal and Hepatitis B
vaccines.
*
*
*
*
*
I 4. Amend § 414.902 by republishing
the introductory text to the section and
adding the definitions of ‘‘Approved
CAP vendor,’’ ‘‘Bid,’’ ‘‘CAP drug,’’
‘‘Competitive acquisition area,’’
‘‘Competitive acquisition program,’’
‘‘Designated carrier,’’ ‘‘Emergency
delivery,’’ ‘‘Emergency situation,’’
‘‘Local carrier,’’ ‘‘Pacific Territories,’’
‘‘Participating CAP physician,’’
‘‘Participating CAP physician election
agreement,’’ ‘‘Prescription order,’’
‘‘Routine delivery,’’ and ‘‘Timely
delivery.’’
§ 414.902
Definitions.
As used in this subpart, unless the
context indicates otherwise—
Approved CAP vendor means an
entity that has been awarded a contract
by CMS to participate in the competitive
acquisition program under 1847B of the
Act.
Bid means an offer to furnish a CAP
drug within a category of CAP drugs in
PO 00000
Frm 00073
Fmt 4701
Sfmt 4700
39093
a competitive acquisition area for a
particular price and time period.
CAP drug means a physicianadministered drug or biological
furnished on or after January 1, 2006
described in section 1842(o)(1)(C) of the
Act and supplied by an approved CAP
vendor under the CAP as provided in
this subpart.
Competitive acquisition area means a
geographic area established by the
Secretary for purposes of implementing
the CAP required by section 1847B of
the Act.
Competitive acquisition program
(CAP) means a program as defined
under section 1847B of the Act.
Designated carrier means an entity
assigned by CMS to process and pay
claims for drugs and biologicals under
the CAP.
*
*
*
*
*
Emergency delivery means delivery of
a CAP drug within one business day in
appropriate shipping and packaging, in
all areas of the United States and its
territories, with the exception of the
Pacific Territories. In the Pacific
Territories, emergency delivery means
delivery of a CAP drug within 5
business days in appropriate shipping
and packaging. In each case, this
timeframe shall be reduced if product
stability requires it, meaning that the
manufacturer’s labeling instructions,
drug compendia, or specialized drug
stability references indicate that a
shorter delivery timeframe is necessary
to avoid adversely affecting the
product’s integrity, safety, or efficacy.
Emergency situation means, for the
purposes of the CAP, an unforeseen
occurrence or situation determined by
the participating CAP physician, in his
or her clinical judgment, to require
prompt action or attention for purposes
of permitting the participating CAP
physician to use a drug from his or her
own stock, if the other requirements of
§ 414.906(e) are met.
Local carrier means an entity assigned
by CMS to process and pay claims for
administration of drugs and biologicals
under the CAP.
*
*
*
*
*
Pacific Territories means, for
purposes of the CAP, American Samoa,
Guam, or the Northern Mariana Islands.
Participating CAP physician means a
physician electing to participate in the
CAP, as described in this subpart. The
participating CAP physician must
complete and sign the participating CAP
physician election agreement.
Physicians who do not participate in
Medicare but who elect to participate in
the CAP must agree to accept
assignment for CAP drug administration
claims.
E:\FR\FM\06JYR2.SGM
06JYR2
39094
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Participating CAP physician election
agreement means the agreement that the
physician signs to notify CMS of the
physician’s election to participate in the
CAP and to agree to the terms and
conditions of CAP participation as set
forth in this subpart.
Prescription order means a written
order submitted by the participating
CAP physician to the approved CAP
vendor that meets the requirements of
this subpart.
Routine delivery means delivery of a
drug within 2 business days in
appropriate shipping and packaging in
all areas of the United States and its
territories, with the exception of the
Pacific Territories. In the Pacific
Territories, routine delivery of drug
means delivery of a CAP drug within 7
business days in appropriate shipping
and packaging. In each case, this
timeframe will be reduced if product
stability requires it, meaning that the
manufacturer’s labeling instructions,
drug compendia, or specialized drug
stability references indicate that a
shorter delivery timeframe is necessary
to avoid adversely affecting the
product’s integrity, safety, or efficacy.
*
*
*
*
*
Timely delivery means delivery of a
CAP drug within the defined routine
and emergency delivery timeframes.
Compliance with timely delivery
standards is also a factor for evaluation
of potential and approved CAP vendors.
*
*
*
*
*
I 5. Amend § 414.904 by revising the
section heading to read as follows:
§ 414.904 Average sales price as the basis
for payment.
*
I
*
*
*
*
6. Add § 414.906 to read as follows:
§ 414.906 Competitive acquisition program
as the basis for payment.
(a) Program payment. Beginning in
2006, as an alternative to payment
under § 414.904, payment for a CAP
drug may be made through the CAP if
the following occurs:
(1) The CAP drug is supplied under
the CAP by an approved CAP vendor as
specified in § 414.908(b).
(2) The claim for the prescribed drug
is submitted by the approved CAP
vendor that supplied the drug, and
payment is made only to that vendor.
(3) The approved CAP vendor collects
applicable deductible and coinsurance
with respect to the drug furnished under
the CAP only after the drug is
administered to the beneficiary.
(4) The approved CAP vendor delivers
CAP drugs directly to the participating
CAP physician in unopened vials or
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
other original containers as supplied by
the manufacturer or from a distributor
that has acquired the products directly
from the manufacturer and includes
language with the shipping material
stating that the drug was acquired in a
manner consistent with all statutory
requirements. If the approved CAP
vendor opts to split shipments, the
participating CAP physician must be
notified in writing which can be
included with the initial shipment, and
each incremental shipment must arrive
at least 2 business days before the
anticipated date of administration.
(5) The approved CAP vendor bills
Medicare only for the amount of the
drug administered to the patient, and
the beneficiary’s coinsurance will be
calculated from the quantity of drug that
is administered.
(b) Exceptions to competitive
acquisition. Specific CAP drugs,
including a category of these drugs, may
be excluded from the CAP if the
application of competitive bidding to
these drugs—
(1) Is not likely to result in significant
savings; or
(2) Is likely to have an adverse impact
on access to those drugs.
(c) Computation of payment amount.
(1) Except as specified in paragraph
(c)(2) of this section, payment for CAP
drugs is based on bids submitted, as a
result of the bidding process as
described in § 414.910. Based on these
bids, a single payment amount for each
CAP drug in the competitive acquisition
area is determined on the basis of the
bids submitted and accepted and
updated from the bidding period to the
payment year. This single payment
amount is then updated on an annual
basis based on the approved CAP
vendor’s reasonable net acquisition
costs for that category as determined by
CMS based, in part, on information
disclosed to CMS and limited by the
weighted payment amount established
under section 1847A of the Act across
all drugs in that category. Adjustment to
the payment amounts may be made
more often than annually, but no more
often than quarterly, in any of the
following cases:
(i) Introduction of new drugs.
(ii) Expiration of a drug patent or
availability of a generic drug.
(iii) Material shortage that results in a
significant price increase for the drug.
(iv) Withdrawal of a drug from the
market.
(2) The alternative payment amount
established under section 1847A of the
Act may be used to establish payment
for a CAP drug if—
(i) The drug is properly assigned to a
category established under the CAP; and
PO 00000
Frm 00074
Fmt 4701
Sfmt 4700
(ii) It is a drug for which a HCPCS
code must be established.
(d) Adjustments. There is an
established process for adjustments to
payments to account for drugs that were
billed, but which were not
administered.
(e) Resupply of participating CAP
physician drug inventory. A
participating CAP physician may
acquire drugs under the CAP to
resupply his or her private inventory if
all of the following requirements are
met:
(1) The drugs were required
immediately.
(2) The participating CAP physician
could not have anticipated the need for
the drugs.
(3) The approved CAP vendor could
not have delivered the drugs in a timely
manner. For purposes of this section,
timely manner means delivery within
the emergency delivery timeframe, as
defined in § 414.902.
(4) The participating CAP physician
administered the drugs in an emergency
situation, as defined in § 414.902.
(f) Substitution of CAP drugs. An
approved CAP vendor may agree to
furnish more than one CAP drug
(defined at the NDC level) for a HCPCS
code. Payment is based on a bid price
defined by the HCPCS code and the unit
of measure for the HCPCS code.
Substitution of a different NDC within
the HCPCS code for the NDC currently
furnished by the approved CAP vendor
can occur in the following situations:
(1) On an occasional basis, if the
approved CAP vendor is willing to
accept the payment amount that was
established for the original NDC within
a HCPCS code under the CAP, and the
participating CAP physician approves
the substitution; or
(2) For an extended period of time
(more than 2 weeks), if the approved
CAP vendor identifies the replacement
product, the designated carrier’s
medical director approves the long-term
substitution on behalf of CMS, and all
participating CAP physicians who have
selected the approved CAP vendor are
notified of the change. In the case of
such long-term substitution, payment is
based on the price established in
accordance with § 414.906(c).
I 7. Add § 414.908 to read as follows:
§ 414.908
program.
Competitive acquisition
(a) Participating CAP physician
selection of an approved CAP vendor.
(1) CMS provides the participating CAP
physician with a process for the
selection of an approved CAP vendor on
an annual basis, with exceptions as
specified in § 414.908(a)(2).
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Participating CAP physicians will also
receive information about the CAP in
the enrollment process for Medicare
participation set forth in section 1842(h)
of the Act.
(2) A participating CAP physician
may select an approved CAP vendor
outside the annual selection process or
opt out of the CAP for the remainder of
the annual selection period when—
(i) The selected approved CAP vendor
ceases participation in the CAP;
(ii) The physician leaves a group
practice participating in CAP;
(iii) The participating CAP physician
relocates to another competitive
acquisition area; or
(iv) For other exigent circumstances
defined by CMS.
(3) The physician participating in the
CAP—
(i) Elects to use an approved CAP
vendor for the drug category and area as
set forth in § 414.908(b);
(ii) Completes and signs the CAP
election agreement;
(iii) Submits a written prescription
order to the approved CAP vendor with
complete patient information for
patients new to the approved CAP
vendor or when information changes.
Abbreviated information may be sent on
all subsequent orders for a patient for
which the approved CAP vendor has
previously received complete
information and that has no changes to
the original information. Prescription
orders may be initiated by telephone,
with a follow-up written order provided
within 8 hours for routine deliveries
and immediately for emergency
deliveries;
(iv) Does not receive payment for the
CAP drug;
(v) Except where applicable State
pharmacy law prohibits it, provides the
following information to the approved
CAP vendor to facilitate collection of
applicable deductible and coinsurance
as described in § 414.906(a)(3):
(A) Date of order.
(B) Beneficiary name, address, and
phone number.
(C) Physician identifying information:
Name, practice location/shipping
address, group practice information (if
applicable), PIN, and UPIN.
(D) Drug name.
(E) Strength.
(F) Quantity ordered.
(G) Dose.
(H) Frequency/instructions.
(I) Anticipated date of administration.
(J) Beneficiary Medicare information/
Health insurance (HIC) number.
(K) Supplementary insurance
information (if applicable).
(L) Medicaid information (if
applicable).
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
(M) Additional patient information:
date of birth, allergies, height/weight,
ICD–9.
(vi) Notifies the approved CAP vendor
when a drug is not administered or a
smaller amount was administered than
was originally ordered. The
participating CAP physician and the
approved CAP vendor agree on how to
handle the unused CAP drug. If it is
agreed that the participating CAP
physician will maintain the CAP drug in
his inventory for administration at a
later date, the participating CAP
physician submits a new prescription
order at that time. This prescription
order specifies that the CAP drug is
being obtained from the participating
CAP physician’s CAP inventory and
shipment should not occur;
(vii) Maintains a separate electronic or
paper inventory for each CAP drug
obtained;
(viii) Agrees to file the Medicare claim
within 14 calendar days of the date of
drug administration;
(ix) Agrees to submit an appeal
accompanied by all required
documentation (such as medical records
or a certification) necessary to support
payment if the participating CAP
physician’s drug administration claim
for a CAP drug is denied;
(x) Agrees not to transport CAP drugs
from one practice location (place of
service) to another location;
(xi) Agrees to provide the CMSdeveloped CAP fact sheet to
beneficiaries; and
(xii) May receive payment under the
ASP system when medical necessity
requires a certain brand or formulation
of a drug that the approved CAP vendor
has not been contracted to furnish under
the CAP.
(4) Physician group practices. If a
physician group practice using a group
billing number(s) elects to participate in
the CAP, all physicians in the group are
considered to be participating CAP
physicians when using the group’s
billing number(s).
(5) Additional opt out provision. In
addition to the circumstances listed in
§ 414.908(a)(2), if the approved CAP
vendor refuses to ship to the
participating CAP physician because the
conditions of § 414.914(h) have been
met, the physician can withdraw from
CAP for the remainder of the year
immediately upon notice to CMS and
the approved CAP vendor.
(b) Program requirements. (1) CMS
selects approved CAP vendors through
a competition among entities based on
the following:
(i) Submission of the bid prices using
the OMB-approved Vendor Application
and Bid Form for CAP drugs within the
PO 00000
Frm 00075
Fmt 4701
Sfmt 4700
39095
category and competitive acquisition
area that—
(A) Places the vendor among the
qualified bidders with the lowest five
composite bids; and
(B) Does not exceed the weighted
payment amount established under
section 1847A of the Act across all
drugs in that category.
(ii) Ability to ensure product integrity.
(iii) Customer service/Grievance
process.
(iv) At least 3 years experience in
furnishing Part B injectable drugs.
(v) Financial performance and
solvency.
(vi) Record of integrity and the
implementation of internal integrity
measures.
(vii) Internal financial controls.
(viii) Acquisition of all CAP drugs
directly from the manufacturer or from
a distributor that has acquired the
products directly from the
manufacturer.
(ix) Maintenance of appropriate
licensure to supply CAP drugs in States
in which they are supplying CAP drugs.
(x) Cost-sharing assistance as
described in § 414.914(g).
(xi) Other factors as determined by
CMS.
(2) Approved CAP vendors must also
meet the contract requirements under
§ 414.914.
(c) Additional considerations. CMS
may refuse to award a contract or
terminate an approved CAP vendor
contract based upon the following:
(1) Suspension or revocation by the
Federal or State government of the
entity’s license for distribution of drugs,
including controlled substances.
(2) Exclusion of the entity under
section 1128 of the Act from
participation in Medicare or other
Federal health care programs. These
considerations are in addition to CMS’
ability to terminate the approved CAP
vendor for cause as specified in
§ 414.914(a).
(3) Past violations or misconduct
related to the pricing, marketing,
distribution, or handling of drugs
provided incident to a physician’s
service.
(d) Multiple source drugs. In the case
of multiple source drugs, there must be
a competition among entities for the
acquisition of at least one CAP drug
within each billing and payment code
within each category for each
competitive acquisition area.
(e) Multiple contracts for a category
and area. The number of bidding
qualified entities that are awarded a
contract for a given category and area
may be limited to no fewer than two.
I 8. Add § 414.910 to read as follows:
E:\FR\FM\06JYR2.SGM
06JYR2
39096
§ 414.910
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
Bidding process.
(a) Entities may bid to furnish CAP
drugs in all competitive acquisition
areas of the United States, or one or
more specific competitive acquisition
areas.
(b) The amount of the bid for any CAP
drug for a specific competitive
acquisition area must be uniform for all
portions of that competitive acquisition
area.
(c) A submitted bid price must
include the following:
(1) All costs related to the delivery of
the drug to the participating CAP
physician.
(2) The costs of dispensing (including
shipping) of the drug and management
fees. The costs related to the
administration of the drug or wastage,
spillage, or spoilage may not be
included.
I 9. Add § 414.912 to read as follows:
§ 414.912
Conflicts of interest.
(a) Approved CAP vendors and
applicants that bid to participate in the
CAP are subject to the following:
(1) The conflict of interest standards
and requirements of the Federal
Acquisition Regulation (FAR)
organizational conflict of interest
guidance, found under FAR subpart 9.5.
(2) Those requirements and standards
contained in each individual contract
awarded to perform functions under
section 1847B of the Act.
(b) Post-award conflicts of interest.
Approved CAP vendors must have a
code of conduct that establishes policies
and procedures for recognizing and
resolving conflicts of interest between
the approved CAP vendor and any
entity, including the Federal
Government, with whom it does
business. The code of conduct which is
submitted as part of the application
must—
(1) State the need for management,
employees, contractors, and agents to
comply with the approved CAP
vendor’s code of conduct, and policies
and procedures for conflicts of interest;
and
(2) State the approved CAP vendor’s
expectations for management,
employees, contractors, and agents to
comply with the approved CAP
vendor’s code of conduct, and policies
and procedures for detecting,
preventing, and resolving conflicts of
interest.
I 10. Add § 414.914 to read as follows:
§ 414.914
Terms of contract.
(a) The contract between CMS and the
approved CAP vendor will be for a term
of 3 years, unless terminated or
suspended earlier as provided in this
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
section or provided in § 414.917. The
contract may be terminated—
(1) By CMS for default if the approved
CAP vendor violates any term of the
contract; or
(2) In the absence of a contract
violation, by either CMS or the
approved CAP vendor, if the
terminating party notifies the other
party by June 30 for an effective date of
termination of December 31 of that year.
(b) The contract will provide for a
code of conduct for the approved CAP
vendor that includes standards relating
to conflicts of interest standards as set
forth at § 414.912.
(c) The approved CAP vendor will
have and implement a compliance plan
that contains policies and procedures
that control program fraud, waste, and
abuse, and consists of the following
minimum elements:
(1) Written policies, procedures, and
standards of conduct articulating the
organization’s commitment to comply
with all applicable Federal and State
laws, regulations, and guidance,
including, but not limited to, the
Prescription Drug Marketing Act
(PDMA), the physician self-referral
(‘‘Stark’’) prohibition, the Anti-Kickback
statute and the False Claims Act.
(2) The designation of a compliance
officer and compliance committee
accountable to senior management.
(3) Effective training and education of
the compliance officer and organization
employees, contractors, agents, and
directors.
(4) Enforcement of standards through
well publicized disciplinary guidelines.
(5) Procedures for effective internal
monitoring and auditing.
(6) Procedures for ensuring prompt
responses to detected offenses and
development of corrective action
initiatives relating to the organization’s
contract as an approved CAP vendor.
(i) If the approved CAP vendor
discovers evidence of misconduct
related to payment or delivery of drugs
or biologicals under the contract, it will
conduct a timely and reasonable inquiry
into that conduct.
(ii) The approved CAP vendor will
conduct appropriate corrective actions
including, but not limited to, repayment
of overpayments and disciplinary
actions against responsible individuals,
in response to potential violations
referenced at paragraph (c)(6)(i) of this
section.
(7) Procedures to voluntarily selfreport potential fraud or misconduct
related to the CAP to the appropriate
government agency.
(d) The contract must provide for
disclosure of the approved CAP
vendor’s reasonable, net acquisition
PO 00000
Frm 00076
Fmt 4701
Sfmt 4700
costs for a specified period of time, not
to exceed quarterly.
(e) The contract must provide for
appropriate adjustments as described in
§ 414.906(c)(1).
(f) Under the terms of the contract, the
approved CAP vendor must also—
(1) Have sufficient arrangements to
acquire and deliver CAP drugs within
the category in the competitive
acquisition area specified by the
contract;
(2) Have arrangements in effect for
shipment at least 5 weekdays each week
of CAP drugs under the contract,
including the ability to comply with the
routine and emergency delivery
timeframes defined in § 414.902;
(3) Have procedures in place to
address and resolve complaints of
participating CAP physicians and
individuals and inquiries regarding
shipment of CAP drugs;
(4) Have a grievance and appeals
process for dispute resolution;
(5) Meet applicable licensure
requirements in each State in which it
supplies drugs under the CAP;
(6) Be enrolled in Medicare as a
participating supplier;
(7) Comply with all applicable
Federal and State laws, regulations and
guidance related to the prevention of
fraud and abuse;
(8) Supply CAP drugs upon receipt of
a prescription order to all participating
CAP physicians who have selected the
approved CAP vendor, except when the
conditions of § 414.914(h) are met;
(9) Ensure that subcontractors who are
involved in providing services under
the approved CAP contractor’s CAP
contract meet all requirements and
comply with all laws and regulations
relating to the services they provide
under the CAP program.
Notwithstanding any relationship the
CAP vendor may have with any
subcontractor, the approved CAP
vendor maintains ultimate
responsibility for adhering to and
otherwise fully complying with all
terms and conditions of its contract with
CMS;
(10) Comply with product integrity
and record keeping requirements
including but not limited to drug
acquisition, handling, storage, shipping,
drug waste, and return processes; and
(11) Comply with such other terms
and conditions as CMS may specify in
the CAP contract consistent with section
1847B of the Act.
(g) Under the terms of the contract,
the approved CAP vendor must provide
assistance to beneficiaries experiencing
financial difficulty in paying their costsharing amounts through any one or all
of the following:
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
(1) Referral to a bona fide and
independent charitable organization.
(2) Implementation of a reasonable
payment plan.
(3) A full or partial waiver of the costsharing amount after determining in
good faith that the individual is in
financial need or the failure of
reasonable collection efforts, provided
that the waiver meets all of the
requirements of section 1128A(i)(6)(A)
of the Act and the corresponding
regulations at paragraph (1) of the
definition of ‘‘Remuneration’’ in
§ 1003.101 of this title. The availability
of waivers may not be advertised or be
made as part of a solicitation. Approved
CAP vendors may inform beneficiaries
that they generally make available the
categories of assistance described in
paragraphs (g)(1), (g)(2), and (g)(3) of
this section. In no event may the
approved CAP vendor include or make
any statements or representations that
promise or guarantee that beneficiaries
will receive cost-sharing waivers.
(h) The approved CAP vendor must
comply with the following procedures
before it may refuse to make further
shipments of CAP drugs to a
participating CAP physician on behalf
of a beneficiary:
(1) Subsequent to receipt of final
payment by Medicare, the approved
CAP vendor must bill any applicable
supplemental insurance policies.
(2) If after that action is taken, a
balance remains, or if there is no
supplemental insurance, the approved
CAP vendor may bill the beneficiary.
(3) At the time of billing, the
approved CAP vendor may inform the
beneficiary of any types of cost-sharing
assistance that may be available
consistent with the requirements of
section 1128A(a)(5) of the Act and
§ 414.914(g).
(4) If the beneficiary demonstrates a
financial need, the approved CAP
vendor must follow the conditions
outlined in paragraph (g) of this section.
(5) If after 45 days from the postmark
date of the approved CAP vendor’s bill
to the beneficiary, the beneficiary’s cost
sharing obligation remains unpaid, the
approved CAP vendor may refuse
further shipments to the participating
CAP physician for that beneficiary;
however, if the beneficiary has
requested cost-sharing assistance within
the 45-day period, the provisions of
paragraph (6), (7), or (8), as applicable,
apply.
(6) If the approved CAP vendor
implements a reasonable payment plan,
as specified in § 414.914(g)(2), the
approved CAP vendor must continue to
ship CAP drugs for the beneficiary, as
long as the beneficiary remains in
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
compliance with the payment plan and
makes an initial payment under the plan
within 15 days after the postmark date
of the approved CAP vendor’s written
notice to the beneficiary offering the
payment plan.
(7) If the approved CAP vendor has
waived the cost-sharing obligations in
accordance with section 1128A of the
Act and § 414.914(g)(3), the approved
CAP vendor may not refuse to ship
drugs for that beneficiary.
(8) If the approved CAP vendor refers
the beneficiary to a bona fide and
independent charity in accordance with
§ 414.914(g)(1), the approved CAP
vendor may refuse to ship drugs if the
past due balance is not paid 15 days
after the postmark date of the approved
CAP vendor’s written notice to the
beneficiary containing the referral for
cost-sharing assistance.
(9) The approved CAP vendor may
refuse to make further shipments to that
participating CAP physician on behalf
of the beneficiary for the lesser of the
end of the calendar year or until the
beneficiary’s balance is paid in full.
I 11–12. § 414.916 to read as follows:
§ 414.916 Dispute resolution for vendors
and beneficiaries.
(a) General rule. Cases of an approved
CAP vendor’s dissatisfaction with
denied drug claims are resolved through
a voluntary alternative dispute
resolution process delivered by the
designated carrier, and a
reconsideration process provided by
CMS.
(b) Dispute resolution. (1) When an
approved CAP vendor is not paid on
claims submitted to the designated
carrier, the vendor may appeal to the
designated carrier to counsel the
responsible participating CAP physician
on his or her agreement to file a clean
claim and pursue an administrative
appeal in accordance with subpart H of
part 405 of this chapter. If problems
persist, the approved CAP vendor may
ask the designated carrier to—
(i) Review the participating CAP
physician’s performance; and
(ii) Potentially recommend to CMS
that CMS suspend the participating CAP
physician’s CAP election agreement.
(2) The designated carrier—
(i) Gathers information from the local
carrier, the participating CAP physician,
the beneficiary, and the approved CAP
vendor; and
(ii) Makes a recommendation to CMS
on whether the participating CAP
physician has been filing his or her CAP
drug administration claims in
accordance with the requirements for
physician participation in the CAP as
set forth in § 414.908(a)(3). The
PO 00000
Frm 00077
Fmt 4701
Sfmt 4700
39097
recommendation will include numbered
findings of fact.
(3) CMS will review the
recommendation of the designated
carrier and gather relevant additional
information from the participating CAP
physician before deciding whether to
suspend the participating CAP
physician’s CAP election agreement. A
suspension commencing before October
1 will conclude on December 31 of the
same year. A suspension commencing
on or after October 1 will conclude on
December 31 of the next year.
(4) The participating CAP physician
may appeal that suspension by
requesting a reconsideration of CMS’
decision. The reconsideration will
address whether the participating CAP
physician’s denied claims and appeals
were the result of the participating CAP
physician’s failure to participate in
accordance with the requirements of
§ 414.908(a)(3).
(c) Reconsideration. (1) Right to
reconsideration. A participating CAP
physician dissatisfied with a
determination that his or her CAP
election agreement has been suspended
by CMS is entitled to a reconsideration
as provided in this subpart.
(2) Eligibility for reconsideration.
CMS reconsiders any determination to
suspend a participating CAP physician’s
election agreement if the participating
CAP physician files a written request for
reconsideration in accordance with
paragraphs (c)(3) and (c)(4) of this
section.
(3) Manner and timing of request for
reconsideration. A participating CAP
physician who is dissatisfied with a
CMS decision to suspend his or her CAP
election agreement may request a
reconsideration of the decision by filing
a request with CMS. The request must
be filed within 30 days of receipt of the
CMS decision letter notifying the
participating CAP physician of CMS’
decision to suspend his or her CAP
election agreement. From the date of
receipt of the decision letter until the
day the reconsideration determination is
final, the ASP payment methodology
under section 1847A of the Act applies
to the physician.
(4) Content of request. The request for
reconsideration must specify—
(i) The findings or issues with which
the participating CAP physician
disagrees;
(ii) The reasons for the disagreement;
(iii) A recital of the facts and law
supporting the participating CAP
physician’s position;
(iv) Any supporting documentation;
and
E:\FR\FM\06JYR2.SGM
06JYR2
39098
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
(v) Any supporting statements from
approved CAP vendors, local carriers, or
beneficiaries.
(5) Withdrawal of request for
reconsideration. A participating CAP
physician may withdraw his or her
request for reconsideration at any time
before the issuance of a reconsideration
determination.
(6) Discretionary informal hearing. In
response to a request for
reconsideration, CMS may, at its
discretion, provide the participating
CAP physician the opportunity for an
informal hearing that—
(i) Is conducted by a hearing officer
appointed by the director of the CMS
Center for Medicare Management or his
or her designee; and
(ii) Provides the participating CAP
physician the opportunity to present, by
telephone or in person, evidence to
rebut CMS’ decision to suspend or
terminate a participating CAP
physician’s CAP election agreement.
(7) Informal hearing procedures. (i)
CMS provides written notice of the time
and place of the informal hearing at
least 10 days before the scheduled date.
(ii) The informal reconsideration
hearing will be conducted in accordance
with the following procedures:
(A) The hearing is open to CMS and
the participating CAP physician
requesting the reconsideration,
including—
(1) Authorized representatives;
(2) Technical advisors (individuals
with knowledge of the facts of the case
or presenting interpretation of the facts);
(3) Representatives from the local
carrier;
(4) Representatives from the approved
CAP vendor; and
(5) Legal counsel.
(B) The hearing is conducted by the
hearing officer who receives relevant
testimony;
(C) Testimony and other evidence
may be accepted by the hearing officer
even though it would be inadmissible
under the rules of evidence applied in
Federal courts;
(D) Either party may call witnesses
from among those individuals specified
in paragraph (c)(7)(ii)(A) of this section;
and
(E) The hearing officer does not have
the authority to compel by subpoena the
production of witnesses, papers, or
other evidence.
(8) Hearing officer’s findings. (i)
Within 30 days of the hearing officer’s
receipt of the hearing request, the
hearing officer presents the findings and
recommendations to the participating
CAP physician who requested the
reconsideration. If the hearing officer
decides to conduct an in-person or
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
telephone hearing, the hearing officer
will send a hearing notice to the
participating CAP physician within 10
days of receipt of the hearing request,
and the findings and recommendations
are due to the participating CAP
physician within 30 days of the
hearing’s conclusion.
(ii) The written report of the hearing
officer includes separate numbered
findings of fact and the legal
conclusions of the hearing officer.
(9) Final reconsideration
determination. (i) The hearing officer’s
decision is final unless the director of
the CMS Center for Medicare
Management or his or her designee
chooses to review that decision within
30 days. If the decision is favorable to
the participating CAP physician, then
the participating CAP physician may
resume his or her participation in CAP.
The hearing officer and the CMS official
may review decisions that are favorable
or unfavorable to the participating CAP
physician.
(ii) The CMS official may accept,
reject, or modify the hearing officer’s
findings.
(iii) If the CMS official reviews the
hearing officer’s decision, the CMS
official issues a final reconsideration
determination to the participating CAP
physician on the basis of the hearing
officer’s findings and recommendations
and other relevant information.
(iv) The reconsideration
determination of the CMS official is
final. If the final decision is unfavorable
to the participating CAP physician, then
the participating CAP physician’s CAP
election agreement is terminated.
(d) The approved CAP vendor may
not charge the beneficiary for the full
drug coinsurance amount if the
designated contractor did not pay the
approved CAP vendor in full, unless a
properly executed advance beneficiary
notice is in place. When a beneficiary
receives an inappropriate coinsurance
bill, the beneficiary may participate in
the approved CAP vendor’s grievance
process to request correction of the
approved CAP vendor’s file. If the
beneficiary is dissatisfied with the result
of the approved CAP vendor’s grievance
process, the beneficiary may request
intervention from the designated carrier.
This is in addition to, rather than in
place of, any other beneficiary appeal
rights. The designated carrier will first
investigate the facts and then facilitate
correction to the appropriate claim
record and beneficiary file.
I 13. Add § 414.917 to read as follows:
PO 00000
Frm 00078
Fmt 4701
Sfmt 4700
§ 414.917 Dispute resolution and process
for suspension or termination of approved
CAP contract.
(a) General rule. If a participating CAP
physician finds an approved CAP
vendor’s service, or the quality of a CAP
drug supplied by the approved CAP
vendor to be unsatisfactory, then the
physician may address the issue first
through the approved CAP vendor’s
grievance process, and second through
an alternative dispute resolution process
administered by the designated carrier
and CMS. If CMS suspends an approved
CAP vendor’s CAP contract for
noncompliance or terminates the CAP
contract in accordance with
§ 414.914(a), the approved CAP vendor
may request a reconsideration in
accordance with paragraph (c) of this
section.
(b) Dispute resolution. (1) When a
participating CAP physician is
dissatisfied with an approved CAP
vendor’s service or the quality of a CAP
drug supplied by the approved CAP
vendor, then the participating CAP
physician may use the approved CAP
vendor’s grievance process. If the
service or quality issues are not resolved
through the grievance process to the
physician’s satisfaction, then the
participating CAP physician may ask
the designated carrier to—
(i) Review the approved CAP vendor’s
performance; and
(ii) Potentially recommend
termination of the approved CAP
vendor’s CAP contract.
(2) Responsibility of the designated
carrier. The designated carrier—
(i) Gathers information from the local
carrier, the participating CAP physician,
the beneficiary, and the approved CAP
vendor; and
(ii) Makes a recommendation to CMS
on whether the approved CAP vendor
has been meeting the service and quality
obligations of its CAP contract. This
recommendation will include numbered
findings of fact.
(3) CMS will review the
recommendation of the designated
carrier and, gather relevant additional
information from the approved CAP
vendor, the participating CAP
physician, the local carrier, and the
beneficiary before deciding whether to
terminate the approved CAP vendor’s
CAP contract.
(4) The approved CAP vendor may
appeal that termination by requesting a
reconsideration. A determination must
be made as to whether the approved
CAP vendor has been meeting the
service and quality obligations of its
CAP contract.
(c) Reconsideration. (1) Right to
reconsideration. An approved CAP
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
vendor dissatisfied with a determination
that its CAP contract has been
suspended or terminated by CMS is
entitled to a reconsideration as provided
in this subpart.
(2) Eligibility for reconsideration.
CMS will reconsider any determination
to suspend or terminate an approved
CAP vendor’s contract if the approved
CAP vendor files a written request for
reconsideration in accordance with
paragraphs (c)(3) and (c)(4) of this
section.
(3) Manner and timing of request for
reconsideration. An approved CAP
vendor that is dissatisfied with a CMS
decision to suspend or terminate its
CAP contract may request a
reconsideration of the decision by filing
a request with CMS. The request must
be filed within 30 days of receipt of the
CMS decision letter notifying the
approved CAP vendor of the suspension
or termination of its CAP contract.
(4) Content of request. The request for
reconsideration must specify—
(i) The findings or issues with which
the approved CAP vendor disagrees;
(ii) The reasons for the disagreement;
(iii) A recital of the facts and law
supporting the approved CAP vendor’s
position;
(iv) Any supporting documentation;
and
(v) Any supporting statements from
participating CAP physicians, the local
carrier, or beneficiaries.
(5) Withdrawal of request for
reconsideration. An approved CAP
vendor may withdraw its request for
reconsideration at any time before the
issuance of a reconsideration
determination.
(6) Discretionary informal hearing. In
response to a request for
reconsideration, CMS may, at its
discretion, provide the approved CAP
vendor the opportunity for an informal
hearing that—
(i) Is conducted by a hearing officer
appointed by the Director of the CMS
Center for Medicare Management or his
or her designee; and
(ii) Provides the approved CAP
vendor the opportunity to present, by
telephone or in person, evidence to
rebut CMS’ decision to suspend or
terminate the approved CAP vendor’s
CAP contract.
(7) Informal hearing procedures. (i)
CMS will provide written notice of the
time and place of the informal hearing
at least 10 days before the scheduled
date.
(ii) The informal reconsideration
hearing will be conducted in accordance
with the following procedures:
(A) The hearing is open to CMS and
the approved CAP vendor requesting the
reconsideration, including—
(1) Authorized representatives;
(2) Technical advisors (individuals
with knowledge of the facts of the case
or presenting interpretation of the facts);
(3) Representatives from the local
carriers and the designated carrier;
(4) The participating CAP physician
who requested the suspension, if any;
and
(5) Legal counsel.
(B) The hearing will be conducted by
the hearing officer, who will receive
relevant testimony;
(C) Testimony and other evidence
may be accepted by the hearing officer
even though it would be inadmissible
under the rules of evidence applied in
Federal courts;
(D) Either party may call witnesses
from among those individuals specified
in the paragraph (c)(7)(ii)(A) of this
section; and
(E) The hearing officer does not have
the authority to compel by subpoena the
production of witnesses, papers, or
other evidence.
(8) Hearing officer’s findings. (i)
Within 30 days of the hearing officer’s
receipt of the hearing request, the
hearing officer will present the findings
and recommendations to the approved
CAP vendor that requested the
reconsideration. If the hearing officer
conducts a hearing in person or by
phone, the hearing officer will send a
hearing notice to the approved CAP
vendor within 10 days of receipt of the
hearing request, and the findings and
recommendations are due to the
approved CAP vendor within 30 days
from of the hearing’s conclusion.
(ii) The written report of the hearing
officer will include separate numbered
findings of fact and the legal
conclusions of the hearing officer.
(9) Final reconsideration
determination. (i) The hearing officer’s
decision is final unless the Director of
the CMS Center for Medicare
Management or his or her designee
(CMS official) chooses to review that
decision within 30 days. If the decision
is favorable to the approved CAP
vendor, then the approved CAP vendor
may resume participation in CAP. The
hearing officer and the CMS official may
review decisions that are favorable or
unfavorable to the approved CAP
vendor.
(ii) The CMS official may accept,
reject, or modify the hearing officer’s
findings.
(iii) If the CMS official reviews the
hearing officer’s decision, the CMS
official will issue a final reconsideration
determination to the approved CAP
vendor on the basis of the hearing
officer’s findings and recommendations
and other relevant information.
(iv) The reconsideration
determination of the CMS official is
final.
I 14. Add § 414.918 to read as follows:
§ 414.918
J0150
J0152
J0170
J0207
J0215
J0280
.....
.....
.....
.....
.....
.....
§ 414.920
VerDate jul<14>2003
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: June 9, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: June 23, 2005.
Michael O. Leavitt,
Secretary.
ADENOSINE FOR THERAPEUTIC USE, 6 MG.
ADENOSINE FOR DIAGNOSTIC USE, 30 MG.
ADRENALIN, EPINEPHRINE, 1 ML AMPULE.
AMIFOSTINE, 500 MG.
ALEFACEPT, 0.5 MG.
AMINOPHYLLIN, 250 MG.
17:37 Jul 05, 2005
Jkt 205001
PO 00000
Frm 00079
Fmt 4701
Sfmt 4700
Judicial review.
The following areas under the CAP
are not subject to administrative or
judicial review:
(a) The establishment of payment
amounts.
(b) The awarding of vendor contracts.
(c) The establishment of competitive
acquisition areas.
(d) The selection of CAP drugs.
(e) The bidding structure.
(f) The number of vendors selected.
Long description
INJECTION,
INJECTION,
INJECTION,
INJECTION,
INJECTION,
INJECTION,
Assignment.
Payment for a CAP drug may be made
only on an assignment-related basis.
I 15. Add § 414.920 to read as follows:
ADDENDUM A.—SINGLE DRUG CATEGORY LIST
HCPCS
39099
E:\FR\FM\06JYR2.SGM
06JYR2
39100
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
ADDENDUM A.—SINGLE DRUG CATEGORY LIST—Continued
HCPCS
J0290
J0475
J0540
J0550
J0570
J0585
J0587
J0600
J0637
J0640
J0670
J0690
J0692
J0696
J0698
J0702
J0704
J0735
J0800
J0880
J0895
J1000
J1020
J1030
J1040
J1051
J1094
J1100
J1190
J1200
J1212
J1245
J1250
J1260
J1335
J1440
J1441
J1450
J1580
J1600
J1626
J1631
J1642
J1644
J1645
J1650
J1655
J1710
J1720
J1745
J1750
J1756
J1885
J1940
J1956
J2001
J2010
J2150
J2260
J2300
J2324
J2353
J2354
J2405
J2430
J2505
J2550
J2680
J2765
J2780
J2820
J2912
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
VerDate jul<14>2003
Long description
INJECTION, AMPICILLIN SODIUM, 500 MG.
INJECTION, BACLOFEN, 10 MG.
INJECTION, PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE, 1,200,000 UNITS.
INJECTION, PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE, 2,400,000 UNITS.
INJECTION, PENICILLIN G BENZATHINE, 1,200,000 UNITS.
BOTULINUM TOXIN TYPE A, PER UNIT.
BOTULINUM TOXIN TYPE B, PER 100 UNITS.
INJECTION, EDETATE CALCIUM DISODIUM, 1000 MG.
INJECTION, CASPOFUNGIN ACETATE, 5 MG.
INJECTION, LEUCOVORIN CALCIUM, PER 50 MG.
INJECTION, MEPIVACAINE HYDROCHLORIDE, PER 10 ML.
INJECTION, CEFAZOLIN SODIUM, 500 MG.
INJECTION, CEFEPIME HYDROCHLORIDE, 500 MG.
INJECTION, CEFTRIAXONE SODIUM, PER 250 MG.
INJECTION, CEFOTAXIME SODIUM, PER GM.
INJECTION, BETAMETHASONE ACETATE & BETAMETHASONE SODIUM PHOSPHATE, PER 3 MG.
INJECTION, BETAMETHASONE SODIUM PHOSPHATE, PER 4 MG.
INJECTION, CLONIDINE HYDROCHLORIDE, 1 MG.
INJECTION, CORTICOTROPIN, 40 UNITS.
INJECTION, DARBEPOETIN ALFA, 5 MCG.
INJECTION, DEFEROXAMINE MESYLATE, 500 MG.
INJECTION, DEPO-ESTRADIOL CYPIONATE, 5 MG.
INJECTION, METHYLPREDNISOLONE ACETATE, 20 MG.
INJECTION, METHYLPREDNISOLONE ACETATE, 40 MG.
INJECTION, METHYLPREDNISOLONE ACETATE, 80 MG.
INJECTION, MEDROXYPROGESTERONE ACETATE, 50 MG.
INJECTION, DEXAMETHASONE ACETATE, 1 MG.
INJECTION, DEXAMETHASONE SODIUM PHOSPHATE, 1MG.
INJECTION, DEXRAZOXANE HYDROCHLORIDE, PER 250 MG.
INJECTION, DIPHENHYDRAMINE HCL, 50 MG.
INJECTION, DMSO, DIMETHYL SULFOXIDE, 50%, 50 ML.
INJECTION, DIPYRIDAMOLE, PER 10 MG.
INJECTION, DOBUTAMINE HYDROCHLORIDE, PER 250 MG.
INJECTION, DOLASETRON MESYLATE, 10 MG.
INJECTION, ERTAPENEM SODIUM, 500 MG.
INJECTION, FILGRASTIM (G-CSF), 300 MCG.
INJECTION, FILGRASTIM (G-CSF), 480 MCG.
INJECTION, FLUCONAZOLE, 200 MG.
INJECTION, GARAMYCIN, GENTAMICIN, 80 MG.
INJECTION, GOLD SODIUM THIOMALATE, 50 MG.
INJECTION, GRANISETRON HYDROCHLORIDE, 100 MCG.
INJECTION, HALOPERIDOL DECANOATE, PER 50 MG.
INJECTION, HEPARIN SODIUM, (HEPARIN LOCK FLUSH), PER 10 UNITS.
INJECTION, HEPARIN SODIUM, PER 1000 UNITS.
INJECTION, DALTEPARIN SODIUM, PER 2500 IU.
INJECTION, ENOXAPARIN SODIUM, 10 MG.
INJECTION, TINZAPARIN SODIUM, 1000 IU.
INJECTION, HYDROCORTISONE SODIUM PHOSPHATE, 50 MG.
INJECTION, HYDROCORTISONE SODIUM SUCCINATE, 100 MG.
INJECTION, INFLIXIMAB, 10 MG.
INJECTION, IRON DEXTRAN, 50 MG.
INJECTION, IRON SUCROSE, 1 MG.
INJECTION, KETOROLAC TROMETHAMI.NE, PER 15 MG.
INJECTION, FUROSEMIDE, 20 MG.
INJECTION, LEVOFLOXACIN, 250 MG.
INJECTION, LIDOCAINE HCL FOR INTRAVENOUS INFUSION, 10 MG.
INJECTION, LINCOMYCIN HCL, 300 MG.
INJECTION, MANNITOL, 25% IN 50 ML.
INJECTION, MILRINONE LACTATE, 5 MG.
INJECTION, NALBUPHINE HYDROCHLORIDE, PER 10 MG.
INJECTION, NESIRITIDE, 0.25 MG.
INJECTION, OCTREOTIDE, DEPOT FORM FOR INTRAMUSCULAR INJECTION, 1 MG.
INJECTION, OCTREOTIDE, NON-DEPOT SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG.
INJECTION, ONDANSETRON HYDROCHLORIDE, PER 1 MG.
INJECTION, PAMIDRONATE DISODIUM, PER 30 MG.
INJECTION, PEGFILGRASTIM, 6 MG.
INJECTION, PROMETHAZINE HCL, 50 MG.
INJECTION, FLUPHENAZINE DECANOATE, 25 MG.
INJECTION, METOCLOPRAMIDE HCL, 10 MG.
INJECTION, RANITIDINE HYDROCHLORIDE, 25 MG.
INJECTION, SARGRAMOSTIM (GM-CSF), 50 MCG.
INJECTION, SODIUM CHLORIDE, 0.9%, PER 2 ML.
17:37 Jul 05, 2005
Jkt 205001
PO 00000
Frm 00080
Fmt 4701
Sfmt 4700
E:\FR\FM\06JYR2.SGM
06JYR2
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
ADDENDUM A.—SINGLE DRUG CATEGORY LIST—Continued
HCPCS
J2916
J2920
J2930
J2997
J3260
J3301
J3302
J3303
J3315
J3370
J3396
J3410
J3420
J3475
J3480
J3487
J7030
J7040
J7042
J7050
J7051
J7060
J7070
J7120
J7317
J7320
J9000
J9001
J9031
J9040
J9045
J9050
J9060
J9062
J9065
J9070
J9080
J9090
J9091
J9092
J9093
J9094
J9095
J9096
J9097
J9098
J9100
J9110
J9130
J9140
J9150
J9170
J9178
J9181
J9182
J9185
J9190
J9200
J9201
J9202
J9206
J9208
J9209
J9211
J9213
J9214
J9219
J9245
J9250
J9260
J9263
J9265
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
VerDate jul<14>2003
Long description
INJECTION, SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 12.5 MG.
INJECTION, METHYLPREDNISOLONE SODIUM SUCCINATE, 40 MG.
INJECTION, METHYLPREDNISOLONE SODIUM SUCCINATE, 125 MG.
INJECTION, ALTEPLASE RECOMBINANT, 1 MG.
INJECTION, TOBRAMYCIN SULFATE, 80 MG.
INJECTION, TRIAMCINOLONE ACETONIDE, PER 10 MG.
INJECTION, TRIAMCINOLONE DIACETATE, PER 5 MG.
INJECTION, TRIAMCINOLONE HEXACETONIDE, PER 5 MG.
INJECTION, TRIPTORELIN PAMOATE, 3.75 MG.
INJECTION, VANCOMYCIN HCL, 500 MG.
INJECTION, VERTEPORFIN, 0.1 MG.
INJECTION, HYDROXYZINE HCL, 25 MG.
INJECTION, VITAMIN B–12 CYANOCOBALAMIN, UP TO 1000 MCG.
INJECTION, MAGNESIUM SULFATE, PER 500 MG.
INJECTION, POTASSIUM CHLORIDE, PER 2 MEQ.
INJECTION, ZOLEDRONIC ACID, 1 MG.
INFUSION, NORMAL SALINE SOLUTION, 1000 CC.
INFUSION, NORMAL SALINE SOLUTION, STERILE (500 ML=1 UNIT).
5% DEXTROSE/NORMAL SALINE (500 ML = 1 UNIT).
INFUSION, NORMAL SALINE SOLUTION , 250 CC.
STERILE SALINE OR WATER, 5 CC.
5% DEXTROSE/WATER (500 ML = 1 UNIT).
INFUSION, D5W, 1000 CC.
RINGERS LACTATE INFUSION, 1000 CC.
SODIUM HYALURONATE, PER 20 TO 25 MG DOSE FOR INTRA-ARTICULAR INJECTION.
HYLAN G-F 20, 16 MG, FOR INTRA ARTICULAR INJECTION.
DOXORUBICIN HCL, 10 MG.
DOXORUBICIN HYDROCHLORIDE, ALL LIPID FORMULATIONS, 10 MG.
BCG (INTRAVESICAL) PER INSTILLATION.
BLEOMYCIN SULFATE, 15 UNITS.
CARBOPLATIN, 50 MG.
CARMUSTINE, 100 MG.
CISPLATIN, POWDER OR S0LUTION, PER 10 MG.
CISPLATIN, 50 MG.
INJECTION, CLADRIBINE, PER 1 MG.
CYCLOPHOSPHAMIDE, 100 MG.
CYCLOPHOSPHAMIDE, 200 MG.
CYCLOPHOSPHAMIDE, 500 MG.
CYCLOPHOSPHAMIDE, 1.0 GRAM.
CYCLOPHOSPHAMIDE, 2.0 GRAM.
CYCLOPHOSPHAMIDE, LYOPHILIZED, 100 MG.
CYCLOPHOSPHAMIDE, LYOPHILIZED, 200 MG.
CYCLOPHOSPHAMIDE, LYOPHILIZED, 500 MG.
CYCLOPHOSPHAMIDE, LYOPHILIZED, 1.0 GRAM.
CYCLOPHOSPHAMIDE, LYOPHILIZED, 2.0 GRAM.
CYTARABINE LIPOSOME, 10 MG.
CYTARABINE, 100 MG.
CYTARABINE, 500 MG.
DACARBAZINE, 100 MG.
DACARBAZINE, 200 MG.
DAUNORUBICIN, 10 MG.
DOCETAXEL, 20 MG.
INJECTION, EPIRUBICIN HCL, 2 MG.
ETOPOSIDE, 10 MG.
ETOPOSIDE, 100 MG.
FLUDARABINE PHOSPHATE, 50 MG.
FLUOROURACIL, 500 MG.
FLOXURIDINE, 500 MG.
GEMCITABINE HCL, 200 MG.
GOSERELIN ACETATE IMPLANT, PER 3.6 MG.
IRINOTECAN, 20 MG.
IFOSFAMIDE, 1 GM.
MESNA, 200 MG.
IDARUBICIN HYDROCHLORIDE, 5 MG.
INTERFERON, ALFA–2A, RECOMBINANT, 3 MILLION UNITS.
INTERFERON, ALFA–2B, RECOMBINANT, 1 MILLION UNITS.
LEUPROLIDE ACETATE IMPLANT, 65 MG.
INJECTION, MELPHALAN HYDROCHLORIDE, 50 MG.
METHOTREXATE SODIUM, 5 MG .
METHOTREXATE SODIUM, 50 MG.
INJECTION, OXALIPLATIN, 0.5 MG.
PACLITAXEL, 30 MG.
17:37 Jul 05, 2005
Jkt 205001
PO 00000
Frm 00081
Fmt 4701
Sfmt 4700
E:\FR\FM\06JYR2.SGM
06JYR2
39101
39102
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules and Regulations
ADDENDUM A.—SINGLE DRUG CATEGORY LIST—Continued
HCPCS
J9268 .....
J9280 .....
J9290 .....
J9291 .....
J9293 .....
J9310 .....
J9320 .....
J9340 .....
J9350 .....
J9355 .....
J9360 .....
J9370 .....
J9375 .....
J9390 .....
J9395 .....
J9600 .....
Q0136 ....
Q0137 ....
Q3025 ....
Long description
PENTOSTATIN, PER 10 MG.
MITOMYCIN, 5 MG.
MITOMYCIN, 20 MG.
MITOMYCIN, 40 MG.
INJECTION, MITOXANTRONE HYDROCHLORIDE, PER 5 MG.
RITUXIMAB, 100 MG.
STREPTOZOCIN, 1 GM.
THIOTEPA, 15 MG .
TOPOTECAN, 4 MG.
TRASTUZUMAB, 10 MG.
VINBLASTINE SULFATE, 1 MG.
VINCRISTINE SULFATE, 1 MG.
VINCRISTINE SULFATE, 2 MG.
VINORELBINE TARTRATE, PER 10 MG.
INJECTION, FULVESTRANT, 25 MG.
PORFIMER SODIUM, 75 MG.
INJECTION, EPOETIN ALPHA, (FOR NON ESRD USE), PER 1000 UNITS.
INJECTION, DARBEPOETIN ALFA, 1 MCG (NON-ESRD USE).
INJECTION, INTERFERON BETA–1A, 11 MCG FOR INTRAMUSCULAR USE.
ADDENDUM B.—NEW DRUGS FOR CAP BIDDING FOR 2006
Code
J0128
J0180
J0878
J1931
J2357
J2469
J2794
J7518
J9035
J9041
J9055
J9305
2005 Description
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
Abarelix injection.
Agalsidase beta injection.
Daptomycin injection.
Laronidase injection.
Omalizumab injection.
Palonosetron HCl.
Risperidone, long acting.
Mycophenolic acid.
Bevacizumab injection.
Bortezomib injection.
Cetuximab injection.
Pemetrexed injection.
[FR Doc. 05–12938 Filed 6–21–05; 4:00 pm]
BILLING CODE 4120–01–P
VerDate jul<14>2003
17:37 Jul 05, 2005
Jkt 205001
PO 00000
Frm 00082
Fmt 4701
Sfmt 4700
E:\FR\FM\06JYR2.SGM
06JYR2
]]>Agencies
[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Rules and Regulations]
[Pages 39022-39102]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12938]
[[Page 39021]]
-----------------------------------------------------------------------
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Part 414
Medicare Program; Competitive Acquisition of Outpatient Drugs and
Biologicals Under Part B; Interim Rule
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Rules
and Regulations
[[Page 39022]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 414
[CMS-1325-IFC]
RIN 0938-AN58
Medicare Program; Competitive Acquisition of Outpatient Drugs and
Biologicals Under Part B
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment period.
-----------------------------------------------------------------------
SUMMARY: This interim final rule with comment period implements
provisions of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 that require the implementation of a
competitive acquisition program for certain Medicare Part B drugs not
paid on a cost or prospective payment system basis. Beginning January
1, 2006, physicians will generally be given a choice between obtaining
these drugs from vendors selected through a competitive bidding process
or directly purchasing these drugs and being paid under the average
sales price system.
DATES: Effective date: The amendments to Sec. 414.906(c); Sec.
414.908(b), (c), (d), and (e); Sec. 414.910, and Sec. 414.912(a) are
effective on July 6, 2005. All other amendments are effective September
6, 2005.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on September 6, 2005.
ADDRESSES: In commenting, please refer to file code CMS-1325-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to https://www.cms.hhs.gov/regulations/
ecomments. (Attachments should be in Microsoft Word, WordPerfect, or
Excel; however, we prefer Microsoft Word.)
2. By mail. You may mail written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-1325-IFC, P.O. Box 8013, Baltimore, MD
21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-7195 in advance to schedule your arrival
with one of our staff members.
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD
21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by mailing your
comments to the addresses provided at the end of the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Lia Prela, (410) 786-0548.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in further considering
issues and developing policies. You can assist us by referencing the
file code CMS-1325-IFC and the specific ``issue identifier'' that
precedes the section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all electronic
comments received before the close of the comment period on its public
Web site as soon as possible after they have been received. Hard copy
comments received timely will be available for public inspection as
they are received, generally beginning approximately 3 weeks after
publication of a document, at the headquarters of the Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore,
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4
p.m. To schedule an appointment to view public comments, phone 1-800-
743-3951.
Information on the competitive acquisition program, including a
copy of this interim final rule with comment period, can be found on
the CMS homepage. You can access this data by going to the following
Web site: https://www.cms.hhs.gov/providers/drugs/compbid.
To assist readers in referencing sections contained in this
preamble, we are providing the following table of contents.
Outline of Contents
I. Background
A. Covered Drugs and Biologicals
1. Drugs Furnished Incident to a Physician's Service
2. Durable Medical Equipment (DME) Drugs
3. Statutorily Covered Drugs and Other Drugs
4. Types of Providers
5. Drugs Paid on a Cost or Prospective Payment Basis
B. Revised Drug Payment Methodology
C. Competitive Acquisition Program (CAP)
D. Requirements for Issuance of Regulations
II. Provisions of the March 4, 2005 Proposed Rule and Our Summary of
and Responses to Public Comments
A. Policy for the CAP
1. General Overview of the CAP
2. Categories of Drugs To Be Included Under the CAP
3. Competitive Acquisition Areas
B. Operational Aspects of the CAP
1. Statutory Requirements Concerning Claims Processing
2. Proposed Claims Processing and Operational Overview
3. Dispute Resolution
C. CAP Contracting Process
1. Quality and Product Integrity Aspects
2. Bidding Entity Qualifications
3. CAP Bidding Process--Evaluation and Selection
4. Contract Requirements
5. Judicial Review
D. Implementation of the CAP
1. Physician Election Process
2. Vendor or Physician Education
3. Beneficiary Education
III. Provisions of the Interim Final Rule
IV. Waiver of Delayed Effective Date
V. Response to Comments
VI. Collection of Information Requirements
VII. Regulatory Impact Analysis
A. Overall Impact
B. Anticipated Effects
C. Impact of Establishment of a Competitive Acquisition Program
[[Page 39023]]
D. Alternatives Considered
E. Impact on Beneficiaries
In addition, because of the many organizations and terms to which
we refer by acronym in this interim final rule with comment period, we
are listing these acronyms and their corresponding terms in
alphabetical order below.
Alphabetical List of Acronyms Appearing in the Interim Final Rule With
Comment Period
ABN--Advanced Beneficiary Notice
ASP--Average sales price
AWP--Average wholesale price
BBA--Balanced Budget Act of 1997, Pub. L. 105-33
CAP--Competitive Acquisition Program
CERT--Comprehensive Error Rate Testing
CFR--Code of Federal Regulations
CMS--Centers for Medicare & Medicaid Services (formerly Health Care
Financing Administration)
COBC--Coordination of Benefits Contractor
DAW--Dispense as written
DME--Durable medical equipment
DMERC--Durable medical equipment regional carrier
DOJ--Department of Justice
EAC--Estimated acquisition cost
ESRD--End-stage renal disease
FAR--Federal Acquisition Regulation
FDA--Food and Drug Administration
GAO--Government Accountability Office
GPOs--Group Purchasing Organizations
GPO Access--Government Printing Office Access
HCPCS--Healthcare Common Procedure Coding System
HHS--Health and Human Services
HIC--Health Insurance Number
HIPAA--Health Insurance Portability and Accountability Act of 1996,
Public Law 104-191
ICD-9--International Classification of Diseases--Ninth Edition
IVIG--Intravenous immune globulin
LCDs--Local coverage determinations
MMA--Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, Public Law 108-173
MSN--Medical summary notice
NDC--National Drug Code
OIG--Office of Inspector General
OPPS--Outpatient prospective payment system
PPAC--Practicing Physicians Advisory Council
PIN--Provider identification number
PSCs--Program Safeguard Contractors
RAC--Recovery Audit Contractor
RFA--Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354)
RFI--Request for information
RTI--Research Triangle Institute
UPIN--Unique provider identification number
WAC--Wholesale acquisition cost
I. Background
A. Covered Drugs and Biologicals
Medicare Part B currently covers a limited number of prescription
drugs. For the purposes of this interim final rule with comment period,
the term ``drugs'' will hereafter refer to both drugs and biologicals.
Currently covered Medicare Part B drugs generally fall into three
categories: Drugs furnished incident to a physician's service, drugs
administered via a covered item of durable medical equipment (DME), and
drugs covered by statute.
1. Drugs Furnished Incident to a Physician's Service
Injectable or intravenous drugs as well as non-injectable or non-
intravenous drugs are administered incident to a physician's service as
specified under section 1861(s)(2)(A) of the Social Security Act (the
Act). Under the ``incident-to'' provision, the physician must incur a
cost for the drug, and must bill for it. The Medicare Prescription
Drug, Improvement, and Modernization Act (MMA) of 2003 (Pub. L. 108-
173, enacted on December 8, 2003) revised the ``incident-to''
provision, permitting payment of ``incident-to'' drugs under the CAP
even though the physician participating in the CAP would not, in fact,
incur a cost for the drug or actually bill for the drug. The Act limits
``incident-to'' coverage to drugs that are not usually self-
administered. Examples include injectable drugs used in connection with
the treatment of cancer (such as epoetin alpha), intravenous drugs used
to treat cancer (such as paclitaxel and docetaxel used to treat breast
cancer), injectable anti-emetic drugs used to treat the nausea
resulting from chemotherapy, infliximab or other similar products used
to treat rheumatoid arthritis, rituximab or other similar products used
to treat non-Hodgkin's lymphoma, and Dermagraft or other similar
products used to treat skin ulcers.
2. Durable Medical Equipment (DME) Drugs
DME drugs are administered through a covered item of DME, such as a
nebulizer or pump. Two of the most common drugs in this category are
the inhalation drugs albuterol sulfate and ipratropium bromide.
3. Statutorily Covered Drugs and Other Drugs
Drugs specifically covered by statute include--immunosuppressive
drugs; hemophilia blood clotting factor; certain oral anti-cancer
drugs; oral anti-emetic drugs; pneumococcal, influenza and hepatitis B
vaccines; antigens; erythropoietin for trained home dialysis patients;
certain other drugs separately billed by end-stage renal disease (ESRD)
facilities (for example, iron dextran, vitamin D injections); and
osteoporosis drugs.
4. Types of Providers
Types of providers and suppliers that are paid based on the current
ASP system for all or some of the Medicare covered drugs they furnish
include the following: physicians and certain non-physician
practitioners, pharmacies, DME suppliers, hospital outpatient
departments, and ESRD facilities.
5. Drugs Paid on a Cost or Prospective Payment Basis
Drugs paid on a cost or prospective payment basis that are outside
of the scope of this interim final rule include--drugs furnished during
an inpatient hospital stay (except clotting factor); drugs paid under
the outpatient prospective payment system (OPPS); drugs furnished by
ESRD facilities whose payments are included in Medicare's composite
rate; and drugs furnished by critical access hospitals, skilled nursing
facilities (unless outside of a covered stay), comprehensive outpatient
rehabilitation facilities, rural health facilities, and federally
qualified health centers.
B. Revised Drug Payment Methodology
The MMA revised the drug payment methodology by creating a new
pricing system based on a drug's Average Sales Price (ASP). The MMA
also provides for a program beginning in 2006 to give physicians a
choice between--(1) Obtaining these drugs from vendors selected through
a competitive bidding process; or (2) directly purchasing these drugs
and being paid under the ASP system.
Effective January 2005, Medicare pays for the majority of Part B
covered drugs using a drug payment methodology based on the ASP. In
accordance with section 1847A of the Act, manufacturers submit to us
the ASP data for their products. These data include the manufacturer's
total sales (in dollars) and number of units of a drug to all
purchasers in the United States in a calendar quarter (excluding
certain sales exempted by statute), with limited exceptions. The sales
price is net of discounts such as volume discounts, prompt pay
discounts, cash discounts, free goods that are contingent on any
purchase requirement, chargebacks, and rebates (other than rebates
under section 1927 of the Act). The Medicare payment rate is based on
106 percent of the ASP (or for single source drugs, 106 percent of
wholesale acquisition cost (WAC), if lower), less applicable deductible
and coinsurance. The WAC is defined, with respect to a drug or
biological, as the
[[Page 39024]]
manufacturer's list price for the drug or biological to wholesalers or
direct purchasers in the United States, not including prompt pay or
other discounts, rebates, or reductions in price, for the most recent
month for which the information is available, as reported in wholesale
price guides or other publications of drug or biological pricing data.
C. Competitive Acquisition Program (CAP)
Section 303(d) of the MMA provides for an alternative payment
methodology for most Part B covered drugs that are not paid on a cost
or prospective payment basis. In particular, section 303(d) of the MMA
amends Title XVIII of the Act by adding a new section 1847B, which
establishes a competitive acquisition program for the acquisition of
and payment for competitively biddable Part B covered drugs and
biologicals furnished on or after January 1, 2006.
Beginning January 1, 2006, physicians will have a choice between--
(1) Obtaining these drugs from entities selected to participate in the
CAP in a competitive bidding process; or (2) acquiring and billing for
Part B covered drugs under the ASP system. The provisions for acquiring
and billing for drugs through this new system, as well as additional
information about this new drug payment system are described in this
interim final rule.
The CAP may provide opportunities for Federal savings to the extent
that aggregate bid prices are less than 106 percent of ASP. However,
the CAP has other purposes than the potential to achieve savings. The
competitive acquisition program provides opportunities for physicians
who do not wish to be in the business of drug acquisition. Engaging in
drug acquisition may require physicians to bear financial burdens such
as employing working capital and bearing financial risk in the event of
non-payment for drugs. The CAP is designated to reduce this financial
burden for physicians. In addition, physicians who furnish drugs often
cite the burden of collecting coinsurance on drugs, which can represent
a substantial dollar amount to a beneficiary and physicians' practice.
The competitive acquisition program eliminates the need for physicians
to collect coinsurance on CAP drugs from Medicare beneficiaries.
D. Requirements for Issuance of Regulations
Section 902 of the MMA amended section 1871(a) of the Act and
requires the Secretary, in consultation with the Director of the Office
of Management and Budget, to establish and publish timelines for the
publication of Medicare final regulations based on the previous
publication of a Medicare proposed or interim final regulation. Section
902 of the MMA also states that the timelines for these regulations may
vary but shall not exceed 3 years after publication of the preceding
proposed or interim final regulation except under exceptional
circumstances. We intend to publish the final rule within the 3-year
timeframe established under section 902 of the MMA.
II. Provisions of the March 4, 2005 Proposed Rule and Our Summary of
and Responses to Public Comments
We received approximately 570 timely pieces of correspondence
containing multiple comments in response to the March 4, 2005 proposed
rule. Summaries of the public comments and our responses are set forth
in the various sections of this preamble under the appropriate heading.
A. Policy for the CAP
1. General Overview of the CAP
In the March 4, 2005 proposed rule, we discussed the activities to
implement the CAP that need to be completed before January 1, 2006,
including--designating or developing quality, service, and financial
performance standards for vendors; creating a pricing methodology;
designing and running a bidding process from solicitation through
contract award; providing physicians with an opportunity to elect to
participate and select a vendor; educating beneficiaries about the
program; and other activities specified in section 1847B of the Act.
The statute provides some flexibility in the development of the CAP
by requiring an appropriate ``phase-in'' of the program and providing
the Secretary with the discretion to select appropriate categories of
drugs and appropriate geographic areas for the program. Section
1847B(a)(1)(B) of the Act states that for purposes of implementing the
CAP, ``the Secretary shall establish categories of competitively
biddable drugs and biologicals. The Secretary shall phase in the
program with respect to those categories beginning in 2006 in such
manner as the Secretary determines to be appropriate.'' Additionally,
the statute states that the competitive acquisition areas for the CAP
on which contracts are to be awarded (and vendors chosen) are
``appropriate geographic regions established by the Secretary.''
We also briefly discussed the activities we had initiated to enable
us to implement the statutory provisions of section 1847B of the Act
including:
The award of a contract to Research Triangle Institute
(RTI) to obtain information and develop alternatives regarding the
implementation of a drug and biological competitive bidding program.
Convening a Special Open Door Listening Session on April
1, 2004, to gather input and allow interested parties to hear and be
heard by other members of the healthcare industry.
Establishment of an electronic mailbox,
MMA303DDrugBid@cms.hhs.gov, for interested parties to submit comments
on the CAP program before the issuance of the March 4, 2005 proposed
rule.
Issuance of a Request for Information (RFI) on December
13, 2004 to assess public interest in bidding on contracts to supply
drugs and biologicals for the CAP.
Comment: A few commenters referenced the discussion in the proposed
rule concerning the activities that we initiated to implement the
statute. These commenters questioned the fact that we only received 15
responses from the issuance of an RFI, given the number of Medicare
beneficiaries, specialty groups (particularly oncology), State
organizations, and providers that could be impacted by the proposed
rule. Another commenter commended us for acknowledging the need to
gather information and obtain industry input through informal processes
and encouraged us to continue to solicit input from the public through
formal and informal means, while an additional commenter implored us to
give serious consideration to the comments on the proposed rule from
affected specialty societies.
Response: The discussion in the March 4, 2005 proposed rule
provided examples of activities and resources we used to establish the
framework for the proposed rule. The reference to 15 responses was
specific to the RFI that we issued on December 13, 2004, which was
vendor interest specific. As mentioned in the March 4, 2005 proposed
rule, our contractor, RTI, also consulted with groups and
organizations, including medical specialty organizations and a national
oncology practice to obtain input concerning establishment of a CAP
program. As with any rulemaking process, we have given serious
consideration to the comments from both specialty groups as well as
individuals on the proposed rule.
[[Page 39025]]
Comment: Some commenters were supportive of the proposal for the
CAP, with several commenters stating that the current buy and bill
reimbursement system has created undue barriers. These commenters
believe the CAP would at least provide an alternative to buy and bill
arrangements for consumers and providers, by simplifying the
reimbursement process.
Response: As discussed in the March 4, 2005 proposed rule, and also
later in this preamble, participation in the CAP is voluntary on the
part of the physician. As pointed out by commenters, implementation of
the CAP provides an alternative to the current buy and bill system. To
the extent that a physician or physicians' group believes that the CAP
is not a viable alternative to the current buy and bill system, that
physician or physicians' group can continue to use the current system
and not elect to participate in the CAP.
Comment: Many commenters believe that we should beta test the CAP
or have a limited trial period or phase-in of some sort, to confirm the
quality of the CAP before full implementation. These commenters
expressed concern that introducing the CAP system, particularly given
the short timeframe, without any formal testing or analysis is risky to
patient care because it is a dramatic potential change to the current
system. Some commenters referenced the Government Accountability
Office's (GAO) final report assessing the durable medical equipment,
prosthetic, orthotics, and supplies (DMEPOS) competitive bidding
demonstrations that suggests that further demonstrations be conducted
for the DMEPOS before implementation. These commenters believe the GAO
report supports taking a slower approach for implementing the CAP for
Part B drugs. The commenters suggested that a slower approach would
allow us to refine our application and vendor selection process. Other
commenters, while cognizant of the January 2006 effective date,
suggested we delay the effective date of the CAP to allow us to fully
structure the CAP to meet congressional objectives and benefit
physicians without compromising beneficiary access to drug therapies
and treatment. In addition, commenters argued that the introduction of
Part D beginning in 2006 may cause significant stress to providers and
beneficiaries, and introducing the CAP at the same time could create
confusion.
Response: Although we understand the concerns of the commenters, we
believe the regulatory framework established through this rulemaking
provides a firm basis for implementing the CAP program in January 2006.
We recognize that the timeframe for implementation is ambitious but we
believe that it is important to provide the physicians' community with
an alternative to the current buy and bill system as soon as possible.
In addition, the statute also requires that we coordinate the
physician's election to participate in the CAP with the Medicare
Participating Physician Process described in section 1842(h) of the
Act. The use of a designated carrier for processing vendor claims is
one of the approaches we will be using to ensure a smooth
implementation. Other aspects of the CAP discussed later in the
preamble also provide information on how we are addressing the
implementation of CAP within this restricted timeframe. Additionally,
the Congress did not intend this to be a demonstration, but instead
established the CAP as an operational program.
We recognize that the Medicare community will be faced with many
new challenges and options in 2006. We will be working to ensure that
providers and beneficiaries are aware of these new choices and programs
and that the transition is as smooth as possible.
Comment: One commenter requested that we continue to issue guidance
to further clarify and refine the CAP requirements. The commenter also
encouraged us to continue our efforts to educate and seek input through
venues such as the ``Open Door'' sessions.
Response: We agree that it is important to continue our educational
efforts and obtain feedback from the provider community and plan to
convene special ``Open Door'' sessions as part of the implementation of
the CAP. Additional discussion of this important aspect of the CAP is
provided later in the preamble.
Comment: A few commenters expressed concern that we were limiting
the CAP to oncology drugs.
Response: As discussed in the proposed rule, we were considering
several alternative approaches to phasing in the CAP with respect to
drug categories, one of which was initially including only all oncology
drugs. The specific drug categories for the CAP that will be effective
January 1, 2006 are discussed in detail later in this section of the
preamble.
Comment: A number of commenters raised concerns about maintaining
the safety of the drug delivery system or ``medication pipeline,''
particularly in light of the frequent changes in the disease status of
certain patient populations (for example, cancer patients).
Response: We understand the commenters concerns, and, as discussed
in more detail later in the preamble, we have established financial and
quality standards to ensure that reputable and experienced vendors are
chosen to participate in the CAP. We have also indicated that under the
dispute resolution requirements, issues connected with drug quality
will be given top priority.
Comment: One commenter stated that private insurers have tried
models similar to the CAP and all of them have resulted in minimal
savings but increased administrative overhead and patient
inconvenience.
Response: We are mindful of the points that the commenter raised
concerning private insurers attempts at similar models and have sought
to address these points in establishing the CAP as reflected in the
requirements we are establishing concerning the operational aspects of
CAP (section II.B of this interim final rule) as well as those
discussed in the CAP contracting process (section II.C of this interim
final rule).
Other Comments
We also received many comments concerning: Payment for drug
administration services, infusion services, and evaluation and
management services for cancer patients; the chemotherapy demonstration
project; price controls for drugs; and the new Medicare Part D
Prescription Drug Program. These issues were outside the scope of this
rulemaking, and, therefore, we will not be responding to these comments
as part of this interim final rule.
Comment: Several commenters contended that our proposed rule did
not satisfy all the requirements of the Administrative Procedure Act
(APA). In particular, these commenters pointed out that the proposed
rule did not include a specific proposal about the drug categories that
would be adopted in the initial implementation of the CAP, or a
specific proposal about the competitive acquisition areas that would be
established. The commenters contended that the proposed rule therefore
did not provide sufficient factual detail and rationale to permit
interested parties to comment meaningfully. These commenters contend
that CMS must either publish a second proposed rule providing specific
proposals on these issues, or at least present our decisions about
these matters in the context of an interim final regulation with
opportunity for public comment. Other commenters recommended that we
implement the
[[Page 39026]]
CAP through the issuance of an interim final rule. This would provide
an extended opportunity for public comment and facilitate the approval
of required program modifications.
Response: We do not believe that our proposed rule failed to
satisfy the requirements of the APA. In our March 4, 2005 proposed
rule, we presented specific options concerning the drug categories and
competitive acquisition areas that we were considering for adoption in
the final rule. We also discussed the advantages and disadvantages of
each option to provide a basis for informed comment, and we received
several comments on these options. These comments addressed in detail
the options that we discussed, and addressed the specific
considerations that we had discussed. The commenters offered specific
recommendations and proposals based on the options that we had
presented. The comments themselves thus are convincing evidence that
our proposed rule provided adequate basis for meaningful comment from
interested parties. Although we do not believe that we are required
under the provisions of the APA to publish another proposed rule with
more specific proposals, as requested by some commenters, we are
exercising our discretion and publishing this rule as an interim final
rule to allow our provisions to take effect and to provide the public
with the opportunity to comment on our final provisions. We believe
that additional public comment on this new and complex program would be
valuable. We especially welcome comments on issues related to phasing
in the program. For example, we describe below how we have decided to
exercise our statutory authority to determine and phase in categories
of drugs under the CAP. We specifically invite comments on the further
development of appropriate drug categories after this initial stage of
implementing the program. We also welcome comments on other issues
regarding the CAP program.
Regulations
In the March 4, 2005 rule, we proposed to codify the requirements
and provisions for the CAP in regulations at 42 CFR Part 414, Subpart
K. We proposed to revise the heading for subpart K to read ``Payment
for Drugs and Biologicals under Part B''; amend existing sections and
section headings; and add new definitions and sections to set forth the
proposed requirements with respect to the CAP. Specifically, we
proposed to make the following changes:
Revise existing Sec. 414.900, which sets forth the basis
and scope for subpart K;
Revise Sec. 414.900(b)(ii) to clarify that the hepatitis
vaccine referred to in this paragraph is the hepatitis ``B'' vaccine;
Add new Sec. 414.906 through Sec. 414.920 to address
requirements with respect to payment under the CAP; and
Revise Sec. 414.902 to add definitions pertaining to the
new CAP addressed in new Sec. 414.906 through Sec. 414.920.
We did not receive comments on the proposed organization of subpart
K or the proposed changes to Sec. 414.900, which sets forth the basis
and scope for subpart K or Sec. 414.900(b)(ii). Therefore, we finalize
them as proposed. Specific comments pertaining to the proposed
definitions for the CAP as well as proposed sections Sec. 414.906
through Sec. 414.920 are addressed later in this preamble.
2. Categories of Drugs To Be Included Under the CAP
Section 1847B of the Act describes a program that will permit
physicians to elect to obtain drugs from vendors rather than purchasing
and billing for those drugs themselves. The statute, therefore, most
closely describes a system for the provision of and the payment for
drugs provided incident to a physician's service. For example, under
the mechanisms described in the statute:
Only physicians are expressly given an opportunity to
elect to participate in the CAP.
The second sentence of section 1847B(a)(1)(A) of the Act
explicitly indicates that such section shall not apply in the case of a
physician who elects section 1847A of the Act to apply.
Physicians who elect to obtain drugs under the CAP make an
annual selection of the contractor through which drugs will be acquired
and delivered to the physician under Part B.
Section 1847B(a)(3)(A) of the Act specifically applies the
CAP to drugs and biologicals that are prescribed by a physician who has
elected the CAP to apply.
Payment for drugs furnished under the CAP is conditioned
upon drug administration.
The requirement for submission of information that will be
used by in the contract for collection of cost sharing applies to
physicians.
The primary site for delivery of drugs furnished under the
CAP is the physician's office.
The statute requires the Secretary to make available to
physicians on an ongoing basis a list of CAP contractors.
The statute explicitly defines a ``selecting physician''
to be one who has elected the CAP program to apply.
Section 1847B(a)(1)(B) of the Act specifically requires the
Secretary to establish categories of drugs that will be included in the
CAP, and requires the Secretary to phase-in the program with respect to
these categories, as the Secretary determines to be appropriate.
Section 1847B(a)(1)(D) of the Act further authorizes the Secretary to
exclude competitively biddable drugs and biologicals from the
competitive bidding system if the application of competitive bidding to
those drugs and biologicals--
(1) Is not likely to result in significant savings; or
(2) Is likely to have an adverse impact on access to those drugs
and biologicals.
Finally, the statute defines the term ``competitively biddable
drugs and biologicals'' for purposes of the CAP as ``a drug or
biological described in section 1842(o)(1)(C) of the Act and furnished
on or after January 1, 2006.'' As discussed in the March 4, 2005
proposed rule, the drugs described in section 1842(o)(1)(C) of the Act
include most drugs paid under Medicare Part B and not otherwise paid
under cost-based or prospective payment basis. Medicare Part B covered
vaccines, drugs infused through a covered item of DME, and blood and
blood products (not including clotting factor and intravenous immune
globulin (IVIG)) are not included under this definition because they
are expressly excluded from section 1842(o)(1)(C) of the Act. The
statutory definition of ``competitively biddable drugs'' therefore
includes drugs administered incident to a physician's service (for
example, drugs commonly furnished by oncologists), drugs administered
through DME (for example, inhalation drugs) with the exception of DME
infusion drugs, and some drugs usually dispensed by pharmacies (for
example, oral immunosuppressive drugs). Although the statutory
definition includes all these categories of drugs, as noted above, the
specific mechanisms described under section 1847B of the Act relate to
the provision of and the payment for drugs provided incident to a
physician's service. Given our concerns about the clear direction of
the statute that the election to participate in this program rests with
physicians, in the proposed rule we indicated that we do not believe it
is possible to include drugs other than those administered as incident
to a physician's service as part of this program. However, we also
recognized that the statute provides a potentially broader definition
of ``competitively biddable drugs and
[[Page 39027]]
biologicals'' in section 1847B(a)(2)(A) of the Act. We, therefore,
requested comments on whether, in the light of these mechanisms, the
CAP is properly restricted under the statute to drugs administered
incident to a physician's service.
We also solicited comments on how an expansion of the drugs covered
under this program might work, given that the option to participate
clearly rests with the physician.
Comment: Many commenters supported our proposal to restrict the
CAP, at least initially, to drugs administered incident to a
physician's service. Some of these commenters endorsed the more
restrictive reading of the statute, under which the CAP is properly
restricted to drugs administered incident to a physician's service. A
congressional commenter advised that the intent of the Congress was to
include all physician injectable drugs within the CAP. Other commenters
expressed the view that the statute would allow the program to include
drugs administered incident to a physician's service (for example,
drugs commonly furnished by oncologists), drugs administered through
DME (for example, inhalation drugs) with the exception of DME infusion
drugs, and some drugs usually dispensed by pharmacies (for example,
oral immunosuppressive drugs). However, some of these commenters also
supported restricting the program, at least initially, to drugs
administered incident to a physician's service as an appropriate
exercise of the Secretary's authority to phase-in the drug categories
established under the CAP. A few commenters supported including some
categories of drugs administered through DME or drugs usually dispensed
by pharmacies in the CAP, either initially or at an early stage of
implementing the program. These commenters generally cited the
statutory definition of ``competitively biddable drugs,'' which in and
of itself is broad enough to include drugs administered incident to a
physician's service, drugs administered through DME (with the exception
of DME infusion drugs), and some drugs usually dispensed by pharmacies.
Some of these commenters acknowledged that the general statutory
structure of the program, which defines acquisition mechanisms
applicable only to physicians, raises practical and/or legal issues
about including drugs administered through DME and drugs usually
dispensed by pharmacies within the program.
Response: We continue to believe that, given the clear direction of
the statute that the election to participate in this program rests with
physicians, it is not advisable to include drugs other than those
administered as incident to a physician's service as part of this
program. As we discuss further below, we, therefore, will implement the
CAP initially for a broad range of drugs administered incident to a
physician's service. However, we will continue to consider whether the
statute allows extension of the program to Part B drugs that are
administered through DME or dispensed by pharmacies. We will continue
to analyze whether drugs other than those administered as incident to a
physician's service can be included in the CAP within the parameters of
the statute. At the same time, we have no present plans to expand the
program beyond the class of drugs administered incident to a
physician's service. If we were to determine that it was warranted to
expand the program beyond the category of drugs furnished incident to a
physician's service, we would first publish a proposed rule and allow
for public comment before proceeding, as necessary.
The March 4, 2005 proposed rule included discussions on the merits
of several options for defining the drug categories to be included
within the CAP, as well as for phasing in the program with respect to
drug categories. These are summarized below:
Drugs Furnished Incident to a Physician's Service
Under this option, all drugs furnished incident to a physician's
service would be included in the CAP. The majority (more than 80
percent) of Medicare Part B drug expenditures are for drugs furnished
incident to a physician's service, such as chemotherapy drugs.
Therefore, it is important to include all drugs furnished incident to a
physician's service to provide an alternative to physicians who did not
want to purchase drugs directly. It may also provide more opportunity
for realizing savings to the program than some other options.
Phasing in CAP Drugs by Physician Specialty
Another option would be to phase-in the program by implementing the
CAP initially for a limited set of drugs that are typically
administered by a single physician specialty, such as a set of drugs
commonly furnished by oncologists. Drugs commonly furnished by
additional specialties could be included over the next few years of the
program. Drugs typically furnished by oncologists constitute a large
portion of the Part B drug market. Drugs typically administered by
other physician specialties represent smaller portions of physician-
administered drugs. A basic decision with respect to a phase-in for
drugs administered in physician offices would be whether to begin
implementation of the program only with drugs typically administered by
oncologists, or with some set of drugs that other specialties (for
example, urology) tend to administer.
A few of the alternative approaches that could be used to phase-in
the CAP with respect to drug categories discussed in the proposed rule
were:
Initially include all drugs typically administered by
oncologists within the program.
Begin with some set of the drugs that are typically
administered in physician offices by other specialties (for example,
drugs typically administered by urologists).
Implement the CAP for all Part B drugs that are furnished
incident to a physician's service.
We stated that we were actively considering all these options, and
encouraged comments on all the options that we have discussed. We also
welcomed recommendations of other options for consideration that could
be adopted. We especially encouraged comments from physicians
concerning their preferences about how a phase-in should be designed
and more generally how the categories of drugs under the CAP should be
structured.
Comment: Many commenters (especially from the oncology community)
recommended beginning the phase-in with drugs that are typically used
by some specialty that is less drug-intensive than oncology. However,
many other commenters recommended beginning a phase-in with oncology
drugs, on the grounds that doing so would provide much of the potential
benefit of the CAP immediately. Other commenters, including some
members of the oncology community, recommended inclusion of all
physicians' drugs within the program immediately, in order to provide
an alternative method of obtaining drugs for all physicians. A
congressional commenter recommended that the program start with a
sufficiently large category of drugs to provide a sufficiently sized
market for vendors and that the program ramp up quickly to include all
physician-administered Part B drugs.
Response: We have been convinced by the commenters that it is
feasible and appropriate to implement the CAP initially for the broad
range of drugs administered incident to a physician's service. As we
discuss in more detail
[[Page 39028]]
below, in response to these comments, we have identified a set of 169
drugs that are most commonly administered incident to a physician's
service for inclusion in the initial stage of the CAP. We have not
included drugs with very low volumes of billing by physicians because
we believe including such drugs at this time would impose a greater
burden on vendors, and undercut the goal of providing a sufficiently
sized market. As described in further detail below, in response to
concerns raised by commenters we have also not included certain drugs
whose patterns of use do not make them suitable for inclusion under the
CAP. For example, certain vaccines, such as tetanus and diphtheria
vaccines, are most commonly used in emergency situations. These drugs
are therefore poorly suited for the normal ordering and billing
procedures contemplated by the CAP statute. Physicians often will not
be in the position to submit to their approved CAP vendor in advance a
patient-specific order for these drugs. Although section 1847B(b)(5) of
the Act outlines special rules to allow approved CAP vendors to
resupply drugs used in emergency situations, we do not believe that it
is advisable to include within the CAP drugs for which this special
mechanism will be routinely employed, at least during this initial
stage of implementing the program. (It is important to note that the
statute specifically excludes pneumococcal vaccine, influenza vaccine,
and hepatitis B vaccine from the CAP.) As we discuss in response to the
specific comments below, we have also not included, at least initially,
certain types of drugs that pose special issues. For example, we have
not included drugs that pose special implementation issues such as some
controlled substances and orphan drugs.
Comment: One commenter asked about the status of opioid medications
administered intrathecally through implanted variable-rate infusion
devices (for example, Prialt[reg]). The commenter notes that
historically, when these pain medications have been furnished by
physicians in their offices, they have been covered and billed through
the local carriers as drugs administered incident to physicians'
services, rather than as drugs infused through covered durable medical
equipment billed through the DMERCs. In the light of this, the
commenter requested that we confirm specifically that those medications
will be eligible for the CAP, at least once the program is fully phased
in.
Response: We agree in principle that opioid medications
administered intrathecally through implanted variable-rate infusion
devices could be included under the CAP, when they are administered by
physicians in their offices incident to their services. In the specific
case of Prialt[supreg], we have not been able to include the drug in
this initial phase of the CAP because it is very new and has not yet
been assigned a code. (We discuss treatment of new drugs in greater
detail below.) However, our analysis has suggested that some pain
medications may be inappropriate for inclusion in the CAP, at least in
the initial stage. Specifically, we are concerned that the special
recordkeeping and other requirements that apply to Schedule II, III,
and IV controlled substances would make inclusion of these drugs in the
CAP problematic. Under the CAP, the approved CAP vendor retains title
to the drug, even after it is shipped to the physician, which may make
it more difficult to ensure compliance with the special rules for
controlled substances. We, therefore, are not including Schedule II,
III, and IV controlled substances in the initial stage of implementing
the CAP. We welcome comments on the implications of these special
requirements for including these drugs in the CAP during later stages
of implementation.
Comment: Several commenters recommended that we exclude orphan
drugs from the CAP. (``Orphan drug'' is defined by FDA, under 21 CFR
316.3(b)(10), as a ``drug intended for use in a rare disease or
condition as defined in section 526 of the Federal Food, Drug, and
Cosmetic Act.'') These commenters pointed out that orphan drugs often
pose access challenges. Specifically, one commenter noted that vendors
may not be able to provide orphan drugs adequately in a timely manner.
The same commenter noted that CMS has provided a special exception for
payment of orphan drugs in the outpatient prospective payment system.
Response: We agree with the commenters that access problems provide
a sound reason for not including some orphan drugs from the CAP, at
least in the initial stages of the program. However, we do not believe
that it is necessary to decline to include all orphan drugs from the
program, even in this initial stage of implementation. This is because
many orphan drugs are not approved exclusively for the treatment of
orphan indications, but they are also approved for other non-orphan
indications that affect broader groups of the public. In contrast,
other orphan drugs are approved exclusively for the treatment of orphan
indications. The latter group of orphan drugs poses much more severe
access issues than other orphan drugs precisely because their use is
generally limited to relatively rare orphan indications. As one
commenter noted, we provide special payment consideration under the
outpatient prospective payment system (OPPS) to this latter set of
orphan drugs. Specifically, we designate drugs that meet the following
criteria as single indication orphan drugs under the OPPS:
The drug is designated as an orphan drug by the FDA and
approved by the FDA only for treatment of only one or more orphan
conditions(s); and
The current United States Pharmacopoeia Drug Information
(USPDI) shows that the drug has neither an approved use nor an off-
label use for other than the orphan condition(s).
In this interim final rule, we, therefore, are not including those
orphan drugs that meet the above criteria within the CAP, at least
during the initial stage of implementing the program. Under these
criteria, the following drugs are not included, at least for the
initial stage of CAP:
J0205 (Injection, Alglucerase, per 10 units);
J0256 (Injection, Alpha 1-proteinase inhibitor, 10 mg);
J9300 (Gemtuzumab ozogamicin, 5mg);
J1785 (Injection, Imiglucerase, per unit);
J2355 (Injection, Oprelvekin, 5 mg)
J3240 (Injection, Thyrotropin alpha, 0.9 mg);
J7513 (Daclizumab, parenteral, 25 mg);
J9010 (Alemtuzumab, 10 mg);
J9015 (Aldesleukin, per single use vial);
J9017 (Arsenic trioxide, 1 mg);
J9160 (Denileukin diftitox, 300 mcg); and
J9216 (Interferon, gamma 1-b, 3 million units).
We welcome comments on whether these drugs should be included in the
CAP during later stages of implementation.
Comment: Several commenters also recommended that we not include
contrast agents within the CAP. Some of these commenters recommended
permanent exclusion of contrast agents from the program. Others
recommended that we phase-in these agents during later stages of
implementing the CAP. Contrast drugs are used only in diagnostic
imaging tests. The commenters cited various reasons for excluding
contrast agents. These included the difficulty of determining
appropriate categories for these products, fast pace of change in this
[[Page 39029]]
field, and the rapid changes in coding and payment for these products.
These changes may not yet be well understood among physicians, and this
may hamper their ability to select the vendor that provides the most
appropriate contrast agents for their patients.
Response: We agree with the commenters that the rapid pace of
change in this field, in conjunction with major changes in coding and
payment in recent years, may pose special possibilities for confusion
during the initial stage of the CAP. We, therefore, are not including
contrast agents under the CAP during this initial stage of implementing
the program. We, however, will consider including them as we refine and
develop the drug categories under the program in future stages of
implementation.
Comment: Several commenters requested that CMS clarify whether
carriers' least costly alternative (LCA) policies would apply under the
CAP. Most of these commenters maintained that those policies should not
be applied under the CAP. For example, one commenter argued that
substituting one manufacturer's price for another is inconsistent with
a system of establishing prices for HCPCS codes on the basis of
submitted bids. Others pointed out that it would be administratively
difficult to apply LCA policies within the CAP claims processing
system.
Response: As we note in section II.B of this interim final rule,
least costly alternative policies are established by our contractors.
Nothing in this interim final rule is intended to disrupt the
longstanding ability of contractors to apply this policy under section
1862(a)(1)(A) of the Act. Section 1862(a)(1)(A) provides that
notwithstanding any other provision in the Medicare statute (that is,
including section 1847B), no payment may be made under Part A or Part B
for any expenses incurred for items and services that are not
reasonable and necessary. Medicare carriers establish local coverage
determinations (LCDs), under which coverage for a particular drug is
limited to the coverage level for its least costly alternative. As
stated in the March 2005 proposed rule, physicians who submit claims
under the CAP must comply with applicable LCDs.
However, we acknowledge that the existence of LCA policies, and the
fact that they will apply under the CAP just as they apply outside the
CAP, have obvious implications for the provision of certain drugs under
the CAP. If a carrier applies an LCA policy to a particular drug, the
approved CAP vendor's claim for that drug, when ordered by a
participating CAP physician in that carrier's jurisdiction, would be
subject to LCA. We are aware of one instance in which every carrier has
applied the ``least costly alternative'' policy to a drug that would
otherwise meet the criteria outlined in this section for inclusion in
the CAP. Every carrier has applied an LCA policy to injectable forms of
leuprolide (not, however, to leuprolide implant). Under these polices,
claims for leuprolide are paid at the level of its least costly
alternative (goserelin). We are implementing the CAP initially through
a single, broad drug category and a single, national competitive
acquisition area; therefore, because leuprolide is subject to LCA
policies in all carrier jurisdictions, its inclusion in the current CAP
drug category would have the effect of requiring vendors to supply the
drug at the cost of goserelin in each instance in which a participating
CAP physician orders it, regardless of the price established for
leuprolide under the bidding and single price determination processes
that we describe below, and regardless of the geographic location (and
local carrier jurisdiction) of the participating CAP physician. For
this reason, we have decided to exercise our authority under
1847B(a)(1)(B) not to include leuprolide in this initial stage of
implementing the CAP. This decision is based on our authority under the
CAP statute, and does not affect the applicability of LCA policies to
leuprolide. We welcome comments on how to deal with this issue in later
stages of implementing the program.
Comment: We received a number of comments recommending that we
exclude blood clotting factors and intravenous immune globulin (IVIG)
from the CAP. A number of these commenters recommended that we employ
the authority under section 1847B(a)(1)(D) of the Act to exclude these
products on the grounds that their inclusion within the program would
not result in significant savings or would have an adverse impact on
access. Many of these commenters also argued that IVIG is implicitly
excluded from the CAP by section 1842(o)(1)(E)(ii) of the Act (section
303(b)(1)(E)(ii) of the MMA), which provides that the payment for IVIG
``in 2005 and subsequent years'' is the amount determined under the ASP
system. Some commenters also pointed to the Conference Report on the
MMA, which states that ``[c]ompetitively biddable drugs and biologicals
exclude IVIG products and blood products.'' Other commenters contended
that IVIG is inappropriate for inclusion under the CAP because it is
frequently not administered incident to a physician's services. A
number of commenters also pointed out that hemophilia patients commonly
receive treatment with blood clotting factor at special treatment
centers, or self-administer blood clotting factor at home. As in the
case of IVIG, these commenters contended that blood clotting factor is
therefore inappropriate for inclusion in a program intended and
designed primarily for drugs administered incident to a physician's
services.
Response: In this interim final rule, we continue to rely solely on
the Secretary's statutory authority under section 1847B(a)(1)(B) of the
Act to establish categories of drugs that will be included in the CAP,
and to phase-in the program with respect to these categories. Using
this authority, we have not included blood clotting factors or IVIG
within the CAP. If we were to consider including blood clotting factors
or IVIG, we would first publish a proposed rule and seek public
comment.
We are also exercising our statutory authority to establish and
phase-in drug categories in deciding not to include other immune
globulins from the CAP in this initial stage of implementing the
program. As in the case of tetanus and diphtheria vaccines, these
products are commonly used in emergency situations, and are therefore
poorly suited for the normal ordering and billing procedures
contemplated by the CAP statute. We do not believe that it is advisable
to include within the CAP drugs for which the special emergency
mechanism will be routinely employed, at least during this initial
stage of implementing the program. In addition, immune globulins are
considered by some to belong to the category of blood products, which
are explicitly excluded under the definition of competitively biddable
drugs (see section 1847B(a)(2)(A) of the Act). Although we do not
necessarily agree that immune globulins are properly classified as
blood products within the meaning of the statute, we will not include
them in our initial drug category in order to provide opportunity for
further comment on whether they should properly be excluded on a
permanent basis.
Comment: Numerous members of the mental health community
(physicians, representatives of mental health clinics, and other mental
health professionals) have requested inclusion of physicians'
injectable psychiatric medications (for example, long-acting anti-
psychotic drugs) in the initial phase-in of the CAP.
[[Page 39030]]
These commenters contend that including these medications within the
CAP would enhance access to treatments of proven therapeutic value to a
very vulnerable population. Some commenters specifically requested
inclusion of these drugs in the CAP in order to make it more feasible
for community mental health centers (CMHCs) to acquire and provide
these therapies for their patients. Other commenters also noted that
coinsurance for these drugs can be approximately 50 percent (in
contrast to the 20 percent coinsurance for other Part B drugs) under
the mental health limit (section 1833(c) of the Act, Sec. 410.155 of
our regulations).
Response: We will include drugs commonly billed incident to the
services of psychiatrists in this initial stage of implementing the
CAP. The single drug category that we are establishing for this initial
stage of the program does in fact include many of the drugs that
commenters specifically recommended for inclusion in the CAP. However,
it is important to note that, under the statutory structure of the CAP
as we are implementing it, CMHCs themselves will not be able to elect
to participate in the CAP for provision of Part B drugs. This is
because, as we have noted before, the specific mechanisms described
under section 1847B of the Act as we have implemented them relate to
the provision of and the payment for drugs provided incident to a
physician's service. Therefore, only physicians are eligible to elect
participation in the CAP for provision of the drugs that they
administer incident to their services.
The issue of the appropriate coinsurance for mental health drugs in
the light of the mental health limit provision is outside the scope of
this regulation.
Comment: Several commenters asked for clarification of how codes
for drugs that are not otherwise classified (NOC codes, including codes
J3490, J3590, J7199, J7599, J7699, J7799, J9999, and Q0181) would be
treated for purposes of the CAP.
Response: We do not believe that it would be appropriate to include
the drugs billed under these codes within the CAP. Bidding and
determination of payment for these codes would present insurmountable
problems and pose unwarranted risks for potential vendors under the
CAP. These are codes into which new drugs are assigned before receiving
an appropriate permanent code. Some new drugs are assigned to these
codes on a temporary basis, and each code thus represents a shifting
collection of miscellaneous, unrelated products. It is not feasible for
potential vendors to develop meaningful bids on these codes, given the
fact that the codes represent such disparate products and that the
specific drugs assigned to these codes are constantly changing.
Comment: Some commenters recommended that we establish narrowly
defined drug categories. These commenters argued that broader
categories would place a greater burden on vendors, who would have to
bid and supply all drugs within broad categories. However, other
commenters strongly supported the establishment of drug categories that
are broadly defined to include all the drugs typically administered by
a given medical specialty. These commenters argued that broadly defined
categories would simplify the program for vendors, physicians, and the
agency. Specifically, broad categories would allow most physicians to
be able to choose one CAP vendor to meet all their Part B drug needs.
One commenter in particular recommended establishing a single category
including all Part B drugs administered incident to a physician's
services. This commenter argued that such a broad category would make
the CAP most accessible to all physicians, and allow vendors to bid on
a wide array of products, give them a wider market, and allow for
greater flexibility in designing their bids.
Response: We are persuaded that establishing relatively broad
categories of drugs is the most appropriate and feasible approach for
implementing the CAP, at least in the initial stage. We agree with the
commenters that broad categories will promote greater access to the
program for physicians, and provide vendors with flexibility in
designing their bids. Broad categories will also, as noted by a number
of commenters, allow most physicians to meet all (or almost all) their
Part B drug needs.
We are also convinced by the arguments for establishing one broad
category, at least for this initial stage of implementing the CAP. Such
a broad category would make the CAP most accessible to all physicians.
It would also allow vendors to bid on a wide array of products, give
them a wider market, and provide them with greater flexibility in
designing their bids. We, therefore, believe that employing a single
category for the broad range of drugs administered incident to a
physician's service is an appropriate measure, at least for the initial
stage of implementing the CAP. We intend this single drug category as
an interim measure, for this initial stage of implementing the program.
We believe that establishing a single, broad drug category in this
initial stage of implementing the CAP is an appropriate exercise of the
Secretary's authority under the statute to establish categories of
competitively biddable drugs and to phase-in the program with respect
to those categories. We expect to phase-in multiple drugs categories,
probably defined around the drugs commonly used by physicians'
specialties (for example, urology, rheumatology), as we refine and
develop the CAP. We welcome comments on how to develop and refine
multiple drug categories for later stages of implementing the program.
As described below, we are therefore providing in this interim
final rule for the establishme
