Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements, 24437-24449 [2010-10505]
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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations
CHAPTER 302—RELOCATION
ALLOWANCES
PART 302–6—ALLOWANCE FOR
TEMPORARY QUARTERS
SUBSISTENCE EXPENSES
28. The authority citation for 41 CFR
part 302–6 is revised to read as follows:
■
Authority: 5 U.S.C. 5738; 20 U.S.C. 905(a);
E.O. 11609, as amended, 3 CFR, 1971–1973
Comp., p. 586.
§ 302–6.2
[Amended]
29. Amend § 302–6.2 by removing the
word ‘‘local’’.
■
30. Revise § 302–6.18 to read as
follows:
■
§ 302–6.18 May I be reimbursed for
transportation expenses incurred while I am
occupying temporary quarters?
Transportation expenses incurred in
the vicinity of the temporary quarters
are not TQSE, and therefore, there is no
authority to pay such expenses under
TQSE.
PART 302–9—ALLOWANCES FOR
TRANSPORTATION AND EMERGENCY
STORAGE OF A PRIVATELY OWNED
VEHICLE
31. The authority citation for 41 CFR
part 302–9 is revised to read as follows:
■
Authority: 5 U.S.C. 5738; 20 U.S.C. 905(a);
E.O. 11609, as amended, 3 CFR, 1971–1973
Comp., p. 586.
§ 302–9.10
[Amended]
32. Amend § 302–9.10, by removing
the word ‘‘local’’ wherever it appears.
■
[FR Doc. 2010–10235 Filed 5–4–10; 8:45 am]
BILLING CODE 6820–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 424 and 431
[CMS–6010–IFC]
RIN 0938–AQ01
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Medicare and Medicaid Programs;
Changes in Provider and Supplier
Enrollment, Ordering and Referring,
and Documentation Requirements; and
Changes in Provider Agreements
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
SUMMARY: This interim final rule with
comment period implements several
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provisions set forth in the Patient
Protection and Affordable Care Act
(Affordable Care Act). It implements the
provision which requires all providers
of medical or other items or services and
suppliers that qualify for a National
Provider Identifier (NPI) to include their
NPI on all applications to enroll in the
Medicare and Medicaid programs and
on all claims for payment submitted
under the Medicare and Medicaid
programs. This interim final rule with
comment period also requires
physicians and eligible professionals to
order and refer covered items and
services for Medicare beneficiaries to be
enrolled in Medicare. In addition, it
adds requirements for providers,
physicians, and other suppliers
participating in the Medicare program to
provide documentation on referrals to
programs at high risk of waste and
abuse, to include durable medical
equipment, prosthetics, orthotics and
supplies (DMEPOS), home health
services, and other items or services
specified by the Secretary.
DATES: Effective date: These regulations
are effective on July 6, 2010. Comment
date: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on July 6, 2010.
ADDRESSES: In commenting, please refer
to file code CMS–6010–IFC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed).
• Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the instructions for submitting
comments on the home page.
• By regular mail. You may mail
written comments to the following
address only: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–6010–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.
• By express or overnight mail. You
may send written comments to the
following address only: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–6010–IFC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
• By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
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24437
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey 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.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
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.
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 following
the instructions 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:
Patricia Peyton, (410) 786–1812 for
Medicare issues. Rick Friedman, (410)
786–4451 for Medicaid issues.
SUPPLEMENTARY INFORMATION: 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 comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://regulations.gov.
Follow the search instructions on that
Web site to view public comments.
Comments received timely will be
also 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
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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.
I. Background
The Medicare program, title XVIII of
the Social Security Act (the Act), is the
primary payer of health care for 42
million enrolled beneficiaries. Under
section 1802 of the Act, a beneficiary
may obtain health services from an
individual or an organization qualified
to participate in the Medicare program.
Qualifications to participate are
specified in statute and in regulations
(see, for example, sections 1814, 1815,
1819, 1833, 1834, 1842, 1861, 1866, and
1891 of the Act); and 42 CFR chapter IV,
subchapter E, which concerns standards
and certification requirements).
Providers and suppliers furnishing
services must comply with the Medicare
requirements stipulated in the Act and
in our regulations. These requirements
are meant to ensure compliance with
applicable statutes, as well as to
promote the furnishing of high quality
care. As Medicare program expenditures
have grown, we have increased our
efforts to ensure that only qualified
individuals and organizations are
allowed to enroll or maintain their
Medicare billing privileges.
Medicaid is a joint Federal and State
health care program for eligible lowincome individuals. States have
considerable flexibility in how they
administer their Medicaid programs
within a broad Federal framework and
programs vary from State to State.
The Patient Protection and Affordable
Care Act (the Affordable Care Act) (Pub.
L. 111–148) makes a number of changes
to the Medicaid program, strengthening
tools for quality and integrity, adding
new benefits, and expanding coverage.
To maintain program integrity and
assure quality, it is consistent with these
changes to assure that only qualified
providers participate in the program and
that these providers bill accurately for
their services. Although our regulations
provide States with considerable
flexibility, the Federal framework
includes some key requirements to
ensure program integrity and quality
care. For example, Medicaid providers
must generally meet all State licensing
and scope-of-practice requirements, and
may be subject to additional Federal and
State quality standards. Additionally,
our regulations require timely filing of
claims by providers.
Including the NPI on claims and
enrollment applications is an important
step in controlling fraud and abuse,
ensuring a unique identifier so that
States can assure that only qualified
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Medicaid providers have provider
agreements and maintain their Medicaid
billing privileges. This practice
implements the requirement in section
1128J(e) of the Act, as added by section
6402(a) of the Affordable Care Act and
will also help in implementing other
important protections under the
Affordable Care Act that ensure quality
health care services for program
beneficiaries.
A. Statutory Authority
The following is an overview of the
sections that grant this authority.
• Sections 1102 and 1871 of the Act
provide general authority for the
Secretary of Health and Human Services
(the Secretary) to prescribe regulations
for the efficient administration of the
Medicare program.
• Section 1128J(e) of the Act, added
by section 6402(a) of the Affordable
Care Act, requires that the Secretary
require by regulation that all providers
of medical or other items or services and
suppliers under titles XVIII and XIX that
are eligible for a national provider
identifier (NPI) include the NPI on all
applications to enroll in such programs
and on all claims for payment under
such programs.
• Sections 1814(a), 1815(a), and
1833(e) of the Act require the
submission of information necessary to
determine the amounts due a provider
or other person.
• Section 1834(j)(1)(A) of the Act
states that no payment may be made for
items furnished by a supplier of medical
equipment and supplies unless such
supplier obtains (and renews at such
intervals as the Secretary may require)
a supplier number. In order to obtain a
supplier number, a supplier must
comply with certain supplier standards
as identified by the Secretary.
• Section 1842(r) of the Act requires
the Centers for Medicare and Medicaid
Services (CMS) to establish a system for
furnishing a unique identifier for each
physician who furnishes services for
which payment may be made.
• Section 1862(e)(1) of the Act states
that no payment may be made when an
item or service was at the medical
direction of an individual or entity that
is excluded in accordance with sections
1128, 1128A, 1156, or 1842(j)(2) of the
Act.
• Section 4313 of the Balanced
Budget Act of 1997 (BBA) (Pub. L. 105–
33) amended sections 1124(a)(1) and
1124A of the Act to require disclosure
of both the Employer Identification
Number (EIN) and Social Security
Number (SSN) of each provider or
supplier, each person with ownership or
control interest in the provider or
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supplier, any subcontractor in which
the provider or supplier directly or
indirectly has a 5 percent or more
ownership interest, and any managing
employees including Directors and
Board Members of corporations and
non-profit organizations and charities.
The ‘‘Report to Congress on Steps Taken
to Assure Confidentiality of Social
Security Account Numbers as Required
by the Balanced Budget Act’’ was signed
by the Secretary and sent to the
Congress on January 26, 1999. This
report outlines the provisions of a
mandatory collection of SSNs and EINs
effective on or after April 26, 1999.
• Section 4312(a) of the Balanced
Budget Act of 1997 amended section
1834(a)(16) of the Act by requiring
certain Medicare suppliers of durable
medical equipment, prosthetics,
orthotics and supplies (DMEPOS) to
furnish CMS with a surety bond.
Section 4312(b) requires that a surety
bond be in an amount of not less than
$50,000.
• Section 31001(i)(1) of the Debt
Collection Improvement Act of 1996
(DCIA) (Pub. L. 104–134) amended
section 7701 of 31 U.S.C. by adding
paragraph (c) to require that any person
or entity doing business with the
Federal Government must provide their
Taxpayer Identification Number (TIN).
• Section 936(j)(1)(A) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173) amended the Act to require
the Secretary to establish a process for
the enrollment of providers of services
and suppliers.
We are authorized to collect
information on the Medicare enrollment
application (that is, the CMS–855,
(Office of Management and Budget
(OMB) approval number 0938–0685)) to
ensure that correct payments are made
to providers and suppliers under the
Medicare program as established by title
XVIII of the Act.
• Section 1902(a)(27) of the Act
provides general authority for the
Secretary to require provider agreements
under the Medicaid State Plans with
every person or institution providing
services under the State Plan. Under
these agreements, the Secretary may
require information regarding any
payments claimed by such person or
institution for providing services under
the State plan.
B. Historical Enrollment Initiatives
Historically, Medicare has permitted
the enrollment of providers and
suppliers whose qualifications for
meeting all of our enrollment standards
were sometimes questionable. This has
raised concern that providers and
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suppliers in our program may be
underqualified or even fraudulent and
has led us to increase our efforts to
establish more stringent controls on
provider and supplier entry into the
Medicare program. The following is a
summary of the regulations that we have
published over the past 10 years to
ensure that only qualified providers and
suppliers are participating in the
Medicare program.
In the October 11, 2000 Federal
Register, we published the Additional
Supplier Standards final rule with
comment period where we established
additional standards with which a
DMEPOS supplier must comply in order
to receive and maintain Medicare billing
privileges. This final rule with comment
period outlined the supplier
requirements to ensure that suppliers of
DMEPOS are qualified to furnish
DMEPOS and to help safeguard the
Medicare program and its beneficiaries
from fraudulent or abusive billing
practices.
In the April 21, 2006, Federal
Register, we published the
Requirements for Providers and
Suppliers to Establish and Maintain
Medicare Enrollment final rule that
implemented section 1866(j)(1)(A) of the
Act. In this final rule, we required that
all providers and suppliers (other than
those who have elected to ‘‘opt-out’’ of
the Medicare program) complete an
enrollment application and submit
specific information to CMS in order to
obtain Medicare billing privileges. This
final rule also required that all providers
and suppliers must periodically update
and certify the accuracy of their
enrollment information to receive and
maintain billing privileges in the
Medicare program. These regulatory
provisions include requirements to
protect beneficiaries and the Medicare
Trust Fund by preventing unqualified,
fraudulent, or excluded providers and
suppliers from providing items or
services to Medicare beneficiaries or
from billing the Medicare program or its
beneficiaries.
In the December 1, 2006, Federal
Register (71 FR 69624), we published a
final rule titled, ‘‘Medicare Program;
Revisions to Payment Policies, FiveYear Review of Work Relative Value
Units, Changes to the Practice Expense
Methodology Under the Physician Fee
Schedule, and Other Changes to
Payment Under Part B; Revisions to the
Payment Policies of Ambulance
Services Under the Fee Schedule for
Ambulance Services; and Ambulance
Inflation Factor Update for CY 2007.’’ In
part, this final rule with comment
established performance standards for
independent diagnostic testing facilities.
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In the April 10, 2007, Federal
Register (72 FR 17992), we published a
final rule titled, ‘‘Competitive
Acquisition for Certain Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS).’’ This final rule
implemented section 302 of the MMA
requiring that DMEPOS suppliers meet
certain quality standards and
established DME competitive bidding.
In the November 27, 2007 Federal
Register (72 FR 66222), we published a
final rule titled, ‘‘Medicare Program;
Revisions to Payment Policies Under the
Physician Fee Schedule, and Other Part
B Payment Policies for CY 2008;
Revisions to the Payment Policies of
Ambulance Services Under the
Ambulance Fee Schedule for CY 2008;
and the Amendment of the
E–Prescribing Exemption for Computer
Generated Facsimile Transmissions;
Final Rule.’’ In this final rule, we
clarified our interpretation of several of
the existing independent diagnostic
testing facility (IDTF) performance
standards found at § 410.33(b) and
§ 410.33(g), proposed a new IDTF
performance standard at § 410.33(g)(15),
and a new proposed IDTF provision at
§ 410.33(i).
In the June 27, 2008, Federal Register
(73 FR 36448), we published a final rule
titled, ‘‘Appeals of CMS or CMS
Contractor Determinations When a
Provider or Supplier Fails to Meet the
Requirements for Medicare Billing
Privileges.’’ This final rule implemented
section 936 of the MMA and extended
appeal rights to all providers and
suppliers, including DMEPOS suppliers,
whose enrollment applications for
Medicare billing privileges are denied or
revoked by CMS or a Medicare
contractor (that is, carrier, fiscal
intermediary, National Supplier
Clearinghouse Medicare Administrative
Contractor (MAC), or Part A/Part B
MAC). This final rule also allowed
providers and suppliers to seek judicial
review after they have exhausted the
administrative appeals process. In
addition, this final rule also
implemented provider enrollment
provisions that apply to all provider and
supplier types.
In the November 19, 2008, Federal
Register (73 FR 69726), we published a
final rule with comment titled,
‘‘Payment Policies Under the Physician
Fee Schedule and Other Revisions to
Part B for CY 2009; E–Prescribing
Exemption for Computer Generated
Facsimile Transmissions; and Payment
for Certain Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS).’’ In part, this final rule with
comment period established a number
of provider enrollment provisions
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affecting physicians, non-physician
practitioners, and other providers and
suppliers, such as the re-enrollment bar
of 1 to 3 years on revoked providers and
suppliers, as well as the limitation on
retroactive billing by providers and
suppliers.
In the January 2, 2009, Federal
Register (74 FR 166), we published a
final rule titled, ‘‘Medicare Program;
Surety Bond Requirement for Suppliers
of Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS); Final Rule.’’ Consistent with
section 4312(a) of the BBA, this final
rule implemented section 1834(a)(16) of
the Act by requiring certain Medicare
suppliers of DMEPOS to furnish CMS
with a surety bond of no less than
$50,000.
Historically, the States in operating
the Medicaid program have permitted
the enrollment of providers and
suppliers who meet the State
requirements for Medicaid enrollment.
Due to the increased risk of fraud and
abuse in public health care programs of
all types, the NPI requirement will
strengthen cross-program integrity
efforts.
II. Provisions of the Interim Final Rule
With Comment Period
A. Inclusion of the National Provider
Identifier (NPI) on all Medicare and
Medicaid Enrollment Applications and
Claims
1. Background
Section 1128J(e) of the Act builds on
the past Congressional mandate to
require the adoption of a unique
identifier for health care providers and
codifies the NPI requirements that
Medicare is already requiring for its feefor-service (FFS) providers and
suppliers.
‘‘Health care provider’’ is defined in
the Health Insurance Portability and
Accountability Act (HIPAA) definitions
found at 45 CFR 160.103. With the
exception of organ procurement
organizations and Part B CAP drug
vendors, the term ‘‘health care provider’’
includes all of the providers and
suppliers who are eligible to enroll in
the Medicare program and most who are
eligible to enroll in the Medicaid
program. In this discussion, we use the
term ‘‘health care provider’’ when
referring to HIPAA and HIPAA
regulations, and we use ‘‘providers and
suppliers’’ when referring to those
health care providers who are eligible to
enroll in the Medicare program.
In the January 23, 2004, NPI final rule
(69 FR 3434), we adopted the NPI as the
standard unique health identifier for
health care providers. This fulfilled the
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requirement of section 1173(b) of the
Act, which was added by HIPAA. The
final rule stated that HIPAA does not
prohibit health plans from requiring
their enrolled health care providers to
obtain NPIs. Accordingly, the Medicare
program required enrolling fee-forservice (FFS) providers and suppliers
(and their subparts, in accordance with
the NPI Final Rule) to report their NPIs
on their Medicare enrollment
applications beginning in May 2006.
When FFS providers and suppliers who
had enrolled prior to May 2006
submitted enrollment applications to
update their enrollment information,
they were required to report their NPIs
on those enrollment applications. These
requirements ensured that the Medicare
provider and supplier enrollment
records included the NPIs and, in effect,
already implemented one of the
provisions of section 1128J(e) of the Act.
In accordance with the NPI final rule
and the subsequent guidance from the
Secretary, beginning May 23, 2008,
Medicare required its enrolled FFS
providers and suppliers to use NPIs in
their electronic claims to identify not
only themselves as the billing providers,
but any other providers or suppliers
who, according to the Implementation
Guides for the adopted standard claims
transactions, were also required to be
identified in those claims. These other
health care providers include rendering
providers, supervising providers, and
ordering and referring providers. The
regulations that adopted the HIPAA
standard transactions are found at (65
FR 50312, 68 FR 8381, and 74 FR 3296).
In addition, at that same time, Medicare
required its enrolled FFS providers and
suppliers to make this same use of NPIs
in their paper claims.
The Provider Enrollment, Chain, and
Ownership System (PECOS),
implemented in 2003, is the national
repository of enrolled Medicare FFS
providers and suppliers (except
DMEPOS suppliers, who will be added
to PECOS later in 2010). PECOS
contains the information furnished by
providers and suppliers in their
Medicare FFS enrollment applications
and additional information added as
required to keep the information current
and to protect the integrity of the
Medicare program (for example, fact and
date of death, Office of Inspector
General exclusions). In 2007, PECOS
began sending the NPIs in the daily
provider and supplier enrollment data
extract going to the Part A and Part B
FFS claims systems. In 2009, Medicare
added the NPIs to the enrollment
records of the DMEPOS suppliers,
which are currently housed in the
DMEPOS supplier enrollment repository
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at the National Supplier Clearinghouse
MAC. After the DMEPOS supplier
enrollment records are added to PECOS,
PECOS will send a daily DMEPOS
supplier enrollment data extract, which
will include the NPIs, to the DMEPOS
FFS claims system. Medicare FFS
claims systems link the NPIs that are
reported in claims with the appropriate
enrollment records in order to properly
price and pay the claims.
In summary, Medicare has been
requiring its providers and suppliers to
report their NPIs on their Medicare
enrollment applications; its enrolled
providers and suppliers to report their
NPIs, and the NPIs of other providers
and suppliers (as required and as
explained previously) in their electronic
and paper Medicare claims; and
suppliers who order or refer covered
items or services for Medicare
beneficiaries to have NPIs so that they
can be identified, as required, in the
claims for the covered items and
services that they have ordered and
referred. Similarly, consistent with NPI
final rule and subsequent guidance from
the Secretary, beginning May 23, 2008,
Medicaid providers have also been
required to report their NPIs on their
Medicaid claims. This IFC now requires
their NPIs be submitted for Medicaid
provider agreements.
2. Provisions of the Affordable Care Act
Section 6402(a) of the Affordable Care
Act added a new section 1128J of the
Act, entitled ‘‘Medicare and Medicaid
Program Integrity Provisions.’’ Section
1128J(e), as added by section 6402(a) of
the Affordable Care Act, requires the
Secretary to promulgate a regulation
that requires, not later than January 1,
2011, all providers of medical or other
items or services and suppliers under
the programs under titles XVIII and XIX
that qualify for a NPI to include their
NPI on all applications to enroll in such
programs and on all claims for payment
submitted under such programs. In
Medicaid, there is no Federally required
process for provider enrollment except
that all Medicaid providers are required
to enter into a provider agreement with
the State as a condition of participating
in the program under section
1902(a)(27) of the Act. Therefore, in the
Medicaid context we are including the
submission of an NPI to the State agency
as a requirement under the provider
agreement. The NPI requirements in this
IFC are thus applicable to the reporting
of NPIs—(1) Pursuant to Medicaid
provider agreements; (2) on Medicare
provider and supplier enrollment
applications; and (3) on Medicare and
Medicaid claims.
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3. Requirements Established by This IFC
For the Medicare program, we are
establishing, at § 424.506(b),
requirements that a provider or supplier
who is eligible for an NPI must report
the NPI on the Medicare enrollment
application; and, if the provider or
supplier enrolled in Medicare prior to
obtaining an NPI and the NPI is not in
the provider’s or supplier’s enrollment
record, the provider or supplier must
report the NPI to Medicare in an
enrollment application so that the NPI
will be added to the provider’s or
supplier’s enrollment record in PECOS.
We are also establishing, at
§ 424.506(b)(1), a requirement that a
provider or supplier who is enrolled in
fee-for-service (FFS) Medicare report its
NPI, as well as the NPI of any other
provider or supplier who is required to
be identified in those claims, on any
electronic or paper claims that the
provider or supplier submits to
Medicare. We are also establishing, at
§ 424.506(b)(2), that a claim submitted
by a Medicare beneficiary contain the
legal name and, if the beneficiary knows
the NPI, the NPI of any provider or
supplier who is required to be identified
in that claim.
If a Medicare beneficiary does not
know the NPI of a provider or supplier
who is required to be identified in the
claim that he or she is submitting, the
beneficiary may submit the claim
without the NPI(s) as long as the claim
contains the legal name(s) of the health
care provider(s). If a beneficiary so
desires, he or she can obtain a
provider’s or a supplier’s NPI by
requesting it directly from the provider
or supplier or from a member of his or
her office staff, or by looking it up in the
NPI Registry at https://
nppes.cms.hhs.gov/NPPES/
NPIRegistryHome.do.
Furthermore, we are establishing, at
§ 424.506(c)(3), that a Medicare claim
from a provider or a supplier will be
rejected if it does not contain the
required NPI(s).
For the Medicaid program, we are
establishing, at § 431.107(b)(5), a
requirement that the agreement between
a State agency and each provider
furnishing services under the State plan
include a requirement that any
Medicaid provider eligible for an NPI
furnish its NPI to the State agency under
that agreement and on all Medicaid
claims.
B. Ordering and Referring Covered Items
and Services for Medicare Beneficiaries
1. Background
Section 1833(q) of the Act requires
that claims for items or services for
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which payment may be made under Part
B and for which there was a referral by
a referring physician shall include the
name and the unique identification
number of the referring physician.
Physicians are doctors of medicine and
osteopathy, optometry, podiatry, dental
medicine, dental surgery, and
chiropractic. Referring physicians are
those who order covered items or
services for Medicare beneficiaries from
Medicare providers and suppliers as
well as those who refer Medicare
beneficiaries to Medicare providers and
suppliers for covered services. We
consider those who ‘‘refer’’ to also be
authorized to ‘‘order.’’ In this IFC, we
refer to physicians who both order and
refer as ‘‘ordering and referring
suppliers’’ and the act of ordering items
or services for Medicare beneficiaries or
referring Medicare beneficiaries to other
providers or suppliers for services as
‘‘ordering and referring.’’
The Implementation Guides for the
adopted HIPAA standard transactions
do not use the word ‘‘supplier’’ in their
descriptions of the health care providers
who must be identified in those
transactions. For example, and as stated
earlier in this preamble, the
Implementation Guides use the terms
‘‘billing provider, ordering provider,
referring provider’’ and others. Because
this section of this IFC relates only to
the Medicare program, and because the
statute and regulations use the term
‘‘supplier’’ (not ‘‘provider’’) when
referring to physicians and nonphysician practitioners, we are using the
term ‘‘ordering and referring suppliers’’
in this IFC. This term corresponds to
‘‘ordering provider’’ and ‘‘referring
provider’’ described in the
Implementation Guides.
The Medicare providers and suppliers
who furnish the covered ordered or
referred items and services send claims
to Medicare for reimbursement for those
covered items and services.
With the establishment and
implementation of surrogate Unique
Physician Identification Numbers
(UPINs) in 1992, suppliers could be
identified, but not uniquely identified,
in claims as ordering and referring
suppliers. These suppliers included
physicians, physician assistants, clinical
nurse specialists, nurse practitioners,
clinical psychologists, certified nurse
midwives, and clinical social workers.
Sections 6405(a) and (c) of the
Affordable Care Act indicate that orders
and referrals for DMEPOS and for other
categories of items and services may be
made by a physician or an ‘‘eligible
professional under section
1848(k)(3)(B).’’ Section 1848(k)(3)(B) of
the Act discusses covered professional
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services for which payment may be
made under, or is based on, the fee
schedule, and which are furnished by:
(1) A physician; (2) a practitioner
described in section 1842(b)(18)(C) of
Act; (3) a physical or occupational
therapist or a qualified speech-language
pathologist; and (4) a qualified
audiologist. Section 1842(b)(18)(C) of
the Act discusses billing and payment
for Medicare services furnished by
physician assistants, nurse practitioners,
clinical nurse specialists, certified
registered nurse anesthetists, certified
nurse-midwives, clinical social workers,
clinical psychologists, and registered
dietitians or nutrition professionals.
Neither section 1848(k)(3)(B) of the Act
nor section 1842(b)(18)(C) of the Act
discuss the issue of ordering or referring
covered items or services for Medicare
beneficiaries. Although section 6405(a)
of the Affordable Care Act indicates that
DMEPOS may be ordered by enrolled
physicians or enrolled eligible
professionals under section
1848(k)(3)(B) of the Act, our policy has
not been to permit all of the eligible
professionals listed in that section or in
section 1842(b)(18)(C) of the Act to
order and refer. Section 6405(c) of the
Affordable Care Act gives the Secretary
the discretion to determine the
professions that can order and refer for
all covered items and services under
title XVIII that are not mentioned in
sections 6405(a) and (b) of the
Affordable Care Act (DMEPOS and
home health, respectively). In addition,
the claims processing edits that we
established in 2009 require that the
ordering and referring suppliers for
DMEPOS and for laboratory, imaging,
and specialist services be those
physicians and professionals who were
eligible for UPINs: Physicians,
physician assistants, clinical nurse
specialists, nurse practitioners, clinical
psychologists, certified nurse midwives,
and clinical social workers. In this IFC,
the term eligible professional means any
of the professionals listed in section
1848(k)(3)(B) of the Act. In this
preamble, we distinguish physicians
from eligible professionals (even though
physicians are included in section
1848(k)(3)(B) as eligible professionals)
because sections 6405(a) and (b) of the
Affordable Care Act reference
physicians separately from eligible
professionals. Section 6405(c) of the
Affordable Care Act gives the Secretary
the discretion to determine the health
professions that can order and refer
items and services other than DMEPOS
and home health.
In the past, prior to the Medicare
implementation of the NPI on May 23,
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24441
2008, physicians and eligible
professionals were identified in claims
as ordering or referring suppliers by
their UPINs. Physicians and eligible
professionals applied for and were
assigned UPINs as part of the process of
enrolling in the Medicare program;
therefore, physicians and eligible
professionals were expected to be
identified in claims as ordering or
referring suppliers by their UPINs.
Surrogate UPINs were established to
be used in claims to temporarily
identify certain ordering and referring
suppliers who had not yet completed
the Medicare enrollment process and,
therefore, had not yet been assigned
UPINs. Surrogate UPINs were used to
collectively identify the following: (1)
Physicians who were serving in the
military or with the Department of
Veterans Affairs or the Public Health
Service (including the Indian Health
Service); (2) interns, residents, and
fellows; and (3) retired physicians.
There was also a surrogate UPIN
(OTH000) that could be used for any
other supplier who ordered or referred
who could not be identified by any of
the other surrogate UPINs.
Over time, providers and suppliers
began using surrogate UPINs in their
claims to identify ordering and referring
suppliers who had been assigned their
own UPINs, as well as individuals who
had never been assigned UPINs. In
addition, they also used UPINs that had
been assigned to physicians other than
the physicians who they were
identifying in their claims as the
ordering or referring suppliers. We
believe that many providers and
suppliers became aware that the use of
any UPIN would get their claims
processed and paid. They learned, over
time, that Medicare claims edits on the
ordering and referring suppliers were
based on the format of the UPIN, and all
UPINs had the same format. The claims
process did not verify the UPINs of
ordering or referring suppliers. These
practices negated the intent of the UPIN,
which was to uniquely identify the
ordering or referring supplier.
Analysis of Medicare claims data
prior to 2008 (UPINs were not permitted
to be used in Medicare claims after May
23, 2008) revealed that these practices
were widespread and, as a result, we
had reason to believe that many
physicians and eligible professionals
were unaware of the requirement that
their assigned UPINs were intended to
uniquely identify them as ordering or
referring suppliers and, more
importantly, that they needed to apply
for UPINs. As a result, Medicare may
have paid claims for covered ordered
and referred items and services that may
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have been ordered or referred by
professionals who were not of a
profession eligible to order and refer; by
physicians or eligible professionals who
were not enrolled in the Medicare
program; or by physicians or eligible
professionals who were not in an
approved Medicare enrollment status
(for example, they were sanctioned,
their licenses were suspended or
revoked, their billing privileges were
terminated, or they were deceased).
With the Medicare implementation of
the NPI in May 2008, Medicare
discontinued the assignment of UPINs
and no longer allowed UPINs to be used
in Medicare claims. Medicare required
providers and suppliers who were
sending claims to Medicare for covered
ordered and referred items and services
to use the NPI, rather than the UPIN, to
identify the ordering and referring
suppliers in their claims. Because the
NPI Final Rule did not discuss the
concept of ‘‘surrogate NPIs’’ nor did it
contain a provision for the
establishment of ‘‘surrogate NPIs,’’
surrogate NPIs do not and cannot exist.
Because physicians and non-physician
practitioners are eligible for NPIs, only
the NPI may be used in Medicare claims
to identify ordering and referring
suppliers.
We believe that the new requirements
discussed below will address concerns
expressed by the Department of Health
and Human Services’ (DHHS) Office of
Inspector General (OIG) report titled,
‘‘Durable Medical Equipment Ordered
with Surrogate Physician Identification
Numbers, OEI–03–01–00270, September
2002,’’ which found that the use of
surrogate UPINs on Medicare claims
poses a vulnerability to the Medicare
program. The HHS OIG found a
substantial number of documentation
problems in the supporting evidence
submitted by suppliers for claims
processed with surrogate UPINs. The
DHHS OIG estimated that, in 1999,
Medicare paid $61 million for services
ordered with a surrogate UPIN that had
missing or incomplete supporting
documentation. Finally, the DHHS OIG
stated that the findings in its report also
revealed misuse of surrogate UPINs on
Medicare claims. The HHS OIG found
that surrogate UPINs were incorrectly
used for many services since the
ordering physician had already been
issued a permanent UPIN. The HHS OIG
believed this to be a significant problem
given that the use of a surrogate UPIN
on medical equipment claims allows
them to be processed automatically
whether the equipment has been
ordered by a physician or not. The HHS
OIG stated that the inappropriate use of
surrogate UPINs by suppliers goes
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unchecked, the Medicare program
becomes vulnerable to fraudulent
billings and inappropriate payments.
To ensure the unique identification of
ordering and referring suppliers and
that they were qualified to order and
refer, Medicare implemented claims
edits in 2009 that require the ordering
and referring suppliers identified in Part
B claims for items of DMEPOS and
services of laboratories, imaging
suppliers, and specialists be identified
by their legal names and their NPIs and
that they have enrollment records in
PECOS. Claims edits are under
development to ensure that claims for
Part A and Part B home health services
identify the physicians who ordered the
home health services by their legal
names and their NPIs and that those
physicians have enrollment records in
PECOS.
2. Provisions of the Affordable Care Act
Section 6405(a) amended section
1834(a)(11)(B) of the Act to specify, with
respect to suppliers of durable medical
equipment, that payment may be made
under that subsection only if the written
order for the item has been
communicated to the DMEPOS supplier
by a physician who is enrolled under
section 1866(j) of the Act or an eligible
professional under section 1848(k)(3)(B)
who is enrolled under section 1866(j)
before delivery of the item. Section
1128J(e) requires that he or she be
identified by his or her NPI in claims for
those services. Medicare requires the
ordering supplier (the physician or the
eligible professional) to be identified by
legal name and NPI in the claim
submitted by the supplier of DMEPOS.
Section 10604 of the Affordable Care
Act, amended section 6405(b) of the
Affordable Care Act as follows: (1)
Section 1814(a)(2) of the Act to specify,
with respect to home health services
under Part A, that payment may be
made to providers of services if they are
eligible and only if a physician enrolled
under section 1866(j) of the Act certifies
(and recertifies, as required) that the
services are or were required in
accordance with section 1814(a)(1)(C) of
the Act; and (2) section 1835(a)(2) of the
Act to specify, with respect to home
health services under Part B, that
payments may be made to providers of
services if they are eligible and only if
a physician enrolled under section
1866(j) of the Act certifies (and
recertifies, as required) that the services
are or were medically required in
accordance with section 1835(a)(1)(B) of
the Act. Section 1128J(e) requires that
the physician be identified by his or her
NPI in claims for those services.
Medicare requires the ordering supplier
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(the physician) to be identified by legal
name and NPI in the claim submitted by
the provider of home health services.
In addition, section 6405(c) of the
Affordable Care Act gives the Secretary
the authority to extend the requirements
made by subsections (a) and (b) to all
other categories of items or services
under title XVIII of the Social Security
Act, including covered Part D drugs as
defined in section 1860D–2(e) of the
Act, that are ordered, prescribed, or
referred by a physician enrolled under
section 1866(j) of the Act or an eligible
professional under section 1848(k)(3)(B)
of the Act. Section 1128J(e) requires that
he or she be identified by his or her NPI
in claims for those services. Medicare
requires the ordering or referring
supplier (the physician or the eligible
professional) to be identified by legal
name and NPI in the claims submitted
by the suppliers of laboratory, imaging,
and specialist services. These
amendments are effective on or after
July 1, 2010.
3. Requirements of This IFC
To ensure that ordering suppliers
(physicians and eligible professionals)
are uniquely identified in Medicare
claims for covered items of DMEPOS as
required by section 6405(a) of the
Affordable Care Act, and to ensure that
those DMEPOS items are ordered by
qualified physicians or eligible
professionals, we are requiring at a new
§ 424.507(a), the following:
• In Part B claims for covered items
of DMEPOS that require the
identification of the ordering supplier,
and with the exception noted below, the
ordering supplier be a physician or an
eligible professional with an approved
enrollment record in PECOS (see the
exception below), and be identified in
the claim by his or her legal name and
by his or her own NPI (that is, by the
NPI that was assigned to him or her by
the National Plan and Provider
Enumeration System [NPPES] as an
Entity type 1 [an individual]).
To ensure that ordering suppliers are
uniquely identified in Medicare Part A
claims for covered Part A or Part B
home health services as required by
section 6405(b), as amended by section
10604 of the Affordable Care Act, and to
ensure that those home health services
are ordered by qualified physicians, we
are requiring at a new § 424.507, the
following:
• In Part A claims for covered Part A
and Part B home health items or
services that require the identification of
the ordering supplier, and with the
exception noted below, the ordering
supplier be a physician with an
approved enrollment record in PECOS
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(see the exception below), and be
identified in the claim by his or her
legal name and by his or her own NPI
(that is, by the NPI that was assigned to
him or her by the National Plan and
Provider Enumeration System [NPPES]
as an Entity type 1 [an individual]).
To ensure that ordering or referring
suppliers are uniquely identified in Part
B claims for covered services of
laboratories, imaging suppliers, and
specialists, under the discretion
afforded the Secretary in section
6405(c), and to ensure that those items
or services are ordered or referred by
qualified physicians or eligible
professionals, we are requiring at a new
§ 424.507(b), the following:
• In Part B claims for covered services
of laboratories, imaging suppliers, and
specialists that require the identification
of the ordering or referring supplier, and
with the exception noted below, the
ordering or referring supplier be a
physician or an eligible professional
with an approved enrollment record in
PECOS (see the exception below), and
be identified in the claim by his or her
legal name and by his or her own NPI
(that is, by the NPI that was assigned to
him or her by the National Plan and
Provider Enumeration System (NPPES)
as an Entity Type 1 (an individual).
We are requiring at a new § 424.507(c)
that Medicare contractors will reject
claims from providers and suppliers for
the above-described covered ordered or
referred items or services if the legal
names and the NPIs are not reported in
the claims or, with the exception noted
below, if the ordering or referring
supplier does not have an approved
enrollment record in PECOS.
We are requiring at a new § 424.507(d)
that Medicare contractors may deny a
claim submitted by a Medicare
beneficiary for the above-described
ordered or referred covered items and
services if the ordering or referring
supplier is not identified by his or her
legal name or, with the exception noted
below, if the ordering or referring
supplier does not have an approved
enrollment record in PECOS.
Our continuing outreach efforts stress
the need for those who order and refer
to have approved enrollment records in
PECOS.
While we are not including additional
categories of ordered or referred covered
items or services in this IFC (such as
Part B drugs), we reserve the right to
apply these requirements to additional
categories through future rulemaking
once the policies have been developed.
We are considering proposing the
requirements for covered prescribed
Part B drugs within the next year.
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A physician or eligible professional
who orders or refers must be enrolled in
the Medicare program by having an
enrollment record in an approved status
in PECOS, even if he or she is enrolled
only for the purposes of ordering and
referring. To ensure that orders and
referrals for Medicare beneficiaries are
written by qualified physicians and
eligible professionals, it is necessary
that their credentials be verified; such
verification can occur only as part of the
Medicare provider/supplier enrollment
process. PECOS, as described earlier in
this preamble, is the national Medicare
FFS provider and supplier enrollment
repository. All providers and suppliers
who enrolled in Medicare within the
past 6 years, as well as those who
enrolled more than 6 years ago and who
have submitted updates to their
enrollment information within the past
6 years, have enrollment records in
PECOS that contain verified credentials.
Those who enrolled more than 6 years
ago and who have not updated their
enrollment information in the past 6 (or
more) years will need to submit
enrollment applications to Medicare to
establish enrollment records in PECOS.
They may do this by filling out the
paper Medicare provider enrollment
applications (using the appropriate
form(s) from the CMS–855 series of
forms) and mailing the completed
application(s) to the appropriate
Medicare enrollment contractor or by
using Internet-based PECOS to submit
their enrollment application to the
Medicare enrollment contractor over the
Internet. With the implementation in
2009 of the claims processing edits to
ensure the NPI and the name reported
in claims to identify the ordering or
referring suppliers matched information
in PECOS for physicians and
professionals of a profession eligible to
order and refer, many enrolled
physicians and eligible professionals
who do not have enrollment records in
PECOS are submitting enrollment
applications in order to establish those
enrollment records. We expect that
most, if not all, of them will have
submitted enrollment applications
before the end of 2010, including those
who are enrolling solely to continue to
order and refer. A physician or eligible
professional who is deceased, retired, or
excluded from the Medicare program, or
who otherwise would not have an
approved enrollment record in PECOS,
would not be eligible to order or refer
items or services for Medicare
beneficiaries. Please note the following
exception for physicians and eligible
professionals who do not have an
approved enrollment record in PECOS:
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24443
Under section 1802(b) of the Act and
the implementing regulations at 42 CFR
405.400 et seq., physicians and nonphysician practitioners can opt out of
the Medicare program and enter into
private contracts with Medicare
beneficiaries. By entering into these
types of contracts, these suppliers do
not bill the Medicare program for
services that they furnish to Medicare
beneficiaries. We require that
physicians and eligible professionals
who have properly filed an appropriate
affidavit with a Medicare contractor in
order to opt out of the Medicare
program be required to be identified in
claims by their names and their NPIs if
they order or refer covered items or
services for Medicare beneficiaries. We
are creating an exception to the
requirement that ordering and referring
suppliers be required to have an
approved enrollment record in PECOS
for those physicians and non-physician
practitioners who have validly opted
out of the Medicare program. Therefore,
physicians and non-physician
practitioners who have validly opted
out of Medicare are eligible to order and
refer covered items and services for
Medicare beneficiaries. If they have
properly completed the appropriate
affidavit in order to opt out of Medicare,
they will have records in PECOS that
contain their NPIs and that indicate that
they have validly opted out of the
Medicare program. In January 2009,
there were approximately 10,000
physicians and eligible professionals
who had opted out of the Medicare
program. Compared to the more than
800,000 enrolled physicians and eligible
professionals, there are relatively few
physicians and eligible professionals
who have opted out of Medicare.
Accordingly, the physicians or
eligible professional that opted out must
meet the following:
• A currently enrolled physician or
eligible professional who does not have
an enrollment record in PECOS is
required to establish an enrollment
record in PECOS so that he or she can
order and refer covered items or services
for Medicare beneficiaries. A physician
or eligible professional who has validly
opted out of the Medicare program will
have a valid opt-out record in PECOS
and is not required to submit an
enrollment application.
• A physician or eligible professional
who is employed by the Public Health
Service, the Department of Defense, or
the Department of Veterans Affairs is
required to have an approved
enrollment record in PECOS in order to
order and refer covered items and
services for Medicare beneficiaries, even
though he or she would not be
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submitting claims to Medicare for
services furnished to Medicare
beneficiaries. We require, therefore, that
these physicians and eligible
professionals enroll in Medicare solely
to order and refer (and not to be paid for
services furnished to Medicare
beneficiaries).
• A dentist furnishes many services
that are not covered by Medicare and, as
a result, most dentists are not enrolled
in Medicare. However, a dentist may
order services for patients who are
Medicare beneficiaries, such as sending
oral specimens to laboratories for
testing. Doctors of dental medicine or
dental surgery are considered
physicians and we require that they
have approved enrollment records in
PECOS if they order or refer covered
items or services for patients who are
Medicare beneficiaries.
• A pediatrician may treat Medicare
beneficiaries (for example, those of any
age who are enrolled in the Medicare
end-stage renal disease (ESRD) program
or those who are entitled to Medicare
benefits under other Federal programs),
although the volume of such patients is
generally so low that most pediatricians
are not enrolled in Medicare. We require
that a pediatrician have an approved
enrollment record in PECOS if he or she
orders or refers covered items or
services for patients who are Medicare
beneficiaries.
• Residents and interns order and
refer covered items and services for
Medicare beneficiaries. Prior to the
implementation of the NPI, residents
and interns were identified in claims as
the ordering or referring providers by
surrogate UPINs. Interns are not issued
medical licenses by States; therefore,
they are not eligible to enroll in
Medicare. Residents have medical
licenses if they practice in States that
issue medical licenses to residents; as a
result, some residents are eligible to
enroll in Medicare. Due to the variances
in licensure and the necessity for
interns and residents to be able to
continue to order and refer covered
items and services for Medicare
beneficiaries, we require that the
teaching physician—not the resident or
intern—be identified in the claim as the
ordering or referring provider whenever
a resident or intern orders or refers.
These ordering and referring
requirements, when implemented, will
allow us to uniquely identify the
ordering and referring supplier in
claims (except when the teaching
physician is identified as the ordering or
referring supplier in situations where an
intern or a resident ordered or referred)
and assure, because of the requirement
to have an approved enrollment or valid
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opt out record in PECOS, that the
ordering and referring supplier is
qualified to order and refer items and
services for Medicare beneficiaries. This
will enable us to edit claims for ordering
and referring suppliers who do not have
approved enrollment records in PECOS
(that is, those who are excluded,
deceased, or retired, and those whose
Medicare billing privileges have been
terminated through exclusion,
revocation, or otherwise), and those
who have voluntarily terminated their
relationship with Medicare or who have
validly opted out of Medicare.
Further, we are requiring that Part A
claims for covered ordered Part A and
Part B home health services must
include the legal name and the NPI of
the ordering supplier, who must be a
physician. We are requiring that Part B
claims for covered, ordered, and
referred Part B items and services
(excluding Part B drugs) must include
the legal name and the NPI of the
ordering or referring supplier. We place
these same requirements (except for the
NPI) on claims submitted by Medicare
beneficiaries for these same ordered or
referred items and services. Although
suppliers are required to submit claims
on behalf of beneficiaries under the
mandatory claim submission policy at
section 1848(g)(4)(A) of the Act, we
recognize that beneficiaries may submit
claims to Medicare for payment. In
order to fully enforce the ordering and
referring requirement established by
section 6405 of the Affordable Care Act,
we plan to deny a beneficiary claim for
a service when the legal name of the
ordering or referring supplier is not
included on the claim.
We believe that these requirements
will promote quality health care
services for Medicare beneficiaries
because orders and referrals would be
written by qualified physicians and
eligible professionals, as their
credentials would have been verified as
part of the Medicare provider/supplier
enrollment process.
Additionally, we believe these
requirements will eliminate the abusive
practice of reporting identifiers in
claims as being assigned to specific
ordering or referring suppliers when, in
fact, those identifiers had not been
assigned to those specific ordering or
referring suppliers. As a result, our
requirements should eliminate these
types of problematic claims and ensure
the qualifications of the ordering and
referring suppliers.
Our requirements will enable us to
know the identity of the individual who
ordered or referred and, if appropriate,
we could establish edits to check for
over-ordering specific items or services,
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over-referring specific services, and/or
over-ordering or over-referring to
specific providers of services and
suppliers.
Furthermore, these requirements
support our existing authority, at
§ 424.516(f), under which the ordering
and referring suppliers, and those
providers of services and suppliers who
furnish covered items or services based
on orders or referrals, are required to
maintain documentation (to include the
NPI) that supports the orders and
referrals for 7 years in order to maintain
an active enrollment status in the
Medicare program.
Lastly, these requirements may lead to
a reduction in inappropriate Medicare
payments.
We are aware that, in some cases,
Medicare beneficiaries may be patients
of physicians or eligible professionals
who do not have approved enrollment
records in PECOS, or may be patients of
professionals who are not of a
profession that is eligible to order or
refer, and that these physicians and
professionals may be ordering and
referring covered items and services for
these Medicare beneficiaries at this
time. We expect to conduct outreach
activities to educate Medicare
beneficiaries, as well as Medicare
providers of services and suppliers who
furnish covered items and services
based on orders and referrals, so that we
can eliminate situations where those
providers of services and suppliers who
would be furnishing covered ordered
and referred items and services would
not be paid for those covered items or
services because their claims failed the
edits.
Finally, we believe that the
requirements will address the
recommendations offered by the DHHS
OIG report titled, ‘‘Medicare Payments
in 2007 for Medical Equipment and
Supply Claims with Invalid or Inactive
Referring Physician Identifiers, OEI–04–
08–00470, February 2009.’’ Specifically,
the OIG recommended that CMS:
(1) Determine why Medicare claims
with identifiers associated with
deceased referring physicians continue
to be paid;
(2) Implement claims-processing
system changes to ensure that NPIs for
both referring physicians and suppliers
be listed on medical equipment and
supply claims are valid and active.
(3) Emphasize to suppliers the
importance of using accurate NPIs for
both referring physicians and suppliers
when submitting Medicare claims; and
(4) Determine the earliest date to end
the provision that allows suppliers to
submit claims without referring
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physician NPIs while maintaining
beneficiary access to services.
With respect to recommendation (4),
we began requiring Medicare claims to
identify ordering and referring providers
by NPIs beginning May 23, 2008. If the
provider of services or the supplier
submitting the claim for the covered
ordered or referred items or services
could not determine the NPI of the
ordering or referring supplier, we
permitted the provider of services or the
supplier submitting the claim to use its
own NPI in place of the NPI of the
ordering or referring provider. These
types of claims for DMEPOS items now
fail the claims processing edits that
were implemented in 2009. Medicareenrolled physicians and professionals
are required to have NPIs. The NPI
Registry (available at https://
nppes.cms.hhs.gov/NPPES/
NPIRegistryHome.do) enables anyone
with a computer with Internet access to
look up a health care provider’s NPI by
name or NPI, and the NPPES
downloadable file (downloadable from
https://nppesdata.cms.hhs.gov/
CMS_NPI_files.html) contains the NPIs
of all health care providers who have
active NPIs, as well as identifying
information about the health care
providers that is publicly disclosable
under the Freedom of Information Act.
(The National Plan and Provider
Enumeration System Data
Dissemination Notice, published in the
May 30, 2007 Federal Register, further
describes the NPI Registry and the
NPPES downloadable file.) The existing
claims processing edits described earlier
in this preamble check to ensure that
the NPI reported on a Part B claim for
ordered or referred covered items or
services (excluding Part B home health
services and Part B drug claims) belongs
to the ordering or referring supplier
whose name is also reported in those
claims, and not to the supplier who
submitted the claim. As stated
previously, the provisions of section
6405 of the Affordable Care Act are
effective July 1, 2010.
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C. Requirement for Physicians, Other
Suppliers, and Providers to Maintain
and Provide Access to Documentation
on Referrals to Programs at High Risk of
Waste and Abuse
1. Background
On November 19, 2008, we published
a final rule with comment titled,
‘‘Revisions to Payment Policies Under
the Physician Fee Schedule and Other
Revisions to Part B for CY 2009;
Revisions to the Amendment of the E–
Prescribing Exemption for Computer
Generated Facsimile Transmissions; and
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the Competitive Acquisition for Certain
Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS)’’ in the Federal Register. In
this IFC, we established § 424.516(f) to
require providers and suppliers to
maintain ordering and referring
documentation, including the NPI,
received from a physician or eligible
non-physician practitioner. We also
established in § 424.516(f) that
physicians and eligible professionals are
required to maintain written ordering
and referring documentation for 7 years
from the date of service. Finally, we
established in § 424.535(a)(10) that
failure to comply with the
documentation requirements specified
in § 424.516(f) is a reason for revocation.
2. Provisions of the Affordable Care Act
Section 6406 of the Affordable Care
Act amends section 1866(a)(1) of the Act
and added a new subparagraph (W)
which requires providers to agree to
‘‘maintain and, upon request of the
Secretary, provide access to
documentation relating to written orders
or requests for payment for durable
medical equipment, certifications for
home health services, or referrals for
other items or services written or
ordered by the provider under this title,
as specified by the Secretary.’’
In addition, section 6406 of the
Affordable Care Act amended section
1842(h) of the Act by adding a new
paragraph which states, ‘‘The Secretary
may revoke enrollment, for a period of
not more than one year for each act, for
a physician or supplier under section
1866(j) if such physician or supplier
fails to maintain and, upon request of
the Secretary, provide access to
documentation relating to written orders
or requests for payment for durable
medical equipment, certifications for
home health services, or referrals for
other items or services written or
ordered by such physician or supplier
under this title, as specified by the
Secretary.’’
Section 6406(b)(3) of the Affordable
Care Act amends section 1866(a)(1) of
the Act to require that providers and
suppliers maintain and, upon request,
provide to the Secretary, access to
written or electronic documentation
relating to written orders or requests for
payment for durable medical
equipment, certifications for home
health services, or referrals for other
items or services written or ordered by
the provider as specified by the
Secretary. Section 6406(b)(3) does not
limit the authority of the Office of
Inspector General to fulfill the Inspector
General’s responsibilities in accordance
with applicable Federal law.
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24445
3. Requirements of This IFC
In our requirements, in our revision of
§ 424.516(f), we are replacing the term
‘‘eligible non-physician practitioner’’
with ‘‘eligible professional.’’ This change
is consistent with our definition of
‘‘eligible professional’’ and correctly
identifies the professionals who, in
addition to physicians, are eligible to
order and refer.
At this time, we are expanding
§ 424.516(f) to include requirements for
documentation and access to
documentation related to orders and
referrals for covered home health,
laboratory, imaging, and specialist
services. Section 424.516(f) currently
includes requirements for
documentation and access to
documentation for orders for DMEPOS.
We reserve the right to, at a future date,
publish proposed requirements for
documentation and access to
documentation for additional items and
services that may be ordered or referred
under title XVIII and that are programs
of high risk of waste and abuse.
We are revising the existing
§ 424.516(f) to now read ‘‘Maintaining
and providing access to
documentation.’’ A provider or a
supplier who furnishes covered ordered
DMEPOS or referred home health,
laboratory, imaging, or specialist
services is required to maintain
documentation for 7 years from the date
of service and, upon the request of CMS
or a Medicare contractor, to provide
access to that documentation. The
documentation includes written and
electronic documents (including the NPI
of the physician who ordered the home
health services and the NPI of the
physician or the eligible professional
who ordered or referred the DMEPOS,
laboratory, imaging, or specialist
services) relating to written orders and
requests for payments for items of
DMEPOS and home health, laboratory,
imaging, and specialist services. A
physician who ordered home health
services and a physician and an eligible
professional who ordered or referred
items of DMEPOS or laboratory,
imaging, and specialist services is
required to maintain documentation for
7 years from the date of the order,
certification, or referral and, upon
request of CMS or a Medicare
contractor, to provide access to that
documentation. The documentation
includes written and electronic
documents (including the NPI of the
physician who ordered the home health
services and the NPI of the physician or
the eligible professional who ordered or
referred the DMEPOS, laboratory,
imaging, or specialist services) relating
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to written orders or requests for
payments for items of DMEPOS and
home health, laboratory, imaging, and
specialist services. Note that we are
clarifying that the documentation
includes both written and electronic
documentation.
We are revising § 424.535(a)(10) to
read, ‘‘The Centers for Medicare &
Medicaid Services’’ (CMS) may revoke
enrollment, for a period of not more
than one year for each act, for a provider
or a supplier under section 1866(j) of
the Act if such provider or supplier fails
to meet the requirements of § 424.516(f).
Providers and suppliers will continue to
have appeal rights afforded to them in
accordance with part 498.
III. 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.
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IV. Waiver of Proposed Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule. The notice of
proposed rulemaking includes a
reference to the legal authority under
which the rule is proposed, and the
terms and substances of the proposed
rule or a description of the subjects and
issues involved. This procedure can be
waived, however, if an agency finds
good cause that a notice-and-comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporates a statement of
the finding and its reasons in the rule
issued. The NPI requirements set forth
in this IFC are necessary to implement
the data reporting requirements in
section 1128J(e) of the Act, as amended
by section 6402(a) of the Affordable
Care Act, which require that the
Secretary promulgate a regulation to
implement this requirement no later
than January 2011. Moreover these NPI
requirements are needed to implement
the Medicare requirements specified in
section 6405 of the Affordable Care Act
that are effective July 1, 2010. Section
6406 of the Affordable Care Act was
effective January 1, 2010. It is
imperative that the regulatory
provisions be set forth as soon as
possible to deliver the guidance
necessary to enact the provisions.
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In addition, several of these
provisions may be issued as an IFC
because they fall under the exception in
Medicare to the section 1871(b)(1)(B) of
the Act rulemaking requirements.
Section 1871 of the Act generally
requires that we issue a notice of
proposed rulemaking prior to issuing a
final rule under the Medicare program.
However, section 1871(b)(1)(b) provides
that the Secretary is not required to
issue a notice of proposed rulemaking
before issuing a final rule if ‘‘* * * a
statute establishes a specific deadline
for the implementation of a provision
and the deadline is less than 150 days
after the date of the enactment of the
statute in which the deadline is
contained.’’ Section 6405 establishes an
effective date of July 1, 2010, which is
less than 150 days from the date of
enactment of this statute. Moreover,
section 6406 establishes an effective
date of January 1, 2010, which has
already passed.
We do not believe that the portions of
this rule not exempted from notice and
comment rulemaking pursuant to
section 1871(b)(1)(B) of the Act add any
new burdens for Medicare or Medicaid
providers and suppliers. Both Medicare
and Medicaid programs generally
require unique provider identifiers, and
thus delaying this rule is unnecessary.
Finally, a delay in implementing these
provisions would be contrary to the
public interest and to CMS’ efforts to
reduce and eliminate fraud and abuse in
the Medicare and Medicaid programs.
For these reasons, we find good cause to
waive the notice of proposed
rulemaking and to issue this final rule
on an interim basis. We are providing a
60-day comment period.
V. Collection of Information
Requirements
In accordance with section 3507(j) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection included in this interim final
rule with comment period will be
submitted for emergency approval to the
Office of Management and Budget
(OMB). The revised information
collection requirements associated with
0938–0685, 0938–0931, and 0938–0999
(see sections V.A. and V.D. of this IFC)
will not be effective until approved by
OMB.
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day 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
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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
(ICRs):
A. ICRs Regarding National Provider
Identifier (NPI) on All Medicare
Enrollment Applications and Claims
(§ 424.506)
Section 424.506(b)(1) states that
providers and suppliers who are eligible
for NPIs be required to report their NPIs
on their enrollment applications for
Medicare. Similarly, § 424.506 (b)(2)
states that if providers or suppliers
enrolled in Medicare prior to obtaining
NPIs and their NPIs are not in their
enrollment records, they must submit
enrollment applications containing their
NPIs.
The burden associated with the
requirements in § 424.506(b) is the time
and effort necessary for a provider or a
supplier to apply for an NPI and the
time and effort necessary to report the
NPIs on their enrollment applications
for Medicare.
Sections § 424.510 and § 424.515 state
that providers and suppliers must
submit enrollment information on the
applicable enrollment application and
update, resubmit, and recertify the
accuracy of their enrollment
information every 5 years. In addition,
§ 424.516 lists reporting requirements
for providers and suppliers. To submit
enrollment information for an initial
application (even if enrolling solely to
order and refer), a change of
information, or to respond to a
revalidation request, a provider or
supplier must complete and submit the
applicable CMS–855 enrollment
application or complete and submit the
enrollment application over the Internet
using Internet-based PECOS. Although
we are unable to quantify the number,
we do not believe that a significant
number of physicians and eligible
professionals will enroll in Medicare
solely to order and refer. The burden
associated with the enrollment
requirements found in § 424.510,
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§ 424.515, and§ 424.516 is the time and
effort necessary to complete and submit
applicable Medicare enrollment
applications. While this burden is
subject to the PRA, it is currently
approved under existing OMB control
numbers (OCN). Specifically, the
burden associated with obtaining an NPI
is currently approved under OCN 0938–
0931. The burden associated with
submitting initial Medicare enrollment
applications and updating Medicare
enrollment information to include NPI
is approved under OCN 0938–0685
(Applications CMS–855 A, B, I, and R)
0938–1056 (Application CMS–855 S).
Section 424.506(b)(1) states that
providers and suppliers who are
enrolled in Medicare must report their
National Provider Identifiers (NPIs) and
the NPIs of any other providers or
suppliers who are required to be
identified in their claims on all paper
and electronic claims that they send to
Medicare. The burden associated with
this requirement is the time and effort
necessary to complete and submit a
claim form. While this requirement is
subject to the PRA, the associated
burden is currently approved under
OCN 0938–0999.
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B. ICRs Regarding Ordering and
Referring Covered Items and Services for
Medicare Beneficiaries (§ 424.507)
Section 424.507 states that to receive
payment for covered Part A or Part B
home health services, the claim must
contain the legal name and the NPI of
the ordering physician; and to receive
payment for covered items of DMEPOS,
and certain other covered Part B items
or services (excluding Part B drugs), the
claim must contain the legal name and
the NPI of the ordering or referring
physician or eligible professional. The
burden associated with these
requirements is the time and effort
necessary to submit a claim with the
required information. While these
requirements are subject to the PRA, the
associated burden is currently approved
under OCN 0938–0999.
C. ICRs Regarding Additional Provider
and Supplier Requirements for Enrolling
and Maintaining Active Enrollment
Status in the Medicare Program
(§ 424.516)
Section 424.516(f)(1) discusses the
documentation requirements for
providers and suppliers. A provider or
supplier is required for 7 years from the
date of service to maintain and upon
request of CMS or a Medicare
contractor, provide access to
documentation, including the NPI of the
physician or the eligible professional
who ordered or referred the item or
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service, relating to written orders or
requests for payments for items of
DMEPOS and referrals for home health,
laboratory, imaging, and specialist.
Similarly, § 424.516(f) discusses the
documentation requirements for
providers and suppliers. At
§ 424.516(f)(1), providers and suppliers
are required for 7 years from the date of
service to maintain and, upon request of
CMS or a Medicare contractor, provide
access to documentation, including the
NPI of the physician or the eligible
professional who ordered or referred the
item or service, relating to written
orders or requests for payments for
items of DMEPOS and referrals for home
health, laboratory, imaging, and
specialist. At § 424.516(f)(2), physicians
and eligible professionals are required
for 7 years from the date of service to
maintain and, upon request of CMS or
a Medicare contractor, provide access to
written and electronic documentation
relating to written orders or
certifications for items of DMEPOS and
home health, laboratory, imaging, and
specialist services, written, ordered,
referred by such physician or nonphysician practitioner.
The burden associated with the
requirements in § 424.516(f) is the time
and effort necessary to both maintain
documentation on file and to furnish the
information upon request to CMS or a
Medicare contractor. While the
requirement is subject to the PRA, we
believe the associated burden is exempt.
As discussed in the final rule that was
published November 19, 2008 (73 FR
69726), we believe the burden
associated with maintaining
documentation and furnishing it upon
request is a usual and customary
business practice and thereby exempt
from the PRA under 5 CFR 1320.3(b)(2).
D. ICRs Regarding the Reporting of
National Provider Identifier by Medicaid
Providers (§ 431.507(b)(5))
Section 431.107(b)(5) states that a
Medicaid provider has to furnish its NPI
(if eligible for an NPI) to its State agency
and include its NPI on all claims
submitted under the Medicaid program.
The burden associated with the
Medicaid requirements in
§ 431.107(b)(5) is the time and effort
necessary for a provider to report the
NPIs to the State agency and on claims
submitted to the Medicaid program.
We are in the process of revising the
information collection requirements
contained in OCNs 0938–0685, 0938–
0931, and 0938–0999 in accordance
with the provisions of this rulemaking.
These information collection
requirements will be sent to OMB for
review and approval in accordance with
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24447
the emergency procedures of the PRA
and will not go into effect until
approved by OMB.
If you comment on these information
collection and recordkeeping
requirements, please do either of the
following:
1. Submit your comments
electronically as specified in the
ADDRESSES section of this proposed rule;
or
2. Submit your comments to the
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: CMS Desk Officer,
[CMS–6010–IFC]
Fax: (202) 395–6974; or E-mail:
OIRA_submission@omb.eop.gov
VI. Regulatory Impact Analysis
We have examined the impact 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 Act, the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104–4), and
Executive Order 13132 on Federalism,
and the Congressional Review Act (5
U.S.C. 804 et seq.). Executive Order
12866 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
($100 million or more in any 1 year).
Virtually all providers and suppliers
who wish to enroll in Medicare and
Medicaid programs have already
obtained NPIs. Most enrolled Medicare
and Medicaid providers and suppliers
who will be affected by the statutory
and regulatory requirements are already
meeting those requirements. For
example, Medicare providers and
suppliers have been reporting their NPIs
on their enrollment applications for 4
years and have been using NPIs in their
paper and electronic Medicare claims as
well as electronic Medicaid claims for 2
years. The majority of suppliers who
submit claims for ordered or referred
DMEPOS and laboratory, imaging, and
specialist services are ensuring that
their claims meet the requirements of
this IFC. In addition, the majority of
Medicare physicians and eligible
professionals who order and refer but
who do not have approved enrollment
records in PECOS are aware of the need
to establish those records and many
have already submitted their enrollment
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applications to Medicare in order to do
so. Medicare DMEPOS suppliers and
those physicians and eligible
professionals who order DMEPOS are
already maintaining documentation in
accordance with the requirements of
this IFC. Other Medicare providers and
suppliers who will be required to do so
by this IFC are likely already in full or
partial compliance as part of their
routine business operations. Therefore,
we do not believe this rule reaches the
economic threshold and thus is not
considered a major rule.
The RFA requires agencies to analyze
options for regulatory relief for small
businesses. For purposes of the RFA,
small entities include small businesses,
nonprofit organizations, and
government agencies. Most hospitals
and most other providers and suppliers
are small entities, either by nonprofit
status or by having revenues of $6.5 to
$31.5 million in any one year.
Individuals and States are not included
in the definition of a small entity. We
are not preparing an analysis for the
RFA because we have determined that
this rule will not have a significant
economic impact on a substantial
number of small entities. We maintain
that this final rule would not have an
adverse impact on small entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have 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 are not
preparing an analysis for section 1102(b)
of the Act because we have determined
that this final rule will not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule that may result in expenditure in
any 1 year by State, local, or tribal
governments, in the aggregate, or by the
private sector, of $135 million. This rule
does not mandate expenditures by
either the governments mentioned or
the private sector; therefore, no analysis
is required. Executive Order 13132
establishes certain requirements that an
agency must meet when it promulgates
a proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
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governments, preempts State law, or
otherwise has Federalism implications.
Since this regulation does not impose
significant costs on State or local
governments, the requirements of E.O.
13132 are not applicable. In accordance
with the provisions of Executive Order
12866, this regulation was reviewed by
the Office of Management and Budget.
B. Alternatives Considered
Since this final rule is a codification
of statutory provisions found in the
Affordable Care Act, we did not
consider alternatives to this process.
List of Subjects
42 CFR Part 424
Emergency medical services, Health
facilities, Health professions, Medicare,
Reporting and recordkeeping
requirements.
42 CFR Part 431
Grant programs-health, Health
facilities, Medicaid, Privacy, Reporting
and recordkeeping requirements.
■ For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
PART 424—CONDITIONS FOR
MEDICARE PAYMENT
1. The authority citation for part 424
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
2. Section 424.506 is added to read as
follows:
■
§ 424.506 National Provider Identifier (NPI)
on all enrollment applications and claims.
(a) Definition. Eligible professional
means any of the professionals specified
in section 1848(k)(3)(B) of the Act.
(b) Enrollment requirements. (1) A
provider or a supplier who is eligible for
an NPI must report its National Provider
Identifier (NPI) on its Medicare
enrollment application.
(2) If a provider or a supplier who is
eligible for an NPI enrolled in the
Medicare program prior to obtaining an
NPI and the provider’s or the supplier’s
NPI is not in the provider’s or the
supplier’s Medicare enrollment record,
the provider or the supplier must
submit a Medicare enrollment
application that contains the NPI.
(3) A physician or an eligible
professional who has validly opted out
of the Medicare program does not need
to submit an enrollment application.
(c) Claims reporting requirements. (1)
A provider or a supplier who is enrolled
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in Medicare and who submits a paper or
an electronic claim to Medicare include
its National Provider Identifier (NPI)
and the NPI(s) of any other provider(s)
or suppliers(s) who is required to be
identified.
(2) A Medicare beneficiary who
submits a claim for service to
Medicare—
(i) Must include the legal name of any
provider or supplier who is required to
be identified in that claim; and
(ii) May, if known to the beneficiary,
include the National Provider Identifier
(NPI) of any provider or supplier who is
required to be identified in that claim.
(3) A Medicare contractor will reject
a claim from a provider or a supplier if
the required NPI(s) is not reported.
■ 3. Section 424.507 is added to read as
follows:
§ 424.507 Ordering and referring covered
items and services for Medicare
beneficiaries.
(a) Conditions for payment of claims
for ordered or referred covered Part B
items and services (excluding home
health services described in § 424.507(b)
and Part B drugs). (1) Part B provider
and supplier claims. To receive
payment for ordered or referred covered
Part B items and services (excluding
home health services described in
§ 424.507(b), and Part B drugs), a
provider’s or supplier’s must meet all of
the following requirements:
(i) The Part B items and services must
have been ordered or referred by a
physician or, when permitted, an
eligible professional (as defined in
§ 424.506(a) of this part).
(ii) The claim from the Part B provider
or supplier must contain the legal name
and the National Provider Identifier
(NPI) of the physician or the eligible
professional (as defined in § 424.506(a)
of this part) who ordered or referred.
(iii) The physician or the eligible
professional who ordered or referred
must have an approved enrollment
record or a valid opt-out record in the
Provider Enrollment, Chain and
Ownership System (PECOS).
(iv) If the items or services were
ordered or referred by a resident or an
intern, the claim must identify the
teaching physician as the ordering or
referring supplier. The claim must
identify the teaching physician by his or
her legal name and NPI and he or she
must have an approved enrollment
record or a valid opt-out record in
PECOS.
(2) Part B beneficiary claims. To
receive payment for ordered or referred
covered Part B items and services
(excluding home health services
described in § 424.507(b), and Part B
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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations
drugs), a beneficiary’s claim must meet
all of the following requirements:
(i) The Part B items and services must
have been ordered or referred by a
physician or, when permitted, an
eligible professional (as defined in
§ 424.506(a) of this part).
(ii) The claim must contain the legal
name of the physician or the eligible
professional (as defined in § 424.506(a)
of this part) who ordered or referred.
(iii) The physician or the eligible
professional who ordered or referred
must have an approved enrollment
record or a valid opt-out record in the
Provider Enrollment, Chain and
Ownership System (PECOS).
(iv) If the items or services were
ordered or referred by a resident or an
intern, the claim must identify the
teaching physician as the ordering or
referring supplier. The claim must
identify the teaching physician by his or
her legal name and he or she must have
an approved enrollment record or a
valid opt-out record in PECOS.
(b) Conditions for payment of claims
for ordered covered home health
services. (1) Home health provider
claims. To receive payment for ordered,
covered Part A or Part B home health
services, a provider’s home health
services claim must meet all of the
following requirements:
(i) The Part A or Part B home health
services must have been ordered by a
physician;
(ii) The claim from the provider of
home health services must contain the
legal name and the National Provider
Identifier (NPI) of the ordering
physician;
(iii) The ordering physician must have
an approved enrollment record or a
valid opt-out record in the Provider
Enrollment, Chain, and Ownership
System (PECOS); and
(iv) If the services were ordered by a
resident or an intern, the claim must
identify the teaching physician as the
ordering or referring physician. The
claim must identify the teaching
physician by his or her legal name and
NPI and he or she must have an
approved enrollment record or a valid
opt-out record in PECOS.
(2) Home health beneficiary claims.
To receive payment for ordered covered
Part A or Part B home health services,
a beneficiary’s home health services
claim must meet all of the following
requirements:
(i) The Part A or Part B home health
services must have been ordered by a
physician.
(ii) The claim from the provider of
home health services must contain the
legal name of the ordering physician.
VerDate Mar<15>2010
14:33 May 04, 2010
Jkt 220001
(iii) The ordering physician must have
an approved enrollment record or a
valid opt-out record in the Provider
Enrollment, Chain, and Ownership
System (PECOS).
(iv) If the services were ordered by a
resident or an intern, the claim must
identify the teaching physician as the
ordering or referring physician. The
claim must identify the teaching
physician by his or her legal name and
he or she must have an approved
enrollment record or a valid opt-out
record in PECOS.
(c) A Medicare contractor will reject
a claim from a provider or a supplier for
covered services described in
paragraphs (a) and (b) of this section if
the claim does not meet the
requirements of paragraph (a)(1) and
(b)(1) of this section, respectively.
(d) A Medicare contractor may deny
a claim from a Medicare beneficiary for
covered items or services described in
paragraphs (a) and (b) of this section if
the claim does not meet the
requirements of paragraphs (a)(2) and
(b)(2) of this section, respectively.
■ 4. Section 424.516 is amended by
revising paragraph (f) to read as follows:
§ 424.516 Additional provider and supplier
requirements for enrolling and maintaining
active enrollment status in the Medicare
program.
*
*
*
*
*
(f) Maintaining and providing access
to documentation. (1) A provider or a
supplier who furnishes covered ordered
DMEPOS or referred home health,
laboratory, imaging, or specialist
services is required to maintain
documentation for 7 years from the date
of service and, upon the request of CMS
or a Medicare contractor, to provide
access to that documentation. The
documentation includes written and
electronic documents (including the NPI
of the physician who ordered the home
health services and the NPI of the
physician or the eligible professional
who ordered or referred the DMEPOS,
laboratory, imaging, or specialist
services) relating to written orders and
requests for payments for items of
DMEPOS and home health, laboratory,
imaging, and specialist services.
(2) A physician who ordered home
health services and a physician and an
eligible professional who ordered or
referred items of DMEPOS or laboratory,
imaging, and specialist services is
required to maintain documentation for
7 years from the date of the order,
certification, or referral and, upon
request of CMS or a Medicare
contractor, to provide access to that
documentation. The documentation
includes written and electronic
PO 00000
Frm 00077
Fmt 4700
Sfmt 9990
24449
documents (including the NPI of the
physician who ordered the home health
services and the NPI of the physician or
the eligible professional who ordered or
referred the DMEPOS, laboratory,
imaging, or specialist services) relating
to written orders or requests for
payments for items of DMEPOS and
home health, laboratory, imaging, and
specialist services.
5. Section 424.535 is amended by
revising (a)(10) to read as follows:
■
§ 424.535 Revocation of enrollment and
billing privileges in the Medicare program.
(a) * * *
(10) Failure to document or provide
CMS access to documentation. (i) The
provider or supplier (as described in
section 1866(j) of the Act) did not
comply with the documentation or CMS
access requirements specified in
§ 424.516(f) of this subpart.
(ii) A provider or supplier that meets
the revocation criteria specified in
paragraph (a)(10)(i) of this section, is
subject to revocation for a period of not
more than 1 year for each act of
noncompliance.
*
*
*
*
*
PART 431—STATE ORGANIZATION
AND GENERAL ADMINISTRATION
6. The authority citation for part 431
continues to read as follows:
■
Authority: Sec. 1102 of the Social Security
Act, (42 U.S.C. 1302).
7. Section 431.107 is amended by
adding a new paragraph (b)(5) to read as
follows:
■
§ 431.107
Required provider agreement.
*
*
*
*
*
(b) * * *
(5)(i) Furnish to the State agency its
National Provider Identifier (NPI) (if
eligible for an NPI); and
(ii) Include its NPI on all claims
submitted under the Medicaid program.
Dated: April 28, 2010.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: April 29, 2010.
Kathleen Sebelius,
Secretary.
Authority: Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program, and Program No. 93.778,
Medical Assistance Program.
[FR Doc. 2010–10505 Filed 4–30–10; 4:15 pm]
BILLING CODE P
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Agencies
[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Rules and Regulations]
[Pages 24437-24449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10505]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 424 and 431
[CMS-6010-IFC]
RIN 0938-AQ01
Medicare and Medicaid Programs; Changes in Provider and Supplier
Enrollment, Ordering and Referring, and Documentation Requirements; and
Changes in Provider Agreements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment period.
-----------------------------------------------------------------------
SUMMARY: This interim final rule with comment period implements several
provisions set forth in the Patient Protection and Affordable Care Act
(Affordable Care Act). It implements the provision which requires all
providers of medical or other items or services and suppliers that
qualify for a National Provider Identifier (NPI) to include their NPI
on all applications to enroll in the Medicare and Medicaid programs and
on all claims for payment submitted under the Medicare and Medicaid
programs. This interim final rule with comment period also requires
physicians and eligible professionals to order and refer covered items
and services for Medicare beneficiaries to be enrolled in Medicare. In
addition, it adds requirements for providers, physicians, and other
suppliers participating in the Medicare program to provide
documentation on referrals to programs at high risk of waste and abuse,
to include durable medical equipment, prosthetics, orthotics and
supplies (DMEPOS), home health services, and other items or services
specified by the Secretary.
DATES: Effective date: These regulations are effective on July 6, 2010.
Comment date: To be assured consideration, comments must be received at
one of the addresses provided below, no later than 5 p.m. on July 6,
2010.
ADDRESSES: In commenting, please refer to file code CMS-6010-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed).
Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the instructions for
submitting comments on the home page.
By regular mail. You may mail written comments to the
following address only: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-6010-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.
By express or overnight mail. You may send written
comments to the following address only: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Attention: CMS-6010-
IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-
1850.
By hand or courier. If you prefer, you may deliver (by
hand or courier) your written comments before the close of the comment
period to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey 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.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
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.
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 following the
instructions 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: Patricia Peyton, (410) 786-1812 for
Medicare issues. Rick Friedman, (410) 786-4451 for Medicaid issues.
SUPPLEMENTARY INFORMATION: 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 comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: https://regulations.gov. Follow the search instructions on
that Web site to view public comments.
Comments received timely will be also 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
[[Page 24438]]
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.
I. Background
The Medicare program, title XVIII of the Social Security Act (the
Act), is the primary payer of health care for 42 million enrolled
beneficiaries. Under section 1802 of the Act, a beneficiary may obtain
health services from an individual or an organization qualified to
participate in the Medicare program. Qualifications to participate are
specified in statute and in regulations (see, for example, sections
1814, 1815, 1819, 1833, 1834, 1842, 1861, 1866, and 1891 of the Act);
and 42 CFR chapter IV, subchapter E, which concerns standards and
certification requirements).
Providers and suppliers furnishing services must comply with the
Medicare requirements stipulated in the Act and in our regulations.
These requirements are meant to ensure compliance with applicable
statutes, as well as to promote the furnishing of high quality care. As
Medicare program expenditures have grown, we have increased our efforts
to ensure that only qualified individuals and organizations are allowed
to enroll or maintain their Medicare billing privileges.
Medicaid is a joint Federal and State health care program for
eligible low-income individuals. States have considerable flexibility
in how they administer their Medicaid programs within a broad Federal
framework and programs vary from State to State.
The Patient Protection and Affordable Care Act (the Affordable Care
Act) (Pub. L. 111-148) makes a number of changes to the Medicaid
program, strengthening tools for quality and integrity, adding new
benefits, and expanding coverage. To maintain program integrity and
assure quality, it is consistent with these changes to assure that only
qualified providers participate in the program and that these providers
bill accurately for their services. Although our regulations provide
States with considerable flexibility, the Federal framework includes
some key requirements to ensure program integrity and quality care. For
example, Medicaid providers must generally meet all State licensing and
scope-of-practice requirements, and may be subject to additional
Federal and State quality standards. Additionally, our regulations
require timely filing of claims by providers.
Including the NPI on claims and enrollment applications is an
important step in controlling fraud and abuse, ensuring a unique
identifier so that States can assure that only qualified Medicaid
providers have provider agreements and maintain their Medicaid billing
privileges. This practice implements the requirement in section
1128J(e) of the Act, as added by section 6402(a) of the Affordable Care
Act and will also help in implementing other important protections
under the Affordable Care Act that ensure quality health care services
for program beneficiaries.
A. Statutory Authority
The following is an overview of the sections that grant this
authority.
Sections 1102 and 1871 of the Act provide general
authority for the Secretary of Health and Human Services (the
Secretary) to prescribe regulations for the efficient administration of
the Medicare program.
Section 1128J(e) of the Act, added by section 6402(a) of
the Affordable Care Act, requires that the Secretary require by
regulation that all providers of medical or other items or services and
suppliers under titles XVIII and XIX that are eligible for a national
provider identifier (NPI) include the NPI on all applications to enroll
in such programs and on all claims for payment under such programs.
Sections 1814(a), 1815(a), and 1833(e) of the Act require
the submission of information necessary to determine the amounts due a
provider or other person.
Section 1834(j)(1)(A) of the Act states that no payment
may be made for items furnished by a supplier of medical equipment and
supplies unless such supplier obtains (and renews at such intervals as
the Secretary may require) a supplier number. In order to obtain a
supplier number, a supplier must comply with certain supplier standards
as identified by the Secretary.
Section 1842(r) of the Act requires the Centers for
Medicare and Medicaid Services (CMS) to establish a system for
furnishing a unique identifier for each physician who furnishes
services for which payment may be made.
Section 1862(e)(1) of the Act states that no payment may
be made when an item or service was at the medical direction of an
individual or entity that is excluded in accordance with sections 1128,
1128A, 1156, or 1842(j)(2) of the Act.
Section 4313 of the Balanced Budget Act of 1997 (BBA)
(Pub. L. 105-33) amended sections 1124(a)(1) and 1124A of the Act to
require disclosure of both the Employer Identification Number (EIN) and
Social Security Number (SSN) of each provider or supplier, each person
with ownership or control interest in the provider or supplier, any
subcontractor in which the provider or supplier directly or indirectly
has a 5 percent or more ownership interest, and any managing employees
including Directors and Board Members of corporations and non-profit
organizations and charities. The ``Report to Congress on Steps Taken to
Assure Confidentiality of Social Security Account Numbers as Required
by the Balanced Budget Act'' was signed by the Secretary and sent to
the Congress on January 26, 1999. This report outlines the provisions
of a mandatory collection of SSNs and EINs effective on or after April
26, 1999.
Section 4312(a) of the Balanced Budget Act of 1997 amended
section 1834(a)(16) of the Act by requiring certain Medicare suppliers
of durable medical equipment, prosthetics, orthotics and supplies
(DMEPOS) to furnish CMS with a surety bond. Section 4312(b) requires
that a surety bond be in an amount of not less than $50,000.
Section 31001(i)(1) of the Debt Collection Improvement Act
of 1996 (DCIA) (Pub. L. 104-134) amended section 7701 of 31 U.S.C. by
adding paragraph (c) to require that any person or entity doing
business with the Federal Government must provide their Taxpayer
Identification Number (TIN).
Section 936(j)(1)(A) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173)
amended the Act to require the Secretary to establish a process for the
enrollment of providers of services and suppliers.
We are authorized to collect information on the Medicare enrollment
application (that is, the CMS-855, (Office of Management and Budget
(OMB) approval number 0938-0685)) to ensure that correct payments are
made to providers and suppliers under the Medicare program as
established by title XVIII of the Act.
Section 1902(a)(27) of the Act provides general authority
for the Secretary to require provider agreements under the Medicaid
State Plans with every person or institution providing services under
the State Plan. Under these agreements, the Secretary may require
information regarding any payments claimed by such person or
institution for providing services under the State plan.
B. Historical Enrollment Initiatives
Historically, Medicare has permitted the enrollment of providers
and suppliers whose qualifications for meeting all of our enrollment
standards were sometimes questionable. This has raised concern that
providers and
[[Page 24439]]
suppliers in our program may be underqualified or even fraudulent and
has led us to increase our efforts to establish more stringent controls
on provider and supplier entry into the Medicare program. The following
is a summary of the regulations that we have published over the past 10
years to ensure that only qualified providers and suppliers are
participating in the Medicare program.
In the October 11, 2000 Federal Register, we published the
Additional Supplier Standards final rule with comment period where we
established additional standards with which a DMEPOS supplier must
comply in order to receive and maintain Medicare billing privileges.
This final rule with comment period outlined the supplier requirements
to ensure that suppliers of DMEPOS are qualified to furnish DMEPOS and
to help safeguard the Medicare program and its beneficiaries from
fraudulent or abusive billing practices.
In the April 21, 2006, Federal Register, we published the
Requirements for Providers and Suppliers to Establish and Maintain
Medicare Enrollment final rule that implemented section 1866(j)(1)(A)
of the Act. In this final rule, we required that all providers and
suppliers (other than those who have elected to ``opt-out'' of the
Medicare program) complete an enrollment application and submit
specific information to CMS in order to obtain Medicare billing
privileges. This final rule also required that all providers and
suppliers must periodically update and certify the accuracy of their
enrollment information to receive and maintain billing privileges in
the Medicare program. These regulatory provisions include requirements
to protect beneficiaries and the Medicare Trust Fund by preventing
unqualified, fraudulent, or excluded providers and suppliers from
providing items or services to Medicare beneficiaries or from billing
the Medicare program or its beneficiaries.
In the December 1, 2006, Federal Register (71 FR 69624), we
published a final rule titled, ``Medicare Program; Revisions to Payment
Policies, Five-Year Review of Work Relative Value Units, Changes to the
Practice Expense Methodology Under the Physician Fee Schedule, and
Other Changes to Payment Under Part B; Revisions to the Payment
Policies of Ambulance Services Under the Fee Schedule for Ambulance
Services; and Ambulance Inflation Factor Update for CY 2007.'' In part,
this final rule with comment established performance standards for
independent diagnostic testing facilities.
In the April 10, 2007, Federal Register (72 FR 17992), we published
a final rule titled, ``Competitive Acquisition for Certain Durable
Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS).''
This final rule implemented section 302 of the MMA requiring that
DMEPOS suppliers meet certain quality standards and established DME
competitive bidding.
In the November 27, 2007 Federal Register (72 FR 66222), we
published a final rule titled, ``Medicare Program; Revisions to Payment
Policies Under the Physician Fee Schedule, and Other Part B Payment
Policies for CY 2008; Revisions to the Payment Policies of Ambulance
Services Under the Ambulance Fee Schedule for CY 2008; and the
Amendment of the E-Prescribing Exemption for Computer Generated
Facsimile Transmissions; Final Rule.'' In this final rule, we clarified
our interpretation of several of the existing independent diagnostic
testing facility (IDTF) performance standards found at Sec. 410.33(b)
and Sec. 410.33(g), proposed a new IDTF performance standard at Sec.
410.33(g)(15), and a new proposed IDTF provision at Sec. 410.33(i).
In the June 27, 2008, Federal Register (73 FR 36448), we published
a final rule titled, ``Appeals of CMS or CMS Contractor Determinations
When a Provider or Supplier Fails to Meet the Requirements for Medicare
Billing Privileges.'' This final rule implemented section 936 of the
MMA and extended appeal rights to all providers and suppliers,
including DMEPOS suppliers, whose enrollment applications for Medicare
billing privileges are denied or revoked by CMS or a Medicare
contractor (that is, carrier, fiscal intermediary, National Supplier
Clearinghouse Medicare Administrative Contractor (MAC), or Part A/Part
B MAC). This final rule also allowed providers and suppliers to seek
judicial review after they have exhausted the administrative appeals
process. In addition, this final rule also implemented provider
enrollment provisions that apply to all provider and supplier types.
In the November 19, 2008, Federal Register (73 FR 69726), we
published a final rule with comment titled, ``Payment Policies Under
the Physician Fee Schedule and Other Revisions to Part B for CY 2009;
E-Prescribing Exemption for Computer Generated Facsimile Transmissions;
and Payment for Certain Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS).'' In part, this final rule with
comment period established a number of provider enrollment provisions
affecting physicians, non-physician practitioners, and other providers
and suppliers, such as the re-enrollment bar of 1 to 3 years on revoked
providers and suppliers, as well as the limitation on retroactive
billing by providers and suppliers.
In the January 2, 2009, Federal Register (74 FR 166), we published
a final rule titled, ``Medicare Program; Surety Bond Requirement for
Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS); Final Rule.'' Consistent with section 4312(a) of the
BBA, this final rule implemented section 1834(a)(16) of the Act by
requiring certain Medicare suppliers of DMEPOS to furnish CMS with a
surety bond of no less than $50,000.
Historically, the States in operating the Medicaid program have
permitted the enrollment of providers and suppliers who meet the State
requirements for Medicaid enrollment. Due to the increased risk of
fraud and abuse in public health care programs of all types, the NPI
requirement will strengthen cross-program integrity efforts.
II. Provisions of the Interim Final Rule With Comment Period
A. Inclusion of the National Provider Identifier (NPI) on all Medicare
and Medicaid Enrollment Applications and Claims
1. Background
Section 1128J(e) of the Act builds on the past Congressional
mandate to require the adoption of a unique identifier for health care
providers and codifies the NPI requirements that Medicare is already
requiring for its fee-for-service (FFS) providers and suppliers.
``Health care provider'' is defined in the Health Insurance
Portability and Accountability Act (HIPAA) definitions found at 45 CFR
160.103. With the exception of organ procurement organizations and Part
B CAP drug vendors, the term ``health care provider'' includes all of
the providers and suppliers who are eligible to enroll in the Medicare
program and most who are eligible to enroll in the Medicaid program. In
this discussion, we use the term ``health care provider'' when
referring to HIPAA and HIPAA regulations, and we use ``providers and
suppliers'' when referring to those health care providers who are
eligible to enroll in the Medicare program.
In the January 23, 2004, NPI final rule (69 FR 3434), we adopted
the NPI as the standard unique health identifier for health care
providers. This fulfilled the
[[Page 24440]]
requirement of section 1173(b) of the Act, which was added by HIPAA.
The final rule stated that HIPAA does not prohibit health plans from
requiring their enrolled health care providers to obtain NPIs.
Accordingly, the Medicare program required enrolling fee-for-service
(FFS) providers and suppliers (and their subparts, in accordance with
the NPI Final Rule) to report their NPIs on their Medicare enrollment
applications beginning in May 2006. When FFS providers and suppliers
who had enrolled prior to May 2006 submitted enrollment applications to
update their enrollment information, they were required to report their
NPIs on those enrollment applications. These requirements ensured that
the Medicare provider and supplier enrollment records included the NPIs
and, in effect, already implemented one of the provisions of section
1128J(e) of the Act.
In accordance with the NPI final rule and the subsequent guidance
from the Secretary, beginning May 23, 2008, Medicare required its
enrolled FFS providers and suppliers to use NPIs in their electronic
claims to identify not only themselves as the billing providers, but
any other providers or suppliers who, according to the Implementation
Guides for the adopted standard claims transactions, were also required
to be identified in those claims. These other health care providers
include rendering providers, supervising providers, and ordering and
referring providers. The regulations that adopted the HIPAA standard
transactions are found at (65 FR 50312, 68 FR 8381, and 74 FR 3296). In
addition, at that same time, Medicare required its enrolled FFS
providers and suppliers to make this same use of NPIs in their paper
claims.
The Provider Enrollment, Chain, and Ownership System (PECOS),
implemented in 2003, is the national repository of enrolled Medicare
FFS providers and suppliers (except DMEPOS suppliers, who will be added
to PECOS later in 2010). PECOS contains the information furnished by
providers and suppliers in their Medicare FFS enrollment applications
and additional information added as required to keep the information
current and to protect the integrity of the Medicare program (for
example, fact and date of death, Office of Inspector General
exclusions). In 2007, PECOS began sending the NPIs in the daily
provider and supplier enrollment data extract going to the Part A and
Part B FFS claims systems. In 2009, Medicare added the NPIs to the
enrollment records of the DMEPOS suppliers, which are currently housed
in the DMEPOS supplier enrollment repository at the National Supplier
Clearinghouse MAC. After the DMEPOS supplier enrollment records are
added to PECOS, PECOS will send a daily DMEPOS supplier enrollment data
extract, which will include the NPIs, to the DMEPOS FFS claims system.
Medicare FFS claims systems link the NPIs that are reported in claims
with the appropriate enrollment records in order to properly price and
pay the claims.
In summary, Medicare has been requiring its providers and suppliers
to report their NPIs on their Medicare enrollment applications; its
enrolled providers and suppliers to report their NPIs, and the NPIs of
other providers and suppliers (as required and as explained previously)
in their electronic and paper Medicare claims; and suppliers who order
or refer covered items or services for Medicare beneficiaries to have
NPIs so that they can be identified, as required, in the claims for the
covered items and services that they have ordered and referred.
Similarly, consistent with NPI final rule and subsequent guidance from
the Secretary, beginning May 23, 2008, Medicaid providers have also
been required to report their NPIs on their Medicaid claims. This IFC
now requires their NPIs be submitted for Medicaid provider agreements.
2. Provisions of the Affordable Care Act
Section 6402(a) of the Affordable Care Act added a new section
1128J of the Act, entitled ``Medicare and Medicaid Program Integrity
Provisions.'' Section 1128J(e), as added by section 6402(a) of the
Affordable Care Act, requires the Secretary to promulgate a regulation
that requires, not later than January 1, 2011, all providers of medical
or other items or services and suppliers under the programs under
titles XVIII and XIX that qualify for a NPI to include their NPI on all
applications to enroll in such programs and on all claims for payment
submitted under such programs. In Medicaid, there is no Federally
required process for provider enrollment except that all Medicaid
providers are required to enter into a provider agreement with the
State as a condition of participating in the program under section
1902(a)(27) of the Act. Therefore, in the Medicaid context we are
including the submission of an NPI to the State agency as a requirement
under the provider agreement. The NPI requirements in this IFC are thus
applicable to the reporting of NPIs--(1) Pursuant to Medicaid provider
agreements; (2) on Medicare provider and supplier enrollment
applications; and (3) on Medicare and Medicaid claims.
3. Requirements Established by This IFC
For the Medicare program, we are establishing, at Sec. 424.506(b),
requirements that a provider or supplier who is eligible for an NPI
must report the NPI on the Medicare enrollment application; and, if the
provider or supplier enrolled in Medicare prior to obtaining an NPI and
the NPI is not in the provider's or supplier's enrollment record, the
provider or supplier must report the NPI to Medicare in an enrollment
application so that the NPI will be added to the provider's or
supplier's enrollment record in PECOS. We are also establishing, at
Sec. 424.506(b)(1), a requirement that a provider or supplier who is
enrolled in fee-for-service (FFS) Medicare report its NPI, as well as
the NPI of any other provider or supplier who is required to be
identified in those claims, on any electronic or paper claims that the
provider or supplier submits to Medicare. We are also establishing, at
Sec. 424.506(b)(2), that a claim submitted by a Medicare beneficiary
contain the legal name and, if the beneficiary knows the NPI, the NPI
of any provider or supplier who is required to be identified in that
claim.
If a Medicare beneficiary does not know the NPI of a provider or
supplier who is required to be identified in the claim that he or she
is submitting, the beneficiary may submit the claim without the NPI(s)
as long as the claim contains the legal name(s) of the health care
provider(s). If a beneficiary so desires, he or she can obtain a
provider's or a supplier's NPI by requesting it directly from the
provider or supplier or from a member of his or her office staff, or by
looking it up in the NPI Registry at https://nppes.cms.hhs.gov/NPPES/NPIRegistryHome.do.
Furthermore, we are establishing, at Sec. 424.506(c)(3), that a
Medicare claim from a provider or a supplier will be rejected if it
does not contain the required NPI(s).
For the Medicaid program, we are establishing, at Sec.
431.107(b)(5), a requirement that the agreement between a State agency
and each provider furnishing services under the State plan include a
requirement that any Medicaid provider eligible for an NPI furnish its
NPI to the State agency under that agreement and on all Medicaid
claims.
B. Ordering and Referring Covered Items and Services for Medicare
Beneficiaries
1. Background
Section 1833(q) of the Act requires that claims for items or
services for
[[Page 24441]]
which payment may be made under Part B and for which there was a
referral by a referring physician shall include the name and the unique
identification number of the referring physician. Physicians are
doctors of medicine and osteopathy, optometry, podiatry, dental
medicine, dental surgery, and chiropractic. Referring physicians are
those who order covered items or services for Medicare beneficiaries
from Medicare providers and suppliers as well as those who refer
Medicare beneficiaries to Medicare providers and suppliers for covered
services. We consider those who ``refer'' to also be authorized to
``order.'' In this IFC, we refer to physicians who both order and refer
as ``ordering and referring suppliers'' and the act of ordering items
or services for Medicare beneficiaries or referring Medicare
beneficiaries to other providers or suppliers for services as
``ordering and referring.''
The Implementation Guides for the adopted HIPAA standard
transactions do not use the word ``supplier'' in their descriptions of
the health care providers who must be identified in those transactions.
For example, and as stated earlier in this preamble, the Implementation
Guides use the terms ``billing provider, ordering provider, referring
provider'' and others. Because this section of this IFC relates only to
the Medicare program, and because the statute and regulations use the
term ``supplier'' (not ``provider'') when referring to physicians and
non-physician practitioners, we are using the term ``ordering and
referring suppliers'' in this IFC. This term corresponds to ``ordering
provider'' and ``referring provider'' described in the Implementation
Guides.
The Medicare providers and suppliers who furnish the covered
ordered or referred items and services send claims to Medicare for
reimbursement for those covered items and services.
With the establishment and implementation of surrogate Unique
Physician Identification Numbers (UPINs) in 1992, suppliers could be
identified, but not uniquely identified, in claims as ordering and
referring suppliers. These suppliers included physicians, physician
assistants, clinical nurse specialists, nurse practitioners, clinical
psychologists, certified nurse midwives, and clinical social workers.
Sections 6405(a) and (c) of the Affordable Care Act indicate that
orders and referrals for DMEPOS and for other categories of items and
services may be made by a physician or an ``eligible professional under
section 1848(k)(3)(B).'' Section 1848(k)(3)(B) of the Act discusses
covered professional services for which payment may be made under, or
is based on, the fee schedule, and which are furnished by: (1) A
physician; (2) a practitioner described in section 1842(b)(18)(C) of
Act; (3) a physical or occupational therapist or a qualified speech-
language pathologist; and (4) a qualified audiologist. Section
1842(b)(18)(C) of the Act discusses billing and payment for Medicare
services furnished by physician assistants, nurse practitioners,
clinical nurse specialists, certified registered nurse anesthetists,
certified nurse-midwives, clinical social workers, clinical
psychologists, and registered dietitians or nutrition professionals.
Neither section 1848(k)(3)(B) of the Act nor section 1842(b)(18)(C) of
the Act discuss the issue of ordering or referring covered items or
services for Medicare beneficiaries. Although section 6405(a) of the
Affordable Care Act indicates that DMEPOS may be ordered by enrolled
physicians or enrolled eligible professionals under section
1848(k)(3)(B) of the Act, our policy has not been to permit all of the
eligible professionals listed in that section or in section
1842(b)(18)(C) of the Act to order and refer. Section 6405(c) of the
Affordable Care Act gives the Secretary the discretion to determine the
professions that can order and refer for all covered items and services
under title XVIII that are not mentioned in sections 6405(a) and (b) of
the Affordable Care Act (DMEPOS and home health, respectively). In
addition, the claims processing edits that we established in 2009
require that the ordering and referring suppliers for DMEPOS and for
laboratory, imaging, and specialist services be those physicians and
professionals who were eligible for UPINs: Physicians, physician
assistants, clinical nurse specialists, nurse practitioners, clinical
psychologists, certified nurse midwives, and clinical social workers.
In this IFC, the term eligible professional means any of the
professionals listed in section 1848(k)(3)(B) of the Act. In this
preamble, we distinguish physicians from eligible professionals (even
though physicians are included in section 1848(k)(3)(B) as eligible
professionals) because sections 6405(a) and (b) of the Affordable Care
Act reference physicians separately from eligible professionals.
Section 6405(c) of the Affordable Care Act gives the Secretary the
discretion to determine the health professions that can order and refer
items and services other than DMEPOS and home health.
In the past, prior to the Medicare implementation of the NPI on May
23, 2008, physicians and eligible professionals were identified in
claims as ordering or referring suppliers by their UPINs. Physicians
and eligible professionals applied for and were assigned UPINs as part
of the process of enrolling in the Medicare program; therefore,
physicians and eligible professionals were expected to be identified in
claims as ordering or referring suppliers by their UPINs.
Surrogate UPINs were established to be used in claims to
temporarily identify certain ordering and referring suppliers who had
not yet completed the Medicare enrollment process and, therefore, had
not yet been assigned UPINs. Surrogate UPINs were used to collectively
identify the following: (1) Physicians who were serving in the military
or with the Department of Veterans Affairs or the Public Health Service
(including the Indian Health Service); (2) interns, residents, and
fellows; and (3) retired physicians. There was also a surrogate UPIN
(OTH000) that could be used for any other supplier who ordered or
referred who could not be identified by any of the other surrogate
UPINs.
Over time, providers and suppliers began using surrogate UPINs in
their claims to identify ordering and referring suppliers who had been
assigned their own UPINs, as well as individuals who had never been
assigned UPINs. In addition, they also used UPINs that had been
assigned to physicians other than the physicians who they were
identifying in their claims as the ordering or referring suppliers. We
believe that many providers and suppliers became aware that the use of
any UPIN would get their claims processed and paid. They learned, over
time, that Medicare claims edits on the ordering and referring
suppliers were based on the format of the UPIN, and all UPINs had the
same format. The claims process did not verify the UPINs of ordering or
referring suppliers. These practices negated the intent of the UPIN,
which was to uniquely identify the ordering or referring supplier.
Analysis of Medicare claims data prior to 2008 (UPINs were not
permitted to be used in Medicare claims after May 23, 2008) revealed
that these practices were widespread and, as a result, we had reason to
believe that many physicians and eligible professionals were unaware of
the requirement that their assigned UPINs were intended to uniquely
identify them as ordering or referring suppliers and, more importantly,
that they needed to apply for UPINs. As a result, Medicare may have
paid claims for covered ordered and referred items and services that
may
[[Page 24442]]
have been ordered or referred by professionals who were not of a
profession eligible to order and refer; by physicians or eligible
professionals who were not enrolled in the Medicare program; or by
physicians or eligible professionals who were not in an approved
Medicare enrollment status (for example, they were sanctioned, their
licenses were suspended or revoked, their billing privileges were
terminated, or they were deceased).
With the Medicare implementation of the NPI in May 2008, Medicare
discontinued the assignment of UPINs and no longer allowed UPINs to be
used in Medicare claims. Medicare required providers and suppliers who
were sending claims to Medicare for covered ordered and referred items
and services to use the NPI, rather than the UPIN, to identify the
ordering and referring suppliers in their claims. Because the NPI Final
Rule did not discuss the concept of ``surrogate NPIs'' nor did it
contain a provision for the establishment of ``surrogate NPIs,''
surrogate NPIs do not and cannot exist. Because physicians and non-
physician practitioners are eligible for NPIs, only the NPI may be used
in Medicare claims to identify ordering and referring suppliers.
We believe that the new requirements discussed below will address
concerns expressed by the Department of Health and Human Services'
(DHHS) Office of Inspector General (OIG) report titled, ``Durable
Medical Equipment Ordered with Surrogate Physician Identification
Numbers, OEI-03-01-00270, September 2002,'' which found that the use of
surrogate UPINs on Medicare claims poses a vulnerability to the
Medicare program. The HHS OIG found a substantial number of
documentation problems in the supporting evidence submitted by
suppliers for claims processed with surrogate UPINs. The DHHS OIG
estimated that, in 1999, Medicare paid $61 million for services ordered
with a surrogate UPIN that had missing or incomplete supporting
documentation. Finally, the DHHS OIG stated that the findings in its
report also revealed misuse of surrogate UPINs on Medicare claims. The
HHS OIG found that surrogate UPINs were incorrectly used for many
services since the ordering physician had already been issued a
permanent UPIN. The HHS OIG believed this to be a significant problem
given that the use of a surrogate UPIN on medical equipment claims
allows them to be processed automatically whether the equipment has
been ordered by a physician or not. The HHS OIG stated that the
inappropriate use of surrogate UPINs by suppliers goes unchecked, the
Medicare program becomes vulnerable to fraudulent billings and
inappropriate payments.
To ensure the unique identification of ordering and referring
suppliers and that they were qualified to order and refer, Medicare
implemented claims edits in 2009 that require the ordering and
referring suppliers identified in Part B claims for items of DMEPOS and
services of laboratories, imaging suppliers, and specialists be
identified by their legal names and their NPIs and that they have
enrollment records in PECOS. Claims edits are under development to
ensure that claims for Part A and Part B home health services identify
the physicians who ordered the home health services by their legal
names and their NPIs and that those physicians have enrollment records
in PECOS.
2. Provisions of the Affordable Care Act
Section 6405(a) amended section 1834(a)(11)(B) of the Act to
specify, with respect to suppliers of durable medical equipment, that
payment may be made under that subsection only if the written order for
the item has been communicated to the DMEPOS supplier by a physician
who is enrolled under section 1866(j) of the Act or an eligible
professional under section 1848(k)(3)(B) who is enrolled under section
1866(j) before delivery of the item. Section 1128J(e) requires that he
or she be identified by his or her NPI in claims for those services.
Medicare requires the ordering supplier (the physician or the eligible
professional) to be identified by legal name and NPI in the claim
submitted by the supplier of DMEPOS.
Section 10604 of the Affordable Care Act, amended section 6405(b)
of the Affordable Care Act as follows: (1) Section 1814(a)(2) of the
Act to specify, with respect to home health services under Part A, that
payment may be made to providers of services if they are eligible and
only if a physician enrolled under section 1866(j) of the Act certifies
(and recertifies, as required) that the services are or were required
in accordance with section 1814(a)(1)(C) of the Act; and (2) section
1835(a)(2) of the Act to specify, with respect to home health services
under Part B, that payments may be made to providers of services if
they are eligible and only if a physician enrolled under section
1866(j) of the Act certifies (and recertifies, as required) that the
services are or were medically required in accordance with section
1835(a)(1)(B) of the Act. Section 1128J(e) requires that the physician
be identified by his or her NPI in claims for those services. Medicare
requires the ordering supplier (the physician) to be identified by
legal name and NPI in the claim submitted by the provider of home
health services.
In addition, section 6405(c) of the Affordable Care Act gives the
Secretary the authority to extend the requirements made by subsections
(a) and (b) to all other categories of items or services under title
XVIII of the Social Security Act, including covered Part D drugs as
defined in section 1860D-2(e) of the Act, that are ordered, prescribed,
or referred by a physician enrolled under section 1866(j) of the Act or
an eligible professional under section 1848(k)(3)(B) of the Act.
Section 1128J(e) requires that he or she be identified by his or her
NPI in claims for those services. Medicare requires the ordering or
referring supplier (the physician or the eligible professional) to be
identified by legal name and NPI in the claims submitted by the
suppliers of laboratory, imaging, and specialist services. These
amendments are effective on or after July 1, 2010.
3. Requirements of This IFC
To ensure that ordering suppliers (physicians and eligible
professionals) are uniquely identified in Medicare claims for covered
items of DMEPOS as required by section 6405(a) of the Affordable Care
Act, and to ensure that those DMEPOS items are ordered by qualified
physicians or eligible professionals, we are requiring at a new Sec.
424.507(a), the following:
In Part B claims for covered items of DMEPOS that require
the identification of the ordering supplier, and with the exception
noted below, the ordering supplier be a physician or an eligible
professional with an approved enrollment record in PECOS (see the
exception below), and be identified in the claim by his or her legal
name and by his or her own NPI (that is, by the NPI that was assigned
to him or her by the National Plan and Provider Enumeration System
[NPPES] as an Entity type 1 [an individual]).
To ensure that ordering suppliers are uniquely identified in
Medicare Part A claims for covered Part A or Part B home health
services as required by section 6405(b), as amended by section 10604 of
the Affordable Care Act, and to ensure that those home health services
are ordered by qualified physicians, we are requiring at a new Sec.
424.507, the following:
In Part A claims for covered Part A and Part B home health
items or services that require the identification of the ordering
supplier, and with the exception noted below, the ordering supplier be
a physician with an approved enrollment record in PECOS
[[Page 24443]]
(see the exception below), and be identified in the claim by his or her
legal name and by his or her own NPI (that is, by the NPI that was
assigned to him or her by the National Plan and Provider Enumeration
System [NPPES] as an Entity type 1 [an individual]).
To ensure that ordering or referring suppliers are uniquely
identified in Part B claims for covered services of laboratories,
imaging suppliers, and specialists, under the discretion afforded the
Secretary in section 6405(c), and to ensure that those items or
services are ordered or referred by qualified physicians or eligible
professionals, we are requiring at a new Sec. 424.507(b), the
following:
In Part B claims for covered services of laboratories,
imaging suppliers, and specialists that require the identification of
the ordering or referring supplier, and with the exception noted below,
the ordering or referring supplier be a physician or an eligible
professional with an approved enrollment record in PECOS (see the
exception below), and be identified in the claim by his or her legal
name and by his or her own NPI (that is, by the NPI that was assigned
to him or her by the National Plan and Provider Enumeration System
(NPPES) as an Entity Type 1 (an individual).
We are requiring at a new Sec. 424.507(c) that Medicare
contractors will reject claims from providers and suppliers for the
above-described covered ordered or referred items or services if the
legal names and the NPIs are not reported in the claims or, with the
exception noted below, if the ordering or referring supplier does not
have an approved enrollment record in PECOS.
We are requiring at a new Sec. 424.507(d) that Medicare
contractors may deny a claim submitted by a Medicare beneficiary for
the above-described ordered or referred covered items and services if
the ordering or referring supplier is not identified by his or her
legal name or, with the exception noted below, if the ordering or
referring supplier does not have an approved enrollment record in
PECOS.
Our continuing outreach efforts stress the need for those who order
and refer to have approved enrollment records in PECOS.
While we are not including additional categories of ordered or
referred covered items or services in this IFC (such as Part B drugs),
we reserve the right to apply these requirements to additional
categories through future rulemaking once the policies have been
developed. We are considering proposing the requirements for covered
prescribed Part B drugs within the next year.
A physician or eligible professional who orders or refers must be
enrolled in the Medicare program by having an enrollment record in an
approved status in PECOS, even if he or she is enrolled only for the
purposes of ordering and referring. To ensure that orders and referrals
for Medicare beneficiaries are written by qualified physicians and
eligible professionals, it is necessary that their credentials be
verified; such verification can occur only as part of the Medicare
provider/supplier enrollment process. PECOS, as described earlier in
this preamble, is the national Medicare FFS provider and supplier
enrollment repository. All providers and suppliers who enrolled in
Medicare within the past 6 years, as well as those who enrolled more
than 6 years ago and who have submitted updates to their enrollment
information within the past 6 years, have enrollment records in PECOS
that contain verified credentials. Those who enrolled more than 6 years
ago and who have not updated their enrollment information in the past 6
(or more) years will need to submit enrollment applications to Medicare
to establish enrollment records in PECOS. They may do this by filling
out the paper Medicare provider enrollment applications (using the
appropriate form(s) from the CMS-855 series of forms) and mailing the
completed application(s) to the appropriate Medicare enrollment
contractor or by using Internet-based PECOS to submit their enrollment
application to the Medicare enrollment contractor over the Internet.
With the implementation in 2009 of the claims processing edits to
ensure the NPI and the name reported in claims to identify the ordering
or referring suppliers matched information in PECOS for physicians and
professionals of a profession eligible to order and refer, many
enrolled physicians and eligible professionals who do not have
enrollment records in PECOS are submitting enrollment applications in
order to establish those enrollment records. We expect that most, if
not all, of them will have submitted enrollment applications before the
end of 2010, including those who are enrolling solely to continue to
order and refer. A physician or eligible professional who is deceased,
retired, or excluded from the Medicare program, or who otherwise would
not have an approved enrollment record in PECOS, would not be eligible
to order or refer items or services for Medicare beneficiaries. Please
note the following exception for physicians and eligible professionals
who do not have an approved enrollment record in PECOS:
Under section 1802(b) of the Act and the implementing regulations
at 42 CFR 405.400 et seq., physicians and non-physician practitioners
can opt out of the Medicare program and enter into private contracts
with Medicare beneficiaries. By entering into these types of contracts,
these suppliers do not bill the Medicare program for services that they
furnish to Medicare beneficiaries. We require that physicians and
eligible professionals who have properly filed an appropriate affidavit
with a Medicare contractor in order to opt out of the Medicare program
be required to be identified in claims by their names and their NPIs if
they order or refer covered items or services for Medicare
beneficiaries. We are creating an exception to the requirement that
ordering and referring suppliers be required to have an approved
enrollment record in PECOS for those physicians and non-physician
practitioners who have validly opted out of the Medicare program.
Therefore, physicians and non-physician practitioners who have validly
opted out of Medicare are eligible to order and refer covered items and
services for Medicare beneficiaries. If they have properly completed
the appropriate affidavit in order to opt out of Medicare, they will
have records in PECOS that contain their NPIs and that indicate that
they have validly opted out of the Medicare program. In January 2009,
there were approximately 10,000 physicians and eligible professionals
who had opted out of the Medicare program. Compared to the more than
800,000 enrolled physicians and eligible professionals, there are
relatively few physicians and eligible professionals who have opted out
of Medicare.
Accordingly, the physicians or eligible professional that opted out
must meet the following:
A currently enrolled physician or eligible professional
who does not have an enrollment record in PECOS is required to
establish an enrollment record in PECOS so that he or she can order and
refer covered items or services for Medicare beneficiaries. A physician
or eligible professional who has validly opted out of the Medicare
program will have a valid opt-out record in PECOS and is not required
to submit an enrollment application.
A physician or eligible professional who is employed by
the Public Health Service, the Department of Defense, or the Department
of Veterans Affairs is required to have an approved enrollment record
in PECOS in order to order and refer covered items and services for
Medicare beneficiaries, even though he or she would not be
[[Page 24444]]
submitting claims to Medicare for services furnished to Medicare
beneficiaries. We require, therefore, that these physicians and
eligible professionals enroll in Medicare solely to order and refer
(and not to be paid for services furnished to Medicare beneficiaries).
A dentist furnishes many services that are not covered by
Medicare and, as a result, most dentists are not enrolled in Medicare.
However, a dentist may order services for patients who are Medicare
beneficiaries, such as sending oral specimens to laboratories for
testing. Doctors of dental medicine or dental surgery are considered
physicians and we require that they have approved enrollment records in
PECOS if they order or refer covered items or services for patients who
are Medicare beneficiaries.
A pediatrician may treat Medicare beneficiaries (for
example, those of any age who are enrolled in the Medicare end-stage
renal disease (ESRD) program or those who are entitled to Medicare
benefits under other Federal programs), although the volume of such
patients is generally so low that most pediatricians are not enrolled
in Medicare. We require that a pediatrician have an approved enrollment
record in PECOS if he or she orders or refers covered items or services
for patients who are Medicare beneficiaries.
Residents and interns order and refer covered items and
services for Medicare beneficiaries. Prior to the implementation of the
NPI, residents and interns were identified in claims as the ordering or
referring providers by surrogate UPINs. Interns are not issued medical
licenses by States; therefore, they are not eligible to enroll in
Medicare. Residents have medical licenses if they practice in States
that issue medical licenses to residents; as a result, some residents
are eligible to enroll in Medicare. Due to the variances in licensure
and the necessity for interns and residents to be able to continue to
order and refer covered items and services for Medicare beneficiaries,
we require that the teaching physician--not the resident or intern--be
identified in the claim as the ordering or referring provider whenever
a resident or intern orders or refers.
These ordering and referring requirements, when implemented, will
allow us to uniquely identify the ordering and referring supplier in
claims (except when the teaching physician is identified as the
ordering or referring supplier in situations where an intern or a
resident ordered or referred) and assure, because of the requirement to
have an approved enrollment or valid opt out record in PECOS, that the
ordering and referring supplier is qualified to order and refer items
and services for Medicare beneficiaries. This will enable us to edit
claims for ordering and referring suppliers who do not have approved
enrollment records in PECOS (that is, those who are excluded, deceased,
or retired, and those whose Medicare billing privileges have been
terminated through exclusion, revocation, or otherwise), and those who
have voluntarily terminated their relationship with Medicare or who
have validly opted out of Medicare.
Further, we are requiring that Part A claims for covered ordered
Part A and Part B home health services must include the legal name and
the NPI of the ordering supplier, who must be a physician. We are
requiring that Part B claims for covered, ordered, and referred Part B
items and services (excluding Part B drugs) must include the legal name
and the NPI of the ordering or referring supplier. We place these same
requirements (except for the NPI) on claims submitted by Medicare
beneficiaries for these same ordered or referred items and services.
Although suppliers are required to submit claims on behalf of
beneficiaries under the mandatory claim submission policy at section
1848(g)(4)(A) of the Act, we recognize that beneficiaries may submit
claims to Medicare for payment. In order to fully enforce the ordering
and referring requirement established by section 6405 of the Affordable
Care Act, we plan to deny a beneficiary claim for a service when the
legal name of the ordering or referring supplier is not included on the
claim.
We believe that these requirements will promote quality health care
services for Medicare beneficiaries because orders and referrals would
be written by qualified physicians and eligible professionals, as their
credentials would have been verified as part of the Medicare provider/
supplier enrollment process.
Additionally, we believe these requirements will eliminate the
abusive practice of reporting identifiers in claims as being assigned
to specific ordering or referring suppliers when, in fact, those
identifiers had not been assigned to those specific ordering or
referring suppliers. As a result, our requirements should eliminate
these types of problematic claims and ensure the qualifications of the
ordering and referring suppliers.
Our requirements will enable us to know the identity of the
individual who ordered or referred and, if appropriate, we could
establish edits to check for over-ordering specific items or services,
over-referring specific services, and/or over-ordering or over-
referring to specific providers of services and suppliers.
Furthermore, these requirements support our existing authority, at
Sec. 424.516(f), under which the ordering and referring suppliers, and
those providers of services and suppliers who furnish covered items or
services based on orders or referrals, are required to maintain
documentation (to include the NPI) that supports the orders and
referrals for 7 years in order to maintain an active enrollment status
in the Medicare program.
Lastly, these requirements may lead to a reduction in inappropriate
Medicare payments.
We are aware that, in some cases, Medicare beneficiaries may be
patients of physicians or eligible professionals who do not have
approved enrollment records in PECOS, or may be patients of
professionals who are not of a profession that is eligible to order or
refer, and that these physicians and professionals may be ordering and
referring covered items and services for these Medicare beneficiaries
at this time. We expect to conduct outreach activities to educate
Medicare beneficiaries, as well as Medicare providers of services and
suppliers who furnish covered items and services based on orders and
referrals, so that we can eliminate situations where those providers of
services and suppliers who would be furnishing covered ordered and
referred items and services would not be paid for those covered items
or services because their claims failed the edits.
Finally, we believe that the requirements will address the
recommendations offered by the DHHS OIG report titled, ``Medicare
Payments in 2007 for Medical Equipment and Supply Claims with Invalid
or Inactive Referring Physician Identifiers, OEI-04-08-00470, February
2009.'' Specifically, the OIG recommended that CMS:
(1) Determine why Medicare claims with identifiers associated with
deceased referring physicians continue to be paid;
(2) Implement claims-processing system changes to ensure that NPIs
for both referring physicians and suppliers be listed on medical
equipment and supply claims are valid and active.
(3) Emphasize to suppliers the importance of using accurate NPIs
for both referring physicians and suppliers when submitting Medicare
claims; and
(4) Determine the earliest date to end the provision that allows
suppliers to submit claims without referring
[[Page 24445]]
physician NPIs while maintaining beneficiary access to services.
With respect to recommendation (4), we began requiring Medicare
claims to identify ordering and referring providers by NPIs beginning
May 23, 2008. If the provider of services or the supplier submitting
the claim for the covered ordered or referred items or services could
not determine the NPI of the ordering or referring supplier, we
permitted the provider of services or the supplier submitting the claim
to use its own NPI in place of the NPI of the ordering or referring
provider. These types of claims for DMEPOS items now fail the claims
processing edits that were implemented in 2009. Medicare-enrolled
physicians and professionals are required to have NPIs. The NPI
Registry (available at https://nppes.cms.hhs.gov/NPPES/NPIRegistryHome.do) enables anyone with a computer with Internet access
to look up a health care provider's NPI by name or NPI, and the NPPES
downloadable file (downloadable from https://nppesdata.cms.hhs.gov/CMS_NPI_files.html) contains the NPIs of all health care providers who
have active NPIs, as well as identifying information about the health
care providers that is publicly disclosable under the Freedom of
Information Act. (The National Plan and Provider Enumeration System
Data Dissemination Notice, published in the May 30, 2007 Federal
Register, further describes the NPI Registry and the NPPES downloadable
file.) The existing claims processing edits described earlier in this
preamble check to ensure that the NPI reported on a Part B claim for
ordered or referred covered items or services (excluding Part B home
health services and Part B drug claims) belongs to the ordering or
referring supplier whose name is also reported in those claims, and not
to the supplier who submitted the claim. As stated previously, the
provisions of section 6405 of the Affordable Care Act are effective
July 1, 2010.
C. Requirement for Physicians, Other Suppliers, and Providers to
Maintain and Provide Access to Documentation on Referrals to Programs
at High Risk of Waste and Abuse
1. Background
On November 19, 2008, we published a final rule with comment
titled, ``Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2009; Revisions to the
Amendment of the E-Prescribing Exemption for Computer Generated
Facsimile Transmissions; and the Competitive Acquisition for Certain
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS)'' in the Federal Register. In this IFC, we established Sec.
424.516(f) to require providers and suppliers to maintain ordering and
referring documentation, including the NPI, received from a physician
or eligible non-physician practitioner. We also established in Sec.
424.516(f) that physicians and eligible professionals are required to
maintain written ordering and referring documentation for 7 years from
the date of service. Finally, we established in Sec. 424.535(a)(10)
that failure to comply with the documentation requirements specified in
Sec. 424.516(f) is a reason for revocation.
2. Provisions of the Affordable Care Act
Section 6406 of the Affordable Care Act amends section 1866(a)(1)
of the Act and added a new subparagraph (W) which requires providers to
agree to ``maintain and, upon request of the Secretary, provide access
to documentation relating to written orders or requests for payment for
durable medical equipment, certifications for home health services, or
referrals for other items or services written or ordered by the
provider under this title, as specified by the Secretary.''
In addition, section 6406 of the Affordable Care Act amended
section 1842(h) of the Act by adding a new paragraph which states,
``The Secretary may revoke enrollment, for a period of not more than
one year for each act, for a physician or supplier under section
1866(j) if such physician or supplier fails to maintain and, upon
request of the Secretary, provide access to documentation relating to
written orders or requests for payment for durable medical equipment,
certifications for home health services, or referrals for other items
or services written or ordered by such physician or supplier under this
title, as specified by the Secretary.''
Section 6406(b)(3) of the Affordable Care Act amends section
1866(a)(1) of the Act to require that providers and suppliers maintain
and, upon request, provide to the Secretary, access to written or
electronic documentation relating to written orders or requests for
payment for durable medical equipment, certifications for home health
services, or referrals for other items or services written or ordered
by the provider as specified by the Secretary. Section 6406(b)(3) does
not limit the authority of the Office of Inspector General to fulfill
the Inspector General's responsibilities in accordance with applicable
Federal law.
3. Requirements of This IFC
In our requirements, in our revision of Sec. 424.516(f), we are
replacing the term ``eligible non-physician practitioner'' with
``eligible professional.'' This change is consistent with our
definition of ``eligible professional'' and correctly identifies the
professionals who, in addition to physicians, are eligible to order and
refer.
At this time, we are expanding Sec. 424.516(f) to include
requirements for documentation and access to documentation related to
orders and referrals for covered home health, laboratory, imaging, and
specialist services. Section 424.516(f) currently includes requirements
for documentation and access to documentation for orders for DMEPOS. We
reserve the right to, at a future date,