Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute, 21314-21320 [2013-08314]
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Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Proposed Rules
making it necessary to retain the
electronic prescribing capability
requirement in the electronic health
records exception.
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of $7.0 million to $34.5 million in any
1 year. Individuals and States are not
included in the definition of a small
entity. The Secretary has determined
that this proposed rule would not have
a significant economic impact on a
substantial number of 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 603 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 for
Medicare payment regulations and has
fewer than 100 beds. The Secretary has
determined, that this proposed rule
would 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 whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2013, that threshold is approximately
$141 million. This proposed rule would
have no consequential effect on State,
local, or tribal governments or on the
private sector.
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
governments, preempts State law, or
otherwise has Federalism implications.
Since this regulation does not impose
any costs on State or local governments,
the requirements of Executive Order
13132 are not applicable.
In accordance with the provisions of
Executive Order 12866, this rule was
reviewed by the Office of Management
and Budget.
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List of Subjects for 42 CFR Part 411
Kidney diseases, Medicare, Physician
Referral, Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR part 411 as set forth below:
PART 411—EXCLUSIONS FROM
MEDICARE AND LIMITATIONS ON
MEDICARE PAYMENT
1. The authority citation for part 411
continues to read as follows:
■
Authority: Secs. 1102, 1860D–1 through
1860D–42, 1871, and 1877 of the Social
Security Act (42 U.S.C. 1302, 1395w–101
through 1395w–152, 1395hh, and 1395nn).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
42 CFR Part 1001
RIN 0936–AA03
Medicare and State Health Care
Programs: Fraud and Abuse;
Electronic Health Records Safe Harbor
Under the Anti-Kickback Statute
Office of Inspector General
(OIG), HHS.
ACTION: Proposed rule.
AGENCY:
§ 411.357 Exceptions to the referral
prohibition related to compensation
arrangements.
In this proposed rule, the
Office of Inspector General (OIG)
proposes to amend the safe harbor
regulation concerning electronic health
records items and services, which
defines certain conduct that is protected
from liability under the Federal antikickback statute in the Social Security
Act (the Act). The proposed
amendments include an update to the
provision under which electronic health
records software is deemed
interoperable; removal of the electronic
prescribing capability requirement; and
extension of the sunset provision. In
addition, OIG is requesting public
comment on other changes it is
considering.
*
DATES:
2. Section 411.357 is amended by:
A. Revising paragraph (w)(2).
■ B. Removing and reserving paragraph
(w)(11).
■ C. In paragraph (w)(13), removing the
date ‘‘December 31, 2013’’ and adding
the date ‘‘December 31, 2016’’ in its
place.
The revision reads as follows:
■
■
*
*
*
*
(w) * * *
(2) The software is interoperable (as
defined in § 411.351) at the time it is
provided to the physician. For purposes
of this paragraph (w), software is
deemed to be interoperable if a
certifying body authorized by the
National Coordinator for Health
Information Technology has certified
the software to any edition of electronic
health record certification criteria
identified in the then-applicable
definition of Certified EHR Technology
in 45 CFR part 170, on the date it is
provided to the physician.
*
*
*
*
*
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: January 24, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: March 7, 2013
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2013–08312 Filed 4–8–13; 4:15 pm]
BILLING CODE 4120–01–P
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SUMMARY:
To assure consideration,
comments must be delivered to the
address provided below by no later than
5 p.m. Eastern Standard Time on June
10, 2013.
ADDRESSES: In commenting, please
reference file code OIG–404–P. Because
of staff and resource limitations, we
cannot accept comments by facsimile
(fax) transmission. However, you may
submit comments using one of three
ways (no duplicates, please):
1. Electronically. You may submit
electronically through the Federal
eRulemaking Portal at https://
www.regulations.gov. (Attachments
should be in Microsoft Word, if
possible.)
2. By regular, express, or overnight
mail. You may mail your printed or
written submissions to the following
address: Patrice Drew, Office of
Inspector General, Department of Health
and Human Services, Attention: OIG–
404–P, Room 5541C, Cohen Building,
330 Independence Avenue SW.,
Washington, DC 20201.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By hand or courier. You may
deliver, by hand or courier, before the
close of the comment period, your
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Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Proposed Rules
printed or written comments to: Patrice
Drew, Office of Inspector General,
Department of Health and Human
Services, Cohen Building, Room 5541C,
330 Independence Avenue SW.,
Washington, DC 20201.
Because access to the interior of the
Cohen Building is not readily available
to persons without Federal Government
identification, commenters are
encouraged to schedule their delivery
with one of our staff members at (202)
619–1368.
Inspection of Public Comments: All
comments received before the end of the
comment period will be posted on
https://www.regulations.gov for public
viewing. Hard copies will also be
available for public inspection at the
Office of Inspector General, Department
of Health and Human Services, Cohen
Building, 330 Independence Avenue
SW., Washington, DC 20201, Monday
through Friday from 8:30 a.m. to 4 p.m.
To schedule an appointment to view
public comments, phone (202) 619–
1368. Comments received by OIG will
be shared with the Centers for Medicare
& Medicaid Services (CMS).
FOR FURTHER INFORMATION CONTACT:
James A. Cannatti III or Heather L.
Westphal, Office of Counsel to the
Inspector General, (202) 619–0335.
SUPPLEMENTARY INFORMATION:
Social Security Act
Citation
1128B ........................
United States Code
Citation
42 U.S.C. 1320a–7b
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Executive Summary
A. Purpose of the Regulatory Action
Pursuant to section 14 of the Medicare
and Medicaid Patient and Program
Protection Act of 1987 and its legislative
history, Congress required the Secretary
of Health and Human Services (the
Secretary) to promulgate regulations
setting forth various ‘‘safe harbors’’ to
the anti-kickback statute, which would
be evolving rules that would be
periodically updated to reflect changing
business practices and technologies in
the health care industry. In accordance
with this authority, OIG published a
safe harbor to protect certain
arrangements involving the provision of
interoperable electronic health records
software or information technology and
training services. The final rule for this
safe harbor was published on August 8,
2006 (71 FR 45110) and is scheduled to
sunset on December 31, 2013 (42 CFR
1001.952(y)(13)). The purpose of this
proposed rule is to update certain
aspects of the electronic health records
safe harbor and to extend the sunset
date.
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B. Summary of the Major Provisions
This proposed rule would amend the
current safe harbor in at least three
ways. First, the proposed rule would
update the provision under which
electronic health records software is
deemed interoperable. Second, we
propose to remove the requirement
related to electronic prescribing
capability from the safe harbor. Third,
we propose to extend the sunset date of
the safe harbor. In addition to these
proposals, we are soliciting public
comment on other possible amendments
to the safe harbor, including limiting the
scope of protected donors and adding or
modifying conditions to limit the risk of
data and referral lock-in.
C. Costs and Benefits
The proposed rule would modify an
already-existing safe harbor to the antikickback statute. This safe harbor
permits certain entities to provide
technology-related items and services to
certain parties to be used to create,
maintain, transmit, or receive electronic
health records. Parties may voluntarily
seek to comply with safe harbors so that
they have assurance that their conduct
will not subject them to any
enforcement actions under the antikickback statute, but safe harbors do not
impose new requirements on any party.
This is not a major rule, as defined at
5 U.S.C. 804(2). It is also not
economically significant, because it will
not have a significant effect on program
expenditures, and there are no
additional substantive costs to
implement the resulting provisions. The
proposed rule would update the
provision under which electronic health
records software is deemed
interoperable, remove the requirement
related to electronic prescribing
capability, and extend the safe harbor’s
sunset date (currently set at December
31, 2013). We expect these proposed
changes to continue to facilitate the
adoption of electronic health records
technology.
I. Background
A. Anti-Kickback Statute and Safe
Harbors
Section 1128B(b) of the Social
Security Act (the Act) (42 U.S.C. 1320a–
7b(b), the anti-kickback statute)
provides criminal penalties for
individuals or entities that knowingly
and willfully offer, pay, solicit, or
receive remuneration in order to induce
or reward the referral of business
reimbursable under any of the Federal
health care programs, as defined in
section 1128B(f) of the Act. The offense
is classified as a felony and is
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punishable by fines of up to $25,000
and imprisonment for up to 5 years.
Violations of the anti-kickback statute
may also result in the imposition of civil
monetary penalties (CMP) under section
1128A(a)(7) of the Act (42 U.S.C. 1320a–
7a(a)(7)), program exclusion under
section 1128(b)(7) of the Act (42 U.S.C.
1320a–7(b)(7)), and liability under the
False Claims Act (31 U.S.C. 3729–33).
The types of remuneration covered
specifically include, without limitation,
kickbacks, bribes, and rebates, whether
made directly or indirectly, overtly or
covertly, in cash or in kind. In addition,
prohibited conduct includes not only
the payment of remuneration intended
to induce or reward referrals of patients,
but also the payment of remuneration
intended to induce or reward the
purchasing, leasing, or ordering of, or
arranging for or recommending the
purchasing, leasing, or ordering of, any
good, facility, service, or item
reimbursable by any Federal health care
program.
Because of the broad reach of the
statute, concern was expressed that
some relatively innocuous commercial
arrangements were covered by the
statute and, therefore, potentially
subject to criminal prosecution. In
response, Congress enacted section 14 of
the Medicare and Medicaid Patient and
Program Protection Act of 1987, Public
Law 100–93 (section 1128B(b)(3)(E) of
the Act; 42 U.S.C. 1320a–7b(B)(3)(E)),
which specifically required the
development and promulgation of
regulations, the so-called ‘‘safe harbor’’
provisions, that would specify various
payment and business practices that
would not be subject to sanctions under
the anti-kickback statute, even though
they may potentially be capable of
inducing referrals of business under the
Federal health care programs. Since July
29, 1991, we have published in the
Federal Register a series of final
regulations establishing ‘‘safe harbors’’
in various areas.1 These OIG safe harbor
provisions have been developed ‘‘to
limit the reach of the statute somewhat
by permitting certain non-abusive
arrangements, while encouraging
beneficial or innocuous arrangements.’’
56 FR 35952, 35958 (July 29, 1991).
Health care providers and others may
voluntarily seek to comply with safe
harbors so that they have the assurance
that their business practices will not be
subject to any enforcement action under
the anti-kickback statute, the CMP
provision for anti-kickback violations,
1 56 FR 35952 (July 29, 1991); 61 FR 2122 (Jan.
25, 1996); 64 FR 63518 (Nov. 19, 1999); 64 FR
63504 (Nov. 19, 1999); 66 FR 62979 (Dec. 4, 2001);
71 FR 45109 (Aug. 8, 2006); and 72 FR 56632 (Oct.
4, 2007).
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or the program exclusion authority
related to kickbacks. In giving the
Department of Health and Human
Services (Department or HHS) the
authority to protect certain
arrangements and payment practices
under the anti-kickback statute,
Congress intended the safe harbor
regulations to be updated periodically to
reflect changing business practices and
technologies in the health care industry.
B. The Electronic Health Records Safe
Harbor
In the October 11, 2005 Federal
Register (70 FR 59015), we published a
notice of proposed rulemaking (the 2005
Proposed Rule) that would promulgate
two safe harbors to address donations of
certain electronic health records
software and directly related training
services, using our authority at section
1128B(b)(3)(E) of the Act. See 70 FR
59015, 59021 (Oct. 11, 2005). One
proposed safe harbor would have
protected certain arrangements
involving donations of electronic health
records technology made before the
adoption of certification criteria. The
other proposed safe harbor would have
protected certain arrangements
involving nonmonetary remuneration in
the form of interoperable electronic
health records software certified in
accordance with criteria adopted by the
Secretary of HHS (Secretary) and
directly related training services. In the
same issue of the Federal Register (70
FR 59182 (Oct. 11, 2005)), CMS
simultaneously proposed similar
exceptions to the physician self-referral
law.
On August 8, 2006 (71 FR 45110), we
published a final rule (the 2006 Final
Rule) that, among other things, finalized
a safe harbor 2 at 42 CFR 1001.952(y)
(the electronic health records safe
harbor) for protecting certain
arrangements involving interoperable
electronic health records software or
information technology and training
services. In the same issue of the
Federal Register (71 FR 45140 (Aug. 8,
2006)), CMS simultaneously published
similar final regulations at 42 CFR
411.357(w). The electronic health
records safe harbor is scheduled to
sunset on December 31, 2013. 42 CFR
1001.952(y)(13).
The present proposed rule sets forth
certain proposed changes to the
electronic health records safe harbor.
CMS is proposing almost identical
2 For the reasons discussed in more detail in the
preamble to the 2006 Final Rule, we abandoned the
proposal to have separate pre- and postinteroperability safe harbors for electronic health
records arrangements. See 71 FR 45110, 45121
(Aug. 8, 2006).
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changes to the physician self-referral
law electronic health records
exception 3 elsewhere in this issue of
the Federal Register. We attempted to
ensure as much consistency as possible
between our proposed safe harbor
changes and CMS’s proposed exception
changes, despite the differences in the
respective underlying statutes. We
intend the final rules to be similarly
consistent. Because of the close nexus
between this proposed rule and CMS’s
proposed rule, we may consider
comments submitted in response to
CMS’s proposed rule when crafting our
final rule. Similarly, CMS may consider
comments submitted in response to this
proposed rule in crafting its final rule.
II. Provisions of the Proposed Rule
A. The Deeming Provision
Our current electronic health records
safe harbor specifies at 42 CFR
1001.952(y)(2) that the donated software
must be ‘‘interoperable at the time it is
provided to the recipient.’’ As discussed
in a recently issued Request for
Information (RFI) from the Department,
‘‘HHS envisions an information rich,
person-centered, high performance
health care system where every health
care provider has access to longitudinal
data on patients they treat to make
evidence-based decisions, coordinate
care and improve health outcomes.’’ 78
FR 14793, 14795 (Mar. 7, 2013).
Additionally, as emphasized in the RFI,
interoperability will play a critical role
in supporting this vision.
Interoperability is also an important
concept in the context of the electronic
health records safe harbor. Although we
have long been concerned that parties
could use the offer or donation of
technology to capture referrals, we have
viewed interoperability as a potential
mitigating factor, or safeguard, to justify
other safe harbor conditions that are less
stringent than might otherwise be
appropriate in the absence of
interoperability. This is because if the
donated technology is interoperable, the
recipient will be able to use it to
transmit electronic health records not
only to the donor, but to others,
including competitors of the donor, and
will not be ‘‘locked in’’ to
communications with the donor only.
See 70 FR 59015, 59023 (Oct. 11, 2005);
71 FR 45110, 45126 (Aug. 8, 2006). For
purposes of this safe harbor,
‘‘interoperable’’ means ‘‘able to
communicate and exchange data
accurately, effectively, securely, and
consistently with different information
technology systems, software
3 42
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applications, and networks, in various
settings, and exchange data such that
the clinical or operational purpose and
meaning of the data are preserved and
unaltered.’’ Note to paragraph (y) of 42
CFR 1001.952. The current provisions of
the electronic health records safe harbor
state that for purposes of meeting the
condition set forth in subparagraph
(y)(2), ‘‘software is deemed to be
interoperable if a certifying body
recognized by the Secretary has certified
the software within no more than 12
months prior to the date it is provided
to the recipient.’’ 42 CFR 1001.952(y)(2).
We propose to update two aspects of
this deeming provision to reflect the
current Office of the National
Coordinator for Health Information
Technology (ONC) certification program
for electronic health record technology.
First, we propose to modify the
provision to reflect that ONC is
responsible for ‘‘recognizing’’ certifying
bodies, as referenced in this provision.
See 42 U.S.C. 300jj–11(c)(5). To become
a certifying body ‘‘recognized’’ by the
Secretary, an entity must successfully
complete an authorization process
established by ONC. This authorization
process constitutes the Secretary’s
recognition of a certifying body.
Accordingly, we propose to revise the
phrase ‘‘recognized by the Secretary’’ in
the second sentence of subparagraph
(y)(2) to read ‘‘authorized by the
National Coordinator for Health
Information Technology.’’
Second, we propose to modify the
portion of this provision concerning the
time period within which the software
must have been certified. Currently, the
electronic health records safe harbor
deeming provision requires that
software must have been certified
within no more than 12 months prior to
the date of donation in order to ensure
that products have an up-to-date
certification. Subsequent to issuing the
final electronic health records safe
harbor, ONC developed a regulatory
process for adopting certification
criteria and standards. That process is
anticipated to occur on a 2-year
regulatory interval. (For more
information, see ONC’s September 4,
2012 Final Rule titled ‘‘Health
Information Technology: Standards,
Implementation Specifications, and
Certification Criteria for Electronic
Health Record Technology, 2014
Edition; Revisions to the Permanent
Certification Program for Health
Information Technology’’ (77 FR
54163).) Further, some certification
criteria could remain unchanged from
one edition of the electronic health
record certification criteria to the next.
Thus, the current 12-month timeframe is
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not in line with the anticipated 2-year
regulatory interval and does not account
for the fact that some certification
criteria may not change from one
edition to the next. Therefore, we
propose to modify this portion of the
safe harbor by removing the 12-month
timeframe and substituting a provision
that more closely tracks the current
ONC certification program. Accordingly,
we propose that software would be
eligible for deeming if, on the date it is
provided to the recipient, it has been
certified to any edition of the electronic
health record certification criteria that is
identified in the then-applicable
definition of Certified EHR Technology
in 45 CFR part 170. For example, for
2013, the applicable definition of
Certified EHR Technology identifies
both the 2011 and the 2014 editions of
the electronic health record certification
criteria. Therefore, in 2013, software
certified to meet either the 2011 edition
or the 2014 edition could satisfy the safe
harbor provision as we proposed to
modify it. The current definition of
Certified EHR Technology applicable for
2014, however, identifies only the 2014
edition. Thus, based on that definition,
in 2014, only software certified to the
2014 edition could satisfy our proposed,
modified provision. Future
modifications to the definition of
Certified EHR Technology could result
in the identification of other editions to
which software could be certified and
satisfy our proposed, modified
provision. As we stated in the 2006
Final Rule, we understand ‘‘that the
ability of software to be interoperable is
evolving as technology develops. In
assessing whether software is
interoperable, we believe the
appropriate inquiry is whether the
software is as interoperable as feasible
given the prevailing state of technology
at the time [it] is provided to the
recipient.’’ 71 FR 45110, 45126 (Aug. 8,
2006). We believe our proposed change
is consistent with that understanding
and our objective of ensuring that
products are certified to the current
standard of interoperability when they
are donated. We seek comment on our
proposal, including if removing the 12month period will impact donations and
whether we should consider retaining it
as an additional means of determining
eligibility under the deeming provision.
B. The Electronic Prescribing Provision
Our current electronic health records
safe harbor specifies at 42 CFR
1001.952(y)(10) that the donated
software must ‘‘contain [ ] electronic
prescribing capability, either through an
electronic prescribing component or the
ability to interface with the recipient’s
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existing electronic prescribing system,
that meets the applicable standards
under Medicare Part D at the time the
items and services are provided.’’ In the
preamble to the 2006 Final Rule, we
stated that we included ‘‘this
requirement, in part, because of the
critical importance of electronic
prescribing in producing the overall
benefits of health information
technology, as evidenced by section 101
of the [Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA), Pub. L. 108–173].’’ 71 FR
45110, 45125 (Aug. 8, 2006). As we
noted, it was ‘‘our understanding that
most electronic health records systems
already include an electronic
prescribing component.’’ Id.
We continue to believe in the critical
importance of electronic prescribing.
However, in light of developments since
the 2006 Final Rule, we do not believe
that it is necessary to retain a
requirement related to electronic
prescribing capability in the electronic
health records safe harbor. First,
Congress subsequently enacted
legislation addressing electronic
prescribing. In 2008, Congress passed
the Medicare Improvements for Patients
and Providers Act of 2008 (MIPPA),
Pub. L. 110–275. Section 132 of MIPPA
authorized an electronic prescribing
incentive program (starting in 2009) for
certain types of eligible professionals.
Further, in 2009, Congress passed the
Health Information Technology for
Economic and Clinical Health (HITECH)
Act, Title XIII of Division A and Title IV
of Division B of the American Recovery
and Reinvestment Act of 2009 (ARRA),
Pub. L. 111–5. The HITECH Act
authorizes CMS to establish Medicare
and Medicaid electronic health record
incentive programs for certain eligible
professionals, eligible hospitals, and
critical access hospitals. 42 U.S.C.
1395w–4(o), 1395ww(n), 1395f(l)(3),
and 1396b(t). The HITECH Act requires
that eligible professionals under the
Medicare and Medicaid electronic
health record incentive programs
demonstrate meaningful use of certified
electronic health record technology,
including the use of electronic
prescribing. 42 U.S.C. 1395w–
4(o)(2)(A)(i). Second, the industry has
made great progress related to electronic
prescribing. Recent analysis by ONC
notes an increase in the percentage of
physicians electronically prescribing via
electronic health record technology
from 7 percent in 2008 to 48 percent in
2012, reflecting rapid increases over the
past few years in the rate of electronic
health record-based electronic
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prescribing capabilities.4 Furthermore,
the regulations recently published to
implement Stage 2 of the EHR Incentive
Programs continue to encourage
physicians’ use of electronic prescribing
technology. See 77 FR 53968, 53989
(Sept. 4, 2012); 77 FR 54163, 54198
(Sept. 4, 2012).
In light of these developments, we
propose to delete the electronic
prescribing condition at 42 CFR
1001.952(y)(10). We believe that there
are sufficient alternative policy drivers
supporting the adoption of electronic
prescribing capabilities. We also note
that electronic prescribing technology
would remain eligible for donation
under the electronic health records safe
harbor or under the electronic
prescribing safe harbor at 42 CFR
1001.952(x). Additionally, we
considered whether removing this
condition would increase the risk of
fraud or abuse posed by donations made
under the safe harbor; we do not believe
that it would.
C. The Sunset Provision
The electronic health records safe
harbor is scheduled to sunset on
December 31, 2013. In adopting this
condition of the electronic health
records safe harbor, we acknowledged
‘‘that the need for a safe harbor for
donations of electronic health records
technology should diminish
substantially over time as the use of
such technology becomes a standard
and expected part of medical practice.’’
71 FR 45110, 45133 (Aug. 8, 2006).
Some have suggested that we extend the
sunset date or even remove the sunset
provision entirely.
In recent years, electronic health
record technology adoption has risen
dramatically, largely as a result of the
HITECH Act in 2009. For example, see
Farzad Mostashari, M.D., ScM., National
Coordinator, ONC, U.S. Department of
Health and Human Services, Testimony
before the Subcommittee on Technology
and Innovation Committee on Science
and Technology, available at https://
science.house.gov/sites/
republicans.science.house.gov/files/
documents/HHRG-112-SY19-WStateFMostashari-20121114.pdf and HHS
News Release, ‘‘More than 100,000
health care providers paid for using
electronic health records,’’ June 19,
2012, available at https://www.hhs.gov/
news/press/2012pres/06/
20120619a.html; see also OIG, OEI
Report OEI–04–10–00184,
4 State Variation in E-Prescribing Trends in the
United States—available at: https://
www.healthit.gov/sites/default/files/us_eprescribingtrends_onc_brief_4_nov2012.pdf.
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‘‘Memorandum Report: Use of
Electronic Health Record Systems in
2011 Among Medicare Physicians
Providing Evaluation and Management
Services,’’ June 2012, available at
https://oig.hhs.gov/oei/reports/oei-0410-00184.pdf. However, while the
industry has made great progress, use of
such technology has not yet been
universally adopted nationwide, and
continued electronic health record
technology adoption remains an
important Departmental goal. We
continue to believe that as this goal is
achieved, the need for a safe harbor for
donations of such technology should
continue to diminish over time.
Accordingly, we propose to extend the
sunset date to December 31, 2016. We
selected this date because it corresponds
to the last year in which one may
receive a Medicare electronic health
record incentive payment and the last
year in which one may initiate
participation in the Medicaid electronic
health record incentive program. For
more information, see ‘‘CMS Medicare
and Medicaid EHR Incentive Payment
Milestone Timeline,’’ available at
https://www.cms.gov/Regulations-andGuidance/Legislation/
EHRIncentivePrograms/downloads/
EHRIncentProgtimeline508V1.pdf. As
an alternative to this proposed extended
sunset date of December 31, 2016, we
are also considering establishing a later
sunset date. For example, we are
considering extending the sunset date to
December 31, 2021, which corresponds
to the end of the electronic health
record Medicaid incentives. See id.
While these sunset dates are associated
with specific Medicare and Medicaid
electronic health record incentive
programs, we recognize that not all
health care providers to whom
donations can be made are eligible for
such incentives. These health care
providers include, for example, many in
the mental health and behavioral health
communities as well as long-term and
post-acute care facilities. We
specifically solicit comment on our
proposed extension of the sunset date to
December 31, 2016. We also seek
comment on whether we should, as an
alternative, select a later sunset date and
what that date should be.
D. Additional Proposals and
Considerations
1. Protected Donors
As we stated in the preamble to the
2006 Final Rule for the electronic health
records safe harbor, ‘‘[w]e [originally]
proposed to limit the scope of protected
donors under § 1001.952(y) to hospitals,
group practices, [prescription drug plan
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(PDP)] sponsors, and [Medicare
Advantage (MA)] organizations,
consistent with the MMA-mandated
donors for the electronic prescribing
safe harbor.’’ 71 FR 45110, 45127 (Aug.
8, 2006); see also 70 FR 59015, 59023
(Oct. 11, 2005). However, ‘‘[m]indful
that broad safe harbor protection may
significantly further the important
public policy goal of promoting
electronic health records, and after
carefully considering the
recommendations of the commenters,
we [ ] concluded that the safe harbor
should protect any donor that is an
individual or entity that provides
patients with health care items or
services covered by a Federal health
care program and submits claims or
requests for payment for those items or
services (directly or pursuant to
reassignment) to Medicare, Medicaid, or
other Federal health care programs (and
otherwise meets the safe harbor
conditions).’’ 71 FR 45110, 45127 (Aug.
8, 2006). Notwithstanding this
conclusion, we indicated that ‘‘[w]e
remain concerned about the potential
for abuse by laboratories, durable
medical equipment suppliers, and
others, but believe that the safe harbor
conditions in the [2006 Final Rule] and
the fact that the safe harbor is temporary
should adequately address our
concerns.’’ 71 FR 45110, 45128 (Aug. 8,
2006). We went on to state that ‘‘[w]e
intend to monitor the situation. If
abuses occur, we may revisit our
determination.’’ Id.
We have received comments
suggesting that abusive donations are
being made under the electronic health
records safe harbor. For example, some
responses to our annual solicitation of
safe harbors and special fraud alerts
allege that donors are using the safe
harbor to provide referral sources with
items and services that appear to
support the interoperable exchange of
information on their face, but, in
practice, lead to data and referral lockin. See, e.g., https://oig.hhs.gov/
publications/docs/semiannual/2009/
semiannual_fall2009.pdf.
In light of (1) these comments, (2) our
continued concern about the potential
for fraud and abuse by certain donors
that we articulated in the 2006 Final
Rule,5 and (3) the proposed changes to
the electronic health records safe harbor
conditions discussed in this proposed
rule, we propose to limit the scope of
protected donors under the electronic
health records safe harbor, with the
continued goal of promoting adoption of
interoperable electronic health record
technology that benefits patient care
5 See
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71 FR 45110, 45128 (Aug. 8, 2006).
Frm 00044
Fmt 4702
Sfmt 4702
while reducing the likelihood that
donors will misuse electronic health
record technology donations to secure
referrals. In this regard, we are
considering revising the safe harbor to
cover only the original MMA-mandated
donors: hospitals, group practices, PDP
sponsors, and MA organizations. We are
considering, and seek comments
regarding, whether other individuals or
entities with front-line patient care
responsibilities across health care
settings, such as safety net providers,
should be included, and, if so, which
ones. Alternatively, we are considering
retaining the current definition of
protected donors, but excluding specific
types of donors. Specifically, we are
considering excluding suppliers of
ancillary services associated with a high
risk of fraud and abuse, because
donations by such suppliers may be
more likely to be motivated by a
purpose of securing future business than
by a purpose of better coordinating care
for beneficiaries across health care
settings. In particular, we are
considering excluding laboratory
companies from the scope of
permissible donors as their donations
have been the subject of complaints. We
are also considering excluding other
high-risk categories, such as durable
medical equipment suppliers and
independent home health agencies. We
seek comment on the alternatives under
consideration, including comments,
with supporting reasons, regarding
particular types of providers and
suppliers that should or should not be
protected donors given the goals of the
safe harbor.
2. Data Lock-In and Exchange
In the preceding section, we propose
to limit the scope of permissible donors
as a means to prevent donations that
subvert the intent of the safe harbor—
because they are used to lock in
referrals—from receiving safe harbor
protection. We are also considering
inclusion of new or modified conditions
in the safe harbor as an alternative or
additional means of achieving that
result. We are particularly interested in
new or modified conditions that will
help achieve two related goals. The first
goal is to prevent the misuse of the safe
harbor in a way that results in data and
referral lock-in. The second, related goal
is to encourage the free exchange of data
(in accordance with protections for
privacy). These goals reflect our interest,
which we discussed above, in
promoting the adoption of interoperable
electronic health record technology that
benefits patient care while reducing the
likelihood that donors will misuse
electronic health record technology
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donations to secure referrals. The 2006
Final Rule requires donated software to
be interoperable at the time it is donated
to the recipient. The software is deemed
interoperable if it is certified as
described above. However, it has been
suggested that even when donated
software meets the interoperability
requirements of the rule, policies and
practices sometimes affect the true
ability of electronic health record
technology items and services to be
used to exchange information across
organizational and vendor boundaries.6
We seek comments on what new or
modified conditions could be added to
the electronic health records safe harbor
to achieve our two goals and whether
those conditions, if any, should be in
addition to, or in lieu of, our proposal
to limit the scope of permissible donors.
For example, 42 CFR
1001.952(y)(3)requires, as a condition of
the safe harbor, that ‘‘[t]he donor (or any
person on the donor’s behalf) [ ] not take
any action to limit or restrict the use,
compatibility, or interoperability of the
items or services with other electronic
prescribing or electronic health records
systems.’’ We solicit comments with
regard to whether this condition could
be modified to reduce the possibility of
lock-in.
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3. Covered Technology
We received questions concerning
whether certain items or services, for
example services that enable the
interoperable exchange of electronic
health records data, fall within the
scope of covered technology under the
electronic health records safe harbor.
The answer to such questions depends
on the exact items or services that are
being donated. In the 2006 Final Rule,
we explained that we interpreted the
term ‘‘ ‘software, information technology
and training services necessary and
used predominantly’ for electronic
health records purposes to include the
following, by way of example:
[i]nterface and translation software;
rights, licenses, and intellectual
property related to electronic health
records software; connectivity services,
including broadband and wireless
Internet services; clinical support and
information services related to patient
care (but not separate research or
marketing support services);
6 For more information on interoperability in
health IT, see ‘‘EHR Interoperability’’ on the
HealthIT.gov Web site at https://www.healthit.gov/
providers-professionals/ehr-interoperability. For
further discussion of interoperability and other
health IT issues, see Arthur L. Kellermann and
Spencer S. Jones, ANALYSIS & COMMENTARY:
What It Will Take to Achieve The As-YetUnfulfilled Promises Of Health Information
Technology, Health Aff. January 2013 32:163–68.
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maintenance services; secure messaging
(e.g., permitting physicians to
communicate with patients through
electronic messaging); and training and
support services (such as access to help
desk services).’’ 71 FR 45110, 45125
(Aug. 8, 2006). It also has been
suggested that we modify the regulatory
text of the electronic health records safe
harbor to explicitly reflect this
interpretation. We believe that the
current regulatory text, when read in
light of the preamble discussion, is
sufficiently clear concerning the scope
of covered technology, but we seek
input from the public regarding this
issue.
III. Regulatory Impact Statement
We have examined the impact of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (Sept. 30, 1993); Executive
Order 13563 on Improving Regulation
and Regulatory Review (Jan. 18, 2011);
the Regulatory Flexibility Act (RFA)
(Sept. 19, 1980, Pub. L. 96–354, codified
at 5 U.S.C. 601 et seq.); section 1102(b)
of the Act; section 202 of the Unfunded
Mandates Reform Act of 1995 (Mar. 22,
1995; Pub. L. 104–4); Executive Order
13132 on Federalism (August 4, 1999);
and the Congressional Review Act (5
U.S.C. 804(2)).
Executive Orders 12866 and 13563
direct 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). We
believe this proposed rule does not
reach the economic threshold for being
considered economically significant and
thus is not considered a major rule. We
solicit comment on the assumptions and
findings presented in this initial
regulatory impact analysis.
The proposed rule would update the
provision under which electronic health
records software is deemed
interoperable, remove the requirement
related to electronic prescribing
capability, and extend the safe harbor’s
sunset date (currently set at December
31, 2013). Neither this proposed rule
nor the regulation it amends requires
any entity to donate electronic health
record technology, but we expect these
proposed changes to continue to
facilitate the adoption of electronic
health record technology by filling a gap
rather than creating the primary means
PO 00000
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Sfmt 4702
21319
by which this technology will be
adopted.
The summation of the economic
impact analysis regarding the effects of
electronic health records in the
ambulatory setting that is presented in
the 2006 Final Rule still pertains to this
proposed regulation. 71 FR 45110 (Aug.
8, 2006). However, since the 2006 Final
Rule, several developments have
occurred to make us conclude that it is
no longer necessary to retain a
requirement related to electronic
prescribing capability in the electronic
health records safe harbor. These
developments include: (1) In 2008,
Congress passed the Medicare
Improvements for Patients and
Providers Act of 2008 (MIPPA), Pub. L.
110–275; (2) in 2009, Congress passed
the Health Information Technology for
Economic and Clinical Health (HITECH)
Act, Title XIII of Division A and Title IV
of Division B of the American Recovery
and Reinvestment Act of 2009 (ARRA),
Pub. L. 111–5; and (3) an increase over
the past few years in the rate of
electronic health record-based
electronic prescribing capabilities.
As discussed in more detail earlier in
the preamble, section 132 of MIPPA
authorized an electronic prescribing
incentive program (starting in 2009) for
certain types of eligible professionals.
The HITECH Act authorizes CMS to
establish Medicare and Medicaid
electronic health record incentive
programs for certain eligible
professionals, eligible hospitals, and
critical access hospitals. Also, the
HITECH Act requires that eligible
professionals under the Medicare and
Medicaid electronic health record
incentive programs demonstrate
meaningful use of certified electronic
health record technology, including the
use of electronic prescribing.
Specifically, the final regulation of the
Stage 2 meaningful use (77 FR 53968
(Sept. 4, 2012)) includes more
demanding requirements for electronic
prescribing and identifies electronic
prescribing as a required core measure.
As a result, beginning in CY 2015 an
eligible professional risks a reduction in
the Medicare Physician Fee Schedule
amount that will otherwise apply for
covered professional services if they are
not a meaningful EHR user for an EHR
reporting period during that year. Our
intent remains to allow potential
recipients not to receive products or
services they already own, but rather to
receive electronic health record
technology that advances its adoption
and use. Lastly, according to ONC,
electronic prescribing by physicians
using electronic health record
technology has increased from 7 percent
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in December 2008 to approximately 48
percent in June 2012.7 Furthermore, the
regulations recently published to
implement Stage 2 of the EHR Incentive
Programs continue to encourage
physicians’ use of electronic prescribing
technology. 77 FR 53968, 53989 (Sept.
4, 2012); 77 FR 54163, 54198 (Sept. 4,
2012). Due to data limitations, however,
we are unable to accurately estimate the
level of impact the electronic health
records safe harbor has contributed to
the increase in electronic prescribing.
Therefore, we believe as a result of these
legislative and regulatory developments
advancing in parallel, the increase in
the adoption of electronic prescribing
using electronic health record
technology will continue without
making it necessary to retain the
electronic prescribing capability
requirement in the electronic health
records safe harbor.
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of $7.0 million to $34.5 million in any
1 year. Individuals and States are not
included in the definition of a small
entity. The Secretary has determined
that this proposed rule would not have
a significant economic impact on a
substantial number of 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
section 603 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 a Metropolitan
Statistical Area for Medicare payment
regulations and has fewer than 100
beds. The Secretary has determined that
this proposed rule would 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 whose mandates require spending
in any 1 year of $100 million in 1995
7 State Variation in E-Prescribing Trends in the
United States—available at: https://
www.healthit.gov/sites/default/files/us_eprescribingtrends_onc_brief_4_nov2012.pdf.
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dollars, updated annually for inflation.
In 2013, that threshold is approximately
$141 million. This rule will have no
consequential effect on State, local, or
tribal governments or on the private
sector.
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
governments, preempts State law, or
otherwise has Federalism implications.
Since this regulation does not impose
any costs on State or local governments,
the requirements of Executive Order
13132 are not applicable.
In accordance with Executive Order
12866, this regulation was reviewed by
the Office of Management and Budget.
IV. Paperwork Reduction Act
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
List of Subjects in 42 CFR Part 1001
Administrative practice and
procedure, Fraud, Grant programs—
Health, Health facilities, Health
professions, Maternal and child health,
Medicaid, Medicare, Social Security.
Accordingly, 42 CFR part 1001 is
proposed to be amended as set forth
below:
PART 1001—[AMENDED]
1. The authority citation for part 1001
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1320a–7,
1320a–7b, 1395u(j), 1395u(k), 1395w–
104(e)(6), 1395y(d), 1395y(e),
1395cc(b)(2)(D), (E) and (F), and 1395hh; and
sec. 2455, Pub. L. 103–355, 108 Stat. 3327 (31
U.S.C. 6101 note).
2. Section 1001.952 is amended by
revising the introductory text, paragraph
(y) introductory text, and paragraphs
(y)(2) and (y)(13), and by removing and
reserving paragraph (y)(10).
The revisions read as follows:
■
§ 1001.952
Exceptions.
The following payment practices shall
not be treated as a criminal offense
under section 1128B of the Act and
shall not serve as the basis for an
exclusion:
*
*
*
*
*
(y) Electronic health records items
and services. As used in section 1128B
of the Act, ‘‘remuneration’’ does not
include nonmonetary remuneration
PO 00000
Frm 00046
Fmt 4702
Sfmt 4702
(consisting of items and services in the
form of software or information
technology and training services)
necessary and used predominantly to
create, maintain, transmit, or receive
electronic health records, if all of the
following conditions are met:
*
*
*
*
*
(2) The software is interoperable at
the time it is provided to the recipient.
For purposes of this subparagraph,
software is deemed to be interoperable
if a certifying body authorized by the
National Coordinator for Health
Information Technology has certified
the software to any edition of the
electronic health record certification
criteria identified in the then-applicable
definition of Certified EHR Technology
in 45 CFR part 170, on the date it is
provided to the recipient.
*
*
*
*
*
(13) The transfer of the items and
services occurs, and all conditions in
this paragraph (y) have been satisfied,
on or before December 31, 2016.
*
*
*
*
*
Dated: January 22, 2013.
Daniel R. Levinson,
Inspector General.
Approved: March 7, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013–08314 Filed 4–8–13; 4:15 pm]
BILLING CODE 4152–01–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 15
[ET Docket No. 13–49; FCC 13–22]
Unlicensed National Information
Infrastructure (U–NII) Devices in the 5
GHz Band
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
This document proposes to
amend the Commission’s rules
governing the operation of Unlicensed
National Information Infrastructure (U–
NII) devices in the 5 GHz band. The
Commission has gained much
experience with U–NII devices since it
first made spectrum available in the 5
GHz band for U–NII in 1997. The
Commission believes that the time is
now right to revisit the rules. The
initiation of this proceeding satisfies the
requirements of the ‘‘Middle Class Tax
Relief and Job Creation Act of 2012’’
which requires the Commission to begin
a proceeding to modify the rules to
SUMMARY:
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]]>Agencies
[Federal Register Volume 78, Number 69 (Wednesday, April 10, 2013)]
[Proposed Rules]
[Pages 21314-21320]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08314]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
42 CFR Part 1001
RIN 0936-AA03
Medicare and State Health Care Programs: Fraud and Abuse;
Electronic Health Records Safe Harbor Under the Anti-Kickback Statute
AGENCY: Office of Inspector General (OIG), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In this proposed rule, the Office of Inspector General (OIG)
proposes to amend the safe harbor regulation concerning electronic
health records items and services, which defines certain conduct that
is protected from liability under the Federal anti-kickback statute in
the Social Security Act (the Act). The proposed amendments include an
update to the provision under which electronic health records software
is deemed interoperable; removal of the electronic prescribing
capability requirement; and extension of the sunset provision. In
addition, OIG is requesting public comment on other changes it is
considering.
DATES: To assure consideration, comments must be delivered to the
address provided below by no later than 5 p.m. Eastern Standard Time on
June 10, 2013.
ADDRESSES: In commenting, please reference file code OIG-404-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (fax) transmission. However, you may submit comments using
one of three ways (no duplicates, please):
1. Electronically. You may submit electronically through the
Federal eRulemaking Portal at https://www.regulations.gov. (Attachments
should be in Microsoft Word, if possible.)
2. By regular, express, or overnight mail. You may mail your
printed or written submissions to the following address: Patrice Drew,
Office of Inspector General, Department of Health and Human Services,
Attention: OIG-404-P, Room 5541C, Cohen Building, 330 Independence
Avenue SW., Washington, DC 20201.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By hand or courier. You may deliver, by hand or courier, before
the close of the comment period, your
[[Page 21315]]
printed or written comments to: Patrice Drew, Office of Inspector
General, Department of Health and Human Services, Cohen Building, Room
5541C, 330 Independence Avenue SW., Washington, DC 20201.
Because access to the interior of the Cohen Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to schedule their delivery with one of our
staff members at (202) 619-1368.
Inspection of Public Comments: All comments received before the end
of the comment period will be posted on https://www.regulations.gov for
public viewing. Hard copies will also be available for public
inspection at the Office of Inspector General, Department of Health and
Human Services, Cohen Building, 330 Independence Avenue SW.,
Washington, DC 20201, Monday through Friday from 8:30 a.m. to 4 p.m. To
schedule an appointment to view public comments, phone (202) 619-1368.
Comments received by OIG will be shared with the Centers for Medicare &
Medicaid Services (CMS).
FOR FURTHER INFORMATION CONTACT: James A. Cannatti III or Heather L.
Westphal, Office of Counsel to the Inspector General, (202) 619-0335.
SUPPLEMENTARY INFORMATION:
------------------------------------------------------------------------
Social Security Act Citation United States Code Citation
------------------------------------------------------------------------
1128B..................................... 42 U.S.C. 1320a-7b
------------------------------------------------------------------------
Executive Summary
A. Purpose of the Regulatory Action
Pursuant to section 14 of the Medicare and Medicaid Patient and
Program Protection Act of 1987 and its legislative history, Congress
required the Secretary of Health and Human Services (the Secretary) to
promulgate regulations setting forth various ``safe harbors'' to the
anti-kickback statute, which would be evolving rules that would be
periodically updated to reflect changing business practices and
technologies in the health care industry. In accordance with this
authority, OIG published a safe harbor to protect certain arrangements
involving the provision of interoperable electronic health records
software or information technology and training services. The final
rule for this safe harbor was published on August 8, 2006 (71 FR 45110)
and is scheduled to sunset on December 31, 2013 (42 CFR
1001.952(y)(13)). The purpose of this proposed rule is to update
certain aspects of the electronic health records safe harbor and to
extend the sunset date.
B. Summary of the Major Provisions
This proposed rule would amend the current safe harbor in at least
three ways. First, the proposed rule would update the provision under
which electronic health records software is deemed interoperable.
Second, we propose to remove the requirement related to electronic
prescribing capability from the safe harbor. Third, we propose to
extend the sunset date of the safe harbor. In addition to these
proposals, we are soliciting public comment on other possible
amendments to the safe harbor, including limiting the scope of
protected donors and adding or modifying conditions to limit the risk
of data and referral lock-in.
C. Costs and Benefits
The proposed rule would modify an already-existing safe harbor to
the anti-kickback statute. This safe harbor permits certain entities to
provide technology-related items and services to certain parties to be
used to create, maintain, transmit, or receive electronic health
records. Parties may voluntarily seek to comply with safe harbors so
that they have assurance that their conduct will not subject them to
any enforcement actions under the anti-kickback statute, but safe
harbors do not impose new requirements on any party.
This is not a major rule, as defined at 5 U.S.C. 804(2). It is also
not economically significant, because it will not have a significant
effect on program expenditures, and there are no additional substantive
costs to implement the resulting provisions. The proposed rule would
update the provision under which electronic health records software is
deemed interoperable, remove the requirement related to electronic
prescribing capability, and extend the safe harbor's sunset date
(currently set at December 31, 2013). We expect these proposed changes
to continue to facilitate the adoption of electronic health records
technology.
I. Background
A. Anti-Kickback Statute and Safe Harbors
Section 1128B(b) of the Social Security Act (the Act) (42 U.S.C.
1320a-7b(b), the anti-kickback statute) provides criminal penalties for
individuals or entities that knowingly and willfully offer, pay,
solicit, or receive remuneration in order to induce or reward the
referral of business reimbursable under any of the Federal health care
programs, as defined in section 1128B(f) of the Act. The offense is
classified as a felony and is punishable by fines of up to $25,000 and
imprisonment for up to 5 years. Violations of the anti-kickback statute
may also result in the imposition of civil monetary penalties (CMP)
under section 1128A(a)(7) of the Act (42 U.S.C. 1320a-7a(a)(7)),
program exclusion under section 1128(b)(7) of the Act (42 U.S.C. 1320a-
7(b)(7)), and liability under the False Claims Act (31 U.S.C. 3729-33).
The types of remuneration covered specifically include, without
limitation, kickbacks, bribes, and rebates, whether made directly or
indirectly, overtly or covertly, in cash or in kind. In addition,
prohibited conduct includes not only the payment of remuneration
intended to induce or reward referrals of patients, but also the
payment of remuneration intended to induce or reward the purchasing,
leasing, or ordering of, or arranging for or recommending the
purchasing, leasing, or ordering of, any good, facility, service, or
item reimbursable by any Federal health care program.
Because of the broad reach of the statute, concern was expressed
that some relatively innocuous commercial arrangements were covered by
the statute and, therefore, potentially subject to criminal
prosecution. In response, Congress enacted section 14 of the Medicare
and Medicaid Patient and Program Protection Act of 1987, Public Law
100-93 (section 1128B(b)(3)(E) of the Act; 42 U.S.C. 1320a-
7b(B)(3)(E)), which specifically required the development and
promulgation of regulations, the so-called ``safe harbor'' provisions,
that would specify various payment and business practices that would
not be subject to sanctions under the anti-kickback statute, even
though they may potentially be capable of inducing referrals of
business under the Federal health care programs. Since July 29, 1991,
we have published in the Federal Register a series of final regulations
establishing ``safe harbors'' in various areas.\1\ These OIG safe
harbor provisions have been developed ``to limit the reach of the
statute somewhat by permitting certain non-abusive arrangements, while
encouraging beneficial or innocuous arrangements.'' 56 FR 35952, 35958
(July 29, 1991).
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\1\ 56 FR 35952 (July 29, 1991); 61 FR 2122 (Jan. 25, 1996); 64
FR 63518 (Nov. 19, 1999); 64 FR 63504 (Nov. 19, 1999); 66 FR 62979
(Dec. 4, 2001); 71 FR 45109 (Aug. 8, 2006); and 72 FR 56632 (Oct. 4,
2007).
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Health care providers and others may voluntarily seek to comply
with safe harbors so that they have the assurance that their business
practices will not be subject to any enforcement action under the anti-
kickback statute, the CMP provision for anti-kickback violations,
[[Page 21316]]
or the program exclusion authority related to kickbacks. In giving the
Department of Health and Human Services (Department or HHS) the
authority to protect certain arrangements and payment practices under
the anti-kickback statute, Congress intended the safe harbor
regulations to be updated periodically to reflect changing business
practices and technologies in the health care industry.
B. The Electronic Health Records Safe Harbor
In the October 11, 2005 Federal Register (70 FR 59015), we
published a notice of proposed rulemaking (the 2005 Proposed Rule) that
would promulgate two safe harbors to address donations of certain
electronic health records software and directly related training
services, using our authority at section 1128B(b)(3)(E) of the Act. See
70 FR 59015, 59021 (Oct. 11, 2005). One proposed safe harbor would have
protected certain arrangements involving donations of electronic health
records technology made before the adoption of certification criteria.
The other proposed safe harbor would have protected certain
arrangements involving nonmonetary remuneration in the form of
interoperable electronic health records software certified in
accordance with criteria adopted by the Secretary of HHS (Secretary)
and directly related training services. In the same issue of the
Federal Register (70 FR 59182 (Oct. 11, 2005)), CMS simultaneously
proposed similar exceptions to the physician self-referral law.
On August 8, 2006 (71 FR 45110), we published a final rule (the
2006 Final Rule) that, among other things, finalized a safe harbor \2\
at 42 CFR 1001.952(y) (the electronic health records safe harbor) for
protecting certain arrangements involving interoperable electronic
health records software or information technology and training
services. In the same issue of the Federal Register (71 FR 45140 (Aug.
8, 2006)), CMS simultaneously published similar final regulations at 42
CFR 411.357(w). The electronic health records safe harbor is scheduled
to sunset on December 31, 2013. 42 CFR 1001.952(y)(13).
---------------------------------------------------------------------------
\2\ For the reasons discussed in more detail in the preamble to
the 2006 Final Rule, we abandoned the proposal to have separate pre-
and post-interoperability safe harbors for electronic health records
arrangements. See 71 FR 45110, 45121 (Aug. 8, 2006).
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The present proposed rule sets forth certain proposed changes to
the electronic health records safe harbor. CMS is proposing almost
identical changes to the physician self-referral law electronic health
records exception \3\ elsewhere in this issue of the Federal Register.
We attempted to ensure as much consistency as possible between our
proposed safe harbor changes and CMS's proposed exception changes,
despite the differences in the respective underlying statutes. We
intend the final rules to be similarly consistent. Because of the close
nexus between this proposed rule and CMS's proposed rule, we may
consider comments submitted in response to CMS's proposed rule when
crafting our final rule. Similarly, CMS may consider comments submitted
in response to this proposed rule in crafting its final rule.
---------------------------------------------------------------------------
\3\ 42 CFR 411.357(w).
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II. Provisions of the Proposed Rule
A. The Deeming Provision
Our current electronic health records safe harbor specifies at 42
CFR 1001.952(y)(2) that the donated software must be ``interoperable at
the time it is provided to the recipient.'' As discussed in a recently
issued Request for Information (RFI) from the Department, ``HHS
envisions an information rich, person-centered, high performance health
care system where every health care provider has access to longitudinal
data on patients they treat to make evidence-based decisions,
coordinate care and improve health outcomes.'' 78 FR 14793, 14795 (Mar.
7, 2013). Additionally, as emphasized in the RFI, interoperability will
play a critical role in supporting this vision. Interoperability is
also an important concept in the context of the electronic health
records safe harbor. Although we have long been concerned that parties
could use the offer or donation of technology to capture referrals, we
have viewed interoperability as a potential mitigating factor, or
safeguard, to justify other safe harbor conditions that are less
stringent than might otherwise be appropriate in the absence of
interoperability. This is because if the donated technology is
interoperable, the recipient will be able to use it to transmit
electronic health records not only to the donor, but to others,
including competitors of the donor, and will not be ``locked in'' to
communications with the donor only. See 70 FR 59015, 59023 (Oct. 11,
2005); 71 FR 45110, 45126 (Aug. 8, 2006). For purposes of this safe
harbor, ``interoperable'' means ``able to communicate and exchange data
accurately, effectively, securely, and consistently with different
information technology systems, software applications, and networks, in
various settings, and exchange data such that the clinical or
operational purpose and meaning of the data are preserved and
unaltered.'' Note to paragraph (y) of 42 CFR 1001.952. The current
provisions of the electronic health records safe harbor state that for
purposes of meeting the condition set forth in subparagraph (y)(2),
``software is deemed to be interoperable if a certifying body
recognized by the Secretary has certified the software within no more
than 12 months prior to the date it is provided to the recipient.'' 42
CFR 1001.952(y)(2). We propose to update two aspects of this deeming
provision to reflect the current Office of the National Coordinator for
Health Information Technology (ONC) certification program for
electronic health record technology.
First, we propose to modify the provision to reflect that ONC is
responsible for ``recognizing'' certifying bodies, as referenced in
this provision. See 42 U.S.C. 300jj-11(c)(5). To become a certifying
body ``recognized'' by the Secretary, an entity must successfully
complete an authorization process established by ONC. This
authorization process constitutes the Secretary's recognition of a
certifying body. Accordingly, we propose to revise the phrase
``recognized by the Secretary'' in the second sentence of subparagraph
(y)(2) to read ``authorized by the National Coordinator for Health
Information Technology.''
Second, we propose to modify the portion of this provision
concerning the time period within which the software must have been
certified. Currently, the electronic health records safe harbor deeming
provision requires that software must have been certified within no
more than 12 months prior to the date of donation in order to ensure
that products have an up-to-date certification. Subsequent to issuing
the final electronic health records safe harbor, ONC developed a
regulatory process for adopting certification criteria and standards.
That process is anticipated to occur on a 2-year regulatory interval.
(For more information, see ONC's September 4, 2012 Final Rule titled
``Health Information Technology: Standards, Implementation
Specifications, and Certification Criteria for Electronic Health Record
Technology, 2014 Edition; Revisions to the Permanent Certification
Program for Health Information Technology'' (77 FR 54163).) Further,
some certification criteria could remain unchanged from one edition of
the electronic health record certification criteria to the next. Thus,
the current 12-month timeframe is
[[Page 21317]]
not in line with the anticipated 2-year regulatory interval and does
not account for the fact that some certification criteria may not
change from one edition to the next. Therefore, we propose to modify
this portion of the safe harbor by removing the 12-month timeframe and
substituting a provision that more closely tracks the current ONC
certification program. Accordingly, we propose that software would be
eligible for deeming if, on the date it is provided to the recipient,
it has been certified to any edition of the electronic health record
certification criteria that is identified in the then-applicable
definition of Certified EHR Technology in 45 CFR part 170. For example,
for 2013, the applicable definition of Certified EHR Technology
identifies both the 2011 and the 2014 editions of the electronic health
record certification criteria. Therefore, in 2013, software certified
to meet either the 2011 edition or the 2014 edition could satisfy the
safe harbor provision as we proposed to modify it. The current
definition of Certified EHR Technology applicable for 2014, however,
identifies only the 2014 edition. Thus, based on that definition, in
2014, only software certified to the 2014 edition could satisfy our
proposed, modified provision. Future modifications to the definition of
Certified EHR Technology could result in the identification of other
editions to which software could be certified and satisfy our proposed,
modified provision. As we stated in the 2006 Final Rule, we understand
``that the ability of software to be interoperable is evolving as
technology develops. In assessing whether software is interoperable, we
believe the appropriate inquiry is whether the software is as
interoperable as feasible given the prevailing state of technology at
the time [it] is provided to the recipient.'' 71 FR 45110, 45126 (Aug.
8, 2006). We believe our proposed change is consistent with that
understanding and our objective of ensuring that products are certified
to the current standard of interoperability when they are donated. We
seek comment on our proposal, including if removing the 12-month period
will impact donations and whether we should consider retaining it as an
additional means of determining eligibility under the deeming
provision.
B. The Electronic Prescribing Provision
Our current electronic health records safe harbor specifies at 42
CFR 1001.952(y)(10) that the donated software must ``contain [ ]
electronic prescribing capability, either through an electronic
prescribing component or the ability to interface with the recipient's
existing electronic prescribing system, that meets the applicable
standards under Medicare Part D at the time the items and services are
provided.'' In the preamble to the 2006 Final Rule, we stated that we
included ``this requirement, in part, because of the critical
importance of electronic prescribing in producing the overall benefits
of health information technology, as evidenced by section 101 of the
[Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA), Pub. L. 108-173].'' 71 FR 45110, 45125 (Aug. 8, 2006). As we
noted, it was ``our understanding that most electronic health records
systems already include an electronic prescribing component.'' Id.
We continue to believe in the critical importance of electronic
prescribing. However, in light of developments since the 2006 Final
Rule, we do not believe that it is necessary to retain a requirement
related to electronic prescribing capability in the electronic health
records safe harbor. First, Congress subsequently enacted legislation
addressing electronic prescribing. In 2008, Congress passed the
Medicare Improvements for Patients and Providers Act of 2008 (MIPPA),
Pub. L. 110-275. Section 132 of MIPPA authorized an electronic
prescribing incentive program (starting in 2009) for certain types of
eligible professionals. Further, in 2009, Congress passed the Health
Information Technology for Economic and Clinical Health (HITECH) Act,
Title XIII of Division A and Title IV of Division B of the American
Recovery and Reinvestment Act of 2009 (ARRA), Pub. L. 111-5. The HITECH
Act authorizes CMS to establish Medicare and Medicaid electronic health
record incentive programs for certain eligible professionals, eligible
hospitals, and critical access hospitals. 42 U.S.C. 1395w-4(o),
1395ww(n), 1395f(l)(3), and 1396b(t). The HITECH Act requires that
eligible professionals under the Medicare and Medicaid electronic
health record incentive programs demonstrate meaningful use of
certified electronic health record technology, including the use of
electronic prescribing. 42 U.S.C. 1395w-4(o)(2)(A)(i). Second, the
industry has made great progress related to electronic prescribing.
Recent analysis by ONC notes an increase in the percentage of
physicians electronically prescribing via electronic health record
technology from 7 percent in 2008 to 48 percent in 2012, reflecting
rapid increases over the past few years in the rate of electronic
health record-based electronic prescribing capabilities.\4\
Furthermore, the regulations recently published to implement Stage 2 of
the EHR Incentive Programs continue to encourage physicians' use of
electronic prescribing technology. See 77 FR 53968, 53989 (Sept. 4,
2012); 77 FR 54163, 54198 (Sept. 4, 2012).
---------------------------------------------------------------------------
\4\ State Variation in E-Prescribing Trends in the United
States--available at: https://www.healthit.gov/sites/default/files/us_e-prescribingtrends_onc_brief_4_nov2012.pdf.
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In light of these developments, we propose to delete the electronic
prescribing condition at 42 CFR 1001.952(y)(10). We believe that there
are sufficient alternative policy drivers supporting the adoption of
electronic prescribing capabilities. We also note that electronic
prescribing technology would remain eligible for donation under the
electronic health records safe harbor or under the electronic
prescribing safe harbor at 42 CFR 1001.952(x). Additionally, we
considered whether removing this condition would increase the risk of
fraud or abuse posed by donations made under the safe harbor; we do not
believe that it would.
C. The Sunset Provision
The electronic health records safe harbor is scheduled to sunset on
December 31, 2013. In adopting this condition of the electronic health
records safe harbor, we acknowledged ``that the need for a safe harbor
for donations of electronic health records technology should diminish
substantially over time as the use of such technology becomes a
standard and expected part of medical practice.'' 71 FR 45110, 45133
(Aug. 8, 2006). Some have suggested that we extend the sunset date or
even remove the sunset provision entirely.
In recent years, electronic health record technology adoption has
risen dramatically, largely as a result of the HITECH Act in 2009. For
example, see Farzad Mostashari, M.D., ScM., National Coordinator, ONC,
U.S. Department of Health and Human Services, Testimony before the
Subcommittee on Technology and Innovation Committee on Science and
Technology, available at https://science.house.gov/sites/republicans.science.house.gov/files/documents/HHRG-112-SY19-WState-FMostashari-20121114.pdf and HHS News Release, ``More than 100,000
health care providers paid for using electronic health records,'' June
19, 2012, available at https://www.hhs.gov/news/press/2012pres/06/20120619a.html; see also OIG, OEI Report OEI-04-10-00184,
[[Page 21318]]
``Memorandum Report: Use of Electronic Health Record Systems in 2011
Among Medicare Physicians Providing Evaluation and Management
Services,'' June 2012, available at https://oig.hhs.gov/oei/reports/oei-04-10-00184.pdf. However, while the industry has made great
progress, use of such technology has not yet been universally adopted
nationwide, and continued electronic health record technology adoption
remains an important Departmental goal. We continue to believe that as
this goal is achieved, the need for a safe harbor for donations of such
technology should continue to diminish over time. Accordingly, we
propose to extend the sunset date to December 31, 2016. We selected
this date because it corresponds to the last year in which one may
receive a Medicare electronic health record incentive payment and the
last year in which one may initiate participation in the Medicaid
electronic health record incentive program. For more information, see
``CMS Medicare and Medicaid EHR Incentive Payment Milestone Timeline,''
available at https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/EHRIncentProgtimeline508V1.pdf. As an
alternative to this proposed extended sunset date of December 31, 2016,
we are also considering establishing a later sunset date. For example,
we are considering extending the sunset date to December 31, 2021,
which corresponds to the end of the electronic health record Medicaid
incentives. See id. While these sunset dates are associated with
specific Medicare and Medicaid electronic health record incentive
programs, we recognize that not all health care providers to whom
donations can be made are eligible for such incentives. These health
care providers include, for example, many in the mental health and
behavioral health communities as well as long-term and post-acute care
facilities. We specifically solicit comment on our proposed extension
of the sunset date to December 31, 2016. We also seek comment on
whether we should, as an alternative, select a later sunset date and
what that date should be.
D. Additional Proposals and Considerations
1. Protected Donors
As we stated in the preamble to the 2006 Final Rule for the
electronic health records safe harbor, ``[w]e [originally] proposed to
limit the scope of protected donors under Sec. 1001.952(y) to
hospitals, group practices, [prescription drug plan (PDP)] sponsors,
and [Medicare Advantage (MA)] organizations, consistent with the MMA-
mandated donors for the electronic prescribing safe harbor.'' 71 FR
45110, 45127 (Aug. 8, 2006); see also 70 FR 59015, 59023 (Oct. 11,
2005). However, ``[m]indful that broad safe harbor protection may
significantly further the important public policy goal of promoting
electronic health records, and after carefully considering the
recommendations of the commenters, we [ ] concluded that the safe
harbor should protect any donor that is an individual or entity that
provides patients with health care items or services covered by a
Federal health care program and submits claims or requests for payment
for those items or services (directly or pursuant to reassignment) to
Medicare, Medicaid, or other Federal health care programs (and
otherwise meets the safe harbor conditions).'' 71 FR 45110, 45127 (Aug.
8, 2006). Notwithstanding this conclusion, we indicated that ``[w]e
remain concerned about the potential for abuse by laboratories, durable
medical equipment suppliers, and others, but believe that the safe
harbor conditions in the [2006 Final Rule] and the fact that the safe
harbor is temporary should adequately address our concerns.'' 71 FR
45110, 45128 (Aug. 8, 2006). We went on to state that ``[w]e intend to
monitor the situation. If abuses occur, we may revisit our
determination.'' Id.
We have received comments suggesting that abusive donations are
being made under the electronic health records safe harbor. For
example, some responses to our annual solicitation of safe harbors and
special fraud alerts allege that donors are using the safe harbor to
provide referral sources with items and services that appear to support
the interoperable exchange of information on their face, but, in
practice, lead to data and referral lock-in. See, e.g., https://oig.hhs.gov/publications/docs/semiannual/2009/semiannual_fall2009.pdf.
In light of (1) these comments, (2) our continued concern about the
potential for fraud and abuse by certain donors that we articulated in
the 2006 Final Rule,\5\ and (3) the proposed changes to the electronic
health records safe harbor conditions discussed in this proposed rule,
we propose to limit the scope of protected donors under the electronic
health records safe harbor, with the continued goal of promoting
adoption of interoperable electronic health record technology that
benefits patient care while reducing the likelihood that donors will
misuse electronic health record technology donations to secure
referrals. In this regard, we are considering revising the safe harbor
to cover only the original MMA-mandated donors: hospitals, group
practices, PDP sponsors, and MA organizations. We are considering, and
seek comments regarding, whether other individuals or entities with
front-line patient care responsibilities across health care settings,
such as safety net providers, should be included, and, if so, which
ones. Alternatively, we are considering retaining the current
definition of protected donors, but excluding specific types of donors.
Specifically, we are considering excluding suppliers of ancillary
services associated with a high risk of fraud and abuse, because
donations by such suppliers may be more likely to be motivated by a
purpose of securing future business than by a purpose of better
coordinating care for beneficiaries across health care settings. In
particular, we are considering excluding laboratory companies from the
scope of permissible donors as their donations have been the subject of
complaints. We are also considering excluding other high-risk
categories, such as durable medical equipment suppliers and independent
home health agencies. We seek comment on the alternatives under
consideration, including comments, with supporting reasons, regarding
particular types of providers and suppliers that should or should not
be protected donors given the goals of the safe harbor.
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\5\ See 71 FR 45110, 45128 (Aug. 8, 2006).
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2. Data Lock-In and Exchange
In the preceding section, we propose to limit the scope of
permissible donors as a means to prevent donations that subvert the
intent of the safe harbor--because they are used to lock in referrals--
from receiving safe harbor protection. We are also considering
inclusion of new or modified conditions in the safe harbor as an
alternative or additional means of achieving that result. We are
particularly interested in new or modified conditions that will help
achieve two related goals. The first goal is to prevent the misuse of
the safe harbor in a way that results in data and referral lock-in. The
second, related goal is to encourage the free exchange of data (in
accordance with protections for privacy). These goals reflect our
interest, which we discussed above, in promoting the adoption of
interoperable electronic health record technology that benefits patient
care while reducing the likelihood that donors will misuse electronic
health record technology
[[Page 21319]]
donations to secure referrals. The 2006 Final Rule requires donated
software to be interoperable at the time it is donated to the
recipient. The software is deemed interoperable if it is certified as
described above. However, it has been suggested that even when donated
software meets the interoperability requirements of the rule, policies
and practices sometimes affect the true ability of electronic health
record technology items and services to be used to exchange information
across organizational and vendor boundaries.\6\ We seek comments on
what new or modified conditions could be added to the electronic health
records safe harbor to achieve our two goals and whether those
conditions, if any, should be in addition to, or in lieu of, our
proposal to limit the scope of permissible donors. For example, 42 CFR
1001.952(y)(3)requires, as a condition of the safe harbor, that ``[t]he
donor (or any person on the donor's behalf) [ ] not take any action to
limit or restrict the use, compatibility, or interoperability of the
items or services with other electronic prescribing or electronic
health records systems.'' We solicit comments with regard to whether
this condition could be modified to reduce the possibility of lock-in.
---------------------------------------------------------------------------
\6\ For more information on interoperability in health IT, see
``EHR Interoperability'' on the HealthIT.gov Web site at https://www.healthit.gov/providers-professionals/ehr-interoperability. For
further discussion of interoperability and other health IT issues,
see Arthur L. Kellermann and Spencer S. Jones, ANALYSIS &
COMMENTARY: What It Will Take to Achieve The As-Yet-Unfulfilled
Promises Of Health Information Technology, Health Aff. January 2013
32:163-68.
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3. Covered Technology
We received questions concerning whether certain items or services,
for example services that enable the interoperable exchange of
electronic health records data, fall within the scope of covered
technology under the electronic health records safe harbor. The answer
to such questions depends on the exact items or services that are being
donated. In the 2006 Final Rule, we explained that we interpreted the
term `` `software, information technology and training services
necessary and used predominantly' for electronic health records
purposes to include the following, by way of example: [i]nterface and
translation software; rights, licenses, and intellectual property
related to electronic health records software; connectivity services,
including broadband and wireless Internet services; clinical support
and information services related to patient care (but not separate
research or marketing support services); maintenance services; secure
messaging (e.g., permitting physicians to communicate with patients
through electronic messaging); and training and support services (such
as access to help desk services).'' 71 FR 45110, 45125 (Aug. 8, 2006).
It also has been suggested that we modify the regulatory text of the
electronic health records safe harbor to explicitly reflect this
interpretation. We believe that the current regulatory text, when read
in light of the preamble discussion, is sufficiently clear concerning
the scope of covered technology, but we seek input from the public
regarding this issue.
III. Regulatory Impact Statement
We have examined the impact of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (Sept. 30, 1993);
Executive Order 13563 on Improving Regulation and Regulatory Review
(Jan. 18, 2011); the Regulatory Flexibility Act (RFA) (Sept. 19, 1980,
Pub. L. 96-354, codified at 5 U.S.C. 601 et seq.); section 1102(b) of
the Act; section 202 of the Unfunded Mandates Reform Act of 1995 (Mar.
22, 1995; Pub. L. 104-4); Executive Order 13132 on Federalism (August
4, 1999); and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct 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).
We believe this proposed rule does not reach the economic threshold for
being considered economically significant and thus is not considered a
major rule. We solicit comment on the assumptions and findings
presented in this initial regulatory impact analysis.
The proposed rule would update the provision under which electronic
health records software is deemed interoperable, remove the requirement
related to electronic prescribing capability, and extend the safe
harbor's sunset date (currently set at December 31, 2013). Neither this
proposed rule nor the regulation it amends requires any entity to
donate electronic health record technology, but we expect these
proposed changes to continue to facilitate the adoption of electronic
health record technology by filling a gap rather than creating the
primary means by which this technology will be adopted.
The summation of the economic impact analysis regarding the effects
of electronic health records in the ambulatory setting that is
presented in the 2006 Final Rule still pertains to this proposed
regulation. 71 FR 45110 (Aug. 8, 2006). However, since the 2006 Final
Rule, several developments have occurred to make us conclude that it is
no longer necessary to retain a requirement related to electronic
prescribing capability in the electronic health records safe harbor.
These developments include: (1) In 2008, Congress passed the Medicare
Improvements for Patients and Providers Act of 2008 (MIPPA), Pub. L.
110-275; (2) in 2009, Congress passed the Health Information Technology
for Economic and Clinical Health (HITECH) Act, Title XIII of Division A
and Title IV of Division B of the American Recovery and Reinvestment
Act of 2009 (ARRA), Pub. L. 111-5; and (3) an increase over the past
few years in the rate of electronic health record-based electronic
prescribing capabilities.
As discussed in more detail earlier in the preamble, section 132 of
MIPPA authorized an electronic prescribing incentive program (starting
in 2009) for certain types of eligible professionals. The HITECH Act
authorizes CMS to establish Medicare and Medicaid electronic health
record incentive programs for certain eligible professionals, eligible
hospitals, and critical access hospitals. Also, the HITECH Act requires
that eligible professionals under the Medicare and Medicaid electronic
health record incentive programs demonstrate meaningful use of
certified electronic health record technology, including the use of
electronic prescribing. Specifically, the final regulation of the Stage
2 meaningful use (77 FR 53968 (Sept. 4, 2012)) includes more demanding
requirements for electronic prescribing and identifies electronic
prescribing as a required core measure. As a result, beginning in CY
2015 an eligible professional risks a reduction in the Medicare
Physician Fee Schedule amount that will otherwise apply for covered
professional services if they are not a meaningful EHR user for an EHR
reporting period during that year. Our intent remains to allow
potential recipients not to receive products or services they already
own, but rather to receive electronic health record technology that
advances its adoption and use. Lastly, according to ONC, electronic
prescribing by physicians using electronic health record technology has
increased from 7 percent
[[Page 21320]]
in December 2008 to approximately 48 percent in June 2012.\7\
Furthermore, the regulations recently published to implement Stage 2 of
the EHR Incentive Programs continue to encourage physicians' use of
electronic prescribing technology. 77 FR 53968, 53989 (Sept. 4, 2012);
77 FR 54163, 54198 (Sept. 4, 2012). Due to data limitations, however,
we are unable to accurately estimate the level of impact the electronic
health records safe harbor has contributed to the increase in
electronic prescribing. Therefore, we believe as a result of these
legislative and regulatory developments advancing in parallel, the
increase in the adoption of electronic prescribing using electronic
health record technology will continue without making it necessary to
retain the electronic prescribing capability requirement in the
electronic health records safe harbor.
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\7\ State Variation in E-Prescribing Trends in the United
States--available at: https://www.healthit.gov/sites/default/files/us_e-prescribingtrends_onc_brief_4_nov2012.pdf.
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The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small
governmental jurisdictions. Most hospitals and most other providers and
suppliers are small entities, either by nonprofit status or by having
revenues of $7.0 million to $34.5 million in any 1 year. Individuals
and States are not included in the definition of a small entity. The
Secretary has determined that this proposed rule would not have a
significant economic impact on a substantial number of 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 section 603 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 a Metropolitan Statistical Area for
Medicare payment regulations and has fewer than 100 beds. The Secretary
has determined that this proposed rule would 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 whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2013, that
threshold is approximately $141 million. This rule will have no
consequential effect on State, local, or tribal governments or on the
private sector.
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 governments, preempts State law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on State
or local governments, the requirements of Executive Order 13132 are not
applicable.
In accordance with Executive Order 12866, this regulation was
reviewed by the Office of Management and Budget.
IV. Paperwork Reduction Act
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
List of Subjects in 42 CFR Part 1001
Administrative practice and procedure, Fraud, Grant programs--
Health, Health facilities, Health professions, Maternal and child
health, Medicaid, Medicare, Social Security.
Accordingly, 42 CFR part 1001 is proposed to be amended as set
forth below:
PART 1001--[AMENDED]
0
1. The authority citation for part 1001 continues to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7, 1320a-7b, 1395u(j),
1395u(k), 1395w-104(e)(6), 1395y(d), 1395y(e), 1395cc(b)(2)(D), (E)
and (F), and 1395hh; and sec. 2455, Pub. L. 103-355, 108 Stat. 3327
(31 U.S.C. 6101 note).
0
2. Section 1001.952 is amended by revising the introductory text,
paragraph (y) introductory text, and paragraphs (y)(2) and (y)(13), and
by removing and reserving paragraph (y)(10).
The revisions read as follows:
Sec. 1001.952 Exceptions.
The following payment practices shall not be treated as a criminal
offense under section 1128B of the Act and shall not serve as the basis
for an exclusion:
* * * * *
(y) Electronic health records items and services. As used in
section 1128B of the Act, ``remuneration'' does not include nonmonetary
remuneration (consisting of items and services in the form of software
or information technology and training services) necessary and used
predominantly to create, maintain, transmit, or receive electronic
health records, if all of the following conditions are met:
* * * * *
(2) The software is interoperable at the time it is provided to the
recipient. For purposes of this subparagraph, software is deemed to be
interoperable if a certifying body authorized by the National
Coordinator for Health Information Technology has certified the
software to any edition of the electronic health record certification
criteria identified in the then-applicable definition of Certified EHR
Technology in 45 CFR part 170, on the date it is provided to the
recipient.
* * * * *
(13) The transfer of the items and services occurs, and all
conditions in this paragraph (y) have been satisfied, on or before
December 31, 2016.
* * * * *
Dated: January 22, 2013.
Daniel R. Levinson,
Inspector General.
Approved: March 7, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-08314 Filed 4-8-13; 4:15 pm]
BILLING CODE 4152-01-P
