[Federal Register Volume 82, Number 53 (Tuesday, March 21, 2017)]
[Rules and Regulations]
[Pages 14464-14466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05692]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 510 and 512
[CMS-5519-IFC]
RIN 0938-AS90
Medicare Program; Advancing Care Coordination Through Episode
Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model;
and Changes to the Comprehensive Care for Joint Replacement Model;
Delay of Effective Date
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment period; delay of effective
date.
-----------------------------------------------------------------------
SUMMARY: This interim final rule with comment period (IFC) further
delays the effective date of the final rule entitled ``Advancing Care
Coordination Through Episode Payment Models (EPMs); Cardiac
Rehabilitation Incentive Payment Model; and Changes to the
Comprehensive Care for Joint Replacement Model'' published in the
January 3, 2017 Federal Register (82 FR 180) from March 21, 2017 until
May 20, 2017. This IFC also delays the applicability date of the
regulations at 42 CFR part 512 from July 1, 2017 to October 1, 2017 and
effective date of the specific CJR regulations itemized in the DATES
section from July 1, 2017 to October 1, 2017. We seek comment on the
appropriateness of this delay, as well as a further applicability date
delay until January 1, 2018.
DATES: Effective date: As of March 20, 2017, the effective date for the
provisions of the final rule published in the January 3, 2017 Federal
Register (82 FR 180), which was delayed until March 21, 2017 on
February 18, 2017 (82 FR 10961), is further delayed to May 20, 2017.
Additionally, the effective date of the provisions of the final rule
contained in the following amendatory instructions is delayed from July
1, 2017 to October 1, 2017: Number 3 amending 42 CFR 510.2; number 4
adding 42 CFR 510.110; number 6 amending 42 CFR 510.120; number 14
amending 42 CFR 510.405; number 15 amending 42 CFR 510.410; number 16
revising 42 CFR 510.500; number 17 revising 42 CFR 510.505; number 18
adding 42 CFR 510.506; and number 19 amending 42 CFR 510.515.
Applicability date: The applicability date of the regulations at 42
CFR part 512 is delayed from their current applicability date of July
1, 2017 until October 1, 2017.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on April 19, 2017.
ADDRESSES: In commenting, please refer to file code CMS-5519-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed).
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-5519-IFC, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-5519-IFC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
[[Page 14465]]
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Sean Harris (410) 786-0812.
For questions related to the EPMs: [email protected]. For
questions related to the CJR model: [email protected].
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will be also available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Provisions of the Interim Final Rule With Comment Period
In the January 3, 2017 Federal Register (82 FR 180), we published a
final rule entitled ``Advancing Care Coordination Through Episode
Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model;
and Changes to the Comprehensive Care for Joint Replacement Model''
which implements three new Medicare Parts A and B EPMs and a Cardiac
Rehabilitation (CR) Incentive Payment model, and implements changes to
the existing Comprehensive Care for Joint Replacement model under
section 1115A of the Social Security Act (the Act). Under the three new
episode payment models, acute care hospitals in certain selected
geographic areas will participate in retrospective EPMs targeting care
for Medicare fee-for-service beneficiaries receiving services during
acute myocardial infarction, coronary artery bypass graft, and surgical
hip/femur fracture treatment episodes. All related care within 90 days
of hospital discharge will be included in the episode of care. Under
the CR Incentive Payment model, acute care hospitals in certain
selected geographic areas will receive retrospective incentive payments
for beneficiary utilization of cardiac rehabilitation/intensive cardiac
rehabilitation services during the 90 days following discharge from a
hospitalization treatment of an acute myocardial infarction or coronary
artery bypass graft surgery.
The January 3, 2017 final rule (82 FR 180) included an effective
date of February 18, 2017 for all provisions except those contained in
the following amendatory instructions, which were to become effective
on July 1, 2017: Number 3 amending 42 CFR 510.2; number 4 adding 42 CFR
510.110; number 6 amending 42 CFR 510.120; number 14 amending 42 CFR
510.405; number 15 amending 42 CFR 510.410; number 16 revising 42 CFR
510.500; number 17 revising 42 CFR 510.505; number 18 adding 42 CFR
510.506; and number 19 amending 42 CFR 510.515.
In the February 17, 2017 Federal Register (82 FR 10961), as
directed by the memorandum of January 20, 2017, from the Assistant to
the President and Chief of Staff, entitled ``Regulatory Freeze Pending
Review'', we published a final rule that delayed the effective date of
the final rule published in the January 3, 2017 Federal Register (82 FR
180) for provisions that were to become effective on February 18, 2017,
to an effective date of March 21, 2017. In the February 17, 2017 final
rule (82 FR 10961), we stated that the provisions contained in the
amendatory instructions summarized in the previous paragraph remained
effective July 1, 2017. The January 20, 2017 ``Regulatory Freeze
Pending Review'' memorandum encourages agencies to consider proposing
for notice and comment a rule to delay the effective date for
regulations beyond that 60-day period. As explained below, this interim
final rule with comment period (IFC) further delays the effective date
of the final rule published in the January 3, 2017 Federal Register (82
FR 180), from March 21, 2017 (as provided in the final rule published
in the February 17, 2017 Federal Register (82 FR 10961)) to May 20,
2017. This IFC also delays the applicability date of the regulations
that were to be applicable on July 1, 2017 to an applicability date of
October 1, 2017 and delays the effective date of conforming changes to
CJR provisions that were to be effective July 1, 2017 to October 1,
2017. These delays postpone the applicability of the EPMs and the CR
Incentive Payment model, as well as the date on which conforming
changes to the CJR model regulations take effect, for an additional 3
months. This additional 3-month delay is necessary to allow time for
additional review, to ensure that the agency has adequate time to
undertake notice and comment rulemaking to modify the policy if
modifications are warranted, and to ensure that in such a case
participants have a clear understanding of the governing rules and are
not required to take needless compliance steps due to the rule taking
effect for a short duration before any potential modifications are
effectuated. We note that, in light of this potential need for further
notice and comment rulemaking prior to the start of the models, it
would be problematic not to adjust the start date for EPMs from July 1,
2017. Given the need for advanced notice of the terms of the models by
participants, and the fact that the episodes in the models involved
exceed 90 days in duration, we believe that immediately moving the
start date of the model to October 1, 2017 is appropriate. Moreover, in
the January 3, 2017 final rule, payment year one for the EPMs is
currently established to cover the 6-month period from July 1, 2017
through December 31, 2017. Subsequent EPM model years run a full 12
months in accordance with the calendar year. Considering the length of
episodes in the models, we believe it would be preferable to maintain a
duration of at least 6 months for payment year 1 and it would be less
burdensome for participants to adhere as closely to the calendar year
as possible when defining model payment years. Further, to the extent
that we propose and finalize revisions to the model, should we
determine modifications are warranted, participants should have
reasonable time to prepare. We remain committed
[[Page 14466]]
to providing some period of time between establishing final model
parameters and beginning the model to allow participants to prepare for
the unique attributes of this model. Therefore, we seek comment on a
longer delay of the applicability (model start) date, including to
January 1, 2018, and we will address these comments and effectuate any
additional delay in the model start date when we finalize this IFC. If
we effectuate any additional delay in the model start date, we also
would delay the effective date of the conforming CJR regulation changes
so that the effective date of those changes remains aligned with the
applicability (model start) date of the EPMs.
To the extent that section 553 of the Administrative Procedure Act
(APA) applies to this action to further delay the rule's effective date
for the purpose of ensuring adequate time for subsequent notice and
comment rulemaking if that is warranted, this IFC is exempt from notice
and comment because it constitutes a rule of procedure under 5 U.S.C.
553(b)(A). Furthermore, 5 U.S.C. 553(b)(B) permits a waiver of prior
notice and comment if an agency finds good cause that a notice-and-
comment procedure is impracticable, unnecessary, or contrary to the
public interest. Similarly, section 1871 of the Act, which normally
requires prior notice and a 60-day public comment period for rules that
establish or change a substantive legal standard, permits waiver of
prior notice and comment when there is good cause for an exception
under 5 U.S.C. 553(b)(B). In addition, the requirement under section
553(d) of the APA for a 30-day delay in the effective date of a rule
can be waived for good cause. The January 20, 2017 ``Regulatory Freeze
Pending Review'' executive memorandum stated that the rules under
review should be delayed 60 days from the date of the memorandum. In
addition, that memorandum provided that agencies should consider
issuing a notice of proposed rulemaking and solicit public comment if
they believed that a delay beyond 60 days from the date of the
memorandum was necessary. Given that the provisions of the final rule
that provide for a start date for the EPMs and CR Incentive Payment
model of July 1, 2017 will take effect on March 21, 2017, there is
insufficient time to undertake full notice and comment rulemaking ahead
of the March 21, 2017 effective date. We have determined that issuing
this IFC as a proposed rule, such that it would not become effective
until after public comments are submitted, considered and responded to
in a final rule, would be contrary to the public interest, since the
models would begin July 1, 2017 as originally set forth in the January
3, 2017 final rule, which could lead to a good deal of confusion for
the public. In setting forth revised effective and applicability dates,
we seek to ensure that all parties could participate in any rulemaking
resulting from further review as requested in the January 20, 2017
presidential memorandum. Therefore, we are publishing this IFC to delay
the effective date of the rule to May 20, 2017 and to move the
applicability date for the EPM provisions from July 1, 2017 to October
1, 2017. We are also delaying the effective date of the CJR regulation
amendments that were to take effect July 1, 2017 to October 1, 2017, to
maintain our policy of aligning these changes with EPMs and to avoid
confusion. Because we are immediately adjusting the effective and
applicability dates of the EPMs by 3 months but believe a 6-month delay
in the applicability (model start) date to be warranted, in this IFC we
are soliciting public comment on the appropriateness of a further delay
in the applicability (model start) date and will take those comments
into consideration. For these same reasons, we find good cause to waive
the 30-day delay in effective date provided for in 5 U.S.C. 553(d).
Based on these findings, this rule is effective immediately upon
publication in the Federal Register.
As discussed previously, timing considerations support an immediate
delay to the effective and applicability dates and necessitate that the
delay operate on a quarterly basis. Moreover, our ongoing review of the
policy, consistent with the January 20, 2017 presidential memorandum,
and our identification of the possibility of additional notice and
comment rulemaking to make any warranted modifications to the policy,
further necessitate immediate delay. As discussed in the January 3,
2017 final rule (82 FR 184), under the 5-year models governed by the
rule, participants will have a significant opportunity to redesign
care. Delaying the effective and applicability (model start) dates will
prevent participant confusion and corresponding disruption to these
efforts, ensure that the agency has adequate time to undertake notice
and comment rulemaking to modify the policy if modifications are
warranted, and ensure that in the case of policy modifications,
participants have a clear understanding of the governing rules and are
not required to take needless compliance steps due to the rule taking
effect for a short duration before any potential modifications are
effectuated.
II. Responses to Public Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
CMS-5519-IFC
Dated: March 16, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Approved: March 17, 2017.
Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-05692 Filed 3-20-17; 8:45 am]
BILLING CODE 4120-01-P