[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