[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Rules and Regulations]
[Pages 25958-25966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10545]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 423

[CMS-6107-IFC]
RIN 0938-AS60


Medicare Program; Changes to the Requirements for Part D 
Prescribers

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Interim final rule with comment period.

-----------------------------------------------------------------------

SUMMARY: This interim final rule with comment period revises 
requirements related to beneficiary access to covered Part D drugs. 
Under these revised requirements, pharmacy claims and beneficiary 
requests for reimbursement for Medicare Part D prescriptions, written 
by prescribers other than physicians and eligible professionals who are 
permitted by state or other applicable law to prescribe medications, 
will not be rejected at the point of sale or denied by the plan if all 
other requirements are met. In addition, a plan sponsor will not reject 
a claim or deny a beneficiary request for reimbursement for a drug when 
prescribed by a prescriber who does not meet the applicable enrollment 
or opt-out requirement without first providing provisional coverage of 
the drug and individualized written notice to the beneficiary. This 
interim final rule with comment period also revises certain terminology 
to be consistent with existing policy and to improve clarity.

DATES: 
    Effective date: These regulations are effective on June 1, 2015.
    Applicability date: The provisions at Sec.  423.120(c)(6) are 
applicable January 1, 2016.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on July 6, 2015.

ADDRESSES: In commenting, please refer to file code CMS-6107-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-6107-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-6107-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.
    (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: Frank Whelan, (410) 786-1302 for 
enrollment issues.
    Lisa Thorpe, (410) 786-3048, for provisional coverage, notice, and 
all other issues.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in

[[Page 25959]]

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. Background

A. Purpose

    Under this interim final rule with comment period (IFC), pharmacy 
claims and beneficiary requests for reimbursement for Medicare Part D 
prescriptions, written by prescribers other than physicians and 
eligible professionals who are permitted by state or other applicable 
law to prescribe medications, will not be rejected at the point of sale 
or denied by the plan if all other requirements are met. In addition, a 
plan sponsor will not reject a claim or deny a beneficiary request for 
reimbursement for a drug on the grounds that the prescriber has not 
enrolled in or opted out of Medicare without first providing 
provisional coverage of the drug and individualized written notice to 
the beneficiary. These changes are necessary to help make certain that 
Medicare beneficiaries continue to have access to needed Part D 
medications. As explained in section III. of this IFC, we believe that 
we have good cause to make these changes in an IFC because the ordinary 
notice-and-comment process would be contrary to the public interest; 
furthermore, we believe that notice-and-comment rulemaking for the 
technical changes we are making in this IFC (as described in sections 
II.D., II.E., and II.F. of this IFC) is unnecessary because these 
changes are not substantive and do not alter current policy.

B. Legal Authority

    There are four principal statutory authorities for the provisions 
in this IFC.
    First, sections 1102 and 1871 of the Social Security Act (the Act) 
provide general authority for the Secretary to prescribe regulations 
for the efficient administration of the Medicare program.
    Second, section 1866(j) of the Act provides specific authority with 
respect to the Medicare enrollment process for providers and suppliers.
    Third, section 6405(c) of the Affordable Care Act gives the 
Secretary the authority to require that pharmacy claims and beneficiary 
reimbursement requests for covered Part D drugs prescribed by a 
physician (as defined in section 1861(r) of the Act) or eligible 
professional (as defined in section 1848(k)(3)(B) of the Act) are not 
payable unless the prescribing physician or eligible professional is 
enrolled in Medicare under section 1866(j) of the Act.
    Fourth, section 1860D-12(b)(3)(D) of the Act authorizes the 
Secretary to include in a contract with a Part D sponsor such other 
terms and conditions that are not inconsistent with Part D as the 
Secretary may find necessary and appropriate.

C. Provider Enrollment Process

    The Medicare CMS-855 enrollment application collects information 
from providers and suppliers to confirm that they meet all Medicare 
requirements. Such data includes, but are not limited to, the 
provider's or supplier's licensure, tax identification number, National 
Provider Identifier (NPI), practice locations, final adverse action 
history, and owning and managing individuals and organizations. Upon 
receiving a CMS-855 application from a physician or eligible 
professional, the CMS contractor validates the information and performs 
various screening activities, such as reviewing the System for Award 
Management (SAM) to confirm that the individual is not debarred from 
receiving payments under any federal health program. As explained in 
section II. of this IFC, we have taken measures to improve the provider 
enrollment process to determine whether enrolling physicians and 
eligible professionals meet all Medicare requirements.

D. Section 6405 of the Affordable Care Act and the May 23, 2014 Final 
Rule

    As noted previously, section 6405(c) of the Affordable Care Act 
gives the Secretary the authority to extend the requirements of 
sections 6405(a) and (b) of the Affordable Care Act to all other 
categories of items or services under title XVIII of the Act that are 
ordered, prescribed, or referred by a physician or eligible 
professional, including covered Part D drugs. Sections 6405(a) and (b) 
of the Affordable Care Act require physicians and eligible 
professionals who order or certify durable medical equipment, 
prosthetics, orthotics, supplies, or home health services to be 
enrolled in Medicare.
    In accordance with section 6405(c) of the Affordable Care Act, we 
established new Sec.  423.120(c)(6) as part of a May 23, 2014 final 
rule titled, ``Medicare Program; Contract Year 2015 Policy and 
Technical Changes to the Medicare Advantage and the Medicare 
Prescription Drug Benefit Programs'' (79 FR 29843). Our objective was 
to help confirm that Part D drugs are prescribed only by physicians and 
eligible professionals who are qualified to do so under state law and 
under the requirements of the Medicare program. Section 423.120(c)(6) 
currently contains the following provisions:
     A Part D sponsor must deny, or must require its 
pharmaceutical benefit manager (PBM) to deny, a pharmacy claim for a 
Part D drug if an active and valid physician or eligible professional 
National Provider Identifier (NPI) is not contained on the claim.
     A Part D sponsor must deny, or must require its PBM to 
deny, a pharmacy claim for a Part D drug if the physician or eligible 
professional--is not enrolled in the Medicare program in an approved 
status; and does not have a valid opt-out affidavit on file with a Part 
A/B Medicare Administrative Contractor (MAC).
     A Part D sponsor must deny, or must require its PBM to 
deny, a request for reimbursement from a Medicare beneficiary for a 
drug if the request is not for a Part D drug that was dispensed in 
accordance with a prescription written by a physician or eligible 
professional who is identified by his or her legal name in the request; 
and
    ++ Is enrolled in Medicare in an approved status; or
    ++ Has a valid opt-out affidavit on file with a Part A/B MAC.
     In order for a Part D sponsor to submit to CMS a 
prescription drug event record (PDE), the PDE must contain an active 
and valid individual prescriber NPI and must pertain to a claim for a 
Part D drug that was dispensed in accordance with a prescription 
written by a physician or eligible professional who--is enrolled in 
Medicare in an approved status; or has a valid opt-out affidavit on 
file with a Part A/B MAC.
    These requirements apply as of June 1, 2015. However, on December 
3, 2014, through the Health Plan Management System (HPMS), we announced 
an enforcement delay until December 1, 2015. We are now in this IFC 
making another change to make these requirements applicable on January 
1, 2016. Accordingly, and as explained in section II.C. of this IFC, we 
are making

[[Page 25960]]

conforming changes to the regulation text.

II. Provisions of the Interim Final Rule With Comment Period

A. Enrollment

    There are prescribers other than physicians and eligible 
professionals, such as pharmacists, who are legally authorized under 
state or other law to prescribe covered Part D drugs. For example, 
under a Pharmacist Collaborative Practice Agreement, pharmacists may be 
legally authorized to prescribe covered Part D under state or other 
law. However, pharmacists are not physicians under section 1861(r) of 
the Act or eligible professionals under section 1848(k)(3)(B) of the 
Act, and are therefore not eligible to enroll in or opt-out of 
Medicare. Under Sec.  423.120(c)(6), as described previously in section 
I.D. of this IFC, beneficiaries who have been receiving necessary 
prescriptions from prescribers who are not Medicare-enrolled or opted-
out physicians or eligible professionals will no longer be able to 
obtain Part D coverage for these prescriptions once the requirements of 
Sec.  423.120(c)(6) are enforced. Changes to previously finalized 
policies regarding Sec.  423.120(c)(6) are necessary to preserve 
beneficiaries' ability to obtain prescriptions for covered Part D drugs 
prescribed by certain practitioners ineligible to enroll in Medicare. 
We note that the definition of ``physician'' includes dentists, hence 
dentists are eligible to enroll in or opt-out of Medicare. Accordingly, 
this IFC revises Sec.  423.120(c)(6)(ii), (iii), and (iv) such that 
prescriptions provided by ``other authorized prescribers'' (as defined 
in Sec.  423.100) may be covered under Part D. In other words, Part D 
sponsors will not be required to reject pharmacy claims or deny 
beneficiary requests for reimbursement for prescriptions written by 
``other authorized prescribers'' on the basis that the prescriber is 
not enrolled in or opted-out of Medicare. Therefore, Part D sponsors 
will continue to be able to cover pharmacy claims at the point of sale 
(POS) for prescriptions written by ``other authorized prescribers,'' 
provided all other existing Part D coverage requirements are met. We 
note, for example, that under Sec.  423.120(c)(6)(i), an ``other 
authorized prescriber'' must have an active and valid NPI which is 
contained in the pharmacy claim. This change will help beneficiaries to 
continue to receive needed prescriptions.
    In Sec.  423.100, we are defining ``other authorized prescriber'' 
as a person other than a physician (as defined in section 1861(r) of 
the Act) or eligible professional (as defined in section 1848(k)(3)(B) 
of the Act) who is authorized under state or other applicable law to 
write prescriptions. This definition, which applies to Sec.  
423.120(c)(6) only, will sufficiently protect the Medicare program 
because ``other authorized prescribers'' must have prescribing 
authority under state or other applicable law.

B. Provisional Coverage and Notice

    We conclude that, in order to further minimize interruptions to 
Part D beneficiaries' access to needed medications, other changes are 
also needed to the May 23, 2014 final rule. This conclusion is based on 
our analysis of Medicare prescriber enrollment levels and trends since 
promulgation of the final rule and discussions with various 
stakeholders about their concerns regarding beneficiary access once the 
provisions of Sec.  423.120(c)(6) are enforced. Thus, we are modifying 
the provisions of Sec.  423.120(c)(6) to prohibit sponsors from 
rejecting claims or denying beneficiary requests for reimbursement for 
a drug on the basis of the prescriber's enrollment status, unless the 
sponsor has first covered a 3-month provisional supply of the drug and 
provided individualized written notice to the beneficiary that the drug 
is being covered on a provisional basis. Such provisional supply and 
notice will allow sufficient time for an eligible prescriber to enroll 
in Medicare (or submit an opt-out affidavit), so that a beneficiary can 
continue to receive Part D coverage for the drug if prescribed by the 
same prescriber, or for the beneficiary to find a prescriber who meets 
the Medicare requirements to write Part D prescriptions. Enrolling in 
Medicare to prescribe or filing an opt-out affidavit is a process that 
can typically be completed within 3 months. In presumably rare cases 
when the prescriber will not enroll in Medicare or submit an opt-out 
affidavit, we believe the beneficiary should have sufficient time to 
find a prescriber whose prescriptions are coverable by the Part D 
program, if the beneficiary wishes to continue to receive Part D 
coverage for the drug. Once the Part D sponsor has provided the written 
notice to the beneficiary that a drug is being covered on a provisional 
basis because of the prescriber's current Medicare status, and the 
sponsor has covered the required provisional supply of the drug, the 
sponsor will be required to reject future claims and deny future 
requests for reimbursement for the beneficiary for the same drug if the 
prescription is from the same prescriber (unless the prescriber has 
enrolled or opted out in the meantime). We will issue future guidance 
as necessary on how sponsors and their PBMs should operationalize the 
term ``drug'' in their adjudication systems in addition to other 
guidance, as needed.
    The following discussion provides the rationale for adopting a same 
drug/same prescriber policy. First, beneficiaries may not readily know 
which prescribers are enrolled in or opted-out of Medicare and which 
are not. Therefore, our policy means that beneficiaries will receive a 
provisional supply and written notice about each unenrolled prescriber 
they see. Second, beneficiaries may need to fill multiple prescriptions 
from the same unenrolled prescriber, and we are particularly concerned 
about instances when beneficiaries need to do so in a short time period 
before their prescriber has been able to enroll or they have been able 
to find an enrolled prescriber. Therefore, our policy allows 
beneficiaries to receive more than one provisional supply from the same 
unenrolled prescriber for a different drug.
    The pertinent regulation text in this IFC states that the Part D 
sponsor must do the following: ``provide the beneficiary with . . . a 
3-month provisional supply (as prescribed by the prescriber . . .).'' 
This means that the Part D sponsor will be required to cover a full 3-
month supply, if prescribed by the unenrolled practitioner, regardless 
of how the supply is dispensed. For example, a beneficiary may receive 
a provisional supply in accordance with a prescription written for a 
month's supply with two subsequent refills; a prescription written for 
a one-time 3-month's supply; or three prescriptions written for a 1-
month's supply each. Conversely, an unenrolled prescriber might not 
prescribe a full 3-month's supply, and in such a case, the sponsor 
would of course not be required to provide a 3-month's provisional 
supply.
    In addition, certain prescriptions cannot be refilled, such as 
Schedule II controlled substances, and continuing supplies of such 
drugs are dispensed only upon a new prescription. For this reason, the 
regulation text also states that the provisional supply must be 
``allowed by applicable law.''
    We believe that a sponsor tracking dispensed provisional drug 
supplies is easier than tracking a timeframe after a dispensing event. 
Otherwise, in order to ensure a beneficiary receives a provisional 
supply of each drug prescribed by an unenrolled prescriber, Part D 
sponsors would have to keep track of rolling timeframes associated with 
the first dispensing event of each drug.

[[Page 25961]]

    We note that providing beneficiaries with a provisional supply of a 
drug is consistent with other CMS requirements and Part D policies 
designed to provide reasonable access to needed medications. Under the 
Part D transition policy, for example, sponsors are generally required 
to cover off-formulary drugs (including drugs that are on-formulary but 
require prior authorization or step therapy) when a beneficiary changes 
prescription drug benefit plans and in other circumstances, in order to 
give the beneficiary and his or her prescriber time to find a suitable 
on-formulary drug or pursue an exception to continue taking the same 
drug.
    The existing Part D transition policy is an example of an instance 
in which a beneficiary might not receive a full 3-months' supply under 
the provisions of this IFC, even when prescribed the full 3 months' 
supply, due to other existing Part D transition requirements which take 
precedence. If an unenrolled physician prescribes an off-formulary drug 
for a beneficiary that is subject to the transition requirements set 
forth in Sec.  423.120(b)(3), and thus the provisional supply and 
notice requirements are simultaneously triggered, the beneficiary would 
not be able to receive more than a 30-day supply of the drug from a 
retail pharmacy, unless a formulary exception is approved, consistent 
with existing transition requirements. Conversely, if a formulary 
exception is approved, the beneficiary could receive the remaining 
provisional supply. We will issue guidance as to how sponsors should 
provide written notices to the beneficiary when the sponsor is required 
to issue a both a transition notice under Sec.  423.120(b)(3)(iv) and a 
provisional supply notice under the revised requirements of Sec.  
423.120(c)(6).
    Other examples when a beneficiary might not receive a full 3-
month's provisional supply, or any provisional supply at all, is when 
the prescriber does not have an active and valid NPI. Under Sec.  
423.120(c)(6)(i), the Part D sponsor or its PBM must reject a pharmacy 
claim unless it contains an active and valid prescriber NPI. Thus, a 
sponsor or its PBM cannot cover a provisional supply when the 
applicable pharmacy claim does not contain an active and valid 
prescriber NPI. Without a prescriber NPI, the sponsor or PBM would not 
be able to determine whether a drug should be covered on a provisional 
or regular basis, because the sponsor cannot determine the prescriber's 
Medicare enrollment or opt out status. An additional example is when 
the drug prescribed is subject to approved prior authorization or step 
therapy requirements by the plan. Such utilization management edits 
will still apply to provisional supplies. For these reasons, the 
regulation text in this IFC states that the Part D sponsor or its PBM 
must provide the beneficiary with a provisional supply and written 
notice ``subject to all other Part D rules and plan coverage 
requirements.''
    In light of our previous discussion for provisional coverage, we 
have made the following changes to Sec.  423.120(c)(6):
     Revised paragraphs (c)(6)(ii)(A) and (c)(6)(iii) to add 
the clause ``Except as provided in paragraph (c)(6)(v) of this 
section.'' The revised paragraphs would otherwise require Part D 
sponsors and their PBMs to reject pharmacy claims and deny beneficiary 
requests for reimbursement based on the Medicare status of the 
prescriber.
     Added new paragraph (c)(6)(v) to require that a Part D 
sponsor or its PBM not reject a pharmacy claim for a Part D drug under 
paragraphs (c)(6)(ii) or (c)(6)(iii) of this section unless the sponsor 
has provided the provisional coverage of the drug and written notice to 
the beneficiary required by paragraph (c)(6)(v)(B).
     Added new paragraph (c)(6)(v)(B) to require that upon 
receipt of a pharmacy claim or beneficiary request for reimbursement 
for a Part D drug that a Part D sponsor would otherwise be required to 
reject or deny in accordance with paragraphs (c)(6)(ii) and (iii) of 
this section, a Part D sponsor or its PBM must provide the beneficiary 
with the following two things, subject to all other Part D rules and 
plan coverage requirements.
     Added new paragraph (c)(6)(v)(B)(1)(i) to require a Part D 
sponsor to provide a 3-month provisional supply of the drug (as 
prescribed by the prescriber and if allowed by applicable law).
     Added new paragraph (c)(6)(v)(B)(1)(ii) to require a Part 
D sponsor to provide written notice within 3 business days after 
adjudication of the claim or request in a form and manner specified by 
CMS.
     Added new paragraph (c)(6)(v)(B)(2) to require that a Part 
D sponsor or its PBM must ensure that reasonable efforts are made to 
notify the prescriber of a beneficiary who was sent a notice.

C. Revision to Dates in Sec.  423.120(c)(5) and (c)(6)

    The requirements of Sec.  423.120(c)(5), which address certain NPI 
submission and verification activities related to pharmacy claims for 
Part D drugs, apply before June 1, 2015. As mentioned in section I.C. 
of this IFC, the requirements of Sec.  423.120(c)(6) apply beginning 
June 1, 2015. On December 3, 2014, we announced an enforcement delay of 
Sec.  423.120(c)(6) until December 1, 2015. We are now in this IFC 
making another change to make these requirements applicable on January 
1, 2016. This is to help make certain that stakeholders, such as 
beneficiaries and plan sponsors, have sufficient time to prepare for 
the requirements of Sec.  423.120(c)(6).
    To prevent potential confusion over the applicability of Sec.  
423.120(c)(5) and (c)(6), we are revising the dates identified therein. 
The beginning of Sec.  423.120(c)(5) will be changed from ``Before June 
1, 2015, the following are applicable'' to ``Before January 1, 2016, 
the following are applicable''. The beginning of Sec.  423.120(c)(6) 
will be changed from ``Beginning June 1, 2015, the following are 
applicable'' to ``Beginning January 1, 2016, the following are 
applicable''. We believe these revisions are necessary so that 
stakeholders will understand precisely when the requirements of Sec.  
423.120(c)(5) and (c)(6) apply to them.

D. Rejection of Pharmacy Claims

    This IFC also makes a technical change to Sec.  423.120(c)(6)(i) 
and (ii) by replacing language that requires plan sponsors to ``deny'' 
pharmacy claims that do not meet the requirements of Sec.  
423.120(c)(6) with language requiring plan sponsors to ``reject'' such 
claims. POS claim transactions are not considered coverage 
determinations under Part D program rules unless the plan chooses to 
treat the presentation of the prescription as a request for a coverage 
determination. Therefore, a Part D plan sponsor is not subject to the 
requirements for coverage determinations in part 423, subpart M, such 
as the timeframe and notification rules, nor to the requirements to 
conduct clinical review or to provide notice of appeal rights when a 
prescription cannot be filled under the Part D benefit at the POS. With 
the requirements finalized in the May 23, 2014 final rule (79 FR 
29843), we did not intend to redefine the nature of POS transactions in 
the Part D program specifically for claims that are not paid at the POS 
because the prescriber does not meet the enrollment or opt-out 
requirements. We believe the word ``deny'' in the regulation text may 
incorrectly be interpreted to require plans to issue a standardized 
denial notice with appeal rights (OMB approval 0938-0976, ``Notice of 
Denial of Medicare Prescription Drug Coverage'', CMS-10146) for 
rejected claims at POS, rather than follow our existing requirements at

[[Page 25962]]

Sec. Sec.  423.128(b)(7)(iii) and 423.562(a)(3). These provisions 
require plans to arrange with their network pharmacies to distribute a 
copy of the standardized pharmacy notice (OMB approval 0938-0975, 
``Medicare Prescription Drug Coverage and Your Rights'', CMS-10147) to 
the enrollee. We believe that this technical change will make the 
requirements at Sec.  423.120(c)(6)(i) and (ii) consistent with our 
other requirements for POS claim transactions and existing National 
Council for Prescription Drug Programs guidance. We are retaining use 
of the term ``deny'' at Sec.  423.120(c)(6)(iii), because plan sponsors 
are required to treat an enrollee request for reimbursement as a 
coverage determination under subpart M.

E. Name on Beneficiary Reimbursement Requests

    We also made a technical change at Sec.  423.120(c)(6)(iii) by 
replacing ``legal name'' with ``name'' for beneficiary reimbursement 
requests. Requiring that beneficiary requests for coverage include the 
prescriber's legal name is inconsistent with the existing standard 
required for coverage determination requests at Sec.  423.568(a) and 
related subregulatory guidance and is overly burdensome for 
beneficiaries. Throughout Chapter 18 of the Medicare Prescription Drug 
Manual (particularly section 30.3), CMS guidance to plan sponsors 
includes an expectation that plan sponsors will make reasonable and 
diligent efforts to obtain any missing information required to process 
beneficiary requests when the request does not include all information 
needed to make a decision, such as the prescriber's legal name, if 
necessary to determine coverage under the prescriber enrollment 
requirements. Additionally, Chapter 5, section 90.2.2 contains language 
stating that plans can require beneficiary requests for reimbursement 
to include prescriber name (not ``legal name'') and address or phone 
number or pharmacy name and phone number to assist the plan in locating 
the prescriber NPI necessary to submit the PDE to CMS. We recognize 
that the ``legal name'' standard was included in Sec.  423.120(c)(6) 
because it was adopted for Part A/B ordering and referring claims at 
Sec.  424.507(a)(2). However, given the regulations and manual guidance 
previously discussed, we do not believe this standard is appropriate 
for Part D beneficiary reimbursement requests.

F. Other Technical Changes

    In addition to the previously described revisions, we are making 
the following minor technical changes to Sec.  423.120(a)(6)(i) through 
(iv). (These changes will not affect the requirements or substance of 
these paragraphs.)
     In paragraphs (c)(6)(i), (ii), and (iii), we replaced the 
word ``if'' with ``unless,'' and deleted the word ``not.'' The current 
versions of these paragraphs are written in the negative, which has 
caused confusion for some readers. We believe these changes will 
clarify these paragraphs.
     In paragraphs (c)(6)(i) and (iv), we replaced references 
to ``physicians'' and ``eligible professionals'' with the term 
``prescriber.'' The latter word is necessary to reflect that these 
paragraphs also apply to prescribing individuals other than physicians 
and eligible professionals.
     In paragraph (c)(6)(ii), the current opening paragraph is 
incorporated into revised paragraph (c)(6)(ii)(A). Current paragraphs 
(c)(6)(ii)(A) and (B) are redesignated as new paragraphs 
(c)(6)(ii)(A)(1) and (2). The requirements pertaining to other 
authorized prescribers are addressed in revised paragraph 
(c)(6)(ii)(B). These organizational revisions of (c)(6)(ii) are 
necessary in order to incorporate the substantive and technical changes 
discussed in this IFC.
     In the opening paragraph of (c)(6)(iii), we changed the 
language ``for a drug if the request is not for a Part D drug that was 
dispensed in accordance with a prescription written by'' to ``unless 
the request pertains to a Part D drug that was prescribed by''. This is 
to make the paragraph clearer and more readable. We also--
    ++ Changed paragraph (c)(6)(iii)(A) from ``Is identified by his or 
her legal name in the request'' to ``A physician or, when permitted by 
applicable State law, other eligible professional (as defined in 
section 1848(k)(3)(B) of the Act) who is identified by name in the 
request; and who''.
    ++ Redesignated current paragraphs (c)(6)(iii)(B)(1) and (2) as new 
paragraphs (A)(1) and (2). The requirements pertaining to other 
authorized prescribers are addressed in revised paragraph 
(c)(6)(iii)(B).
    These technical revisions to (c)(6)(iii) are needed to accommodate 
the substantive and technical revisions heretofore discussed in this 
IFC.
     In paragraph (c)(6)(iv) we are making the following 
changes:
    ++ The opening paragraph is changed from ``In order for a Part D 
sponsor to submit to CMS a prescription drug event record (PDE), the 
PDE must contain an active and valid individual prescriber NPI and must 
pertain to a claim for a Part D drug that was dispensed in accordance 
with a prescription written by a physician or, when permitted by 
applicable State law, an eligible professional (as defined in section 
1848(k)(3)(B) of the Act) who'' to''A Part D plan sponsor submitting a 
prescription drug event (PDE) to CMS must include on the PDE the active 
and valid individual NPI of the prescriber of the drug, who must''. We 
believe the new language is more concise and straightforward.
    ++ We have redesignated current paragraphs (c)(6)(iv)(A) and (B) as 
new paragraphs (c)(6)(iv)(A)(1) and (2). The requirements pertaining to 
other authorized prescribers are addressed in revised paragraph 
(c)(6)(iv)(B).
    These technical revisions to paragraph (c)(6)(iv) are needed to 
accommodate the substantive and technical revisions discussed in this 
IFC.

III. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule. The 
notice of proposed rulemaking includes a reference to the legal 
authority under which the rule is proposed and the terms and substance 
of the proposed rule or a description of the subjects and issues 
involved. However, this procedure can be waived if an agency finds good 
cause that a notice-and-comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporates a 
statement of the finding and its reasons in the rule issued.
    We believe we have good cause to make our previously discussed 
changes in this IFC. Concerning the substantive changes, we believe 
that notice-and-comment rulemaking is contrary to the public interest 
for the reasons that follow.
    Several months after publication of the May 23, 2014 final rule 
that imposed the enrollment or opt-out requirement as of June 1, 2015, 
it was brought to our attention during implementation that there are 
prescribers who can and do prescribe Part D medications but who are 
also unable to enroll in Medicare to prescribe because they do not 
technically meet even the broad definition of ``eligible health 
professional.'' The May 23, 2014 final rule was not only complex and 
controversial, but with respect to the prescriber enrollment provisions 
themselves, we were focused on the fact that dentists can enroll and 
represent the largest group of unenrolled current Part D prescribers. 
Additionally, we did

[[Page 25963]]

not receive any explicit comments on the pharmacist issue.
    Once we became aware of the issue, we promptly considered 
alternatives to address it, such as directing pharmacists to opt-out, 
but concluded that this is not permissible under the applicable 
statutory language. Ultimately, we came to the conclusion that the May 
23, 2014 rule must be updated. The existing rule could cause an 
unintended disruption in beneficiaries' access to Part D drugs because 
under the current regulations, as of June 1, 2015, pharmacists' (and 
potentially certain other prescribers') prescriptions could not be 
filled.
    Additionally, we concluded that changes to the May 23, 2014 rule 
needed to include a provisional supply to prevent disruptions to 
beneficiaries' access to Part D drugs. This is based on our monitoring 
of prescriber enrollment levels and trends and meetings with 
stakeholders during implementation. Prescriber enrollment is a 
voluntary act, and while we remain confident that the Part D 
prescribers who need to enroll or opt-out will ultimately do so in 
large numbers, it will take some time. The non-dentist and non-
pharmacist prescribers who need to enroll are ones who did not enroll 
to be able to order and certify under Sec.  424.507. In addition, 
dentists are a group of providers that has not yet had a robust direct 
relationship with Medicare due to the fact that dentists generally do 
not bill Medicare for their services. Since it is in the public's 
interest that we make certain that beneficiary access to needed drugs 
will not be impaired when these important program integrity protections 
become applicable, we have also added the provisional supply provisions 
in this IFC. Without such swift action, we would be forced to either 
enforce the rule as written, which could cause beneficiary harm by 
disrupting access, or further delay enforcement, which also could cause 
beneficiary harm by continuing to permit unqualified individuals to 
prescribe Part D drugs. Both outcomes are contrary to the public 
interest. In addition, the provisional supply provisions include a 
written notice to the beneficiary. We believe that the written notices 
will result in beneficiaries' discussing the enrollment status issue 
with their prescribers, which will assist in our prescriber enrollment 
efforts. In addition, to resolve these problems, it is necessary to 
implement the provisions of this IFC prior to the Medicare Part D bid 
deadline for the 2016 contract year, which begins on January 1, 2016. 
The statutory bid deadline this year is June 1, 2015. Any changes to 
Part D requirements for contract year 2016 must be implemented prior to 
the bid deadline so that Part D sponsors may account for them in their 
bids; we cannot impose costly new requirements on the plans for a 
contract year that are not accounted for in their bids for that 
contract year under section 1860D-12(f)(2) of the Act. Thus, an IFC is 
the only means for ensuring that our requirements do not cause 
unintended disruption to beneficiary access to Part D drugs, while 
ensuring that the changes that will minimize such disruptions are 
incorporated into Part D sponsors' 2016 bids; the length of time 
involved with notice-and rulemaking would prevent us from accomplishing 
these objectives without further delaying enforcement of the existing 
regulations, which for the reasons discussed later in this section, 
could cause beneficiary harm. Moreover, a prompt publication is 
necessary to give Part D plan sponsors time to implement the 
operational changes needed for them to be prepared for these 
requirements in the 2016 contract year.
    If Part D sponsors were unable to account for these new 
requirements in their 2016 bids, we would have to delay the 
applicability date of the enrollment/opt-out requirements to no sooner 
than January 1, 2017. We believe that such an outcome similarly is 
contrary to the public interest because it would unduly delay the 
extremely important program integrity and basic quality assurance 
protection for Medicare beneficiaries that we implemented in our May 
23, 2014 final rule, and beneficiaries could be harmed as a result. As 
we explained in the May 23, 2014 final rule, we have been concerned 
about instances where unqualified individuals are prescribing Part D 
drugs. In fact, in a June 2013 report the OIG found that the Part D 
program inappropriately paid for drugs ordered by individuals who did 
not appear to have the authority to prescribe. (See ``Medicare 
Inappropriately Paid for Drugs Ordered by Individuals Without 
Prescribing Authority'' (OEI-02-09-00608).) There have also been 
reports that the prescriptions of physicians with suspended licenses 
have been covered by the Part D program.
    The Centers for Disease Control and Prevention (CDC) has 
characterized prescription drug abuse as an epidemic, and found that an 
increase in painkiller prescribing is the key driver of the increase in 
prescription overdoses.\1\ The CDC reports that the drug overdose death 
rate has more than doubled from 1999 through 2013, and more than half 
of those deaths were related to pharmaceuticals.\2\ The Department of 
Health and Human Services has several initiatives to address 
prescription drug abuse; for instance, the National Institute on Drug 
Abuse, the National Institutes of Health, and the Substance Abuse and 
Mental Health Services Administration are working with public and 
private stakeholders to reduce opioid overdoses. CMS has also adopted 
an approach to reduce opioid overutilization in Medicare Part D.
---------------------------------------------------------------------------

    \1\ http://www.cdc.gov/vitalsigns/pdf/2014-07-vitalsigns.pdf.
    \2\ http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html.
---------------------------------------------------------------------------

    The new enrollment requirements addressed in the May 23, 2014 final 
rule represent an important component of this effort and are a crucial 
program integrity and basic quality assurance protection for Medicare 
beneficiaries, for the requirements help us to confirm that prescribers 
are qualified to prescribe Part D drugs. It is important that these 
protections are in place as soon as possible. We have identified 68,000 
prescribers that have been removed from Medicare for reasons such as 
licensure issues, operational status, or exclusion by the OIG, and we 
have a responsibility to enforce these protections to beneficiaries as 
soon as possible without compromising continuity of care or beneficiary 
access to needed medications. The CDC has recommended swift regulatory 
action against health care providers acting outside the limits of 
accepted medical practice to decrease provider behaviors that 
contribute to prescription painkiller abuse, diversion, and 
overdose.\3\
---------------------------------------------------------------------------

    \3\ http://www.cdc.gov/drugoverdose/pdf/policyimpact-prescriptionpainkillerod-a.pdf.
---------------------------------------------------------------------------

    Thus, for all of these reasons, we find good cause to waive prior 
notice and comment with respect to the substantive changes being made 
in this IFC.
    With respect to the technical changes being made in this IFC, we 
believe notice-and-comment rulemaking is unnecessary because these 
changes are not substantive and do not alter current policy.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork

[[Page 25964]]

Reduction Act of 1995 requires that we solicit comment on the following 
issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on the following section of this 
document that contains information collection requirements (ICRs).
    We believe the principal information collection requirement 
associated with this IFC is that some Part D sponsors and PBMs will 
need to collect information about which NPIs are for ``other authorized 
prescribers'' in order to properly adjudicate pharmacy claims 
containing such prescriber NPIs in light of the revised provisions of 
Sec.  423.120(c)(6) in this IFC. However, we estimate that half of the 
30 Part D sponsors and PBMs with Part D adjudications systems already 
collect information about the prescriptive authority of prescriber NPIs 
in order to mitigate current potential audit risks associated with 
submitting PDEs to CMS for Part D drugs that were not dispensed upon a 
valid prescription.
    In a CMS analysis of PDE data, there were just over 1.3 million 
prescribers writing Part D prescriptions in 2013. Approximately 17,000 
of these prescribers have NPIs a taxonomy in the National Provider & 
Plan Enumeration System (NPPES) that would fall under the definition of 
``other authorized prescribers'' (largely pharmacist taxonomies).
    NPIs and the addresses and taxonomy codes that pertain to them are 
publicly available information through the CMS Web site for NPPES. We 
estimated that collecting information about which NPIs are for ``other 
authorized prescribers'' would take an average of 30 minutes (0.5 
hours) per NPI associated with a pharmacist or 8,500 hours, and the 
estimated total burden for 15 sponsors/PBMs to be 17,500 hours for 
2016. The estimated total annual cost for this burden is $3,343,050. 
This is based upon the national median hourly rate of $26.22 for 
insurance claim and policy processing clerk multiplied by the number of 
burden hours in 2016. We did not estimate any burden in 2017 and 2018 
for the collection of information about ``other authorized prescriber'' 
NPIs, as the number of new pharmacist NPIs and existing pharmacist NPIs 
becoming inactive will be negligible in light of the fact that there 
are only approximately 17,000 total ``other authorized prescribers'' 
writing Part D prescriptions in 2013.
    We note that since NPPES is not a provider credentialing system, 
but rather an enumeration system that contains self-reported 
credentials, Part D sponsors might not rely upon a taxonomy in NPPES as 
documentation that an NPI in fact belongs to a pharmacist with an 
active license who is permitted to prescribe. We have used data from 
NPPES to provide an estimate as to how many ``other authorized 
prescribers'' NPIs about which Part D sponsors and PBMs will need to 
collect information.
    In the alternative, we understand that Part D sponsors/PBMs may 
purchase prescriber ID validation services from a private company that 
can provide them with a list of ``other authorized providers.'' 
However, we do not provide a collection estimate for all options that 
sponsors/PBMs may have in implementing the provisions of this IFC.
    We also revised the provisions of Sec.  423.120(c)(6) to require 
Part D sponsors to cover a provisional supply of a drug before they 
reject a claim based on a prescriber's Medicare status. These 
modifications will also require Part D sponsors to provide written 
notice to the beneficiary and take reasonable efforts to provide 
written notice to the prescriber. The burden associated with these 
modifications is the time and effort necessary for Part D adjudications 
systems to be programmed, model notices to be created, and such notices 
to be generated and disseminated to perform these tasks. We estimated 
that this will take 30 sponsors and PBMs with Part D adjudications 
systems 156,000 hours for software developers and programmers to 
program their systems in 2016 to comply with the modifications to Sec.  
423.120(c)(6) in this IFC. In 2017 and 2018, we estimated the total 
burden to be 83,000 hours for each year.
    We estimated the total hours by estimating a 6-month preparation 
and testing period. Six months includes approximately 1,040 full-time 
working hours. We estimated 5 full time staff (or 10 staff working half 
their hours on this project). Five staff x 1,040 hours x 30 sponsors/
PBMs = 156,000 total hours. We estimated an hourly rate of $64.32 for 
such developers and programmers, which is $10,033,920 in total burden 
cost.
    We also estimated 212 parent organizations will create two template 
notices to notify beneficiaries and prescribers under the modifications 
of Sec.  423.120(c)(6). We estimated this will take 3 hours per entity 
for a total of 636 hours. We estimated an hourly rate of $45.54 for a 
business operation specialist to create such notices. Thus, the total 
estimated burden cost for parent organizations to create two model 
notices is $28,963.44.
    Once the templates have been developed, we estimated that these 
notices would take an average of 5 minutes (0.083 hours) to prepare. 
Thus, we estimated the annual burden hours for 2016 to be 1,743,000 
hours. This is based upon the national median hourly rate of $26.22 for 
an insurance claim and policy processing clerk multiplied by the number 
of burden hours. The estimated annual burden cost for 2016 is 
$45,701,460.
    Therefore, we estimated the total regulatory impact for these 
provisions in 2016 to be $55,764,343.44 ($10,033,920 + $28,963.44 + 
$45,701,460).
    Approximately 2 million beneficiaries enter the Part D program 
every year. If we assume that 25 percent of these new beneficiaries 
will see 1 prescriber who is not enrolled or opted out, and that 
prescriber prescribes 2 drugs, we anticipate that parent organizations 
will have to send 1 million notices in 2017 and 2018 each (250,000 
beneficiaries x 2 prescriptions x 2 notices each = 1,000,000). We 
estimate these notices would take an average of 5 minutes (0.083 hours) 
to prepare. Thus, we estimate the total burden to be 83,000 hours for 
each year, and the annual cost to be $2,176,260. This is based upon the 
national median hourly rate of $26.22 for insurance claim and policy 
processing clerk multiplied by the number of burden hours.
    Table 1 outlines the projected costs of this IFC commencing 2016 
through 2018:

                                         Table 1--Projected Burden Costs
----------------------------------------------------------------------------------------------------------------
                                         Programming       Create notices      Send notices      Annual impact
----------------------------------------------------------------------------------------------------------------
2016................................        $10,033,920         $28,963.44        $45,701,460     $55,764,343.44
2017................................                N/A                N/A          2,176,260          2,176,260

[[Page 25965]]

 
2018................................                N/A                N/A          2,176,260          2,176,260
----------------------------------------------------------------------------------------------------------------

    If you comment on these information collection and recordkeeping 
requirements, please do either of the following:
    1. Submit your comments electronically as specified in the 
ADDRESSES section of this interim final rule with comment period; or
    2. Submit your comments to the Office of Information and Regulatory 
Affairs, Office of Management and Budget, Attention: CMS Desk Officer, 
[CMS-6107-IFC]; Fax: (202) 395-6974; or Email: 
OIRA_submission@omb.eop.gov.

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VI. Regulatory Impact Statement

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4) and Executive Order 13132 on Federalism (August 4, 
1999).
    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). 
The impact of this IFC is directly associated with the information 
collection requirements discussed in section IV. of this IFC and will 
not exceed $100 million in any one year. Therefore, this is IFC is not 
a major rule.
    The average Part D beneficiary takes 9 drugs prescribed by three 
prescribers annually. Based on 2013 PDE data, approximately 380,000 (28 
percent) Part D prescribers were not found in the Provider Enrollment, 
Chain, and Ownership System (PECOS) and are associated with just under 
8,000,000 unique beneficiaries. Generally, PECOS is the CMS record 
database of all physicians and eligible professionals who are or were 
enrolled in or opted out of Medicare. Thus, these prescribers write 
prescriptions on average for 21 beneficiaries (8,000,000/380,000 = 21). 
For purposes of this analysis, we assumed that on January 1, 2016, 
250,000 prescribers will still need to enroll in or opt-out of Medicare 
to prescribe coverable Part D drugs. We also assume that these 250,000 
prescribers will write prescriptions for 5.25 million beneficiaries 
(250,000 x 21). We further assume that no beneficiaries will switch 
prescribers until they receive a notice that a drug is being covered on 
a provisional basis. Additionally, we assumed that these prescribers 
will write on average two prescriptions for each of these 
beneficiaries. We assumed that Part D parent organizations will be able 
to send each prescriber a notice. Finally, we did not offset our 
estimation in light of our expectation that, in some cases, transition 
and provisional supply notices will be combined into one notice. We 
estimated that parent organizations will send 21 million beneficiary 
and prescriber notices in accordance with the modifications to Sec.  
423.120(c)(6) in 2016 (5,250,000 beneficiaries x 2 prescriptions x 2 
notices each = 21,000,000), which we expect to occur as a downward 
trend that we do not reflect in this analysis.
    Prescribers are expected to enroll on a steady basis throughout 
2016 as a result of the prescriber enrollment requirements. By 2017, we 
expect that the majority of Part D prescribers will have enrolled in or 
opted out of Medicare in order for their prescriptions to be coverable 
by the Part D program. When a prescriber does not enroll or opt out, 
the beneficiary will either change to a prescriber who is enrolled or 
opted out, or the beneficiary will pay out of pocket for the 
prescriptions written by that prescriber. Nevertheless, parent 
organizations will have to send notices on an ongoing basis to 
beneficiaries who are new to the Part D program and receive a 
prescription from a prescriber who is not enrolled in or opted out of 
Medicare.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most entities and most other providers and suppliers are 
small entities, either by nonprofit status or by having revenues 
between $7.5 million and $38.5 million in any 1 year. Individuals and 
states are not included in the definition of a small entity. We do not 
believe that this IFC would have a significant economic impact on a 
substantial number of small businesses, as Part D sponsors and parent 
organizations do not generally meet the definition of a small business.
    Section 1102(b) of the Act requires us to prepare a regulatory 
impact analysis if a rule may have a significant impact on the 
operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital that is located outside of a Metropolitan Statistical Area for 
Medicare payment regulations and has fewer than 100 beds. We are not 
preparing an analysis for section 1102(b) of the Act because we have 
determined and the Secretary certified that this IFC 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 (UMRA) 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 2015, this 
is approximately $144 million. We believe that this IFC 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 requirements or costs on 
state and local governments, preempts state law, or

[[Page 25966]]

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 IFC was reviewed by the 
Office of Management and Budget.

List of Subjects in 42 CFR Part 423

    Administrative practice and procedure, Emergency medical services, 
Health facilities, Health maintenance organizations (HMO), Health 
professionals, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

    For the reasons stated in the preamble of this interim final rule 
with comment period, the Centers for Medicare & Medicaid Services 
amends 42 CFR part 423 as follows:

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG PROGRAM

0
1. The authority citation for part 423 continues to read as follows:

    Authority:  Secs. 1102, 1106, 1860D-1 through 1860D-42, and 1871 
of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 through 
1395w-152, and 1395hh).


0
2. Amend Sec.  423.100 by adding a definition of ``Other authorized 
prescriber'' in alphabetical order to read as follows:


Sec.  423.100  Definitions.

* * * * *
    Other authorized prescriber means, for purposes of Sec.  
423.120(c)(6) only, an individual other than a physician (as defined in 
section 1861(r) of the Act) or eligible professional (as defined in 
section 1848(k)(3)(B) of the Act) who is authorized under State or 
other applicable law to write prescriptions.
* * * * *

0
3. Amend Sec.  423.120 by revising paragraphs (c)(5) introductory text 
and (c)(6) to read as follows:


Sec.  423.120  Access to covered Part D drugs.

* * * * *
    (c) * * *
* * * * *
    (5) Before January 1, 2016, the following are applicable:
* * * * *
    (6) Beginning January 1, 2016, the following are applicable:
    (i) A Part D plan sponsor must reject, or must require its 
pharmaceutical benefit manager (PBM) to reject, a pharmacy claim for a 
Part D drug unless the claim contains the active and valid National 
Provider Identifier (NPI) of the prescriber who prescribed the drug.
    (ii)(A) Except as provided in paragraph (c)(6)(v) of this section, 
a Part D plan sponsor must reject, or must require its PBM to reject, a 
pharmacy claim for a Part D drug unless the physician or, when 
permitted by applicable State law, the eligible professional (as 
defined in section 1848(k)(3)(B) of the Act) who prescribed the drug--
    (1) Is enrolled in the Medicare program in an approved status; or
    (2) Has a valid opt-out affidavit on file with a Part A/B Medicare 
Administrative Contractor (MAC).
    (B) Pharmacy claims for Part D drugs prescribed by an other 
authorized prescriber (as defined in Sec.  423.100) are not subject to 
the requirements specified in paragraph (c)(6)(ii)(A) of this section.
    (iii) Except as provided in paragraph (c)(6)(v) of this section, a 
Part D plan sponsor must deny, or must require its PBM to deny, a 
request for reimbursement from a Medicare beneficiary unless the 
request pertains to a Part D drug that was prescribed by--
    (A) A physician or, when permitted by applicable State law, other 
eligible professional (as defined in section 1848(k)(3)(B) of the Act) 
who is identified by name in the request and who--
    (1) Is enrolled in Medicare in an approved status; or
    (2) Has a valid opt-out affidavit on file with a Part A/B MAC; or
    (B) An other authorized prescriber (as defined in Sec.  423.100) 
who is identified by name in the request.
    (iv) A Part D plan sponsor submitting a prescription drug event 
(PDE) to CMS must include on the PDE the active and valid individual 
NPI of the prescriber of the drug, who must--
    (A)(1) Be enrolled in Medicare in an approved status, or
    (2) Have a valid opt out affidavit on file with a Part A/B MAC; or
    (B) Be an other authorized prescriber (as defined in Sec.  
423.100).
    (v)(A) A Part D sponsor or its PBM must not reject a pharmacy claim 
for a Part D drug under paragraph (c)(6)(ii) of the section or deny a 
request for reimbursement under paragraph (c)(6)(iii) of this section 
unless the sponsor has provided the provisional coverage of the drug 
and written notice to the beneficiary required by paragraph 
(c)(6)(v)(B) of this section.
    (B) Upon receipt of a pharmacy claim or beneficiary request for 
reimbursement for a Part D drug that a Part D sponsor would otherwise 
be required to reject or deny in accordance with paragraphs (c)(6)(ii) 
or (iii) of this section, a Part D sponsor or its PBM must do the 
following:
    (1) Provide the beneficiary with the following, subject to all 
other Part D rules and plan coverage requirements:
    (i) A 3-month provisional supply of the drug (as prescribed by the 
prescriber and if allowed by applicable law).
    (ii) Written notice within 3 business days after adjudication of 
the claim or request in a form and manner specified by CMS.
    (2) Ensure that reasonable efforts are made to notify the 
prescriber of a beneficiary who was sent a notice under paragraph 
(c)(6)(v)(B)(1)(ii) of this section.
* * * * *

    Dated: April 17, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 29, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-10545 Filed 5-1-15; 4:15 pm]
 BILLING CODE 4120-01-P