25958 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 27, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.632, the section heading 

and paragraph (a) are revised to read as 

follows: 

§ 180.632 Fenazaquin; Tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide fenazaquin, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only fenazaquin, or 4-[2-[4-

(1,1-dimethylethyl)phenyl]

ethoxy]quinazoline. 

Commodity Parts per 

million 

Almond ...................................... 0 .02 

Almond, hulls ............................ 4 .0 

Apple ......................................... 0 .2 

Cherry ....................................... 2 .0 

Citrus Oil ................................... 10 

Fruit, Citrus, Group 10 except 

Grape fruit ............................. 0 .5 

Pear .......................................... 0 .2 

* * * * * 

[FR Doc. 2015–10375 Filed 5–5–15; 8:45 am] 

BILLING CODE 6560–50–P 

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 optout 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 

§ 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 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-andcomment 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 § 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 


tkelley on DSK3SPTVN1PROD with RULES
25960 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

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 optout of Medicare. Under § 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 Medicareenrolled or opted-out physicians or 

eligible professionals will no longer be 

able to obtain Part D coverage for these 

prescriptions once the requirements of 

§ 423.120(c)(6) are enforced. Changes to 

previously finalized policies regarding 

§ 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 

§ 423.120(c)(6)(ii), (iii), and (iv) such 

that prescriptions provided by ‘‘other 

authorized prescribers’’ (as defined in 

§ 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 

§ 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 § 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 

§ 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 § 423.120(c)(6) are 

enforced. Thus, we are modifying the 

provisions of § 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 optout 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. 


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Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 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 offformulary 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 

§ 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 

§ 423.120(b)(3)(iv) and a provisional 

supply notice under the revised 

requirements of § 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 § 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 § 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 § 423.120(c)(5) 

and (c)(6) 

The requirements of § 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 § 423.120(c)(6) apply beginning June 

1, 2015. On December 3, 2014, we 

announced an enforcement delay of 

§ 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 § 423.120(c)(6). 

To prevent potential confusion over 

the applicability of § 423.120(c)(5) and 

(c)(6), we are revising the dates 

identified therein. The beginning of 

§ 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 § 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 

§ 423.120(c)(5) and (c)(6) apply to them. 

D. Rejection of Pharmacy Claims 

This IFC also makes a technical 

change to § 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 

§ 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 


tkelley on DSK3SPTVN1PROD with RULES
25962 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

§§ 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 § 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 § 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 

§ 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 § 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 

§ 423.120(c)(6) because it was adopted 

for Part A/B ordering and referring 

claims at § 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 

§ 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-andcomment 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-andcomment 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 


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Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 25963 

1http://www.cdc.gov/vitalsigns/pdf/2014-07- 

vitalsigns.pdf. 

2http://www.cdc.gov/homeandrecreationalsafety/

overdose/facts.html. 

3http://www.cdc.gov/drugoverdose/pdf/

policyimpact-prescriptionpainkillerod-a.pdf. 

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 § 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. 

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

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 


tkelley on DSK3SPTVN1PROD with RULES
25964 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

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 

§ 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 

§ 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 

§ 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 × 1,040 hours × 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 

§ 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 × 

2 prescriptions × 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 25965 

TABLE 1—PROJECTED BURDEN COSTS—Continued 

Programming Create notices Send notices Annual impact 

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 × 

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 

§ 423.120(c)(6) in 2016 (5,250,000 

beneficiaries × 2 prescriptions × 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 


tkelley on DSK3SPTVN1PROD with RULES
25966 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 

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 

■ 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). 

■ 2. Amend § 423.100 by adding a 

definition of ‘‘Other authorized 

prescriber’’ in alphabetical order to read 

as follows: 

§ 423.100 Definitions. 

* * * * * 

Other authorized prescriber means, 

for purposes of § 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. 

* * * * * 

■ 3. Amend § 423.120 by revising 

paragraphs (c)(5) introductory text and 

(c)(6) to read as follows: 

§ 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 § 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 § 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 § 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 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 120815345–3525–02] 

RIN 0648–XD901 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; 2015 

Commercial Accountability Measure 

and Closure for South Atlantic Gray 

Triggerfish 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS implements 

accountability measures for commercial 

gray triggerfish in the exclusive 

economic zone (EEZ) of the South 

Atlantic. NMFS projects commercial 

landings for gray triggerfish, will reach 

the commercial annual catch limit 

(ACL) on May 8, 2015. Therefore, NMFS 

is closing the commercial sector for gray 

triggerfish in the South Atlantic EEZ on 

May 8, 2015, and it will remain closed 

until NMFS announces the start of the 

next fishing season. This closure is 

necessary to protect the gray triggerfish 

resource. 

DATES: This rule is effective 12:01 a.m., 

local time, May 8, 2015, until NMFS 


tkelley on DSK3SPTVN1PROD with RULES