Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices 13801 

Provider No. 

Wage index 

4/1/2007–

9/30/2007 

230236 .................................. 1.0797 

230254 .................................. 1.0602 

230269 .................................. 1.0602 

230270 .................................. 1.0440 

230273 .................................. 1.0440 

230277 .................................. 1.0602 

250002 .................................. 0.8461 

250122 .................................. 0.8461 

270023 .................................. 0.8956 

270032 .................................. 0.8956 

270057 .................................. 0.8956 

310021 .................................. 1.3113 

310028 .................................. 1.3113 

310051 .................................. 1.3113 

310060 .................................. 1.3113 

310115 .................................. 1.3113 

310120 .................................. 1.3113 

330049 .................................. 1.3113 

330106 .................................. 1.4779 

330126 .................................. 1.3113 

330135 .................................. 1.3113 

330205 .................................. 1.3113 

330209 .................................. 1.2730 

330264 .................................. 1.2730 

340002 .................................. 0.9413 

350002 .................................. 0.8367 

350003 .................................. 0.8367 

350006 .................................. 0.8367 

350010 .................................. 0.8367 

350014 .................................. 0.8367 

350015 .................................. 0.8367 

350017 .................................. 0.8367 

350030 .................................. 0.8367 

380090 .................................. 1.1162 

390001 .................................. 0.9990 

390003 .................................. 0.9990 

390045* ................................ 0.9990 

390054 .................................. 0.9942 

390072 .................................. 0.9990 

390095 .................................. 0.9990 

390119 .................................. 0.9990 

390137 .................................. 0.9990 

390169 .................................. 0.9990 

390185 .................................. 0.9942 

390192 .................................. 0.9990 

390237 .................................. 0.9990 

390270 .................................. 0.9942 

430005 .................................. 0.8708 

430015 .................................. 0.9238 

430048 .................................. 0.9238 

430060 .................................. 0.9238 

430064 .................................. 0.9238 

430077 .................................. 0.9238 

430091 .................................. 0.9238 

450010 .................................. 0.8794 

450072 .................................. 1.0094 

450591 .................................. 1.0094 

470003 .................................. 1.1343 

490001 .................................. 0.8600 

530015 .................................. 1.0060 

* This hospital is assigned a wage index 

value under a special exceptions policy (69 

FR 49105). 

III. Regulatory Impact Statement 

We have examined the impact of this 

notice using the requirements of 

Executive Order 12866 (September 

1993, Regulatory Planning and Review), 

and Executive Order 13132. 

Executive Order 12866 directs 

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). This notice implements 

a statutory provision that would 

increase payments to hospitals by less 

than $100 million and is therefore not 

a major rule. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

Again, although we do not consider this 

notice to be a rule subject to notice and 

comment rulemaking, we note that this 

notice does not impose any costs on 

State or local governments. Therefore, 

the requirements of Executive Order 

13132 would not be applicable. 

Section 106 of the Tax Relief and 

Health Care Act of 2006 extends any 

geographic reclassification that was set 

to expire on March 31, 2007 by six 

months until September 30, 2007. We 

estimate the impact of this provision 

will be to increase payments to 

hospitals by $80 million. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

Authority: Section 106 of Public Law 109–

432. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 8, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–5298 Filed 3–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4083–NR] 

Medicare Program; Applicability of 

Part 405 Medicare Appeals Council 

Own Motion Review Provisions to the 

Part 423 Medicare Prescription Drug 

(Part D) Appeals Process 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of CMS Ruling. 

SUMMARY: This notice announces a CMS 

Ruling that establishes a process for 

own motion review of Medicare 

Prescription Drug Program (Part D) cases 

by the Medicare Appeals Council. 

FOR FURTHER INFORMATION CONTACT: 

Arrah Tabe-Bedward, (410) 786–7129 or 

Kathryn McCann Smith, (410) 786–

7623. 

SUPPLEMENTARY INFORMATION: The CMS 

Acting Administrator signed Ruling 

CMS–4083–NR on March 15, 2007. The 

text of the CMS Ruling is as follows: 

Implementation of a Process for Own 

Motion Review of Part D Cases by the 

Medicare Appeals Council 

Summary: This Ruling establishes a 

process, consistent with the current 

Medicare fee-for-service (FFS) appeals 

rules in title 42 of the Code of Federal 

Regulations, part 405, subpart I, for own 

motion review of Part D cases by the 

Medicare Appeals Council. This Ruling 

is effective on the date the Acting 

Administrator signs the Ruling. 

Citations: Sections 1852(g), 1860D–

4(g)–(h), and 1869 of the Social Security 

Act (42 U.S.C. 1395w–22, 1395w–104 

and 1395ff). 

I. Background on Part D Appeals 

Sections 1860D–4(g) and (h) of the 

Social Security Act (the Act) and the 

implementing regulations at 42 CFR part 

423, subpart M, establish a Part D 

enrollee’s right to appeal an adverse 

coverage determination made by a Part 

D plan sponsor (‘‘plan sponsor’’), as 

defined at 42 CFR 423.4, that results in 

the denial of prescription drug coverage 

the enrollee believes he or she is 

entitled to receive under the Part D 

program. This includes a plan sponsor’s 

decision not to provide or pay for a Part 

D drug, failure to provide a coverage 

determination in a timely manner when 

a delay would adversely affect the 

enrollee’s health, a decision concerning 

a tiering or non-formulary exceptions 

request, and a decision on the amount 


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of cost sharing for a drug. The appeals 

process establishes that enrollees who 

are dissatisfied with a coverage 

determination have the right to request 

that the plan sponsor conduct a 

redetermination of its coverage 

determination. The enrollee then has 

the right to request a reconsideration by 

the Part D independent review entity 

(IRE) if the enrollee is dissatisfied with 

the plan sponsor’s redetermination. If 

the enrollee is dissatisfied with the Part 

D IRE’s decision, and the amount in 

controversy (AIC) requirement is 

satisfied, the enrollee has the right to 

request an administrative law judge 

(ALJ) hearing. An enrollee who is 

dissatisfied with the ALJ’s decision has 

the right to file a request for review with 

the Medicare Appeals Council (MAC). If 

the enrollee is dissatisfied with the 

MAC’s decision and the AIC 

requirement is satisfied, the enrollee has 

the right to file a civil action in Federal 

district court. 

II. Background on MAC Own Motion 

Review Authority 

Section 1860D–4(h) of the Act 

provides that plan sponsors follow 

appeals procedures in § 1852(g)(5) of the 

Act that are similar to those applicable 

to Medicare Advantage (MA) 

organizations for Part C appeals. Section 

1860D–4(h) is silent with respect to own 

motion review by the MAC. Section 

1852(g)(5) provides that enrollees in MA 

plans who are dissatisfied with 

determinations regarding their Part C 

benefits are entitled, if they meet the 

amount in controversy requirement, to a 

hearing before the Secretary to the same 

extent as is provided in § 205(b) of the 

Act and judicial review of the 

Secretary’s final decision as provided in 

§ 205(g) of the Act. Section 

1869(b)(1)(A) of the Act, which sets 

forth the requirements for FFS appeals, 

contains similar language to that set 

forth in § 1852(g)(5) and also refers to 

§ 205(b) and (g). Again, these sections of 

the Act do not discuss own motion 

review by the MAC. 

These statutory concepts are reflected 

in the Part D regulations at 42 CFR part 

423, subpart M and the Part C 

regulations at 42 CFR part 422, subpart 

M. The Part D regulations state that, 

unless otherwise provided, the Part C 

regulations regarding appeals will apply 

to Part D appeals ‘‘to the extent they are 

appropriate.’’ 42 CFR 423.562(c). The 

Part D regulations regarding MAC 

review do not provide any guidance on 

own motion review and, instead, at 

§ 423.620, explicitly state that the 

regulations in part 422, subpart M, 

regarding MAC review apply to Part D 

appeals ‘‘to the extent applicable.’’ The 

Part C regulations governing appeals at 

the ALJ and MAC levels provide that 

adjudicators apply the FFS appeals 

procedures in 42 CFR part 405 ‘‘to the 

extent that they are appropriate.’’ 42 

CFR 422.562(d). Like the Part D 

regulations, the Part C regulations 

governing MAC review are silent on 

own motion review and state that the 

FFS regulations ‘‘regarding MAC review 

apply to matters addressed by this 

subpart to the extent that they are 

appropriate.’’ 42 CFR 422.608. 

Therefore, because there is no 

guidance on own motion review by the 

MAC in the existing Part C and Part D 

statutory and regulatory frameworks, we 

look to the FFS regulations. This Ruling 

is intended to establish the process for 

own motion review of Part D cases by 

the MAC using the process established 

under the FFS regulations, as 

appropriate. This Ruling does not limit 

the authority of the Secretary to issue 

future rulemaking or guidance 

documents addressing Part D appeals 

issues, including the MAC’s own 

motion review authority. 

III. MAC Own Motion Review Under 

Part 405 and Under This Ruling 

We believe that it is appropriate to 

provide a process for making own 

motion referrals to the MAC for Part D 

appeals so that there is a means for 

seeking MAC review of ALJ decisions 

that may warrant review. Based on the 

existing statutory and regulatory 

frameworks, and for the limited purpose 

of this Ruling, we look to the FFS 

appeals process for MAC own motion 

review set out in 42 CFR part 405, 

subpart I to assist in developing this 

process and determining (1) who may 

refer cases to the MAC, (2) the standards 

of referral and review, and (3) other 

procedural requirements. 

A. Who May Refer Part D Cases to the 

MAC for Own Motion Review 

Under 42 CFR 405.1110(a), the MAC 

may decide on its own motion to review 

a decision or dismissal by an ALJ. In 

addition, CMS or its contractors may 

refer a case to the MAC for 

consideration under this own motion 

authority if the referral is made anytime 

within 60 days after the date of an ALJ’s 

decision or dismissal. 

Section 1860D–4(h)(1) of the Act 

establishes that only a ‘‘Part D eligible 

individual shall be entitled to bring 

such an appeal.’’ Moreover, existing 

regulations do not provide plan 

sponsors with the ability to bring an 

appeal or afford plan sponsors party 

status to an appeal. Thus, plan sponsors 

do not have a direct right of appeal to 

the MAC. Similarly, the existing Part D 

statute and regulations do not explicitly 

allow either CMS or its contractors to 

participate in or be parties to ALJ 

hearings. 

For purposes of this Ruling, we 

believe it is appropriate for the MAC to 

decide on its own motion to review a 

decision or dismissal by an ALJ. In 

addition, we believe that it is 

appropriate that only CMS or the Part D 

IRE make referrals to the MAC for own 

motion review. As a procedural matter 

and for efficiency, we expect that most 

of the referrals will be made through the 

Part D IRE, because it is the entity 

responsible for monitoring plan 

effectuation of favorable decisions and 

serves as a repository for all completed 

Part D ALJ cases and associated files. 

The Part D IRE has neither a business 

nor a financial interest in the outcome 

of a case. As such, the Part D IRE is 

generally in the best position to 

objectively examine whether a 

particular case meets the standard for 

referral. While the process established 

by this Ruling does not permit a plan 

sponsor to refer a Part D case to the 

MAC for own motion review, plan 

sponsors will continue to have the 

opportunity to communicate with the 

Part D IRE about cases that may warrant 

such a referral. Thus, we consider it 

appropriate, and consistent with part 

405, subpart I, to allow the MAC to 

review an ALJ decision or dismissal on 

its own motion, and to allow only CMS 

or the Part D IRE to refer cases to the 

MAC to consider review under its own 

motion authority. 

B. Standards for Referral and Review of 

Part D Cases for Own Motion Review by 

the MAC 

With respect to the standards for 

referral of cases, the regulations at 

§ 405.1110 distinguish between cases in 

which CMS or its contractor 

participated or appeared as a party in 

the appeal at the ALJ level and cases in 

which CMS or its contractor did not 

participate. Where CMS or its contractor 

did not participate or appear as a party, 

§ 405.1110(b)(1) and (c)(2) establish that 

CMS or any of its contractors may refer 

a case to the MAC if the ALJ decision 

or dismissal contains an error of law 

material to the outcome of the claim or 

presents a broad policy or procedural 

issue that may affect the public interest. 

In addition to the referral standards that 

apply when CMS or its contractor did 

not participate or appear as a party, for 

cases in which CMS or its contractor 

participated or was a party at the ALJ 

level, § 405.1110(b)(1)(ii) and (c)(1) 

provide that CMS or its contractor may 

also refer cases for own motion review 

by the MAC if, in CMS’ view, the ALJ 


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decision or dismissal is not supported 

by the preponderance of evidence in the 

record or the ALJ abused his or her 

discretion. Since CMS and its contractor 

do not have explicit authority under the 

existing statutes and regulations to 

participate in or be parties to ALJ 

hearings in Part D cases, we believe it 

is appropriate and consistent with part 

405, subpart I, to allow CMS or the Part 

D IRE to refer Part D cases to the MAC 

to consider review under its own 

motion authority based on the standards 

for referral that apply when CMS or its 

contractor did not participate in the ALJ 

proceedings or appear as a party. 

Similar to how § 405.1110 sets forth 

different referral standards depending 

on whether or not CMS or its contractor 

participate in the ALJ hearing, the 

regulations provide differing standards 

for review. Section 405.1110(c)(1) 

provides that when a referral is made in 

instances where CMS or its contractor 

participated or appeared as a party, the 

MAC exercises its own motion authority 

if there is an error of law material to the 

outcome of the case, an abuse of 

discretion by the ALJ, the decision is 

not consistent with the preponderance 

of the evidence of record, or there is a 

broad policy or procedural issue that 

may affect the public interest. In 

deciding whether to accept review 

under this standard, the MAC will limit 

its consideration of the ALJ’s action to 

those exceptions raised by CMS. 

Section 405.1110(c)(2) provides that 

when referral is made in instances 

where CMS or its contractor did not 

participate or appear as a party, the 

MAC will accept review if the decision 

or dismissal contains an error of law 

material to the outcome of the case, or 

presents a broad policy or procedural 

issue that may affect the public interest. 

In deciding whether to accept review, 

the MAC will limit its consideration of 

the ALJ’s action to those exceptions 

raised by CMS. 

As previously noted, since neither the 

Part D statute nor the current Part D 

regulations explicitly allow a Part D 

plan sponsor, CMS, or a CMS contractor 

to participate in or be parties to appeals 

at the ALJ level, we consider it 

appropriate to implement the standard 

of referral and review in § 405.1110 that 

applies when CMS and its contractor do 

not participate in or are not parties to 

the ALJ hearing. Accordingly, under this 

Ruling, CMS or the Part D IRE may refer 

a Part D case to the MAC and the MAC 

will accept review of a Part D case if the 

ALJ’s decision or dismissal contains an 

error of law material to the outcome of 

the case or presents a broad policy or 

procedural issue that may affect the 

general public interest. In deciding 

whether to accept review, the MAC will 

limit its consideration of the ALJ’s 

action to those exceptions raised by 

CMS or the Part D IRE. 

C. Other Issues Regarding MAC Own 

Motion Review of Part D Cases 

For the most part, the other provisions 

set forth under § 405.1110 apply 

appropriately to Part D cases. The 

requirements related to the 60-day time 

frame for filing the written referral and 

for providing notice to other interested 

parties set forth in § 405.1110(b)(2) are 

processes that are appropriate to apply 

to Part D cases. See also 42 CFR 

405.1110(a). Written referrals must state 

the reasons why CMS or its contractors 

believe the MAC must review the case 

on its own motion. CMS or its 

contractors will send a copy of its 

referral to all parties to the ALJ’s action 

and to the ALJ. Similarly, the 

requirements in § 405.1110(b)(2) 

regarding the filing of exceptions to the 

referral by submitting written comments 

to the MAC within 20 days of the 

referral notice, and sending such 

comments to CMS, appropriately apply 

to Part D cases. 

We also believe it is appropriate to 

apply to Part D cases those requirements 

in § 405.1110(d) regarding the MAC’s 

action. This provision states that if the 

MAC decides to review a decision or 

dismissal on its own motion, it will mail 

the results of its action to all the parties 

to the hearing and to CMS if it is not 

already a party to the hearing. The 

notice of the referral in § 405.1110(b)(2) 

requires that the enrollee will be 

notified that the ALJ’s decision may not 

be the final action in the case. If the 

MAC accepts review, it may adopt, 

modify, or reverse the decision or 

dismissal, may remand the case to an 

ALJ for further proceedings or may 

dismiss a hearing request. The MAC 

must issue its action no later than 90 

days after receipt of the CMS referral, 

unless the 90-day period has been 

extended as provided in 405 CFR 

subpart I. The MAC may not, however, 

issue its action before the 20-day 

comment period has expired, unless it 

determines that the agency’s referral 

does not provide a basis for reviewing 

the case. If the MAC does not act within 

the applicable adjudication deadline, 

the ALJ’s decision or dismissal remains 

the final action in the case. We believe 

it is appropriate to apply these 

procedures to Part D cases that the MAC 

reviews on its own motion. 

As described in this section, the 

provisions in § 405.1110 are procedural 

rules that apply appropriately to Part D 

appeals. Further, applying these 

regulatory processes to Part D appeals 

does not conflict with existing Part D 

requirements. 

Authority: Sections 1852, 1860D–4(g)–(h), 

and 1869 of the Social Security Act (42 

U.S.C. 1395w–22, 1395w–104 and 1395ff). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 15, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–5304 Filed 3–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1481–N3] 

Medicare Program; Emergency Medical 

Treatment and Labor Act (EMTALA) 

Technical Advisory Group (TAG) 

Meeting—May 3–4, 2007 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

sixth meeting of the Emergency Medical 

Treatment and Labor Act (EMTALA) 

Technical Advisory Group (TAG). The 

purpose of the EMTALA TAG is to 

review regulations affecting hospital 

and physician responsibilities under 

EMTALA to individuals who come to a 

hospital seeking examination or 

treatment for medical conditions. The 

primary purpose of the sixth meeting is 

to enable the EMTALA TAG to hear 

additional testimony and further 

consider written responses from 

medical societies and other 

organizations on specific issues 

considered by the EMTALA TAG at 

previous meetings. The public is 

permitted to attend this meeting and, to 

the extent that time permits and at the 

discretion of the Chairperson, the 

EMTALA TAG may hear comments 

from the floor. 

DATES: Meeting Date: The meetings of 

the EMTALA TAG announced in this 

notice are as follows: 

Thursday, May 3, 2007, 9 a.m. to 5 p.m. 

Friday, May 4, 2007, 9 a.m. to 5 p.m. 

Registration Deadline: All individuals 

must register in order to attend this 

meeting. Individuals who wish to attend 

the meeting but do not wish to present 

testimony must register by April 26, 


sroberts on PROD1PC70 with NOTICES