Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Proposed Rules 31547 

SUMMARY: In accordance with section 

10(a)(2) of the Federal Advisory 

Committee Act (Public Law 92–463), 

notice is hereby given of the following 

meeting of the Negotiated Rulemaking 

Committee on Designation of Medically 

Underserved Populations and Health 

Professional Shortage Areas. 

DATES: Meetings will be held on June 

22, 2011, 9:30 a.m. to 6 p.m.; June 23, 

2011, 9 a.m. to 6 p.m.; and June 24, 

2011, 9 a.m. to 3 p.m. 

ADDRESSES: Meetings will be held at the 

Legacy Hotel and Meeting Centre, 1775 

Rockville Pike, Rockville, Maryland 

20852, (301) 881–2300. 

FOR FURTHER INFORMATION CONTACT: For 

more information, please contact Nicole 

Patterson, Office of Shortage 

Designation, Bureau of Health 

Professions, Health Resources and 

Services Administration, Room 9A–18, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857, Telephone 

(301) 443–9027, E-mail: 

npatterson@hrsa.gov or visit http:// 

www.hrsa.gov/advisorycommittees/ 

shortage/. 

SUPPLEMENTARY INFORMATION: 

Status: The meeting will be open to 

the public. 

Purpose: The purpose of the 

Negotiated Rulemaking Committee on 

Designation of Medically Underserved 

Populations and Health Professional 

Shortage Areas is to establish a criteria 

and a comprehensive methodology for 

Designation of Medically Underserved 

Populations and Primary Care Health 

Professional Shortage Areas, using a 

Negotiated Rulemaking (NR) process. It 

is hoped that use of the NR process will 

yield a consensus among technical 

experts and stakeholders on a new rule 

for designation of medically 

underserved populations and primary 

care health professions shortage areas, 

which would be published as an Interim 

Final Rule in accordance with Section 

5602 of the Affordable Care Act, Public 

Law 111–148. 

Agenda: The meeting will be held on 

Wednesday, June 22; Thursday, June 23; 

and Friday, June 24. It will include a 

discussion of various components of a 

possible methodology for identifying 

areas of shortage and underservice, 

based on the recommendations of the 

Committee in the previous meeting. 

Members of the public will have the 

opportunity to provide comments 

during the meeting on Friday afternoon. 

Requests from the public to make oral 

comments or to provide written 

comments to the Committee should be 

sent to Nicole Patterson at the contact 

address above at least 10 days prior to 

the first day of the meeting, Wednesday, 

June 22. The meetings will be open to 

the public as indicated above, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the contact person listed above at 

least 10 days prior to the meeting. 

Dated: May 24, 2011. 

Wendy Ponton, 

Director, Office of Management. 

[FR Doc. 2011–13480 Filed 5–31–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 414 

[CMS–3248–P] 

RIN 0938–AR00 

Medicare Program; Proposed Changes 

to the Electronic Prescribing (eRx) 

Incentive Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

modify the 2011 electronic prescribing 

(eRx) quality measure (that is, the eRx 

quality measure used for certain 

reporting periods in calendar year (CY) 

2011), provide additional significant 

hardship exemption categories for 

eligible professionals and group 

practices to request an exemption 

during 2011 for the 2012 eRx payment 

adjustment due to a significant 

hardship, and extend the deadline for 

submitting requests for consideration for 

the two significant hardship exemption 

categories for the 2012 eRx payment 

adjustment that were finalized in the CY 

2011 Medicare Physician Fee Schedule 

(PFS) final rule with comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 25, 2011. 

ADDRESSES: In commenting, please refer 

to file code CMS–3248–P. 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–3248–P, 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–3248–P, 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) 786–1066 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: 

Christine Estella, (410) 786–0485. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 


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31548 Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Proposed Rules 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be 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 

Section 132 of the Medicare 

Improvements for Patients and 

Providers Act of 2008 (MIPPA), Public 

Law 110–275, authorized the Secretary 

to establish a program to encourage the 

adoption and use of eRx technology. 

Implemented in 2009, the program 

offers a combination of financial 

incentives and payment adjustments to 

eligible professionals, which are defined 

under section 1848(k)(3)(B) of the Social 

Security Act (the Act). We understand 

that the term ‘‘eligible professional’’ is 

used in multiple CMS programs. 

However, for the purpose of this 

proposed rule, the eligible professionals 

to whom we refer are only those 

professionals eligible to participate in 

the eRx Incentive Program unless we 

specify otherwise. For more information 

on which professionals are eligible to 

participate in the eRx Incentive 

Program, we refer readers to the Eligible 

Professionals page of the eRx Incentive 

Program section of the CMS Web site at: 

http://www.cms.gov/ERxIncentive/

05_Eligible%20Professionals.asp#

TopOfPage. Under section 

1848(m)(2)(C) of the Act, an eligible 

professional (or group practice 

participating in the eRx group practice 

reporting option (GPRO)) who is a 

successful electronic prescriber during 

2011 can qualify for an incentive 

payment equal to 1.0 percent of its total 

estimated Medicare Part B Physician 

Fee Schedule (PFS) allowed charges for 

covered professional services furnished 

during the 2011 reporting period. 

In accordance with section 

1848(a)(5)(A) of the Act, a PFS payment 

adjustment will begin in 2012 for those 

eligible professionals and group 

practices who are not successful 

electronic prescribers and will increase 

each year through 2014. Specifically, 

under 42 CFR 414.92(c)(2), for covered 

professional services furnished by an 

eligible professional during 2012, 2013, 

and 2014, if an eligible professional (or 

in the case of a group practice, the group 

practice) is not a successful electronic 

prescriber (as specified by CMS for 

purposes of the payment adjustment) for 

an applicable reporting period (as 

specified by CMS), then the PFS amount 

for such services furnished by such 

professional (or group practice) during 

the year shall be equal to the applicable 

percent (99 percent for 2012, 98.5 

percent for 2013, and 98 percent for 

2014) of the PFS amount that would 

otherwise apply. For each year of the 

program thus far, we have established 

program requirements for the eRx 

Incentive Program in the annual 

Medicare PFS rulemaking, including the 

applicable reporting period(s) for the 

year and how an eligible professional 

can become a successful electronic 

prescriber for the year. For example, we 

finalized the program requirements for 

qualifying for 2009 and 2010 eRx 

incentive payments in the CY 2009 and 

2010 PFS final rules with comment 

period (73 FR 69847 through 69852 and 

74 FR 61849 through 61861), 

respectively. In the November 29, 2010 

Federal Register (75 FR 73551 through 

73556), we published the CY 2011 PFS 

final rule with comment period, which 

set forth the requirements for qualifying 

for a CY 2011 incentive payment, as 

well as the requirements for the 2012 

and 2013 eRx payment adjustments. 

Since publication of the CY 2011 PFS 

final rule with comment period, we 

have received a number of inquiries 

from stakeholders regarding the eRx 

Incentive Program. Many stakeholders 

voiced concerns about differences 

between the requirements under the eRx 

Incentive Program and the Medicare 

Electronic Health Record (EHR) 

Incentive Program, which also requires, 

among other things, eligible 

professionals to satisfy an eRx objective 

and measure to be considered a 

meaningful user of certified EHR 

technology (‘‘eligible professional’’ is 

defined at 42 CFR 495.100 for purposes 

of the Medicare EHR Incentive 

Program). (For more information 

regarding the EHR Incentive Program 

see the published Federal Register on 

July 28, 2010; 75 FR 44314 through 

44588.) While Medicare eligible 

professionals and group practices 

cannot earn an incentive under both the 

eRx Incentive Program and the EHR 

Incentive Program for the same year, 

eligible professionals will be subject to 

an eRx payment adjustment if they do 

not meet the requirements under the 

eRx Incentive Program, regardless of 

whether the eligible professional 

participates in and earns an incentive 

under the Medicare EHR Incentive 

Program. 

Stakeholders claim that the 

requirements under both programs are 

administratively confusing, 

cumbersome, and unnecessarily 

duplicative. On February 17, 2011, the 

Government Accountability Office 

(GAO) also published a report which 

indicated that CMS should address the 

inconsistencies between the eRx 

Incentive Program and the EHR 

Incentive Program (GAO–11–159, 

‘‘Electronic Prescribing: CMS Should 

Address Inconsistencies in Its Two 

Incentive Programs That Encourage the 

Use of Health Information Technology,’’ 

available at http://www.gao.gov/ 

products/GAO–11–159). 

As a result of the above concerns and 

in accordance with Executive Order 

13563, which directs government 

agencies to identify and reduce 

redundant, inconsistent, or overlapping 

regulatory requirements and, among 

other things, identify and consider 

regulatory approaches that reduce 

burden and maintain flexibility of 

choice when possible, we are proposing 

to make changes to the eRx Incentive 

Program. As described further in section 

II.A. of the proposed rule, we are 

specifically proposing to modify the 

2011 eRx quality measure (that is, the 

eRx quality measure used for certain 

reporting periods in CY 2011) and to 

create additional significant hardship 

exemption categories for the 2012 eRx 

payment adjustment. 

II. Provisions of the Proposed 

Regulations 

A. Modification of the CY 2011 

Electronic Prescribing Quality Measure 

In the CY 2011 PFS final rule with 

comment period (75 FR 73553 through 

76566), we finalized an eRx quality 

measure that would be used during the 

reporting periods in 2011 used to 

determine whether an eligible 

professional is a successful electronic 

prescriber under the eRx Incentive 

Program for the 2011 eRx incentive, as 

well as for the 2012 and 2013 eRx 

payment adjustments. The measure that 

we adopted for reporting in 2011 (which 

is the same measure that was adopted 

for the 2010 eRx Incentive Program) is 

described as a measure that documents 

whether an eligible professional or 

group practice has adopted a ‘‘qualified’’ 

eRx system. 

A qualified eRx system is a system 

that is capable of performing the 

following four specific functionalities: 

• Generate a complete active 

medication list incorporating electronic 


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data received from applicable 

pharmacies and pharmacy benefit 

managers (PBMs), if available. 

• Allow eligible professionals to 

select medications, print prescriptions, 

electronically transmit prescriptions, 

and conduct alerts (that is, written or 

acoustic signals to warn the prescriber 

of possible undesirable or unsafe 

situations including potentially 

inappropriate doses or routes of 

administration of a drug, drug-drug 

interactions, allergy concerns, or 

warnings and cautions) and this 

functionality must be enabled, 

• Provide information related to 

lower cost therapeutically appropriate 

alternatives (if any) (that is, the ability 

of an eRx system to receive tiered 

formulary information, if available, 

would again suffice for this requirement 

for 2011 and until this function is more 

widely available in the marketplace) 

• Provide information on formulary 

or tiered formulary medications, patient 

eligibility, and authorization 

requirements received electronically 

from the patient’s drug plan (if 

available). 

In addition, to be a qualified eRx 

system under the eRx Incentive 

Program, electronic systems must 

convey the information above using the 

standards currently in effect for the Part 

D eRx program, including certain 

National Council for Prescription Drug 

Programs’ (NCPDP) standards. (To view 

the current eRx quality measure 

specifications, we refer readers to the 

‘‘2011 eRx Measure Specifications, 

Release Notes, and Claims-Based 

Reporting Principles’’ download found 

on the E-Prescribing Measure page of 

the eRx Incentive Program section of the 

CMS Web site at: http://www.cms.gov/ 

ERxIncentive/06_EPrescribing_Measure.asp#TopOfPage.) 

The technological requirements for 

eRx in the EHR Incentive Program are 

similar to the technological 

requirements for the eRx Incentive 

Program. Under the EHR Incentive 

Program, eligible professionals are 

required to adopt certified EHR 

technology, which must include the 

capability to perform certain eRx 

functions that are similar to those 

required for the eRx Incentive Program. 

Certified EHR technology must be tested 

and certified by a certification body 

authorized by the National Coordinator 

for Health Information Technology (at 

the present time, these bodies are Office 

of the National Coordinator for Health 

Information Technology (ONC)- 

Authorized Testing and Certification 

Bodies (ONC–ATCBs)). This means that 

eligible professionals participating in 

the EHR Incentive Program can rely on 

a third party certification body to ensure 

that the vendor’s EHR technology 

includes certain technical capabilities. 

EHR technology is certified as a 

‘‘Complete EHR’’ or an ‘‘EHR module,’’ as 

those terms are defined at 45 CFR 

170.102. A Complete EHR is EHR 

technology that has been developed to 

meet, at a minimum, all applicable 

certification criteria adopted by the 

Secretary. An EHR Module is any 

service, component, or combination 

thereof that can meet the requirements 

of at least one certification criterion 

adopted by the Secretary. 

In contrast, the eRx Incentive Program 

does not require certification of the 

system used for eRx. Thus, eligible 

professionals or group practices are 

generally required to rely on 

information that they obtain from the 

vendors of the systems and 

demonstration of the functionalities of 

the system, to determine if the system 

meets the required standard. We believe 

that the eRx capabilities of certified EHR 

technology are sufficiently similar in 

nature (and in fact, would more than 

likely be capable of performing all of the 

required functionalities) and would be 

appropriate for purposes of the eRx 

Incentive Program. Among other 

requirements, certified EHR technology 

must be able to electronically generate 

and transmit prescriptions and 

prescription-related information in 

accordance with certain standards, some 

of which have been adopted for 

purposes of electronic prescribing under 

Part D. Similar to the required 

functionalities of a qualified eRx 

system, certified EHR technology also 

must be able to check for drug-drug 

interactions and check whether drugs 

are in a formulary or a preferred drug 

list, although the certification criteria do 

not specify any standards for the 

performance of those functions. We 

believe that it is acceptable that not all 

of the Part D eRx standards are required 

for certified EHR technology in light of 

our desire to better align the 

requirements of the eRx and the 

Medicare EHR Incentive Program and 

potentially reduce unnecessary 

investment in multiple technologies for 

purposes of meeting the requirements 

for each program. Furthermore, to the 

extent that an eligible professional uses 

certified EHR technology to 

electronically prescribe under Part D, he 

or she would still be required to comply 

with the Part D standards to do so. 

In addition, we believe it is important 

to provide more certainty to eligible 

professionals (including those in group 

practices) that may be participating in 

both the EHR Incentive Program and the 

eRx Incentive Program with regard to 

purchasing systems for use under these 

programs, and to encourage adoption of 

certified EHR technology. Accordingly, 

we are proposing changes to the eRx 

measure reported in 2011 for purposes 

of reporting for the 2011 eRx incentive 

and the 2013 eRx payment adjustment 

(the ‘‘2011 eRx quality measure’’) in 

accordance with section 1848(k)(2)(C) of 

the Act. This section of the Act requires 

the eRx measure to be endorsed by the 

entity with a contract with the Secretary 

under section 1890(a) of the Act 

(currently, that entity is the National 

Quality Forum (NQF)) except for in the 

case of a specified area or medical topic 

determined appropriate by the Secretary 

for which a feasible and practical 

measure has not been endorsed by the 

NQF. While the electronic prescribing 

measure, as originally implemented in 

the 2009 eRx Incentive Program is an 

NQF-endorsed measure, subsequent 

modifications made to the measure for 

implementation purposes (for example, 

to reduce eligible professionals’ 

reporting burden and to increase 

applicability of the measure to a broader 

range of eligible professionals) have not 

yet been reviewed by the NQF. In light 

of this, we are not aware of any other 

NQF-endorsed measure related to 

electronic prescribing by eligible 

professionals that would be appropriate 

for use in the eRx Incentive Program. 

Therefore, we believe that the use of this 

eRx measure falls within the exception 

under section 1848(k)(2)(C)(ii) of the 

Act. 

Specifically, we are proposing to 

revise the description statement for the 

2011 eRx measure that we adopted for 

reporting in 2011 for purposes of the 

2011 eRx incentive and the 2013 eRx 

payment adjustment. Currently, the 

description statement indicates that the 

measure documents whether an eligible 

professional or group practice has 

adopted a ‘‘qualified’’ eRx system that 

performs the four functionalities 

discussed above. We propose to revise 

this description statement to indicate 

that the measure documents whether an 

eligible professional or group practice 

has adopted a ‘‘qualified’’ eRx system 

that performs the four functionalities 

previously discussed or is certified EHR 

technology as defined at 42 CFR 495.4 

and 45 CFR 170.102. We believe that 

this proposed change merely expands 

on the definition of a ‘‘qualified’’ eRx 

system without altering the original 

intent of the measure, which was to 

evaluate the extent to which eligible 

professionals generate and transmit 

prescriptions and prescription-related 

information electronically. Both eRx 

systems that perform the four 


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functionalities previously discussed and 

certified EHR technology are able to 

generate and transmit prescriptions and 

prescription-related information 

electronically. An eligible professional 

or group practice that has already 

purchased an eRx system that meets the 

definition of a ‘‘qualified’’ eRx system 

would be able to continue using that 

system (that is, even with the proposed 

changes to the measure, systems that 

meet the four functionalities would 

continue to constitute ‘‘qualified’’ eRx 

systems). In accordance with section 

1848(m)(3)(B)(v) of the Act, which 

requires the Secretary, to the extent 

practicable, to ensure that eligible 

professionals utilize electronic 

prescribing systems in compliance with 

standards established for such systems 

pursuant to the Part D eRx Program 

under section 1860D–4(e) of the Act, we 

also propose that for purposes of the 

2011 eRx measure certified EHR 

technology must comply with the Part D 

standards for the electronic 

transmission of prescriptions at 42 CFR 

423.160(b)(2)(ii). This proposed 

requirement is consistent with the ONC 

certification requirements at 45 CFR 

170.304(b) and 170.205(b)(1) and (2). 

With this proposed change to the 2011 

eRx measure, eligible professionals 

(including those in group practices) that 

are participating in the eRx Incentive 

Program would have the option of 

adopting either a qualified eRx system 

that performs the four functionalities 

previously discussed or certified EHR 

technology as defined at 42 CFR 495.4 

and 45 CFR 170.102. Thus, under this 

proposal, certified EHR technology 

would be recognized as a qualified 

system under the revised eRx quality 

measure regardless of whether the 

certified EHR technology has all four of 

the functionalities previously described. 

Because the proposed change to the 

2011 eRx measure, if finalized, would 

not be effective until the effective date 

of a subsequent final rule, this change 

would only be effective for the 

remainder of the reporting periods in 

CY 2011 for the 2011 eRx incentive and 

the 2013 eRx payment adjustment. The 

proposed change to the 2011 eRx quality 

measure, if finalized, would not apply 

retrospectively to any part of the CY 

2011 reporting periods for the 2011 eRx 

incentive or the 2013 eRx payment 

adjustments that occurred prior to the 

effective date of a subsequent final rule. 

The proposed change to the eRx 

measure does not change any of the 

regulations for the eRx Incentive 

Program payment adjustment, which are 

codified at 42 CFR 414.92(c)(2). In 

addition, because this proposed change 

would not be finalized prior to the end 

of the 2012 eRx payment adjustment 

reporting period (that is, June 30, 2011), 

such a change would not apply for 

purposes of reporting the eRx measure 

for the 2012 eRx payment adjustment. 

However, as we noted previously, we 

believe that most certified EHR 

technology meet the requirements for 

‘‘qualified’’ eRx systems under the 

current 2011 eRx quality measure. 

Therefore, for purposes of reporting the 

current eRx quality measure during 

2011 (including reporting for purposes 

of the 2012 eRx payment adjustment), 

nothing precludes eligible professionals 

(or a group practice) that already have 

certified EHR technology that meet the 

four functionalities from using the 

certified EHR technology for purposes of 

the eRx Incentive Program (that is, the 

technology would constitute a 

‘‘qualified’’ system under the current 

2011 eRx quality measure because such 

system meets the four specified 

functionalities). For future program 

years, we anticipate using the revised 

eRx quality measure, which we would 

adopt through future notice and 

comment rulemaking. We invite public 

comment on the proposed modification 

to the 2011 eRx quality measure. 

B. Significant Hardship Exemption 

Categories for the 2012 Payment 

Adjustment 

1. Overview of the 2012 Payment 

Adjustment 

As required by section 1848(a)(5) of 

the Act, and in accordance with our 

regulations at 42 CFR 414.92(c)(2), 

eligible professionals or group practices 

who are not successful electronic 

prescribers (as specified by CMS for 

purposes of the payment adjustment) 

are subject to the eRx payment 

adjustment in 2012. In the CY 2011 PFS 

final rule with comment period (75 FR 

73560 through 73565), we finalized the 

program requirements for the 2012 eRx 

payment adjustment. Specifically, the 

2012 eRx payment adjustment does not 

apply to the following: (1) An eligible 

professional who is not a physician 

(includes doctors of medicine, doctors 

of osteopathy, and podiatrists), nurse 

practitioner, or physician assistant as of 

June 30, 2011; (2) an eligible 

professional who does not have at least 

100 cases (that is, claims for patient 

services) containing an encounter code 

that falls within the denominator of the 

eRx measure for dates of service 

between January 1, 2011 and June 30, 

2011; or (3) an eligible professional who 

is a successful electronic prescriber for 

the January 1, 2011 through June 30, 

2011 reporting period (that is, reports 

the eRx measure 10 times via claims 

between January 1, 2011 and June 30, 

2011). 

We also finalized the requirement that 

the 2012 eRx payment adjustment does 

not apply to an individual eligible 

professional or group practice if less 

than 10 percent of an eligible 

professional’s or group practice’s 

estimated total allowed charges for the 

January 1, 2011 through June 30, 2011 

reporting period are comprised of 

services that appear in the denominator 

of the 2011 eRx measure. Information 

and other details about the eRx 

Incentive Program, including the 

requirements for group practices 

participating in the eRx GPRO in 2011 

with regard to the 2012 eRx payment 

adjustment can be found on the eRx 

Incentive Program section of the CMS 

Web site at: http://www.cms.gov/ 

erxincentive. 

2. Current Significant Hardship 

Exemptions for the 2012 eRx Payment 

Adjustment 

In addition to the requirements for the 

2012 eRx payment adjustment, 42 CFR 

414.92(c)(2)(ii) provides that we may, on 

a case-by-case basis, exempt an eligible 

professional (or group practice) from the 

application of the payment adjustment, 

if we determine, subject to annual 

renewal, that compliance with the 

requirement for being a successful 

electronic prescriber would result in a 

significant hardship. In the CY 2011 

PFS final rule with comment period (75 

FR 73564 through 75 FR 73565), we 

finalized two circumstances under 

which an eligible professional or group 

practice can request consideration for a 

significant hardship exemption for the 

2012 eRx payment adjustment— 

• The eligible professional or group 

practice practices in a rural area with 

limited high speed Internet access; or 

• The eligible professional or group 

practice practices in an area with 

limited available pharmacies for eRx. 

In order for eligible professionals and 

group practices to identify these 

categories for purposes of requesting a 

hardship exemption, we created a Gcode for each of the above situations. 

Thus, to request consideration for a 

significant hardship exemption for the 

2012 eRx payment adjustment, 

individual eligible professionals must 

report the appropriate G-code at least 

once on claims for services rendered 

between January 1, 2011 and June 30, 

2011. Group practices that wished to 

participate in the 2011 eRx GPRO and 

be considered for exemption under one 

of the significant hardship categories 

were required to request a hardship 

exemption at the time they selfVerDate Mar<15>2010 19:26 May 31, 2011 Jkt 223001 PO 00000 Frm 00056 Fmt 4702 Sfmt 4702 E:\FR\FM\01JNP1.SGM 01JNP1

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Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Proposed Rules 31551 

nominated to participate in the 2011 

eRx GPRO earlier this year. 

3. Proposed Additional Significant 

Hardship Exemption Categories for the 

2012 eRx Payment Adjustment 

Since publication of the CY 2011 PFS 

final rule with comment period, we 

have received numerous requests to 

expand the categories under the 

significant hardship exemption for the 

2012 eRx payment adjustment. Some 

stakeholders have recommended 

specific circumstances of significant 

hardship for our consideration (for 

example, eligible professionals who 

have prescribing privileges but do not 

prescribe under their NPI, eligible 

professionals who prescribe a high 

volume of narcotics, and eligible 

professionals who electronically 

prescribe but typically do not do so for 

any of the services included in the eRx 

measure’s denominator), while others 

strongly suggested we consider 

increasing the number of specific 

hardship exemption categories. We 

believe that many of the circumstances 

raised by stakeholders may pose a 

significant hardship and limit eligible 

professionals and group practices in 

their ability to meet the requirements for 

being successful electronic prescribers 

either because of the nature of their 

practice or because of the limitations of 

the eRx measure itself, and as a result, 

such professionals might be unfairly 

penalized. Therefore, we are proposing 

to revise the significant hardship 

regulation at 42 CFR 414.92(c)(2)(ii) to 

add paragraphs that—(1) codify the two 

hardship exemption categories for the 

2012 eRx payment adjustment that we 

finalized in the CY 2011 PFS final rule; 

and (2) codify the additional significant 

hardship categories for the 2012 eRx 

payment adjustment that we are 

proposing in this proposed rule. We also 

are proposing to allow some additional 

time for submitting significant hardship 

exemption requests to CMS. 

Specifically, we are proposing the 

following additional significant 

hardship exemption categories for the 

2012 eRx payment adjustment with 

regard to the reporting period of January 

1, 2011 through June 30, 2011: 

a. Eligible Professionals Who Register 

To Participate in the Medicare or 

Medicaid EHR Incentive Programs and 

Adopt Certified EHR Technology 

We are proposing this exemption 

category at proposed 42 CFR 

414.92(c)(2)(ii)(C) because eligible 

professionals (including those in group 

practices) that intended to participate in 

the EHR Incentive Program may have 

delayed adopting eRx technology for 

purposes of the eRx Incentive Program 

until the list of certified EHR technology 

became available so that the same 

technology could be used to satisfy both 

programs’ requirements. The ONC final 

rule establishing a temporary 

certification program for health 

information technology (75 FR 36158) 

was not published in the Federal 

Register until June 24, 2010. The 

certification and listing of EHR 

technologies (certified Complete EHRs 

and certified EHR Modules) on the ONC 

Certified HIT Products List (CHPL) did 

not begin until September 2010. Until 

then, eligible professionals and group 

practices had no way of knowing which 

EHR technologies would be certified. At 

the same time, we did not propose to 

use the first half of 2011 as the reporting 

period for the 2012 eRx payment 

adjustment until the CY 2011 PFS 

proposed rule went on public display at 

the Office of the Federal Register on 

June 25, 2010. As such, we believe it 

may be a significant hardship for 

eligible professionals in this situation to 

have both adopted certified EHR 

technology and fully integrated the 

technology into their practice’s clinical 

workflows and processes so that they 

would be able to successfully report the 

eRx measure prior to June 30, 2011, 

especially given that an eligible 

professional under the Medicare EHR 

Incentive Program has until October 1, 

2011, to begin a 90-day EHR reporting 

period for the 2011 payment year. 

Similarly, this extended time period 

provides Medicare eligible professionals 

under the eRx Incentive Program but 

who are eligible for incentives under the 

Medicaid EHR Incentive Program with a 

majority of 2011 to adopt, implement, or 

upgrade to certified EHR technology. 

We believe this hardship exemption 

category is necessary and appropriate in 

order to fully support and encourage 

eligible professionals to actively take 

steps to become meaningful users of 

certified EHR technology. Also, in the 

absence of this significant hardship 

exemption category, eligible 

professionals may potentially have to 

adopt two systems (for example, a 

standalone eRx system for purposes of 

participation in the eRx Incentive 

Program, followed by certified EHR 

technology), which could potentially be 

financially burdensome. To be 

considered for a significant hardship 

exemption under this category, we are 

proposing that the eligible professional, 

at a minimum, must: (1) Have registered 

for either the Medicare or Medicaid EHR 

Incentive Program (for instructions on 

how to register for one of the EHR 

Incentive Programs, we refer readers to 

the Registration and Attestation page of 

the EHR Incentive Programs section of 

the CMS Web site at http:// 

www.cms.gov/EHRIncentivePrograms/

20_RegistrationandAttestation.asp#

TopOfPage); and (2) provide identifying 

information as to the certified EHR 

technology (as defined at 45 CFR 

170.102) that has been adopted for use 

no later than October 1, 2011, for a 

hardship exemption to be submitted, 

which then would be reviewed on a 

case-by-case basis. We propose that for 

purposes of this proposed significant 

hardship exemption category, the 

identifying information would consist of 

the certification number that is assigned 

to the EHR technology for purposes of 

ONC’s CHPL. In addition, we are 

considering requiring eligible 

professionals to provide a serial number 

for their specific product but have 

concerns about whether such 

information would be readily accessible 

by eligible professionals. We invite 

comments on the feasibility of requiring 

eligible professionals to provide a serial 

number in addition to the certification 

number for the certified EHR 

technology, or other information 

identifying and verifying the specific 

product. In requesting a significant 

hardship exemption under this 

proposed category, an eligible 

professional would be attesting that he 

or she either has purchased the 

specified certified EHR technology (as 

identified by the certification number 

and/or serial number) or has the 

specified certified EHR technology 

available for immediate use and that the 

professional intends to use that 

technology to qualify for a Medicare or 

Medicaid EHR incentive for payment 

year 2011. 

b. Inability To Electronically Prescribe 

Due to Local, State, or Federal Law or 

Regulation 

We are proposing at 42 CFR 

414.92(c)(2)(ii)(D) that, to the extent that 

local, State, or Federal law or regulation 

limits or prevents an eligible 

professional or group practice that 

otherwise has general prescribing 

authority from electronically prescribing 

(for example, eligible professionals who 

prescribe a large volume of narcotics, 

which may not be electronically 

prescribed in some states, or eligible 

professionals who practice in a State 

that prohibits or limits the transmission 

of electronic prescriptions via a third 

party network such as Surescripts), the 

eligible professional or group practice 

would be able to request consideration 

for an exemption from application of the 

2012 eRx payment adjustment, which 

would be reviewed on a case-by-case 


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basis. We believe eligible professionals 

in this situation face a significant 

hardship with regard to the 

requirements for being successful 

electronic prescribers because while 

they may meet the 10-percent threshold 

for applicability of the payment 

adjustment, they may not have 

sufficient opportunities to meet the 

requirements for being a successful 

electronic prescriber because Federal, 

State, or local law or regulation may 

limit the number of opportunities that 

an eligible professional or group 

practice has to electronically prescribe 

(that is, having at least 100 

denominator-eligible visits prior to June 

30, 2011, but being unable to 

electronically prescribe for at least 10 of 

these denominator-eligible visits due to 

Federal, State, or local law or 

regulation). 

c. Limited Prescribing Activity 

We are proposing at 42 CFR 

414.92(c)(2)(ii)(E) that an eligible 

professional who has prescribing 

privileges but does not prescribe or very 

infrequently prescribes in his or her 

practice (for example, a nurse 

practitioner who may not write 

prescriptions under his or her own NPI, 

a physician who decides to let his Drug 

Enforcement Administration registration 

expire during the reporting period 

without renewing it, or an eligible 

professional who prescribed fewer than 

10 prescriptions between January 1, 

2011 and June 30, 2011 regardless of 

whether the prescriptions were 

electronically prescribed or not), yet 

still meets the 10-percent threshold for 

applicability of the payment adjustment, 

would be able to request consideration 

for a significant hardship exemption 

from application of the 2012 eRx 

payment adjustment, which would be 

reviewed on a case-by-case basis. We 

believe that it is a significant hardship 

for eligible professionals who have 

prescribing privileges, but infrequently 

prescribe, to become successful 

electronic prescribers because the 

nature of their practice may limit the 

number of opportunities an eligible 

professional or group practice to 

prescribe, much less electronically 

prescribe. 

d. Insufficient Opportunities To Report 

the Electronic Prescribing Measure Due 

to Limitations of the Measure’s 

Denominator 

To the extent an eligible professional 

or group practice has an eRx system, 

electronically prescribes, and has 

denominator-eligible visits, but does not 

normally write prescriptions associated 

with any of the types of visits included 

in the eRx measure’s denominator (for 

example, certain types of physicians 

such as surgeons), we are proposing at 

42 CFR 414.92(c)(2)(ii)(F) that the 

eligible professional or group practice 

would be able to request consideration 

for a significant hardship exemption 

from application of the 2012 eRx 

payment adjustment, which would be 

reviewed on a case-by-case basis. 

Similar to the proposed hardship 

category for lack of prescribing activity, 

we believe it would be a significant 

hardship for eligible professionals who 

do not have a sufficient opportunity to 

report the eRx measure because of the 

limitations of the eRx measure’s 

denominator to meet the criteria for 

being a successful electronic prescriber. 

While such eligible professionals may 

meet the 10-percent threshold for 

applicability of the payment adjustment 

and have at least 100 denominatoreligible visits prior to June 30, 2011, 

they may not be able to report their eRx 

activity at least 10 times because the 

bulk of their prescribing activity occurs 

in other circumstances that are not 

accounted for by the measure’s 

denominator. 

We invite public comments on the 

additional hardship exemption 

categories proposed in this proposed 

rule. In addition, we also invite input on 

other categories of significant hardship 

that were not specifically proposed so 

that we may consider them for purposes 

of the 2013 or 2014 eRx payment 

adjustment. 

To request a hardship exemption for 

any of the categories proposed and 

previously described, we are proposing 

that an eligible professional or group 

practice participating in the 2011 eRx 

GPRO provide to us by the date 

specified below, the following: 

• Identifying information such as the 

TIN, NPI, name, mailing address, and email address of all affected eligible 

professionals. 

• The significant hardship exemption 

category(ies) above that apply. 

• A justification statement describing 

how compliance with the requirement 

for being a successful electronic 

prescriber for the 2012 eRx payment 

adjustment during the reporting period 

would result in a significant hardship to 

the eligible professional or group 

practice. 

• An attestation of the accuracy of the 

information provided. 

The justification statement should be 

specific to the category under which the 

eligible professional or group practice is 

submitting its request and must explain 

how the exemption applies to the 

professional or group practice. For 

example, if the eligible professional is 

requesting a significant hardship 

exemption due to Federal, State, or local 

law or regulation, he or she must cite 

the applicable law and how the law 

restricts the eligible professional’s 

ability to electronically prescribe. 

Similarly, if the eligible professional is 

requesting a significant hardship due to 

lack of prescribing activity, the eligible 

professional must provide the number 

of prescriptions generated during the 

2012 eRx payment adjustment reporting 

period. We would review the 

information submitted by each eligible 

professional and group practice on a 

case-by-case basis. In addition, we are 

proposing that an eligible professional 

or group practice must, upon request, 

provide additional supporting 

documentation if there is insufficient 

information (such as, but not limited to, 

a TIN or NPI that we cannot match to 

the Medicare claims, a certification 

number for the certified EHR technology 

that does not appear on the list of 

certified EHR technology, or an 

incomplete justification for the 

significant hardship exemption request) 

to justify the request or make the 

determination of whether a significant 

hardship exists. 

We also are proposing that eligible 

professionals or group practices would 

be able to submit significant hardship 

exemption requests using a Web-based 

tool or interface. However, our ability to 

receive the significant hardship requests 

in this manner would be dependent on 

the development of such a Web site 

being completed prior to the publication 

of the final rule. In the event that such 

a Web site is not available, an eligible 

professional or group practice would be 

required to send us an application for a 

hardship exemption with such 

information by mail. We are not 

proposing to allow an eligible 

professional or group practice to submit 

significant hardship exemption requests 

via e-mail or fax because additional 

security precautions would need to be 

put into place. In some cases, a TIN may 

consist of an eligible professional’s 

social security number, which is 

considered to be personally identifiable 

information. 

We are proposing that the eligible 

professional or group practice must 

submit the hardship request by no later 

than October 1, 2011, which, if 

submitted by mail, means postmarked 

no later than October 1, 2011. We also 

propose to extend the deadline for 

submitting requests for consideration for 

the two significant hardship exemption 

categories (that is, eligible professional 

or group practice practices in rural areas 

with limited high speed Internet access 

and eligible professional or group 


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practice practices in an area with 

limited available pharmacies for eRx) 

for the 2012 eRx payment adjustment 

that were finalized in the CY 2011 PFS 

final rule (75 FR 73564 through 73565) 

to October 1, 2011. Since this rule is not 

expected to be finalized prior to the 

current deadline of June 30, 2011, for 

submitting the G-codes that were 

created for these two significant 

hardship exemption categories via 

claims (or, for group practices, at the 

time group practices self-nominate), we 

propose that the Web-based tool or 

interface, if available, would be used to 

submit all significant hardship 

exemption requests (including those for 

the current significant hardship 

exemption categories). Eligible 

professionals who wish to request a 

significant hardship exemption for one 

of the current significant hardship 

exemption categories via claims-based 

submission of a G-code would still have 

to do so prior to the current deadline of 

June 30, 2011. If the Web-based tool is 

not developed prior to the publication 

of the final rule, then we would default 

to mail submission of all significant 

hardship exemption requests (including 

those for the current hardship 

exemption categories). 

We are proposing October 1, 2011, 

because we seek to complete our review 

of the requests in time to instruct the 

carriers/MACs as to those eligible 

professionals or group practices that are 

not subject to the 2012 eRx payment 

adjustments based on the proposed 

additional significant hardship 

exemption categories. We would like to 

be able to process all such requests 

before we begin making the claims 

processing systems changes later this 

year to adjust eligible professionals’ or 

group practices’ payments starting on 

January 1, 2012. However, we anticipate 

that, in some cases, we may not be able 

to complete our review of the requests 

before the claims processing systems 

updates are made to begin reducing 

eligible professionals’ and group 

practices’ PFS amounts in 2012. In such 

cases, if we ultimately approve the 

eligible professional’s or group 

practice’s request for a significant 

hardship exemption, we would need to 

reprocess all claims for services 

furnished up to that point in 2012 that 

were paid at the reduced PFS amount. 

We also believe that this date allows 

sufficient time for eligible professionals 

(including those in group practices) that 

intend to use certified EHR technology 

and to qualify for the 2011 EHR 

Incentive Program in 2011 to have 

adopted the technology. 

While we considered providing 

eligible professionals and group 

practices with additional time to submit 

requests for a significant hardship 

exemption under the proposed 

additional categories, we believe that 

doing so might result in the need to 

reprocess claims for 2012 services for 

eligible professionals. We invite public 

comment on the proposed process for 

submitting these requests for significant 

hardship exemptions to us (including 

comments on the type of information we 

are proposing eligible professionals and 

group practices must submit, the 

proposed options for how the 

information could be submitted, and the 

proposed timeframes for submission). 

We also invite comment on our proposal 

to extend the timeframe for submitting 

hardship exemption requests for the two 

categories we finalized in the CY 2011 

PFS final rule and the proposed process 

for submitting these requests under the 

extended timeframe. 

To the extent the final rule is not 

effective by October 1, 2011, then we 

propose that the eligible professional or 

group practice must submit the 

hardship request by no later than 5 

business days after the effective date of 

the final rule. Eligible professionals and 

group practices may begin submitting 

significant hardship exemption requests 

at any time after the final rule is made 

available for public inspection by the 

Office of the Federal Register. In the 

event that the final rule is not made 

available for public inspection by the 

Office of the Federal Register by October 

1, 2011, we seek comment on whether 

5 business days after the effective date 

of the final rule would be an adequate 

amount of time for eligible professionals 

and group practices to submit a 

significant hardship exemption request. 

We also are proposing that once we 

have completed our review of the 

eligible professional’s or group 

practice’s request and made a decision, 

we will notify the eligible professional 

or group practice of our decision and all 

such decisions would be final. Eligible 

professionals and group practices would 

not have the opportunity to request 

reconsiderations of their requests for 

significant hardship exemption. 

III. 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 

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 

each of these issues for the following 

sections of this document that contain 

information collection requirements 

(ICRs): 

A. ICRs Related to Proposed Changes to 

the 2011 Electronic Prescribing Measure 

We do not believe there is any burden 

associated with the proposed changes to 

the 2011 eRx measure as the changes 

solely clarify whether we consider 

certified EHR technology to meet the 

technological requirements of the eRx 

measure and do not change the 

reporting requirements for purposes of 

reporting the eRx quality measure for 

the 2011 eRx incentive and 2013 eRx 

payment adjustment. 

B. ICRs Regarding Proposed Additional 

Significant Hardship Exemption 

Categories for the 2012 eRx Payment 

Adjustment 

We believe that any burden associated 

with submitting the hardship exemption 

requests for the additional categories we 

are proposing would be minimal and 

would be limited to the time and effort 

associated with gathering the requested 

information and submitting the 

information to CMS in the specified 

form and manner. Whether the 

application can be submitted online or 

through other means, we do not 

anticipate it taking more than a 2 hours 

per eligible professional to review the 

hardship exemption codes available, 

determine which code(s) applies to their 

particular situation, gather the 

information needed for the justification, 

and then complete and submit the 

information to CMS. 

To provide an estimate of the burden 

associated with submitting a hardship 

exemption request, we need to 

determine the approximate number of 

physicians and eligible professionals 

that could be subject to the eRx payment 

adjustment in 2012 as well as the 

number of eligible professionals that 

could submit a hardship exemption 

request. Based on Medicare Part B 

claims data, it is estimated that 

approximately 209,000 eligible 

professionals could potentially be 


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subject to the 2012 payment adjustment 

unless they become a successful 

electronic prescriber (that is, report the 

electronic prescribing measure at least 

10 times during the 6-month reporting 

period) or request a significant hardship 

exemption. Thus, the maximum total 

number of eligible professionals that 

could potentially need to request a 

significant hardship exemption is 

believed to be approximately 209,000. 

However based on participation 

numbers from previous eRx Incentive 

Program years, we predict that the 

number of eligible professionals 

impacted will in fact be lower. In 2009, 

92,132 eligible professionals 

participated in the eRx program and 

preliminary data for 2010 indicates that 

100,444 professionals have participated 

in the eRx Incentive Program. Based on 

this data, we have determined that it is 

more accurate to estimate that 

approximately 109,000 eligible 

professionals could potentially submit a 

significant hardship exemption request 

as over 100,000 eligible professionals 

are already participating in the program. 

While we do not have a precise estimate 

of how many of the eligible 

professionals that are not able to be 

successful electronic prescribers will 

request a significant hardship, we do 

know that since the proposed hardship 

exemption categories will not apply to 

all eligible professionals since they 

represent specific circumstances. 

Therefore, for purposes of this burden 

estimate, we will assume that, at a 

minimum, approximately 10 percent of 

the 109,000 eligible professionals that 

could potentially request a significant 

hardship exemption will do so. This 

brings our minimum estimated number 

of eligible professionals impacted to 

approximately 10,900. Based on our 

estimate that the time needed to collect 

and report the information requested 

will be 2 hours, we believe that the total 

burden associated with requesting a 

significant hardship exemption will 

range from approximately 21,800 hours 

(10,900 eligible professionals × 2 hours 

per eligible professional) to 418,000 

hours (209,000 eligible professionals × 2 

hours per eligible professional). Based 

on an average group practice labor cost 

of $58 per hour, we predict the annual 

burden cost to be between 

approximately $1,264,400 ($58 per hour 

× 21,800 hours) and $24,244,000 ($58 

per hour × 418,000 hours). We welcome 

comments on the above estimates. 

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 proposed rule; 

or 

2. Submit your comments to the 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Attention: CMS Desk Officer, 

CMS–3248–P. Fax: (202) 395–7245; or 

E-mail: OIRA_submission@omb.eop.gov. 

IV. 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. 

V. Regulatory Impact Statement 

This proposed rule includes changes 

to the eRx Incentive Program. The first 

proposed change involves modifying the 

eRx quality measure used for certain 

reporting periods in CY 2011 to address 

uncertainties related to the 

technological requirements of the 

Medicare eRx Incentive Program. The 

eRx measure would be revised to 

indicate whether an eligible 

professional has adopted a qualified 

electronic prescribing system or 

certified EHR technology as defined at 

45 CFR 170.102. The second proposed 

change involves proposing additions to 

the significant hardship exemption 

categories for the 2012 eRx payment 

adjustment. The proposed additional 

exemption categories for the 2012 e Rx 

payment adjustment include—(1) 

Eligible professionals who register to 

participate in the Medicare or Medicaid 

EHR Incentive Program and Adopt 

Certified EHR Technology; (2) the 

inability to electronically prescribe due 

to local, State, or Federal law; (3) 

limited prescribing activity; and (4) 

insufficient opportunities to report the 

electronic prescribing measure due to 

limitations of the measure’s 

denominator. Finally, this rule proposes 

an extension of the deadline for the 

2012 eRx payment adjustment, thereby 

allowing eligible professionals and 

group practices to submit the existing 

two significant hardship codes 

established in the 2011 PFS final rule 

with comment period. These hardship 

exemption categories are: (1) The 

eligible professional practices in a rural 

area without sufficient high speed 

Internet access; and (2) the eligible 

professional practices in an area without 

sufficient available pharmacies for 

electronic prescribing. 

We have examined the impact 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 (January18, 

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), 

Executive Order 13132 on Federalism 

(August 4, 1999) and the Congressional 

Review Act (5 U.S.C. 804(2)). 

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). We 

estimate that the impact of the proposed 

changes would be $30 million for fiscal 

year (FY) 2012, net of premium offset 

based on the FY 2012 President’s budget 

baseline and $20 million for FY 2013. 

Therefore, this proposed rule does not 

reach the economic threshold and thus 

is not considered a major rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities if a rule has a significant 

economic impact on a substantial 

number of small entities. For purposes 

of the RFA, small entities include small 

businesses, nonprofit organizations, and 

small governmental jurisdictions. 

Individuals and States are not included 

in the definition of a small entity. A 

majority of the physicians and other 

eligible professionals affected by this 

proposed rule are small entities either 

by being nonprofit organizations or by 

meeting the Small Business 

Administration size thresholds for a 

small healthcare business (having 

revenues of less than $7.0 million to 

$34.5 million in any 1 year). While we 

do not have precise estimates, we 

believe this proposed rule would affect 

a substantial number of small entities 

(that is, several thousand or more). We 

welcome detailed information on the 

number of physicians and other 

professionals who would be affected by 

these proposals (that is, the number of 

physicians and other professionals who 

currently believe they are not able to 

meet the requirements for the 2012 eRx 

payment adjustment on the grounds that 

it would pose a significant hardship and 

for whom one or more of the proposed 


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significant hardship exemption 

categories could apply). 

We interpret the requirement for 

preparation of an Initial Regulatory 

Flexibility Analysis as applying to 

proposed rules that impose significant 

economic burden. The Office of the 

Chief Council for Advocacy within the 

Small Business Administration believes 

that the requirement applies whether 

the economic impact is positive or 

negative. Regardless, we normally 

prepare a voluntary analysis when 

proposed rules would have a significant 

positive impact. In this case, the 

proposed change to the eRx measure 

under the eRx Incentive Program for 

purpose of reporting for the 2011 eRx 

incentive and the 2013 eRx payment 

adjustment and the proposed additional 

significant hardship exemption 

categories, if applicable, for purposes of 

the 2012 eRx payment adjustment 

would reduce burden for eligible 

professionals. The proposed 

modification to the eRx measure would 

eliminate any uncertainty as to whether 

eligible professionals who are 

participating in both the eRx Incentive 

Program and the EHR Incentive Program 

can use the certified EHR technology 

that they adopted for the EHR Incentive 

Program to electronically prescribe 

under the eRx Incentive Program. 

Therefore, there would no longer be any 

ambiguity as to whether eligible 

professionals can use the same 

technology for both programs and less 

time and effort spent by eligible 

professionals to determine whether the 

certified EHR technology they have 

adopted for purposes of the EHR 

Incentive Program could be used to 

meet the eRx quality measure under the 

eRx Incentive Program. It is difficult to 

estimate the precise economic impacts 

of these changes on the affected entities. 

We believe that the proposed 

additional significant hardship 

exemption categories for the 2012 eRx 

payment adjustment would reduce the 

number of eligible professionals that 

would otherwise be subject to a 1.0 

percent adjustment in the PFS amount 

for covered professional services 

furnished in 2012. Also, the proposed 

changes would continue to encourage 

adoption of electronic prescribing in the 

interest of improving the medication 

prescription process while 

acknowledging circumstances that may 

prevent physicians and other 

professionals from successfully 

participating in the eRx Incentive 

Program. Based on 2010 Medicare Part 

B claims data, we believe approximately 

209,000 eligible professionals would 

need to either be a successful electronic 

prescriber or request a hardship 

exemption to avoid the 2012 payment 

adjustment. However, we are unable to 

provide a precise estimate as to the 

number of eligible professionals, out of 

the total 209,000, that would potentially 

request a significant hardship 

exemption for one of the proposed 

hardship exemption categories. While 

we are aware, from public comments 

received in response to the 2011 PFS 

proposed and final rules with comment 

period, correspondence, inquiries 

received by our help desk, and 

comments made by eligible 

professionals on our national provider 

calls, open door forums, and a February 

9, 2011 Town Hall Meeting, that there 

are eligible professionals who have 

expressed their inability to meet the 

successful electronic prescriber 

requirements for the 2012 eRx payment 

adjustment for one or more of the 

circumstances addressed by the 

proposed additional significant 

hardship exemption categories, we are 

not able to quantify in detail how many 

eligible professionals these proposed 

additional significant hardship 

exemptions could apply to since each 

eligible professional’s individual 

circumstances are unique. We believe 

that any cost associated with requesting 

the significant hardship exemptions 

would be minimal since it would be 

limited to the time and effort associated 

with submitting a significant hardship 

exemption from the 2012 eRx payment 

adjustment either via the proposed Web 

tool or by mail. We believe that any cost 

associated with requesting a significant 

hardship exemption would, if 

applicable to the eligible professional, 

be offset by the eligible professional 

avoiding the payment adjustment in 

2012. 

Overall, we estimate that the impact 

of the proposed changes would be $30 

million for FY 2012, net of premium 

offset based on the FY 2012 President’s 

budget baseline and $20 million for FY 

2013. We also welcome comments and 

information on the likely magnitudes of 

savings, and the likely numbers of 

affected physicians and other 

professionals who would achieve 

savings of various sizes, under the 

specific alternatives we propose. We 

note that each of the regulatory relief 

options discussed previously in this 

preamble constitutes a distinct 

alternative that we have considered. We 

welcome comments on whether there 

are any additional alternatives that are 

both reasonable and achievable under 

the time constraints imposed by the 

existing rule. 

In addition, 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 603 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a 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 certifies, that this 

proposed rule would not have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. The eRx Incentive Program 

does not apply to small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 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 2011, that threshold is approximately 

$136 million. This rule would 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 

requirement costs on State and local 

governments, preempts State law, or 

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 regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects in 42 CFR Part 414 

Administrative practice and 

procedure, Health facilities, Health 

professions, Kidney diseases, Medicare, 

Reporting and recordkeeping. 

For the reasons set forth in the 

preamble of this proposed rule, the 

Centers for Medicare & Medicaid 

Services proposes to amend 42 CFR part 

414 as set forth below: 

PART 414—PAYMENT FOR PART B 

MEDICAL AND OTHER HEALTH 

SERVICES 

1. The authority citation for part 414 

continues to read as follows: 

Authority: Secs. 1102, 1871, and 1881(b)(l) 

of the Social Security Act (42 U.S.C. 1302, 

1395hh, and 1395rr(b)(l)). 


sroberts on DSK5SPTVN1PROD with PROPOSALS
31556 Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Proposed Rules 

Subpart B—Physicians and Other 

Practitioners 

2. Section 414.92 is amended by 

revising paragraph (c)(2)(ii) to read as 

follows: 

§ 414.92 Electronic Prescribing Incentive 

Program. 

* * * * * 

(c) * * * 

(2) * * * 

(ii) Significant hardship exception. 

CMS may, on a case-by-case basis, 

exempt an eligible professional (or in 

the case of a group practice under 

paragraph (e) of this section, a group 

practice) from the application of the 

payment adjustment under paragraph 

(c)(2) of this section if, CMS determines, 

subject to annual renewal, that 

compliance with the requirement for 

being a successful electronic prescriber 

would result in a significant hardship. 

Eligible professionals (or, in the case of 

a group practice under paragraph (e) of 

this section, a group practice) may 

request consideration for a significant 

hardship exemption from the 2012 eRx 

payment adjustment if one of the 

following circumstances apply: 

(A) The practice is located in a rural 

area without high speed Internet access. 

(B) The practice is located in an area 

without sufficient available pharmacies 

for electronic prescribing. 

(C) Registration to participate in the 

Medicare or Medicaid EHR Incentive 

Program and adoption of certified EHR 

technology. 

(D) Inability to electronically 

prescribe due to local, State or Federal 

law or regulation. 

(E) Limited prescribing activity. 

(F) Insufficient opportunities to report 

the electronic prescribing measure due 

to limitation’s of the measure’s 

denominator. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: April 28, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: May 4, 2011. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2011–13463 Filed 5–26–11; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Parts 223 and 224 

[Docket No. 100903415–1286–02] 

RIN 0648–XW96 

Endangered and Threatened Wildlife 

and Plants; Endangered Species Act 

Listing Determination for Atlantic 

Bluefin Tuna 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Notice of a listing determination 

and availability of a status review 

document. 

SUMMARY: After we, NMFS, received a 

petition to list Atlantic bluefin tuna 

(Thunnus thynnus) as threatened or 

endangered under the Endangered 

Species Act (ESA), we established a 

status review team (SRT) to conduct a 

review of the status of Atlantic bluefin 

tuna. We have reviewed the SRT’s status 

review report (SRR) and other available 

scientific and commercial information 

and have determined that listing 

Atlantic bluefin tuna as threatened or 

endangered under the ESA is not 

warranted at this time. We also 

announce the availability of the SRR. 

DATES: This finding is made as of May 

27, 2011. 

ADDRESSES: The Atlantic bluefin tuna 

status review report and list of 

references are available by submitting a 

request to the Assistant Regional 

Administrator, Protected Resources 

Division, Northeast Region, NMFS, 55 

Great Republic Way, Gloucester, MA 

01930. The status review report and 

other reference materials regarding this 

determination can also be obtained via 

the Internet at: http:// 

www.nero.noaa.gov/prot_res/ 

CandidateSpeciesProgram/cs.htm. 

FOR FURTHER INFORMATION CONTACT: Kim 

Damon-Randall, NMFS Northeast 

Regional Office, (978) 282–8485; or 

Marta Nammack, NMFS, Office of 

Protected Resources (301) 713–1401. 

SUPPLEMENTARY INFORMATION: 

Background 

On May 24, 2010, the National Marine 

Fisheries Service (NMFS) received a 

petition from the Center for Biological 

Diversity (CBD) (hereafter referred to as 

the Petitioner), requesting that we list 

the entire species of Atlantic bluefin 

tuna (Thunnus thynnus) or in the 

alternative, an Atlantic bluefin tuna 

distinct population segment (DPS) 

consisting of one or more 

subpopulations in United States waters, 

as endangered or threatened under the 

ESA, and designate critical habitat for 

the species. The petition contains 

information on the species, including 

the taxonomy; historical and current 

distribution; physical and biological 

characteristics of its habitat and 

ecosystem relationships; population 

status and trends; and factors 

contributing to the species’ decline. The 

Petitioners also included information 

regarding possible DPSs of Atlantic 

bluefin tuna. The petition addresses the 

five factors identified in section 4(a)(1) 

of the ESA as they pertain to Atlantic 

bluefin tuna: (A) Current or threatened 

habitat destruction or modification or 

curtailment of habitat or range; (B) 

overutilization for commercial 

purposes; (C) disease or predation; (D) 

inadequacy of existing regulatory 

mechanisms; and (E) other natural or 

man-made factors affecting the species’ 

continued existence. 

On September 21, 2010, we 

determined that the petition presented 

substantial information indicating that 

the petitioned action may be warranted 

and published a positive 90-day finding 

in the Federal Register (FR) (75 FR 

57431). Following our positive 90-day 

finding, we convened an Atlantic 

bluefin tuna status review team (SRT) to 

review the status of the species. 

In order to conduct a comprehensive 

review, we asked the SRT to assess the 

species’ status and degree of threat to 

the species with regard to the factors 

provided in Section 4(a)(1) of the ESA 

without making a recommendation 

regarding listing. The SRT was provided 

a copy of the petition and all 

information submitted in response to 

the data request in the FR notice 

announcing the 90-day finding. In order 

to provide the SRT with all available 

information, we invited several Atlantic 

bluefin tuna experts to present 

information on the life history, genetics, 

and habitat used by Atlantic bluefin 

tuna to the SRT. 

We also hosted five listening sessions 

with Atlantic bluefin tuna fishermen. 

These sessions were held in Maine, 

Massachusetts, New Jersey, North 

Carolina, and Mississippi. Those with 

information relevant to the discussion 

topics for the sessions were also 

encouraged to submit information via 

mail or electronic mail. The SRT 

reviewed all this information during its 

consideration and analysis of potential 

threats to the species. The SRR is a 

summary of the information assembled 

by the SRT and incorporates the best 

scientific and commercial data available 


sroberts on DSK5SPTVN1PROD with PROPOSALS