Medicare Program; Changes to the Electronic Prescribing (eRx) Incentive Program, 54953-54969 [2011-22629]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 172 (Tuesday, September 6, 2011)]
[Rules and Regulations]
[Pages 54953-54969]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22629]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

[CMS-3248-F]
RIN 0938-AR00


Medicare Program; Changes to the Electronic Prescribing (eRx) 
Incentive Program

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

ACTION: Final rule.

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SUMMARY: This final rule modifies the electronic prescribing (eRx) 
quality measure used for certain reporting periods in calendar year 
(CY) 2011; provides 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 extends 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 final rule with comment period.

DATES: Effective Date: These regulations are effective on October 6, 
2011.
    Deadline for Submission of Hardship Exemption Requests for the 2012 
eRx Payment Adjustment: Hardship exemption requests for the 2012 eRx 
payment must be received by November 1, 2011.

FOR FURTHER INFORMATION CONTACT: Christine Estella, (410) 786-0485.

SUPPLEMENTARY INFORMATION:

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 final 
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: https://www.cms.gov/ERxIncentive/05_Eligible%20Professionals.asp#TopOfPage. Under section 
1848(m)(2) 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 the Secretary's estimate of 
Medicare Part B Physician Fee Schedule (PFS) allowed charges for 
covered professional services furnished by the eligible professional 
(or group practice) 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.
    Following the 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 electronic prescribing 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 final rule published in the 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

[[Page 54954]]

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 https://www.gao.gov/products/GAO-11-159).
    As a result of the concerns noted previously and in accordance with 
Executive Order 13563 (entitled ``Improving Regulation and Regulatory 
Review'' and released January 18, 2011), 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 subsequently proposed to make changes to the 
eRx Incentive Program in a proposed rule that appeared in the June 1, 
2011 Federal Register (76 FR 31547) entitled ``Medicare Program; 
Proposed Changes to the Electronic Prescribing (ERx) Incentive 
Program'' (hereinafter referred to as the June 2011 proposed rule). As 
described further in sections II.A and II.B of this final rule, in that 
proposed rule we specifically proposed 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. Summary of the Proposed Rule and Analysis of and Responses to 
Public Comments

    In this section of the final rule, we summarize our proposals, 
public comments, and our responses. We received over 404 public 
comments on the proposed rule. Approximately 39 comments were from 
groups representing eligible professionals, such as academic 
institutions, government agencies, and professional societies. The 
remaining comments were from individual physicians and private 
citizens.
    We received numerous comments that were not related to our proposal 
to modify the 2011 eRx quality measure or the proposals for additional 
significant hardship exemption categories for the 2012 eRx payment 
adjustment. While we appreciate the commenters' feedback, these 
comments are outside the scope of the issues addressed in this final 
rule. This final rule addresses our proposals to modify the 2011 eRx 
quality measure and establish additional significant hardship exemption 
categories related to the 2012 eRx payment adjustment. We will take 
these comments into consideration for future eRx Incentive Program 
years.

A. Modification of the CY 2011 Electronic Prescribing Quality Measure

    In the CY 2011 PFS final rule with comment period entitled 
``Medicare Program; Payment Policies Under the Physicians Fee Schedule 
and Other Revisions to Part B for CY 2011'' (75 FR 73553 through 
76566), we finalized an eRx quality measure that would be used during 
the reporting periods in 2011 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'' electronic prescribing system.
    A qualified electronic prescribing system is a system that is 
capable of performing the following four specific functionalities:
     Generate a complete active medication list incorporating 
electronic 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 
electronic prescribing 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 being a qualified electronic prescribing 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: https://www.cms.gov/ERxIncentive/06_E-Prescribing_Measure.asp#TopOfPage.)
    The technological requirements for electronic prescribing 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 electronic prescribing 
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 the 
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

[[Page 54955]]

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 electronic prescribing 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 
electronic prescribing 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, in the proposed rule (76 FR 31549), we proposed changes to 
the eRx quality 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. This 2011 eRx measure, as it is 
written prior to the changes to the eRx measure we are finalizing in 
this final rule, is currently NQF-endorsed.
    In the June 2011 proposed rule (76 FR 31549), we proposed 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'' electronic prescribing system that 
performs the four functionalities previously discussed. We proposed to 
revise this description statement to indicate that the measure 
documents whether an eligible professional or group practice has 
adopted a ``qualified'' electronic prescribing 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.
    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, in the June 
2011 proposed rule (76 FR 31549), we also proposed that, for purposes 
of the 2011 eRx measure, Certified EHR Technology is required to comply 
with at least one of the Part D standards for the electronic 
transmission of prescriptions at 42 CFR 423.160(b)(2)(ii) (that is, 
NCPDP SCRIPT Version 8.1 and NCPDP SCRIPT Version 10.6). This 
requirement is consistent with the ONC certification requirements at 45 
CFR 170.304(b) and 170.205(b)(1) and (2). We received no comments 
regarding our proposal to require that Certified EHR Technology comply 
with the Part D standards for the electronic transmission of 
prescriptions at 42 CFR 423.160(b)(2)(ii). Therefore, for the reasons 
we stated previously, we are finalizing this requirement.
    Below we discuss comments regarding our proposal to change the 
description statement and what constitutes a ``qualified'' electronic 
prescribing system under the 2011 eRx quality measure.
    Comment: Several commenters supported our proposal to modify the 
2011 eRx measure to allow for use of Certified EHR Technology, and did 
not offer any other suggestions to modify the 2011 eRx measure.
    Response: We appreciate the commenter's supportive comments and are 
finalizing this proposal.
    Comment: One commenter asked us to reinstate G-codes G8445 and 
G8446, which were G-codes used in the eRx Incentive Program under 
previous program years that indicate actions other than the generation 
of an electronic prescription.
    Response: Our intention for 2011 is to focus on the reporting of 
actual electronic prescribing events. G-code G8445 indicates that, 
although an eligible professional has an electronic prescribing system, 
no prescriptions were generated during the denominator-eligible 
encounter. G-code G8446 indicates that, although an eligible 
professional has access to an electronic prescribing system, a 
prescription was not generated electronically during the encounter 
because, due to State or Federal law or regulation, such as a 
prescription could not be generated electronically. These two G-codes 
do not indicate the use of an electronic prescribing system to generate 
a prescription. Since it is our desire to concentrate solely on the 
reporting of actual prescribing events, we are not allowing for the use 
of G8445 or G8446 for reporting for the 2011 eRx incentive and the 2013 
eRx payment adjustment.
    Comment: Some commenters expressed concern over not being able to 
report the eRx measure in instances where, although an electronic 
prescription was generated, eligible professionals could not 
appropriately report the eRx measure because these encounters did not 
fall within the eRx measure's denominator. Therefore, to account for 
this limitation, these commenters asked us to include codes not 
currently included in the eRx measure's denominator, such as CPT 77427, 
which is a code tied to radiation therapy; CPT 99024, which is a code 
related to postoperative visits; and G0438, which is one of the two 
newly introduced annual wellness visit codes.
    Response: We appreciate the commenters' suggestions to modify the 
eRx measure's denominator to include these CPT and G codes. However, it 
is not operationally feasible to modify the analytics for the eRx 
measure used for the 2011 eRx incentive and 2013 eRx payment adjustment 
in this manner. Whereas our proposal to modify the measure for allowing 
use of Certified EHR Technology expands the types of

[[Page 54956]]

electronic prescribing systems recognized as ``qualified'' for purposes 
of reporting, the addition of denominator codes to the eRx measure for 
the 2011 eRx incentive and 2013 eRx payment adjustment would change the 
analytics of the eRx measure. We believe, however, the commenters' 
concern about not being able to report the eRx measure due to 
electronically prescribing during encounters not included in the 
measure's denominator is addressed by one of the additional significant 
hardship exemption categories we are finalizing in section II.B of this 
final rule. Specifically, for the reasons we state in section II.B.3.d 
of this final rule, we are finalizing a significant hardship exemption 
category due to insufficient opportunities to report the electronic 
prescribing measure due to limitations of the measure's denominator.
    Comment: Some commenters stated that, although they support our 
proposal to modify the eRx measure to allow for use of Certified EHR 
Technology, our proposal does not go far enough to align the eRx 
Incentive Program with the Medicare EHR Incentive Program, as the 
Certified EHR Technology must still meet the four functionalities of a 
``qualified'' electronic prescribing system.
    Response: We appreciate the commenters' feedback. We are working to 
address differences, where appropriate, between the eRx Incentive 
Program and Medicare EHR Incentive Program. However, we did not propose 
to require that Certified EHR Technology to still meet the four 
functionalities identified in the measure to be a ``qualified'' 
electronic system. As we stated in the proposed rule (76 FR 31550), 
``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.'' In addition, as we noted, we believe that Certified EHR 
Technology will be capable of performing all of the required 
functionalities for purposes of reporting the 2011 eRx quality measure.
    After considering the comments received and for the reasons we 
articulated previously, we are finalizing our proposal to modify the 
description of the 2011 eRx measure to indicate that the measure 
documents whether an eligible professional or group practice has 
adopted a ``qualified'' electronic prescribing system that performs the 
four functionalities previously described or is Certified EHR 
Technology as defined at 42 CFR 495.4 and 45 CFR 170.102. We believe 
that this change merely expands on the definition of a ``qualified'' 
electronic prescribing 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.
    However, as stated previously, 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, Certified EHR Technology must comply with the 
Part D standards for the electronic transmission of prescriptions at 42 
CFR 423.160(b)(2)(ii).
    As stated previously, section 1848(k)(2)(C) 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 eRx measure is currently an NQF-endorsed measure, this 
modification to change the 2011 eRx measure description has 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.
    With this change to the 2011 eRx measure description that we are 
finalizing in this final rule, eligible professionals (including those 
in group practices) that are participating in the eRx Incentive Program 
have the option of adopting either a qualified electronic prescribing 
system that performs the four functionalities previously discussed or 
Certified EHR Technology as defined at 42 CFR 495.4 and 45 CFR 170.102 
regardless of whether the Certified EHR Technology has all four of the 
functionalities previously described.
    Because the change to the 2011 eRx measure we are finalizing will 
not be effective until the effective date of this final rule, this 
change will 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 change to the 2011 eRx quality measure does 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 this final rule. The 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 was not finalized prior to 
the end of the 2012 eRx payment adjustment reporting period ended on 
June 30, 2011, the change to the eRx quality measures that we are 
finalizing in this final rule does not apply for purposes of reporting 
the eRx measure for the 2012 eRx payment adjustment. We note that this 
change to the eRx measure is consistent with our proposal under the CY 
2012 PFS proposed rule entitled ``Medicare Program; Payment Policies 
Under the Physician Fee Schedule and Other Revisions to Part B for CY 
2012'' (76 FR 42890) to change the eRx measure for the 2012 through 
2014 program years, which are the remaining years of the eRx Incentive 
Program.

B. Significant Hardship Exemption Categories for the 2012 eRx Payment 
Adjustment

1. Overview of the 2012 eRx Payment Adjustment
    As required by section 1848(a)(5) of the Act, and in accordance 
with our regulations at Sec.  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).

[[Page 54957]]

    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: https://www.cms.gov/erxincentive.
2. Established Significant Hardship Exemption Categories 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 electronic prescribing.
    In order for eligible professionals and group practices to identify 
these categories for purposes of requesting a significant hardship 
exemption, we created a G-code for each of the above situations. Thus, 
to request consideration for a significant hardship exemption for the 
2012 eRx payment adjustment, individual eligible professionals reported 
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 self-nominated to 
participate in the 2011 eRx GPRO earlier this year.
3. Additional Significant Hardship Exemption Categories for the 2012 
eRx Payment Adjustment
    Following the publication of the CY 2011 PFS final rule with 
comment period, we received numerous requests to expand the categories 
under the significant hardship exemption for the 2012 eRx payment 
adjustment. Some stakeholders 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 posed a 
significant hardship and limited 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, 
in the proposed rule (76 FR 31551), we proposed 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. We also proposed to 
allow some additional time for submitting significant hardship 
exemption requests to CMS.
    Specifically, we proposed 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:
     Eligible professionals who register to participate in the 
Medicare or Medicaid EHR Incentive Programs and adopt Certified EHR 
Technology.
     Inability to electronically prescribe due to local, State, 
or Federal law or regulation.
     Limited prescribing activity.
     Insufficient opportunities to report the eRx measure due 
to limitations of the measure's denominator.
    Comment: One commenter suggested that we make changes to the 
regulation text at Sec.  414.92 to reflect our finalized changes.
    Response: We agree and have revised the significant hardship 
regulation at 42 CFR 414.92(c)(2)(ii) to reflect the changes we are 
finalizing in this final rule.
    Comment: One commenter was worried that if these additional 
significant hardship exemption categories to the 2012 eRx payment 
adjustment were finalized, he would not be able to earn a 2011 eRx 
incentive.
    Response: Incentives earned under the eRx Incentive Program are 
governed by section 1848(m)(2)(C) of the Act, whereas payment 
adjustments earned under the eRx Incentive Program are governed by 
section 1848(a)(5)(A) of the Act. The Secretary's authority to 
establish significant hardship exemption categories for those 
circumstances where compliance with the requirement for being a 
successful electronic prescriber would result in a significant hardship 
only apply to the provisions related to eRx payment adjustments. 
Separate criteria for being a successful electronic prescriber were 
established for the 2011 eRx incentive in the CY 2011 PFS final rule 
with comment period (75 FR 73553).
a. Eligible Professionals Who Register To Participate in the Medicare 
or Medicaid EHR Incentive Programs and Adopt Certified EHR Technology
    In the June 2011 proposed rule (76 FR 31551), we proposed this 
exemption category at 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 
electronic prescribing technology for purposes of the eRx Incentive 
Program until the list of Certified EHR Technologies 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 certified 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 considered Certified EHR Technology. 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

[[Page 54958]]

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 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 who are eligible for incentives under the Medicaid 
EHR Incentive Program with the majority of CY 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 electronic prescribing system for purposes of participation 
in the eRx Incentive Program, and Certified EHR Technology for purposes 
of participating in the Medicare and Medicaid EHR Incentive Programs), 
which could potentially be financially burdensome.
    Comment: Several commenters supported our proposal to add a 
significant hardship exemption category for the 2012 eRx payment 
adjustment for eligible professionals who register to participate in 
the Medicare or Medicaid EHR Incentive Programs and adopt Certified EHR 
Technology without offering any other suggestions regarding this 
proposed significant hardship exemption category. Several commenters 
also stated that they would request an exemption under this significant 
hardship exemption category, should the category be finalized.
    Response: We appreciate the commenters' supportive comments and are 
finalizing this significant hardship exemption category for the 2012 
eRx payment adjustment.
    Comment: Although commenters supported this significant hardship 
exemption category, several commenters recommended that we extend this 
significant hardship exemption category to eligible professionals other 
than those who have registered for the Medicare or Medicaid EHR 
Incentive Programs and adopted Certified EHR Technology, such as those 
eligible professionals who: (1) Intend to adopt EHR technology in 
either CY 2011 or 2012; (2) attest in CY 2012; or (3) achieve 
meaningful use in CY 2012.
    Response: We appreciate the commenters' feedback. However, we 
proposed this significant hardship exemption category for the 2012 eRx 
payment adjustment for those eligible professionals who have taken 
proactive steps, such as having an electronic prescribing system 
available for immediate use, towards participating in the Medicare or 
Medicaid EHR Incentive Programs, under which there is a component on 
reporting electronic prescribing activities. With respect to eligible 
professionals who intend to adopt EHR technology in CY 2011 or have not 
yet taken the steps required in order to apply for this significant 
hardship exemption, we believe that mere intent to adopt Certified EHR 
Technology or attest at a later date does not sufficiently demonstrate 
that an eligible professional will adopt Certified EHR Technology to 
participate in the Medicare or Medicaid EHR Incentive Programs. Unlike 
those eligible professionals who have already registered for the 
Medicare or Medicaid EHR Incentive Programs and have Certified EHR 
Technology available for immediate use, we would have to monitor and 
provide oversight over those eligible professionals who have not yet 
taken these steps to participate in the Medicare or Medicaid EHR 
Incentive Programs. To prevent these monitoring and oversight issues, 
we believe that all requirements to qualify for an exemption under this 
significant hardship exemption category must be met by October 1, 2011 
and prior to the time the eligible professional requests an exemption.
    Comment: While commenters supported our proposal to allow eligible 
professionals participating in the Medicaid EHR Incentive Program to 
request a significant hardship exemption from the 2012 eRx payment 
adjustment, some commenters stated that we should use the ``adopt, 
implement, and upgrade'' mechanism for receiving an incentive payment 
under the Medicaid EHR Incentive Program to determine whether an 
eligible professional should be exempt from the 2012 eRx payment 
adjustment.
    Response: We recognize that eligible professionals who participate 
in the Medicaid EHR Incentive Program may qualify for an incentive 
payment if they adopt, implement, upgrade, or demonstrate meaningful 
use of Certified EHR Technology in their first year of participation. 
Eligible professionals who attempt to qualify for an incentive payment 
under the Medicaid EHR Incentive Program by adopting, implementing, or 
upgrading Certified EHR Technology may request an exemption under this 
significant hardship exemption category provided that the eligible 
professional meets the requirements for this significant hardship 
exemption finalized in this final rule.
    Comment: One commenter asked that we clarify the term ``adopted'' 
as it applies to this significant hardship exemption category.
    Response: This significant hardship exemption category is intended 
for those eligible professionals who have registered to participate in 
the Medicare or Medicaid EHR Incentive Programs and adopted Certified 
EHR Technology. That is, in order to potentially qualify for an 
exemption under this significant hardship exemption category, an 
eligible professional or group practice must have Certified EHR 
Technology available for immediate use for purposes of participating in 
the Medicare or Medicaid EHR Incentive Programs.
    Comment: Some commenters asked whether eligible professionals 
practicing in states that have not yet fully implemented their Medicaid 
EHR Incentive Program, and therefore do not have the ability to 
register for participation in the Medicaid EHR Incentive Program, could 
apply for an exemption under this significant hardship exemption 
category.
    Response: We appreciate the commenters' feedback. We realize that 
not all states have fully implemented their Medicaid EHR Incentive 
Programs. Rather, the implementation of these Medicaid EHR Incentive 
Programs is pending. This, however, does not affect an eligible 
professional's ability to register to participate in his/her state's 
Medicaid EHR Incentive Program. Therefore, eligible professionals 
practicing in states where their respective Medicaid EHR Incentive 
Program have not yet been implemented are not precluded from requesting 
or qualifying for an exemption under this significant hardship 
exemption category. We note that eligible professionals must still meet 
the finalized requirements we are finalizing as described below, with 
regard this significant hardship exemption category.
    Comment: One commenter stated that eligible professionals 
participating under Medicare Advantage (MA) also be allowed to submit a 
significant hardship request under this exemption category.
    Response: We appreciate the commenters' feedback. To the extent

[[Page 54959]]

that professionals that participate under MA are eligible to 
participate in the eRx Incentive Program for purposes of the 2012 eRx 
payment adjustment, these eligible professionals may qualify for an 
exemption under this significant hardship exemption category.
    Comment: One commenter asked that practices working with Regional 
Extension Centers to achieve meaningful use under the Medicare or 
Medicaid EHR Incentive Programs be able to apply for this exemption.
    Response: We appreciate the commenter's feedback. As long as the 
eligible professionals within the practice meet the requirements 
described for this significant hardship exemption category for the 2012 
eRx payment adjustment, the eligible professionals within the practice 
may apply for this significant hardship exemption category.
    Comment: Several commenters opposed our proposed requirement to 
provide a serial number of the product the eligible professional has 
adopted in order to be eligible to request a significant hardship 
exemption under this category. Some of these commenters stated that a 
serial number, in some instances, not available for his or her 
Certified EHR Technology.
    Response: We solicited comments on whether eligible professionals 
should provide a serial number for their specific product. Based on the 
comments received and our belief that providing the ``CMS EHR 
Certification ID'' for the Certified EHR Technology which can be 
generated through the Certified HIT Products List (CHPL) Web site 
maintained by the Office of the National Coordinator for Health 
Information Technology (ONC) is sufficient evidence that an eligible 
professional possesses Certified EHR Technology available for immediate 
use, we will not require that eligible professionals provide his or her 
product's serial number when requesting an exemption under this 
significant hardship exemption category.
    Comment: Several commenters suggested that an eligible professional 
be provided with flexibility in providing proof that an eligible 
professional has adopted Certified EHR Technology for purposes of 
participating in the Medicare or Medicaid EHR Incentive Programs. Some 
commenters suggested that eligible professionals have the option of 
either providing a certification or serial number. One commenter stated 
it was unnecessary for eligible professionals to provide such proof 
because CMS already has access to information on those eligible 
professionals participating in the EHR Incentive Program.
    Response: To qualify for an exemption under this significant 
hardship exemption category, an eligible professional must have 
Certified EHR Technology available for immediate use. In order to 
efficiently review and process requests for exemptions under this 
significant hardship exemption category, it is necessary to apply 
uniform requirements for qualifying for an exemption under this 
significant hardship exemption category. Therefore, rather than allow 
eligible professionals to submit either a certification number or 
serial number as proof that these eligible professionals have adopted 
Certified EHR Technology, we are requiring that every eligible 
professional submit the certification number associated with his or her 
Certified EHR Technology in order to qualify for consideration for an 
exemption under this significant hardship exemption category. We are 
requiring an eligible professional provide us with the CMS EHR 
Certification ID, not a serial number, because, as commenters stated, a 
serial number is, in some instances, not available for his or her 
Certified EHR Technology. With respect to the comment stating CMS 
already has this information, we note that providing a certification 
number for his or her Certified EHR Technology is not required at the 
time an eligible professional registers for participation under the 
Medicare or Medicaid EHR Incentive Programs. Rather, an eligible 
professional is not required to provide a certification number for his 
or her Certified EHR Technology by the time of attestation.
    Comment: Some commenters stated that we should not perform a case-
by-case review of exemption under this significant hardship exemption 
category. Rather, eligible professionals participating in the Medicare 
or Medicaid EHR Incentive Programs should be automatically exempt from 
the 2012 eRx payment adjustment.
    Response: We appreciate the commenters' feedback. However, we are 
required by section 1848(a)(5)(b) of the Act to review requests for 
significant hardship exemption on a case-by-case basis.
    After considering the comments received and for the reasons 
previously discussed, we are finalizing this significant hardship 
exemption category for the 2012 eRx payment adjustment for eligible 
professionals or group practices who register to participate in the 
Medicare or Medicaid EHR Incentive Programs and adopt Certified EHR 
Technology. To be considered for a significant hardship exemption under 
this category, an eligible professional 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 https://www.cms.gov/EHRIncentivePrograms/20_RegistrationandAttestation.asp#TopOfPage); and 
(2) provide identifying information as to the Certified EHR Technology 
(as defined at 42 CFR 495.4 and 45 CFR 170.102) that has been adopted 
for use no later than October 1, 2011.
    Please note that, in order to qualify for an exemption to the 2012 
eRx payment adjustment under this significant hardship exemption 
category, it is not necessary that an eligible professional receive an 
incentive payment under the Medicare or Medicaid EHR Incentive Program.
    A request for a significant hardship exemption category under this 
category will then be reviewed on a case-by-case basis. For purposes of 
this significant hardship exemption category, the identifying 
information consists of the ``CMS EHR Certification ID'' for the 
Certified EHR Technology which can be generated through the CHPL Web 
site maintained by ONC. In requesting a significant hardship exemption 
category under this category, an eligible professional is attesting 
that he or she either has purchased the specified Certified EHR 
Technology (as identified by the CMS ID) or has the specified Certified 
EHR Technology (as identified by the CMS ID) available for immediate 
use and that the eligible professional intends to use that Certified 
EHR Technology to qualify for a Medicare or Medicaid EHR incentive for 
payment year 2011 ``CMS EHR Certification ID'' for the Certified EHR 
Technology which can be generated through the CHPL Web site maintained 
by ONC.
b. Inability To Electronically Prescribe Due to Local, State, or 
Federal Law or Regulation
    In the June 2011 proposed rule (76 FR 31551), we proposed 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, 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

[[Page 54960]]

on a case-by-case 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).
    Comment: Several commenters supported our proposal to add a 
significant hardship exemption category for the 2012 eRx payment 
adjustment for eligible professionals who are unable to electronically 
prescribe due to local, State, or Federal law or regulation without 
offering any other suggestions regarding this significant hardship 
exemption category. Several commenters also indicated that they would 
request an exemption under this significant hardship exemption 
category, should the category be finalized.
    Response: We appreciate the commenters' supportive comments and are 
finalizing this category.
    Comment: Some commenters suggested that we encourage eligible 
professionals who cannot electronically prescribe narcotics because 
their electronic prescribing system is not yet compliant with Federal 
or State law to apply for an exemption under this significant hardship 
exemption category.
    Response: This significant hardship exemption category is indeed 
intended for these eligible professionals who mainly prescribe 
narcotics but, due to limitations in local, State, or Federal law or 
regulation, cannot submit these prescriptions electronically.
    After considering the comments received and for the reasons 
discussed, we are finalizing the significant hardship exemption 
category for the 2012 eRx payment adjustment for eligible professionals 
or group practices whose prescribing authority is limited 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). Please note that this significant hardship exemption 
category is not limited to those eligible professionals that practice 
in states that do not allow narcotic prescriptions to be transmitted 
electronically. Eligible professionals or group practices may request 
consideration for an exemption under this significant hardship category 
from application of the 2012 eRx payment adjustment, which will be 
reviewed on a case-by-case basis.
c. Limited Prescribing Activity
    In the June 2011 proposed rule (76 FR 31552), we proposed 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, 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 of an 
eligible professional or group practice to prescribe, much less 
electronically prescribe.
    Comment: Several commenters supported our proposal to add a 
significant hardship exemption category for the 2012 eRx payment 
adjustment for eligible professionals who have limited prescribing 
activity without offering any other suggestions regarding this 
significant hardship exemption category. Several commenters also stated 
that they would request an exemption under this significant hardship 
exemption category, should the category be finalized.
    Response: We appreciate the commenters' supportive comments. We are 
finalizing the significant hardship exemption category for eligible 
professionals who have limited prescribing activity.
    Comment: One commenter suggested that we establish a G-code for 
this significant hardship exemption category, similar to the G-codes 
we've established for the two significant hardship exemption categories 
finalized in 2011 PFS final rule described in section II.B.2 of this 
final rule.
    Response: We appreciate the commenters' feedback. Unfortunately, it 
is not technically feasible for us to create a G-code for this 
significant hardship prior to the deadline we are finalizing in section 
II.B.5 of this final rule for submitting significant hardship exemption 
requests for the 2012 eRx payment adjustment.
    After considering the comments received and for the reasons 
previously discussed, we are finalizing this significant hardship 
exemption category for the 2012 eRx payment adjustment for eligible 
professionals or group practices who have prescribing privileges but do 
not prescribe or very infrequently prescribe in 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 meet the 10-percent threshold for applicability of the payment 
adjustment. Exemption requests under this significant hardship 
exemption category will be reviewed on a case-by-case basis.
d. Insufficient Opportunities To Report the eRx Measure Due to 
Limitations of the Measure's Denominator
    To the extent an eligible professional or group practice has an 
electronic prescribing 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), in the proposed rule (76 FR 31552), we proposed 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 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-

[[Page 54961]]

percent threshold for applicability of the payment adjustment and have 
at least 100 denominator-eligible 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.
    Comment: Several commenters supported our proposal to add a 
significant hardship exemption category for the 2012 eRx payment 
adjustment for eligible professionals who have insufficient 
opportunities to report the electronic prescribing measure due to 
limitations of the measure's denominator without offering any other 
suggestions regarding this proposed significant hardship exemption 
category. Several commenters also stated that they would request an 
exemption under this significant hardship exemption category, should 
the category be finalized.
    Response: We appreciate the commenters' supportive comments and are 
finalizing this category.
    Comment: One commenter stated that eligible professionals who 
provide electronic prescriptions on a day different than the 
beneficiary's visit, such as the situation where an eligible 
professional provides a prescription during a postoperative visit, 
should be able to apply for a significant hardship exemption category.
    Response: We agree. This significant hardship exemption category is 
intended for instances such as these, where an eligible professional 
electronically prescribes but, because the measure's denominator only 
accounts for certain patient encounters, cannot report the electronic 
prescribing instance.
    After considering the comments received, we are finalizing the 
significant hardship exemption category for the 2012 eRx payment 
adjustment for eligible professionals or group practices that have an 
electronic prescribing system, electronically prescribes, and has 
denominator-eligible visits, but do 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). Requests for an exemption under this significant hardship 
exemption category will be reviewed on a case-by-case basis.
e. Significant Hardship Exemption Categories Not Proposed in the 
Proposed Rule
    Comment: While our proposal for additional significant hardship 
exemption categories was appreciated, several commenters suggested we, 
in general, add more hardship exemption categories for the 2012 eRx 
payment adjustment, or offered specific additional hardship 
circumstances for our consideration.
    Response: We appreciate the commenters' feedback. However, as 
discussed below, we are not finalizing any of the additional 
significant hardship exemption categories commenters suggested because 
such suggested significant hardship exemption categories were not 
proposed in the proposed rule, do not constitute a significant hardship 
under section 1848(a)(5) of the Act, or involve circumstances that may 
be covered by the limitations to the 2012 eRx payment adjustment 
established in the CY 2011 PFS final rule (75 FR 73562), the 
significant hardship exemption categories previously established in the 
CY 2011 PFS final rule, or the significant hardship exemption 
categories we are finalizing in this final rule.
    Comment: Several commenters stated that surgeons, neuro-
ophthalmologists, orthopedic doctors, and radio-oncologists could not 
meet the criteria for being a successful electronic prescriber for the 
2012 eRx payment adjustment because these specialties mainly prescribe 
narcotics. Several commenters also stated that optometrists, eligible 
professionals who prescribe narcotics, eligible professionals who 
prescribe durable equipment, and other physicians whose specialties do 
not necessitate providing prescriptions on a regular basis should be 
exempt from the 2012 eRx payment adjustment.
    Response: We appreciate the commenters' feedback. However, we 
believe that these suggested additional categories may already be 
addressed under the significant hardship exemption categories we are 
finalizing in this final rule.
    For those eligible professionals who mainly prescribe narcotics, 
durable equipment, or only provide prescriptions on a limited basis, we 
believe that that these circumstances may be addressed by the 
additional significant hardship exemption categories we are finalizing, 
such as the significant hardship exemption categories discussed in 
sections II.B.3.b, II.B.3.c, and II.B.3.d of this final rule. For 
example, the significant hardship exemption category for eligible 
professionals or group practices whose prescribing authority is limited 
to the extent that local, State, or Federal law or regulation described 
in section II.B.3.b. of this final rule is intended to provide for 
possible exemptions for those eligible professionals or group practices 
who cannot meet the criteria for being a successful prescriber for the 
2012 eRx payment adjustment because they mainly prescribe narcotics. 
This significant hardship exemption category may apply, for example, to 
eligible professionals such as surgeons who mainly prescribe narcotics 
in a State that does not permit or limits the transmission of a 
narcotic prescription through electronic means.
    The significant hardship exemption category for eligible 
professionals and group practices with limited prescribing activity 
described in section II.B.3.c of this final rule is intended to provide 
for possible exemption of eligible professionals who rarely prescribe 
yet still meet the 10-percent threshold for applicability of the 
payment adjustment and have at least 100 denominator eligible visits 
prior to June 30, 2011. This significant hardship exemption category 
may, for example, apply to those specialties where prescriptions are 
not given on a regular basis.
    Furthermore, the significant hardship exemption category for 
eligible professionals or group practices who do not normally write 
prescriptions associated with any of the types of visits included in 
the eRx quality measure's denominator described in section II.B.3.d of 
this final rule is intended to exempt those eligible professionals such 
as surgeons or radio-oncologists who usually provide prescriptions 
outside denominator-eligible encounters.
    Comment: Several commenters