[Federal Register Volume 76, Number 172 (Tuesday, September 6, 2011)]
[Rules and Regulations]
[Pages 54953-54969]
From the Federal Register Online via the Government Publishing 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: http://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 http://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: http://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: http://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 http://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 stated that chiropractors should be
exempt from the 2012 eRx payment adjustment.
Response: With respect to chiropractors, as we mentioned previously
in section II.B.1. of this final rule, we note that we finalized
limitations to the 2012 eRx payment adjustment in the CY 2011 PFS final
rule (75 FR 73562). Because chiropractors are not within the category
of eligible professionals to which the 2012 eRx payment adjustment
applies, chiropractors are not subject to the 2012 eRx payment
adjustment.
Comment: Some commenters stated that eligible professionals who
only see Medicare patients on an occasional basis, part-time providers,
eligible professionals who dispense medications from their offices,
eligible professionals who only perform home visits for patients,
eligible professionals who practice on military bases, and eligible
professionals who work in nursing homes or long-term care facilities
should be exempt from the 2012 eRx
[[Page 54962]]
payment adjustment because these eligible professionals either only
have limited opportunities to prescribe medications or cannot
electronically prescribe on-site.
Response: With respect to these eligible professionals with a
limited practice, such as part-time providers, we believe that, given
the limitations finalized in the CY 2011 PFS final rule (75 FR 73562)
that are described in section II.B.1 of this final rule, these groups
potentially may not be subject to the 2012 eRx payment adjustment.
Specifically, an eligible professional will not be subject to the 2012
eRx payment adjustment if the eligible professional 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. For those
eligible professionals who practice off-site, such as eligible
professionals who perform home visits, we note that, although an
eligible professional may not have a readily available electronic
prescribing system during instances such as a home visit, we believe
that these eligible professionals still have the ability to dispense an
electronic prescription. Therefore, we do not believe that these
instances constitute significant hardships in the manner that these
significant hardship exemption categories we are finalizing do.
Comment: Several commenters stated that physicians who are over 60,
eligible for Social Security benefits, or nearing retirement may find
it difficult to justify the cost of implementing electronic prescribing
systems.
Response: With respect to eligible professionals who are over 60,
eligible for social security benefits, or nearing retirement, these
scenarios were raised by commenters during the comment period and
addressed in the CY 2011 PFS rule. As we stated in the CY 2011 PFS
final rule (75 FR 73564), we believe these instances do not constitute
significant hardships in the manner that these significant hardship
exemption categories we are finalizing do. We believe that encouraging
the use of electronic prescribing outweighs the cost of purchasing an
electronic prescribing system, because we believe use of these systems
will readily provide patient prescription history leading to better
management of patient prescriptions and greater patient safety and
care.
Comment: Some commenters also suggested that a significant hardship
category be created for eligible professionals who did not meet the
criteria for being a successful electronic prescriber for the 2012 eRx
payment adjustment due to circumstances beyond one's control, such as
natural disasters (for example, major floods), being on maternity
leave, or having patients who do not consent to the use of electronic
prescribing.
Response: With respect to eligible professionals who did not meet
the criteria for being a successful electronic prescriber for the 2012
eRx payment adjustment due to circumstances beyond one's control, such
as being on maternity leave or having patients who do not consent to
the use of electronic prescribing, we understand that unforeseen
circumstances may arise that prevent an eligible professional from
reporting the eRx measure. However, we beleive that these circumstances
may be addressed by the limitations to the 2012 eRx payment adjustment
we have finalized.
With respect to those eligible professionals who have experienced
natural disasters during a substantial portion of the 2012 eRx payment
adjustment reporting period (that is, January 1, 2011 through June 30,
2011), such as the case of major flooding in the Midwest, we believe
that these eligible professionals may apply for an exemption under the
significant hardship exemption categories we have previously finalized
(that is, the significant hardship exemption categories we finalized in
the CY 2011 PFS final rule). For example, as described in section
II.B.2 of this final rule, in the CY 2011 PFS final rule, we
established a significant hardship exemption for those eligible
professionals who practice in an area with limited available pharmacies
for electronic prescribing. If a natural disaster such as a major flood
leaves electronic prescribing systems, both in physician offices and
pharmacies, offline, then an eligible professional may potentially
qualify for a significant hardship exemption under this significant
hardship exemption category. In addition, if, for instance, an eligible
professional's practice is severely stunted due to a devastating
natural disaster, an eligible professional could request consideration
for an exemption under the limited prescribing activity significant
hardship exemption category.
Comment: Several commenters have also requested that a significant
hardship exemption category to the 2012 eRx payment adjustment be
established for those eligible professionals who attempted but did not
meet the criteria for being a successful electronic prescriber for the
2012 eRx payment adjustment due to problems encountered using the
electronic prescribing system or reporting the eRx quality measure via
claims. For example, some commenters stated they reported G-code G8443
(which was the eRx measure's numerator under the 2009 eRx Incentive
Program) instead of G-code G8553, which is the 2011 eRx measure's
numerator. Several commenters stated that, although they reported G-
code G8553 on claims, the G-codes were stripped because the eligible
professionals were submitting claims with a zero dollar amount. Some
commenters have also encountered vendor issues with respect to
reporting the eRx measure.
Response: We appreciate the commenters' feedback. In general, we
understand that problems may occur that prevent the successful
reporting of the eRx measure. However, we do not believe that these
errors constitute a significant hardship under section 1848(a)(5)(B) of
the Act. Rather, these are reporting errors that may have prevented an
eligible professional from successfully reporting the eRx measure.
In addition, with respect to those eligible professionals who
mistakenly reported G-code G8443, which was one of codes in the eRx
measure's numerator in 2009, instead of G8553, which has been the only
code in the eRx measure's numerator since 2010, we note that the public
was given ample notice via rulemaking, which included an opportunity to
comment on the eRx measure's proposed numerator G-code. Educational
materials and other outreach opportunities such as national provider
calls and special open door forums also provided instruction to report
G8553 for all reporting periods occurring in 2011.
With respect to those instances where the G-codes were stripped
because the eligible professionals were submitting claims with a zero
dollar amount, we note that eligible professionals were provided with
guidance as to how to successfully report the eRx measure.
Specifically, we provided a guidance document titled ``Claims-Based
Reporting Principles for Electronic Prescribing (eRx) Incentive
Program,'' which provided instructions on how to properly report the
eRx measure via claims. This document, which is available at https://www.cms.gov/ERxIncentive/06_E-Prescribing_Measure.asp#TopOfPage,
states that, if a system does not allow a $0.00 line-item charge, a
nominal amount can be substituted.''
With respect to experiencing vendor issues, we understand that
these eligible professionals have made a good faith
[[Page 54963]]
effort to successfully report the eRx measure for the 2012 eRx payment
adjustment. However, we do not believe that these errors constitute a
significant hardship.
Comment: Some commenters also stated that small business practices
should be exempt from the 2012 eRx payment adjustment, since the
purchase of an electronic prescribing system puts a significant
financial burden on these small practices.
Response: We understand that there are significant costs associated
with purchasing an electronic prescribing system. However, we do not
believe that this constitutes a significant hardship under section
1848(a)(5)(8) of the Act. We believe that encouraging the use of
electronic prescribing outweighs the cost of purchasing an electronic
prescribing system, because we believe use of these systems will
readily provide patient prescription history, leading to better
management of patient prescriptions and greater patient safety and
care.
As stated earlier, after considering the comments received and for
the reasons we discussed previously, we are finalizing the all of the
following additional significant hardship exemption categories for the
2012 eRx payment adjustment:
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.
Therefore, we are finalizing our proposal to modify 42 CFR 414.92
to specify these significant hardship exemption categories to the 2012
eRx payment adjustment as well as making a minor edit to 42 CFR 414.92.
4. Process for Requesting Significant Hardship Exemption Categories for
the 2012 eRx Payment Adjustment
In the June 2011 proposed rule (76 FR 31552), we proposed a process
different from that finalized in the CY 2011 PFS final rule for
requesting the significant hardships for the 2012 eRx payment
adjustment described above. Specifically, to request a significant
hardship exemption for any of the categories proposed and previously
described for the 2012 eRx payment adjustment, we proposed that an
eligible professional or group practice provide to us, via a Web-based
tool or interface (or by mail, if it is not technically feasible for
use to develop such a Web site) the following:
Identifying information such as the TIN, NPI, name,
mailing address, and e-mail 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.
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.
An attestation of the accuracy of the information
provided.
In addition, we proposed 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 whether a significant
hardship exists.
We did not propose, nor are we allowing, 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.
Comment: While several commenters supported our proposal to use a
Web-based tool to process requests for significant hardship exemptions,
some commenters stated that we should allow an eligible professional or
group practice's administration and staff to complete a significant
hardship exemption request on his/her behalf.
Response: We appreciate the commenter's feedback. However, we
believe it is necessary that the eligible professional complete the
request for an exemption to the 2012 eRx payment adjustment for the
finalized significant hardship exemption category(ies). The eligible
professional must personally attest with respect to the accuracy of the
statements provided in the request for an exemption. We believe that
requiring an eligible professional, rather than his or her staff, to
apply for an exemption will not result in a significant burden to the
eligible professional as the eligible professional need only request an
exemption once.
However, for group practices, according to the CY 2011 PFS final
rule, a single individual is designated as the single contact person
for that group practice. Because, this individual has previously been
chosen to act on behalf of the group for issues relating to the eRx
Incentive Program, the contact person for the respective group practice
must submit the request for an exemption for the respective group
practice under these finalized significant hardship exemption
categories. In submitting the request for an exemption under these
finalized significant hardship exemption categories, this contact
person is attesting to the accuracy of the information provided on
behalf of the group practice.
Comment: One commenter suggested that we develop a tool that allows
for the submission of supporting documentation, should additional
information need to be submitted in order to thoroughly review a
request for an exemption.
Response: While we agree that such a tool would be useful, at this
time, it is not technically feasible for us to develop an upload
function on the Web-based tool in time to receive supporting
documentation. Despite our inability to provide an upload tool for
submitting additional documentation, we note that all required
information for a request for an exemption may be provided on the Web-
based tool. In the event that we specifically requests additional
documentation in order to thoroughly review an exemption request
though, the eligible professional will send this documentation to us
via mail.
Comment: One commenter suggested that CMS develop the submission
tool in such a way as to prevent an eligible professional from
submitting incomplete information. Another commenter suggested that we
develop the Web-based tool to be user friendly.
[[Page 54964]]
Response: It is our intention that the Web-based tool be easily
navigable. This includes indicating which fields are required for the
eligible professional to complete in order to submit a complete request
for a significant hardship exemption. We also intend to provide
additional guidance for eligible professionals to learn how to navigate
through the Web-based tool for purposes of submitting a significant
hardship exemption request and to minimize the potential for errors.
Comment: Some commenters stated that we should encourage eligible
professionals to submit more than one significant hardship exemption,
should more than one apply.
Response: While an eligible professional need only request a
significant hardship exemption to the 2012 eRx payment adjustment under
one category, we are allowing eligible professionals to request a
significant hardship exemption under more than one exemption category,
should more than one category apply. While an eligible professional
will only be required to select one applicable significant hardship
exemption category when entering their request in the Web-based tool,
they can include the other categories that apply in their justification
statement should more than one category apply.
Comment: One commenter stated that we should encourage eligible
professionals who have already reported the eRx measure during the
applicable 2012 eRx payment adjustment payment reporting period to
apply for a significant hardship exemption, should one apply.
Response: We did not propose to limit the pool of eligible
professionals who can apply for an exemption request under the
finalized significant hardship exemption categories. If an eligible
professional believes that he or she qualifies for an exemption under
one or more of the significant hardship exemption categories for the
2012 eRx payment adjustment, he or she may submit a request for an
exemption regardless of whether he or she attempted to report the eRx
measure for purposes of the 2012 eRx payment adjustment. As noted
previously, all requests for a significant hardship exemption from the
2012 eRx payment adjustment will be reviewed on a case-by-case basis.
Comment: One commenter stated that CMS should provide a resource to
address questions eligible professionals may have about submitting
significant hardship exemption requests.
Response: We appreciate the commenter's feedback. We note that
questions regarding use of the Web-based tool may be directed to the
Quality Net Help Desk. The Quality Net Help Desk may be contacted via
telephone at 1-866-288-8912 or via e-mail at [email protected].
Further information on the QualityNet Help Desk is available at https://www.cms.gov/ERxIncentive/11_HelpDeskSupport.asp#TopOfPage.
Comment: Some commenters stated that CMS should, prior to allowing
for submission of significant hardship requests, notify each eligible
professional of the following: (1) Whether an eligible professional
falls under a limitation to the 2012 eRx payment adjustment that was
finalized in the 2011 PFS Final Rule and described in section II.B.1 of
this final rule and (2) whether an eligible professional has met the
criteria for being a successful electronic prescriber for the 2012 eRx
payment adjustment.
Response: We appreciate the commenter's feedback. However, it is
not technically feasible for us to provide notification to each
eligible professional as to whether the 2012 eRx payment adjustment
applies or whether an eligible professional has met the criteria for
being a successful electronic prescriber for the 2012 eRx payment
adjustment prior to the deadline for submitting a significant hardship
request. Claims for dates of service within the 2012 eRx payment
adjustment reporting period (that is, January 1, 2011 through June 30,
2011) are still being processed and analyzed.
Furthermore, we note that the burden of requesting an exemption to
the 2012 eRx payment adjustment under the finalized significant
hardship exemption categories lies with the eligible professional or
group practice.
Comment: Some commenters stressed the importance of providing
sufficient education and outreach so that eligible professionals are
aware of the finalized proposals relating to the addition of
significant hardship exemption categories, as well as the process for
submitting significant hardship requests for the 2012 eRx payment
adjustment. Some commenters suggested that we work with physician
organizations to inform eligible professionals of these changes.
Response: We agree and intend to provide education and outreach
opportunities to inform eligible professionals of the changes to the
program we are finalizing in this final rule. We also plan to work with
organizations outside of CMS to ensure that the provider community is
aware of these changes.
Comment: One commenter suggested that CMS work to avoid the
reprocessing of claims.
Response: We appreciate the commenter's feedback. We will work to
avoid the reprocessing of claims. We intend to complete our review of
the request for exemptions under the significant hardship exemption
categories finalized in this final rule and the CY 2011 PFS final rule
in time to instruct the carrier/MACs as to those eligible professionals
or group practices we determine are exempted from the 2012 eRx payment
adjustment. 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, particularly in instances where eligible professionals submit
significant hardship exemption requests closer towards the November 1,
2011 deadline, 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
or group practice's request for a significant hardship exemption after
January 1, 2012, we would need to reprocess all claims for services
furnished up to that point in 2012 that were paid at the reduced PFS
amount, which we anticipate may take several months. In order to avoid
the reprocessing of claims, we encourage eligible professionals who
wish to submit a significant hardship exemption request to do so as
soon as possible, rather than waiting until the November 1, 2011
deadline to submit such a request.
Comment: One commenter stated that submitting significant hardship
exemption requests via mail would be too burdensome.
Response: We appreciate the commenter's feedback. Based on the
comments received, we believe the Web-based tool is the most effective
way to receive and process significant hardship exemption requests. We
are only allowing individual eligible professionals to submit a
significant hardship exemption request via the Web-based tool.
Comment: One commenter sought clarification and instructions as to
how to request an exemption under the significant hardship exemption
categories via the Web-based tool and asked how we will provide a case-
by-case review of these requests.
[[Page 54965]]
Response: We appreciate the commenter's feedback. Instructions on
how to access the Web-based tool and request an exemption will be
available on the eRx Incentive Program Web site at http://www.cms.gov/ERxIncentive/. With respect to how we will review all exemption
requests, given the requirement that we do so on a case-by-case basis,
we expect that each review will be tailored to the specific case
presented.
After considering all the comments received and for the reasons
stated previously, we are finalizing the following process to request a
significant hardship exemption from the 2012 eRx payment adjustment
under any of the categories (including multiple categories, if
applicable) that we are finalizing in this final rule:
Identifying information which include the TIN, NPI, name,
mailing address, and e-mail 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
(as was previously described).
An attestation of the accuracy of the information
provided.
Individual eligible professionals must submit significant hardship
exemption requests using a Web-based tool only. Information on how to
access the Web-based tool as well as detailed instructions for applying
for a significant hardship exemption will be available on the eRx
Incentive Program Web site at http://www.cms.gov/erxincentive/.
Although in the June 2011 proposed rule (76 FR 31552), we proposed
to allow group practices participating in the eRx Incentive Program as
an eRx GPRO to also submit an exemption request via the Web-based tool,
for technical reasons, we cannot allow group practices to submit
significant hardship exemption requests using this Web-based tool. In
the proposed rule, we also stated that, if not technically feasible to
use a Web-based tool, an eligible professional or group practice may
submit an exemption request via mail. As such, group practices who wish
to submit an exemption request under one or more of the finalized 2012
eRx payment adjustment significant hardship exemption categories must
submit this request via a mailed letter containing all of the
information specified in the bullet points previously listed. More
information on how group practices may request a significant hardship
via mail, such as the mailing address for submitting this request, will
be available on the eRx Incentive Program Web site at http://www.cms.gov/erxincentive/.
Comment: Some commenters asked us to establish a process whereby an
eligible professional or group practice may appeal a denial of a
request for an exemption from the 2012 eRx payment adjustment under the
finalized significant hardship exemption categories.
Response: We appreciate the commenters' feedback. We will perform a
case-by-case review of each request for an exemption to the 2012 eRx
payment adjustment. We believe that this review of a request will be
sufficient to determine whether an eligible professional or group
practice should be granted the exemption. Therefore, we are not
providing a means for reconsideration of our determination to approve
or deny exemption requests. We note that, although there is no
reconsideration of our determination regarding an exemption, eligible
professionals and group practices may contact the QualityNet Help Desk
should they have additional questions regarding our determination.
5. Deadline for Submission of Significant Hardship Exemption Requests
for the 2012 eRx Payment Adjustment
We proposed 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 (76 FR
31553). We also proposed to extend the deadline for submitting requests
for consideration for the two significant hardship exemption category
categories (that is, eligible professional or group practice practices
in rural areas with limited high speed internet access and eligible
professional or group practice practices in an area with limited
available pharmacies for electronic prescribing) 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.
We also considered providing eligible professionals and group
practices with additional time to submit requests for a significant
hardship exemption under the proposed additional categories but stated
that we believed that doing so might result in the need to reprocess
claims for 2012 services for eligible professionals. We also proposed a
submission deadline for significant hardship exemption requests no
later than 5 business days after the effective date of the final rule
to the extent the final rule was not effective by October 1, 2011, and
sought comments whether such time would be adequate.
Comment: Some commenters stated that CMS will be overwhelmed by
requests for significant hardship exemption categories, even with the
creation and use of a Web-based tool, and, as a result, will not be
able to timely review all significant hardship exemption requests.
Response: Since this is the first payment adjustment implemented
under the eRx Incentive Program, we cannot determine how many requests
we will receive. However, we will make every effort to review and
process requests for significant hardship exemption categories in a
manner as to avoid the reprocessing of claims.
Comment: Several commenters supported our proposal to extend the
deadline for submitting significant hardship exemption requests for
purposes of the 2012 eRx payment adjustment to October 1, 2011. Several
commenters stated that a deadline of 5 business days after the
effective date provides insufficient time for eligible professionals to
be informed of and learn how to request a significant hardship
exemption. Therefore, these commenters suggested other deadlines that
they believe would allow for sufficient time for eligible professionals
to be informed of and request an exemption. Some commenters suggested
that eligible professionals and group practices be given at least 30 or
60 days after the effective date of the rule to submit significant
hardship requests. Some commenters asked that the deadline for
submitting a significant hardship exemption be extended to December 31,
2011. One commenter asked that the deadline for submitting requests for
significant hardship exemption categories be extended to 180 days
following publication of this final rule.
Response: We appreciate the commenters' feedback. We understand the
commenters' concerns and believe it is important to provide eligible
professionals with sufficient time to be informed of our finalized
changes to the eRx Incentive Program for CY 2011. In order to ensure
that eligible professionals are fully informed about these significant
hardship exemption categories to the 2012 eRx payment adjustment, we
are finalizing a deadline of November 1, 2011 for eligible
professionals to submit a significant hardship request under the
finalized significant hardship exemption
[[Page 54966]]
categories for the 2012 eRx payment adjustment.
Although we still believe the October 1, 2011 deadline would
provide sufficient time for eligible professionals to be informed of
and request an exemption, we are finalizing an extended deadline of
November 1, 2011 to provide eligible professionals with more time to
submit requests for a significant hardship exemption. Eligible
professionals and group practices do not need to wait until the
effective date of this final rule to submit a request for an exemption
from the 2012 eRx payment adjustment. Rather, eligible professionals
and group practices may begin submitting exemption requests immediately
following the display of this final rule. As such, we believe that
eligible professionals will have ample time to submit an exemption
request.
Comment: Some commenters asked to align the deadline for submitting
significant hardship exemption requests under the eRx Incentive Program
with the deadline for achieving meaningful use under the Medicare or
Medicaid EHR Incentive Programs.
Response: We appreciate the commenters' feedback. However, it is
not technically feasible for us to extend the deadline for submitting
significant hardship exemption category requests past November 1, 2011
in order to align it with the deadline for achieving meaningful use
under the Medicare or Medicaid EHR Incentive Programs which for payment
year 2011 does not occur until 2012. In order to avoid retroactive
payments and claims reprocessing, we must allow for sufficient time to
analyze the request and make the necessary system changes prior to
January 1, 2012.
After considering the comments received and for the reasons we
explained previously, we are finalizing a deadline of November 1, 2011,
for the submission of significant hardship exemption requests for
purposes of the 2012 eRx payment adjustment. Therefore, an individual
eligible professional must submit his or her request for a request for
a significant hardship exemption via the Web-based tool by November 1,
2011. Please note that eligible professionals who wish to request a
significant hardship exemption for one of the two significant hardship
exemption categories that were previously finalized in the CY 2011 PFS
final rule (75 FR 73564 through 73565) will not be able to do so via
claims-based submission of a G-code, as the June 30, 2011 deadline for
requesting the two established significant hardship categories in this
manner has passed. Group practices must submit a request for a
significant hardship exemption via letter that must be postmarked no
later than November 1, 2011.
We are implementing a deadline of November 1, 2011, and not later,
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 adjustment. 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 will need
to reprocess all claims for services furnished up to that point in 2012
that were paid at the reduced PFS amount.
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 will be final.
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 solicited public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
A. ICRs Related to Changes to the 2011 eRx 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 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 proposed would be
minimal and would be limited to the time and effort associated with
gathering the requested information described in section II.B.4 of this
final rule and submitting the information to CMS in the specified form
and manner. Whether the application can be submitted online or mail, we
do not anticipate it taking more than a 2 hours per eligible
professional or group practice to review the significant hardship
exemption, determine which category(ies) 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 subject to the 2012 eRx
payment adjustment unless they become a successful electronic
prescriber (that is, report the eRx measure at least 10 times during
the 6-month reporting period) or receive 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
[[Page 54967]]
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 209,000 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 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 209,000 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 x 2 hours per eligible
professional) to 418,000 hours (209,000 eligible professionals x 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 x 21,800 hours) and
$24,244,000 ($58 per hour x 418,000 hours).
Comment: Some commenters suggested that CMS' estimates regarding
how many eligible professionals will apply for a significant hardship
exemption for the 2012 eRx payment adjustment is too low.
Response: We appreciate the commenters' feedback. While our minimum
estimate are based on our participation numbers from the 2009 eRx
Incentive Program, which is the latest complete participation
information available for the eRx Incentive Program at this time, we
note that the maximum estimate was based on an analysis of 2010 claims
data to determine how many MDs, DOs, podiatrists, nurse practitioners,
and physician assistants have at least 100 denominator eligible visits
and meet the 10% threshold in a 6-month period. Thus, the maximum
estimate assumes that every eligible professional who needs to report
the eRx measure or be subject to the payment adjustment will apply for
a significant hardship exemption. Unfortunately, because we never
implemented a payment adjustment under the eRx Incentive Program
before, we cannot precisely estimate how many eligible professionals
will apply for a significant hardship exemption.
IV. Regulatory Impact Statement
This final rule includes changes to the eRx Incentive Program. The
first change we are finalizing 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 is being revised to indicate
whether an eligible professional has adopted a qualified electronic
prescribing system, which is a system that meets the four
functionalities discussed above, or Certified EHR Technology as defined
at 42 CFR 495.4 and 45 CFR 170.102. The second change we are finalizing
is the adoption of additional significant hardship exemption categories
for the 2012 eRx payment adjustment. The additional significant
hardship exemption categories we are finalizing 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 eRx measure due to
limitations of the measure's denominator. Finally, this final rule
provides an extension of the deadline for submitting requests for
exemptions from the 2012 eRx payment adjustment under the additional
significant hardship exemption categories, as well as the two
significant hardship codes established in the CY 2011 PFS final rule
with comment period: (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
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), 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 changes will 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 final 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 final 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
final rule will affect a substantial number of small entities (that is,
several thousand or more).
We interpret the requirement for preparation of an Initial
Regulatory Flexibility Analysis as applying to final 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
final rules will have a significant positive impact. In this case, the
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 additional significant hardship exemption
categories, if applicable, for purposes of the 2012 eRx payment
adjustment will
[[Page 54968]]
reduce burden for eligible professionals. The modification to the eRx
measure eliminates 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 is no 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 additional significant hardship exemption
categories for the 2012 eRx payment adjustment we are finalizing in
this final rule will reduce the number of eligible professionals that
will otherwise be subject to a 1.0 percent adjustment in the PFS amount
for covered professional services furnished in 2012. Also, the changes
we are finalizing will 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 will need to
either be a successful electronic prescriber or request a hardship
exemption to avoid the 2012 eRx 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 will potentially request
a significant hardship exemption for one of the hardship exemption
categories. While we are aware, from public comments received in
response to the CY 2011 PFS proposed rule and final rule 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 additional significant hardship exemption categories, we are not
able to quantify in detail how many eligible professionals these
additional significant hardship exemption categories could apply to
since each eligible professional's individual circumstances are unique.
We believe that any cost associated with requesting a significant
hardship exemption under these categories will be minimal since it will
be limited to the time and effort associated with submitting an
exemption request based on a finalized significant hardship exemption
category from the 2012 eRx payment adjustment either via the Web tool
or by mail. We believe that any cost associated with requesting a
significant hardship exemption will, 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 changes we are
finalizing will 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.
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 604 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
final rule will 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 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 for 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, the Centers for Medicare
& Medicaid Services amends 42 CFR part 414 as set forth below:
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
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)).
Subpart B--Physicians and Other Practitioners
0
2. Section 414.92 is amended by revising paragraph (c)(2)(ii) to read
as follows:
Sec. 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.
[[Page 54969]]
(D) Inability to electronically prescribe due to local, State or
Federal law or regulation.
(E) Limited prescribing activity.
(F) Insufficient opportunities to report the eRx measure due to
limitations 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: August 25, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
Approved: August 26, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2011-22629 Filed 8-31-11; 11:15 am]
BILLING CODE 4120-01-P