Medicare and Medicaid Program; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction, 65909-65926 [2011-27176]

Agencies

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

[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Proposed Rules]
[Pages 65909-65926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27176]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Chapter IV

[CMS-9070-P]
RIN 0938-AQ96


Medicare and Medicaid Program; Regulatory Provisions To Promote 
Program Efficiency, Transparency, and Burden Reduction

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule identifies and proposes reforms in Medicare 
and Medicaid regulations that CMS has identified as unnecessary, 
obsolete, or excessively burdensome on health care providers and 
beneficiaries. This proposed rule would increase the ability of health 
care professionals to devote resources to improving patient care, by 
eliminating or reducing requirements that impede quality patient care 
or that divert providing high quality patient care. This is one of 
several rules that we are proposing to achieve regulatory reforms under 
Executive Order 13563 on Improving Regulation and Regulatory Review and 
the Department's Plan for Retrospective Review of Existing Rules.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on December 23, 
2011.

ADDRESSES: In commenting, please refer to file code CMS-9070-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-9070-P, P.O. Box 8012, 
Baltimore, MD 21244-1850.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-9070-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-9994 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Ronisha Davis, (410) 786-6882.
    We have also included a subject matter expert and contact 
information under the ``Provisions of the Proposed Regulations'' 
section for each provision set out in this proposed rule.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

    In January 2011, the President issued Executive Order 13563, 
``Improving Regulations and Regulatory Review.'' Section 6 of that 
order requires agencies to identify rules that may be ``outmoded, 
ineffective, insufficient, or excessively burdensome, and to modify, 
streamline, expand, or repeal them in accordance with what has been 
learned.'' In accordance with the Executive Order, the Secretary of the 
Department of Health & Human Services (HHS) published on May 18, 2011, 
a Preliminary Plan for Retrospective Review of Existing Rules (https://www.whitehouse.gov/21stcenturygov/actions/21st-century-regulatory-system). As shown in the plan, the Centers for Medicare & Medicaid 
Services (CMS) has identified many obsolete and burdensome rules that 
could be eliminated or reformed to improve effectiveness or reduce 
unnecessary red tape and other costs, with a particular focus on 
freeing up resources that health care providers, health plans, and 
States could use to improve or enhance patient health and safety. CMS 
has also examined policies and practices not codified in rules that 
could be changed or streamlined to achieve better outcomes for patients 
while reducing burden on providers of care. CMS has also identified 
non-regulatory changes to increase transparency and to become a better 
business partner.
    As explained in the plan, HHS is committed to the President's 
vision of creating an environment where agencies incorporate and 
integrate the ongoing retrospective review of regulations into 
Department operations to achieve a more streamlined and effective 
regulatory framework. The objective is to improve the quality of 
existing regulations consistent with statutory requirements; streamline 
procedural solutions for businesses to enter and operate in the 
marketplace; maximize net benefits (including benefits that are 
difficult to quantify); and reduce costs and other burdens on 
businesses to comply with regulations. Consistent with the commitment 
to periodic review and to public participation, HHS will continue to 
assess its existing significant regulations in accordance with the 
requirements of Executive Order 13563.

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HHS welcomes public suggestions about appropriate reforms. If, at any 
time, members of the public identify possible reforms to streamline 
requirements and to reduce existing burdens, HHS will give those 
suggestions careful consideration. Therefore, along with this proposed 
rule, we seek ideas from the public to help identify areas for possible 
reform.

II. Provisions of the Proposed Regulations

    The following is a description of each of the proposals set forth 
in this proposed rule. We have grouped the proposals into three 
categories--(1) Removes unnecessarily burdensome requirements; (2) 
removes obsolete regulations; and (3) responds to stakeholder concerns. 
There are 14 specific reforms included in this proposed rule. As noted 
above, we seek comments on additional areas for future reforms in these 
three areas or others.

A. Removes Unnecessarily Burdensome Requirements

    The following proposals seek to provide some form of burden relief 
to providers and suppliers by modifying, removing, or streamlining 
current regulations that we have identified as excessively burdensome.
1. End-Stage Renal Disease (ESRD) Facilities (Sec.  494.60)
    Current regulations at 42 CFR part 494 provide Conditions for 
Coverage (CfCs) for Medicare-participating end-stage renal disease 
(ESRD) facilities. Effective February 9, 2009, these regulations were 
updated to include Federal Life Safety Code (LSC) provisions that we 
applied to ESRD facilities to standardize CMS regulations across 
provider types. When the new regulation was first promulgated, we 
believed that standardized application of the LSC was desirable and 
that the costs for ESRD facilities would not be excessive. However, we 
have since determined that standardization may not be appropriate given 
the non-residential and unique characteristics of ESRD facilities and 
the increased burden created by these requirements without the 
commensurate benefit. Chapters 20 and 21 of the National Fire 
Protection Agency's (NFPA) 101 LSC, 2000 Edition, were incorporated by 
reference in the ESRD regulations at Sec.  494.60(e).
    When implemented, these Federal LSC regulations were found to 
duplicate many provisions of already existing State and local fire 
safety codes covering ESRD facilities. Although the State and local 
codes protected patients from fire hazards, the NFPA 101 LSC 
retroactively imposed some additional structural requirements. We 
believe that some of these additional requirements, such as smoke 
compartments (per section 20.3.7/21.3.7 of NFPA 101) are unnecessary 
for most ESRD facilities. Smoke compartments, for example, are required 
in hospital and ambulatory surgical centers where patients are 
anesthetized, unconscious, or sleeping overnight. Smoke compartments 
are unnecessary in ESRD facilities as these compartments support a 
``defend in place'' fire strategy which assumes the occupants of a 
location cannot immediately evacuate in case of fire. However, in 
dialysis facilities, the evacuation process from fire is rapid 
disconnection from the dialysis machine and a quick exit.
    In retrospect, the additional structural requirements of NFPA 101 
potentially could improve patient safety from fire in specific dialysis 
facilities that pose a higher risk for life safety from fire by their 
proximity to a potential fire source or their barriers to prompt 
evacuation from fire. These higher risk locations are those dialysis 
facilities that are adjacent to occupancies that contain ``industrial 
high hazard contents'' and those facilities that do not have a readily 
available exit to the outside for swift, unencumbered evacuation.
    Data demonstrate that there is an extremely low risk of fire in 
outpatient dialysis facilities, and there are no recorded patient 
injuries or death due to fire in the 40 years of the Medicare ESRD 
program. The Federal Emergency Management Agency's (FEMA) Topical Fire 
Report Series (TFRS) documented the low fire risk of ESRD facilities, 
which ranked lowest (0.1 percent) in fire incidence among all health 
care facilities. (Medical Facility Fires, TFRS Volume 9, Issue 4). The 
reason that the fire risk is so low in dialysis facilities is due to 
the following combination of factors:
     ESRD facilities do not have fire ignition sources commonly 
found in other medical facilities, for example, cooking, anesthesia, 
paint shops, or piped-in gases, and are generally configured with open 
patient treatment areas providing exits directly to the outside;
     Dialysis patients are not anesthetized and are required at 
Sec.  494.60(d)(2) of the ESRD regulation to be trained in emergency 
disconnect from their dialysis treatment and evacuation from the 
building;
     Section 494.60(d)(4) of the ESRD regulation requires that 
staff be present in the patient treatment area at all times during 
treatment and therefore immediately available to assist in emergency 
evacuation.
    While the risks of fire are very low in a dialysis facility, the 
costs of complying with the Federal LSC requirements in dialysis 
facilities are high. Through research discussed in the following 
paragraph, CMS has learned that the actual costs for renovation and 
construction necessary for compliance with the additional requirements 
of NFPA 101 for dialysis facilities are considerable and profoundly 
exceed the original government estimate of $1,960 as published in the 
preamble to the new 2008 ESRD/LSC regulations.
    To estimate the true costs for renovation and construction 
necessary to comply with the requirements for NFPA 101, in June 2011, 
CMS asked ESRD providers to provide estimates of the financial impact 
of implementing four potentially-costly additional requirements of NFPA 
101. They included smoke compartment barriers, occupancy separations, 
hazardous area separations, and upgraded fire alarms. Owners of 3,756 
of 5,600 existing certified dialysis facilities responded to the CMS 
request for cost projections. The responders represented approximately 
70 percent of existing dialysis facilities, including hospital-owned 
facilities and those owned by small, medium, and large dialysis 
organizations.
    The data collected showed that approximately 50 percent (an 
estimated 2,800) of the existing ESRD facilities would require 
renovations or upgrading of at least one of the four elements to comply 
with the requirements of NFPA 101. There are several reasons why, in 
June 2011, approximately 50 percent of existing dialysis facilities had 
not been renovated to comply with the February 2009 implementation 
date. The primary reason is the pervasive inconsistency in knowledge, 
interpretation, and application of NFPA 101 to ESRD facilities that we 
have become aware of since the 2009 implementation date. There was a 
high variability in the cost estimates submitted, ranging from a low of 
$23,500 to a high of $222,000 for an existing facility which needed to 
renovate, construct and upgrade all four components. The average per 
facility cost estimates submitted for the additional structural 
requirements of NFPA 101 are as follows:
     Smoke compartments--$32,544.
     Occupancy separation--$28,139.
     Hazardous areas separation--$16,976.
    The total average cost for a facility to meet all three would be 
$77,659. We suspect that the variability of the estimates may be due to 
different State

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and local requirements already in existence, differences in contractor 
costs, varying building characteristics (for example, age, size, 
construction type), and the inconsistent interpretations and 
applications of NFPA 101 that are prevalent across the nation. The wide 
range of estimates makes it difficult to determine an average cost 
related to implementation of NFPA 101. However, using the average costs 
for the individual structural requirements listed above, if 50 percent 
or 2,800 facilities required only renovation for hazardous area 
separation, the savings would be $47.5 million. If 2,800 facilities 
required renovation for all three structural requirements, the total 
savings from the burden reduction at the average estimate for all three 
would be $217 million.
    These amounts represent a significant financial burden on 
facilities, with little or no improvement in patient safety from fire 
for a majority of them. Expenditures of this magnitude would likely 
divert resources away from areas which do affect dialysis patient 
safety, such as infection control and prevention.
    The cost estimates do not account for the added burden that 
renovation to comply with NFPA 101 would impose on dialysis patients 
who must be relocated to other ESRD facilities for their treatments 
during construction. Significant additional costs would also be 
incurred by Federal government agencies and State Survey Agencies for 
oversight activities of LSC surveys which often duplicate State LSC 
surveys.
    Based on information gained since publication of the updated ESRD 
CfC, we have concluded that the enforcement of the Federal LSC 
requirements of NFPA 101 add costs out of proportion to any added 
protection that they may afford in dialysis facilities which are not at 
higher risk of fire penetration from adjacent industrial ``high 
hazard'' occupancies and where swift, unencumbered evacuation to the 
outside is available. Therefore, we propose revising Sec.  494.60(e)(1) 
to restrict mandatory compliance with the NFPA 101 LSC to those ESRD 
facilities located adjacent to ``high hazardous'' occupancies and those 
facilities whose patient treatment areas are not located at grade level 
with direct access to the outside. This revision would retain the NFPA 
101 LSC protections for those facilities in higher-risk locations while 
relieving burden on those for whom the subdivision of building space 
and other additional LSC requirements of NFPA 101 are unnecessary.
    We intend to use the NFPA definition of ``high hazard occupancy'' 
found at A.3.3.134.8.2, Annex A, NFPA 101, Life Safety Code 2000, which 
applies to ``occupancies where gasoline and other flammable liquids are 
handled, used or stored under such conditions that involve possible 
release of flammable vapors; where grain dust, wood flour or plastic 
dusts, aluminum or magnesium dust, or other explosive dusts are 
produced; where hazardous chemicals or explosives are manufactured, 
stored, or handled; where cotton or other combustible fibers are 
processed or handled under conditions that might produce flammable 
flyings; and where other situations of similar hazard exist.''
    We note that all ESRD facilities would still be required to comply 
with State and local fire codes and safety standards under Sec.  
494.20. We also propose revising Sec.  494.60(e)(2) to clarify which 
ESRD facilities must use sprinkler-equipped buildings: those housed in 
multi-story buildings of lesser fire protected construction types 
(Types II(000), III(200), or V(000), as defined in NFPA 101), which 
were constructed after January 1, 2008; and those housed in high rise 
buildings over 75 feet in height. We note that this revision would not 
change the meaning or intent of Sec.  494.60(e)(2), but instead would 
clarify it. That provision states that dialysis facilities 
participating in Medicare as of October 14, 2008, may continue to use 
non-sprinklered buildings if such buildings were constructed before 
January 1, 2008, and State law so permits.
    The ESRD CfCs also address other topics related to fire and 
building safety that will remain in place under our proposed revision. 
These existing CfC requirements include specific rules on how to handle 
chemicals related to the dialysis process, as well as general 
requirements for appropriate training in emergency preparedness for the 
staff and patients, including provisions for instructions on 
disconnecting from the dialysis machine during an emergency and 
instructions on emergency evacuation. We welcome comments from the 
public on whether the other ESRD CfCs can be improved in a way that 
minimizes provider burden while protecting patient safety or, 
alternately, the extent to which remaining requirements are necessary 
and appropriate for the care and safety of dialysis patients. 
Similarly, we note that other CMS regulations include CfCs, and we seek 
comments on whether we should revisit these or other regulatory 
provisions or whether existing requirements are necessary and 
appropriate.
    Contact: Thomas Hamilton, 410-786-9493.
2. ASC Emergency Equipment
    Section 1832(a)(2)(F)(i) of the Act specifies that Ambulatory 
Surgical Centers (ASCs) must meet health, safety, and other 
requirements specified by the Secretary in regulation in order to 
participate in Medicare. The Secretary is responsible for ensuring that 
the Conditions for Coverage (CfCs) and their enforcement are adequate 
to protect the health and safety of all individuals treated by ASCs, 
whether they are Medicare beneficiaries or other patients.
    To implement the CfCs, we determine compliance through State survey 
agencies that conduct onsite inspections using these requirements. ASCs 
also may be deemed to meet Medicare standards if they are certified by 
one of the national accrediting organizations whose standards meet or 
exceed the CfCs. The ASC regulations were first published on August 5, 
1982 (47 FR 34082). Most of the revisions since then have been payment 
related with the exception of a final rule published on November 18, 
2008 (73 FR 68502) that revised four existing health and safety CfCs 
and created three new health and safety CfCs (42 CFR 416.41 through 
416.43 and 416.49 through 416.52).
    Sections 416.44(c)(1) through (c)(9) provide a detailed list of 
specific emergency equipment that must be available to the ASC's 
operating room, for example, emergency call system; oxygen; mechanical 
ventilator assistance equipment including airways, manual breathing 
bag, and ventilator; cardiac defibrillator; cardiac monitoring 
equipment; tracheotomy set; laryngoscopes and endotracheal tubes; 
suction equipment; and emergency medical equipment and supplies 
specified by the medical staff. In recent years, we have learned from 
the ASC community that some of this equipment is outdated, while other 
equipment is not applicable to the emergency needs of all ASCs. The 
emergency equipment CfC has not been revised since its inception in 
1982. To ensure that no ASC is burdened with maintaining unnecessary 
equipment, we are proposing to revise the requirements for this CfC.
    We propose to remove the list of emergency equipment at Sec.  
416.44(c)(1) through (c)(9) and propose at Sec.  416.44(c) to require 
that ASCs, in conjunction with their governing body and the medical 
staff, develop policies and procedures which specify the types of 
emergency equipment that would be appropriate for the facility's 
patient population, and make the items

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immediately available at the ASC to handle inter- or post-operative 
emergencies. We are also proposing that the emergency equipment 
identified by the ASC meet the current acceptable standards of practice 
in the ASC industry. We believe that these proposed changes would 
enable ASCs to better meet current demands, while also ensuring ASCs 
have the flexibility necessary to respond to emergency needs and 
incorporate the use of modern equipment most suitable for the 
procedures performed in the facility.
    We note that a potential disadvantage of the approach we propose is 
that, by allowing ASCs to identify the emergency equipment most 
appropriate for each individual facility, there could be increased 
variation in emergency preparedness between different ASCs, even among 
ASCs that provide very similar services. We therefore invite comment on 
our proposed approach and on any alternatives to our approach. An 
example of such an alternative might be for us to categorize ASCs 
according to the major services they provide (such as ASCs that 
typically use general anesthesia), and then specify a minimum array of 
equipment tailored to the various categories of risk.
    Contact: Jacqueline Morgan, 410-786-4282.
3. Revocation of Enrollment and Billing Privileges in the Medicare 
Program (Sec.  424.535)
    On June 27, 2008, we published a final rule in the Federal Register 
(73 FR 36448) entitled ``Medicare Program; Appeals of CMS or CMS 
Contractor Determinations When a Provider or Supplier Fails to Meet the 
Requirements for Medicare Billing Privileges.'' In that rule, we added 
a new provision at Sec.  424.535(c) to provide that: ``After a 
provider, supplier, delegated official, or authorizing official has had 
their billing privileges revoked, they are barred from participating in 
the Medicare program from the effective date of the revocation until 
the end of the re-enrollment bar. The re-enrollment bar is a minimum of 
1 year, but not greater than 3 years, depending on the severity of the 
basis for revocation.'' The purpose of this provision was to prevent 
providers and suppliers from being able to immediately re-enroll in 
Medicare after their billing privileges were revoked.
    Section 424.535(a)(1) and Sec.  424.535(c), respectively, provide 
that--(1) Medicare billing privileges may be revoked when a provider or 
supplier is determined not to be in compliance with our enrollment 
requirements; and (2) a post-revocation re-enrollment bar of a minimum 
of 1 year shall be imposed.
    We believe that the re-enrollment bar is unnecessary in certain 
situations. Accordingly, we propose to eliminate the re-enrollment bar 
in instances when providers and suppliers have not responded timely to 
requests for revalidation of enrollment or other requests for 
information initiated by CMS. Specifically, we propose revising Sec.  
424.535(c) to expressly provide that the re-enrollment bar would not 
apply if the revocation is based solely upon the failure of a provider 
or supplier to respond timely to a revalidation request or other 
request for information. We believe that this change is appropriate 
because the re-enrollment bar in such circumstances often results in 
unnecessarily harsh consequences for the provider or supplier and 
causes beneficiary access issues in some cases. We have learned of 
numerous instances when the provider's failure to respond to a 
revalidation request was unintentional; that is, the provider was not 
aware of the request due to, for instance, misrouted mail or a clerical 
mistake. This is different from other revocation reasons, which may be 
more serious; for example, we revoke providers that have been excluded 
from Medicare, Medicaid, or other Federal health care programs or that 
have been convicted of a felony under Sec.  424.535(a)(2) and (a)(3), 
respectively. Finally, there is another, less restrictive regulatory 
remedy available for addressing a failure to respond timely to a 
revalidation request. This remedy is discussed below in section 
II.A.4.c.
    Contact: Morgan Burns, 202-690-5145.
4. Deactivation of Medicare Billing Privileges (Sec.  424.540)
    On April 21, 2006, we published a final rule in the Federal 
Register (71 FR 20753) entitled ``Medicare Program; Requirements for 
Providers and Suppliers to Establish and Maintain Medicare 
Enrollment.'' As part of that rule, we established provisions for the 
deactivation of Medicare billing privileges at Sec.  424.540.
a. Section 424.540(a)(1)
    Section 424.540(a)(1) specifies that Medicare billing privileges 
may be deactivated if Medicare claims are not submitted for 12 
consecutive months. The purpose of this provision was to prevent 
situations in which unused, idle Medicare billing numbers could be 
accessed by individuals and entities to submit false claims. Currently, 
Medicare provider or supplier enrollment billing privileges are 
deactivated (made ineligible for Medicare billing purposes) for 
providers or suppliers that have not submitted a Medicare claim for 12 
consecutive months. If the deactivated provider does furnish services 
and attempts to submit a claim after the date of deactivation, the 
claim would be denied. Therefore, once deactivated, a new provider or 
supplier enrollment application must be submitted and processed by the 
Medicare contractor before the billing privileges can be reactivated.
    We propose to revise Sec.  424.540(a) to apply only to those 
providers and suppliers who do not submit a Form CMS-855I (the 
enrollment form for individual physicians and non-physician 
practitioners) to enroll in the Medicare program. Physicians and non-
physician practitioners are deactivated most often due to billing 
inactivity. To reactivate their Medicare billing privileges, they must 
resubmit an enrollment application.
    We are most concerned with organizations that fail to submit a 
claim within a 12-month period, since business organizations would 
generally submit a claim on a more frequent basis. Conversely, we 
believe that there are instances in which individual practitioners may 
have a valid reason for not filing claims within a 12-month period. For 
instance, the practitioner--(1) May be enrolled in Medicare, but 
generally only treats non-Medicare patients; or (2) may have two 
separately-enumerated practice locations listed on its Form CMS-855I, 
yet typically only performs services at one of them.
    Further, the 12-month deactivation and reactivation processes also 
increase the workload and administrative costs of Medicare contractors. 
Accordingly, our proposal to revise Sec.  424.540(a) would remove this 
unnecessary burden without jeopardizing our ability to detect and 
prevent fraud and abuse. We have issued guidance that requires our 
contractors to conduct certain verification activities to guard against 
physician and non-physician practitioner identity theft. We believe 
that this would lessen the danger that the unused billing numbers of 
these individuals would be accessed by others to submit false claims.
b. Section 424.540(a)(2)
    Section 424.540(a)(2) specifies that a provider or supplier's 
Medicare billing privileges may be deactivated if it fails to report a 
change to its enrollment information within 90 calendar days or, for 
changes in ownership or control, within 30 calendar days. We are not 
proposing to alter this provision. We believe it is necessary for 
providers and

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suppliers to understand the importance of furnishing updated enrollment 
information to the Medicare program, for incorrect or aged data can 
lead to improper payments.
c. Section 424.540(a)(3)
    We propose to add a new Sec.  424.540(a)(3) that would allow us to 
deactivate, rather than revoke, the Medicare billing privileges of a 
provider or supplier that fails to furnish complete and accurate 
information and all supporting documentation within 90 calendar days of 
receiving notification to submit an enrollment application and 
supporting documentation, or resubmit and certify to the accuracy of 
its enrollment information. Although the deactivated provider or 
supplier would still have to submit a complete enrollment application 
to reactivate its billing privileges, it would remain enrolled in 
Medicare and would not be subject to other, ancillary consequences that 
a revocation entails: for instance, a prior revocation must be reported 
in section 3 of the Form CMS-855I application, whereas a prior 
deactivation need not. In fact, it is for this reason that we believe 
our proposal would reduce the burden on the provider and supplier 
communities.
    Contact: Morgan Burns, 202-690-5145.
5. Duration of Agreement for Intermediate Care Facilities for the 
Intellectually Disabled (Referred to in Current Regulations as 
Intermediate Care Facilities for the Mentally Retarded) (Sec.  442.15 
Through Sec.  442.109)
    As described elsewhere in this preamble, we are replacing the use 
of the term ``mentally retarded'' with the term ``intellectually 
disabled'' as described in this program, so we have used the new term 
in these proposed provisions.
    Section 1910 of the Act provides for the certification and approval 
of Intermediate Care Facilities for the Intellectually Disabled (ICFs/
ID). Current regulations at Sec.  442.109 and Sec.  442.110 address 
ICFs/ID provider agreements and limit the ICFs/ID provider agreements 
under Medicaid to annual time limits. We propose to remove the time 
limited agreements for ICFs/ID at Sec.  442.16. We also are proposing 
to eliminate this requirement at Sec.  442.15, Sec.  442.109, and Sec.  
442.110. We propose to replace the requirement with an open ended 
agreement which, consistent with nursing facilities (NFs), would remain 
in effect until the Secretary or a State determines that the ICF/ID no 
longer meets the conditions of participation for ICFs/ID at subpart I 
part 483.
    Also, we are proposing to add a requirement that a certified ICF/ID 
must be surveyed on average every 12 months with a maximum 15-month 
survey interval. Current regulations at 42 CFR part 442 require that 
ICFs/ID be surveyed for compliance with conditions of participation at 
least every 12 months on a relatively fixed schedule. By contrast, 
nursing homes must be surveyed for compliance with certification 
standards at intervals of between 12 and 15 months. We anticipate the 
proposed change in the certification period would have positive impacts 
on the care provided in these facilities as well as the efficient and 
effective operation of State survey agencies responsible for regulating 
ICFs/ID. We also anticipate that the adoption of flexible survey 
scheduling would encourage more consistent staffing at levels that 
support certification standards.
    In addition, State survey agency resources are strained by the 
rigid timelines imposed in the current regulation. For example, if a 
complaint results in an abbreviated survey 10 or 11 months into the 
facility's certification period, the current regulation does not allow 
the State agency to expand the complaint survey for the purpose of 
completing the requirements of annual certification at the same time. 
Instead, the State is required to conduct another full survey at 12 
months, which is duplicative. More flexibility would allow States to 
use their survey staff in a targeted fashion, allocating resources 
where needed to assure resident safety and quality of care, rather than 
being forced to meet rigid regulatory timelines that do not bear a 
relationship to the needs of residents.
    Contact: Thomas Hamilton, 410-786-9493.

B. Removes Obsolete or Duplicative Regulations or Provides Clarifying 
Information

    The following proposals seek to remove requirements in the Code of 
Federal Regulations (CFR) that are no longer needed or enforced. We 
have identified regulations that have become obsolete and need to be 
updated.
1. OMB Control Numbers for Approved Collections of Information (Sec.  
400.300 and Sec.  400.310)
    Part 400 subpart C requires the collection and display of control 
numbers assigned by the Office of Management and Budget (OMB) to 
collections of information contained in CMS regulations. The chart at 
Sec.  400.310 that displays the OMB control numbers has not been 
updated since December 8, 1995. We believe that, it is no longer 
necessary to maintain the chart, because an inventory of currently 
approved CMS information collections, including OMB control numbers, is 
displayed on a public Web site at https://www.reginfo.gov/public/do/PRAMain. The Web site provides more timely access to the OMB control 
numbers for CMS information collection requests than the process of 
publishing updates in the CFR. Also, as part of our quarterly notice of 
CMS issuances, which is published each quarter in the Federal Register, 
we will remind reviewers where they can find the most current list of 
information collections and OMB control numbers. For these reasons, we 
are proposing to remove and reserve subpart C since the content of the 
information contained in this subpart is obsolete and more readily 
available on the public Web site.
    Contact: Ronisha Davis, 410-786-6882.
2. Removal of Obsolete Provisions Related to Initial Determinations, 
Appeals, and Reopenings of Part A and Part B Claims and Entitlement 
Determinations (Sec.  405.701 Through Sec.  405.877)
    In this rule, we propose to remove the obsolete provisions 
contained in 42 CFR part 405 subparts G and H governing initial 
determinations, appeals, and reopenings of Part A and Part B claims, 
and determinations and appeals regarding an individual's entitlement to 
benefits under Part A and Part B of Medicare. Section 1869 of the Act 
and 42 CFR part 405 subpart I set forth the current policies for such 
determinations, appeals, and reopenings.
    On November 15, 2002, we published a comprehensive proposed rule in 
the Federal Register (67 FR 69312), entitled ``Changes to the Medicare 
Claims Appeal Procedures,'' to implement the relevant claims and 
appeals provisions contained in the Medicare, Medicaid, and SCHIP 
Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-
554). In this proposed rule, we established, in one location (part 405 
subpart I), provisions governing all aspects of Part A and Part B 
claims appeals. In 2003, the Medicare Prescription Drug, Improvement, 
and Modernization Act of 2003 (MMA) (Pub. L. 108-173) made further 
changes to the Medicare claims appeals process. On March 8, 2005, we 
published an interim final rule with comment period in the Federal 
Register (70 FR 11420) to implement provisions of the proposed

[[Page 65914]]

rule, and to explain how the recently enacted MMA provisions would be 
implemented. On December 9, 2009, we published a final rule in the 
Federal Register (74 FR 65296) entitled, ``Changes to the Medicare 
Claims Appeal Procedures,'' responding to comments received on the 
interim final rule implementing part 405 subpart I.
    Part 405 subparts G and H contain the policies for initial 
determinations, appeals, and reopenings of Medicare Part A and Part B 
claims, before the effective date of BIPA (referred to as ``pre-BIPA 
appeals''). In addition, part 405 subparts G and H contain provisions 
regarding initial determinations and appeals with respect to an 
individual's entitlement to Medicare Parts A and B. Under subparts G 
and H, initial determinations and appeals with respect to an 
individual's entitlement to Medicare Parts A and B were conducted by 
the Social Security Administration (SSA) and governed by the provisions 
set forth in 20 CFR part 404 subpart J. Under part 405 subpart I, we 
explain that the SSA makes initial determinations regarding an 
individual's entitlement to Medicare Parts A and B, and conducts 
reconsiderations of those initial determinations, in accordance with 20 
CFR part 404, subpart J (see 42 CFR 405.904). However, entitlement 
appeals beyond the reconsideration level (that is, to an Administrative 
Law Judge, the Medicare Appeals Council, or Federal District Court) are 
governed by the appeals procedures set forth in part 405 subpart I.
    The provisions in part 405 subpart I were intended to replace the 
provisions in part 405 subparts G and H once all pre-BIPA appeals were 
completed. However, we determined it was necessary to establish a 
phased-in implementation approach for part 405 subpart I appeals, and 
to maintain the existing provisions in subparts G and H until the 
completion of all pre-BIPA appeals (see, 74 FR 11424). With the 
publication of the December 9, 2009 final rule, some pre-BIPA appeals 
had not been completed. Thus, we were unable to remove the appeals 
provisions in subparts G and H at that time.
    In this rule, we propose to remove the obsolete provisions since it 
is our expectation that in the 6 years since publication of the March 
8, 2005 interim final rule, any party with a pending pre-BIPA appeal 
would have received an appeal decision or would have brought the 
pending matter to our attention. We believe that removing these 
regulations would eliminate any possible confusion among Medicare 
beneficiaries, providers, suppliers, and their representatives with 
respect to the applicable appeal rights and procedures. However, while 
we believe that all pre-BIPA appeals have been processed, we cannot be 
completely certain that no pending pre-BIPA appeals currently exist. In 
order to ensure that parties receive due process for their claim 
disputes, we propose that any newly identified pre-BIPA appeals be 
handled under the current appeals provisions set forth in part 405 
subpart I. (We note that all reopening actions, regardless of whether 
the determination or decision was made under the pre-BIPA process, 
initial determinations on claims, and, as explained above, initial 
determinations and appeals with respect to Medicare entitlement, are 
currently processed under the applicable procedures in part 405 subpart 
I.) We believe that maintaining a separate pre-BIPA claim appeals 
process in the unlikely event such an appeal is discovered is 
inefficient and impracticable. Using the current appeals process under 
subpart I, for all appeal requests filed on or after the effective date 
of this rule, as finalized, would reduce potential confusion about 
applicable appeal procedures, and would enable parties to take 
advantage of the reduced decision-making timeframes and other process 
improvements offered throughout part 405 subpart I (for example, panel 
reviews during the Qualified Independent Contractor (QIC) 
reconsideration process for claims denied as not medically reasonable 
and necessary (see Sec.  405.968(c)), and the right to escalate cases 
to the next level of appeal when the QIC, Administrative Law Judge 
(ALJ) or Medicare Appeals Council does not issue a decision within the 
applicable adjudication timeframe (see Sec.  405.970, Sec.  405.1104, 
and Sec.  405.1132).
    Table 1 below illustrates how we propose to process any pre-BIPA 
Part A appeals identified after the effective date of this rule, as 
finalized, under our current regulations at part 405 subpart I. If a 
party demonstrates that they had requested reconsideration under part 
405 subpart G, but did not receive a decision or dismissal, the party 
would be entitled to request a redetermination, followed by a QIC 
reconsideration, ALJ hearing, Medicare Appeals Council review, and 
judicial review in accordance with the provisions in part 405 subpart 
I. If a party demonstrates that they received a reconsideration 
decision and requested an ALJ hearing under part 405 subpart G but did 
not receive an ALJ hearing decision or dismissal, the party would be 
entitled to request a QIC reconsideration, followed by an ALJ hearing, 
Medicare Appeals Council review, and judicial review in accordance with 
the provisions in part 405 subpart I. If a party demonstrates that they 
received an ALJ hearing decision under subpart G, and requested but did 
not receive a decision, dismissal or denial of review notice from the 
Departmental Appeals Board, the party would be entitled to request 
Medicare Appeals Council review under part 405 subpart I.

                    Table 1--Pre-BIPA Part A Appeals
------------------------------------------------------------------------
                                                Appeal resumes at the
 Pending Pre-BIPA level of appeal in part    following level in part 405
               405 subpart G                          subpart I
------------------------------------------------------------------------
Reconsideration (Sec.   405.710)..........  Redetermination (Sec.
                                             405.940).
ALJ Hearing (Sec.   405.720)..............  QIC Reconsideration (Sec.
                                             405.960).
Departmental Appeals Board Review (Sec.     Medicare Appeals Council
 405.724).                                   Review (Sec.   405.1100).
------------------------------------------------------------------------

    Table 2 below illustrates how we propose to process any pre-BIPA 
Part B appeals identified after the effective date of this rule, as 
finalized, under our current regulations at part 405 subpart I. If a 
party demonstrates that they requested a carrier review of an initial 
determination under subpart H, but did not receive a carrier review 
determination or dismissal, the party would be entitled to request a 
redetermination, followed by QIC reconsideration, ALJ hearing, Medicare 
Appeals Council review and judicial review in accordance with the 
provisions in part 405 subpart I. If a party demonstrates that they 
received a carrier review determination and requested a carrier hearing 
but did not receive a carrier hearing officer decision or dismissal 
under subpart H, the party would be entitled to request a QIC 
reconsideration followed by an ALJ hearing, Medicare Appeals Council 
review and judicial review in accordance with the provisions in part 
405 subpart I. If a party demonstrates that they received a carrier 
hearing officer decision, and requested but did not receive an ALJ 
hearing decision or dismissal under subpart H, the party would be 
directed to request a QIC reconsideration, followed by an ALJ hearing, 
Medicare Appeals Council review and judicial review in accordance with 
the provisions in part 405 subpart I. Finally, if a party demonstrates 
that they received an ALJ hearing decision under subpart H, and 
requested but did not receive a decision, dismissal or denial of review 
notice from the Departmental Appeals Board under subpart H, the party 
would be

[[Page 65915]]

entitled to request Medicare Appeals Council review under part 405 
subpart I.
    We are proposing that parties seek a QIC reconsideration before 
requesting and receiving a hearing before an ALJ under subpart I for 
several reasons. First, we note that several subpart I procedural 
requirements at the ALJ level of appeal are predicated on a QIC 
conducting a reconsideration. For example, the right to request an ALJ 
hearing under Sec.  405.1000 and Sec.  405.1002 is premised on a party 
being dissatisfied with a QIC reconsideration decision. In addition, 
under Sec.  405.966(a)(2) and Sec.  405.1028, absent a showing of good 
cause, evidence not submitted before the issuance of the QIC 
reconsideration by a provider, supplier, or beneficiary represented by 
a provider or supplier would be excluded from consideration by the ALJ. 
Thus, channeling appeals through the QIC reconsideration level would 
ensure that parties are afforded an opportunity to submit relevant 
evidence without having to demonstrate good cause for not submitting it 
during the pre-BIPA process. Second, we believe channeling pre-BIPA 
appeals through the QIC reconsideration process would benefit parties. 
For example, we believe parties would benefit from the panel review by 
physicians and other appropriate health care professionals at the QIC 
level when claims are denied as not medically reasonable and necessary 
under section 1862(a)(1)(A) of the Act. We also believe the 
administrative record would be more fully developed with respect to the 
medical and scientific evidence considered by such panels. Third, in 
order for a party to seek expedited access to judicial review under 
Sec.  405.990, the party must first have received a QIC 
reconsideration, or the appeal must have been escalated from the QIC to 
the ALJ level (see, Sec.  405.990(b)). To ensure a party may seek 
expedited access to judicial review, if such review is appropriate, we 
are proposing to channel pre-BIPA appeals through the QIC 
reconsideration process when the party has not received an ALJ 
decision. Finally, as noted above, we believe that having one set of 
rules apply to all appeals would eliminate the confusion and 
uncertainty regarding the appropriate procedures to follow should there 
be any existing pre-BIPA appeals.

                    Table 2--Pre-BIPA Part B Appeals
------------------------------------------------------------------------
                                                Appeal resumes at the
 Pending pre-BIPA level of appeal in part    following level in part 405
               405 subpart H                          subpart I
------------------------------------------------------------------------
Review of Initial Determination (Sec.       Redetermination (Sec.
 405.807).                                   405.940).
Carrier Hearing (Sec.   405.821)..........  QIC Reconsideration (Sec.
                                             405.960).
ALJ Hearing (Sec.   405.855)..............  QIC Reconsideration (Sec.
                                             405.960).
Departmental Appeals Board Review (Sec.     Medicare Appeals Council
 405.856).                                   Review (Sec.   405.1100).
------------------------------------------------------------------------

    With very limited exceptions as noted below, the provisions in 
subparts G and H related to the processing of initial determinations, 
reopenings, and appeals of claims under Part A and Part B of Medicare, 
and determinations and appeals regarding an individual's entitlement to 
benefits under Part A and Part B of Medicare are obsolete because of 
the new procedures set forth in subpart I. We propose to remove all 
such obsolete provisions. The provisions in subparts G and H identified 
below are either unrelated to claims or entitlement appeals and are 
still in effect, or were inadvertently not included in subpart I, and 
accordingly, would be retained and redesignated to subpart I.
    We propose to retain Sec.  405.706, ``Decisions of utilization 
review committees,'' and redesignate the section as Sec.  405.925 in 
subpart I. This regulatory provision explains that--(1) The decisions 
made by the utilization review committees are not initial 
determinations made by the Secretary within the meaning of section 1869 
of the Act; (2) are not subject to the appeal; and (3) further explains 
how utilization review committee decisions may be used in payment and 
coverage decisions. In drafting the regulations under part 405 subpart 
I, we inadvertently omitted this section. For clarity, and to ensure 
that beneficiaries and providers understand that utilization review 
committee decisions are not appealable, and in furtherance of our goal 
to include all relevant claims appeals procedures in one place, we are 
proposing to retain Sec.  405.706, and redesignate it as Sec.  405.925.
    In addition, we propose to retain Sec.  405.874, ``Appeals of CMS 
or a CMS contractor,'' and redesignate the provisions as Sec.  405.800, 
Sec.  405.803, Sec.  405.806, Sec.  405.809, Sec.  405.812, Sec.  
405.815, and Sec.  405.818. These provisions set forth, among other 
things, the procedures related to denials of provider or supplier 
enrollment applications, revocations of Medicare provider or supplier 
billing privileges, and the appeal rights afforded to the parties to 
those determinations. As these procedures do not relate directly to 
initial determinations and appeals of Medicare claims, they were not 
included in part 405 subpart I. However, these provisions are not 
obsolete and are still applicable to provider and supplier enrollment 
actions. We also note that we are making minor technical edits to the 
current text to refine the section.
    Finally, we also propose to remove Sec.  405.753 and Sec.  405.877 
(``Appeal of a categorization of a device.''). These regulations are 
obsolete because they no longer comport with the definition of 
``national coverage determination'' in section 1869(f) of the Act, as 
amended by section 522 of BIPA. The Food and Drug Administration's 
(FDA) categorization of a product as a category A device is not a 
determination of whether or not the item is covered under title XVIII 
of the Act. Under Sec.  405.203(c), we use the FDA categorization in 
making a coverage decision. Thus, our decision (acting on the FDA's 
categorization) to deny a claim for a category A device is an initial 
determination that is subject to review through the claims appeals 
process.
    Contact: Flosetta Rowry, 410-786-8492.
3. ASC Infection Control Program (Sec.  416.44)
    In existing regulations at 42 CFR 416.51, we require all ASCs to 
adhere to regulations regarding Infection Control, which include the 
requirement that all ASCs develop an infection control program. The 
regulations also describe how ASCs must set up their infection control 
program, such as the requirement that the ASC designate a qualified 
professional who has training in infection control and the ASC's 
obligation to establish a plan of action regarding preventing, 
identifying, and managing infections and communicable diseases.
    Current regulations also contain a provision for infection control 
that is located within the physical environment standard in 42 CFR 
416.44(a)(3). The requirement states that an ASC must establish a 
program for identifying and preventing infections, maintaining a 
sanitary environment, and reporting the results to the appropriate 
authorities. This regulatory requirement was part of the original CfCs 
first published for ASCs in 1982. Publication of the November, 2008 ASC 
final rule elevated the infection control requirements from a standard 
level under the Environment condition to a

[[Page 65916]]

separate condition level requirement, thus making the regulatory 
requirement in the Environment CfC duplicative. The Infection Control 
CfC located at Sec.  416.51 expands and broadens the infection control 
requirements that were part of the original ASC requirements in the 
Environment CfC. Therefore, we propose to remove the requirement at 
Sec.  416.44(a)(3), located in the Environment CfC, as it is 
unnecessary and obsolete. We believe this change would alleviate any 
duplicative efforts and confusion regarding the infection control 
requirements.
    Contact: Jacqueline Morgan, 410-786-4282.
4. E-Prescribing (Sec.  423.160)
    The MMA amended title XVIII of the Act to establish a voluntary 
prescription drug benefit program. Under those provisions, prescription 
Drug Plan (PDP) sponsors and Medicare Advantage (MA) organizations 
offering Medicare Advantage-Prescription Drug Plans (MA-PD) are 
required to establish electronic prescription drug programs to provide 
for electronic transmittal of certain information to the prescribing 
provider and dispensing pharmacy and pharmacist. This includes 
information about eligibility, benefits (including drugs included in 
the applicable formulary, any tiered formulary structure and any 
requirements for prior authorization), the drug being prescribed or 
dispensed and other drugs listed in the medication history, as well as 
the availability of lower cost, therapeutically appropriate 
alternatives (if any) for the drug prescribed. The MMA directed the 
Secretary to promulgate uniform standards for the electronic 
transmission of this data.
    In the November 7, 2005, final rule (70 FR 67568), entitled 
``Medicare Program; E-Prescribing and the Prescription Drug Program,'' 
CMS adopted three e-prescribing foundation standards to be used for e-
prescribing for the Medicare Part D program. The three foundation 
standards are--(1) The National Council for Prescription Drug Programs 
(NCPDP) SCRIPT version 5.0., which provides for communications between 
the prescriber and dispenser; (2) the NCPDP Telecommunication Standard 
Version 5 release 1 (NCPDP Telecom 5.1) and equivalent NCPDP Batch 
Standard Batch Implementation Guide version 1.1 which is the 
transaction between the dispenser and the Plan, and the ASC X12N 270/
271 Health Care Eligibility Benefit Inquiry and Response, Version 4010; 
and (3) the Addenda to Health Care Eligibility Inquiry and Response, 
Version 4010A1 (4010/4010A) for conducting eligibility and benefit 
inquiries between the prescriber and Plan Sponsor. The latter two 
transactions, NCPDP Telecom 5.1 and the 4010/4010A are also adopted as 
HIPAA transaction standards.
    In the November 7, 2005 final rule, we discussed the means for 
updating the Part D e-prescribing standards. In instances in which an 
e-prescribing standard has also been adopted as a HIPAA transaction 
standard in 45 CFR part 162, the process for updating the e-prescribing 
standard would have to be coordinated with the maintenance and 
modification of the applicable HIPAA transaction standard. In the 
January 16, 2009 final rule, entitled ``Health Insurance Reform; 
Modifications to the Health Insurance Portability and Accountability 
Act (HIPAA) Electronic Transaction Standards'' (74 FR 3296), we revised 
Sec.  162.1102, Sec.  162.1202, Sec.  162.1302, Sec.  162.1402, Sec.  
162.1502, Sec.  162.1602, Sec.  162.1702, and Sec.  162.1802 to adopt 
the ASC X12 Technical Reports Type 3, Version 005010 (Version 5010), as 
a replacement of the current X12 Version 4010 and 4010A1 standards 
(Version 4010/4010A). Covered entities conducting HIPAA standards are 
required to use Version 5010 by January 1, 2012. The complete 
discussion of these standards may be found in the January 16, 2009 
final rule (74 FR 3296).
    In the same final rule, effective January 1, 2012, we revised Sec.  
162.1102, Sec.  162.1202, Sec.  162.1302, and Sec.  162.1802 by adding 
a new paragraph (c) to each of these sections to adopt the NCPDP 
Telecommunication Standard Implementation Guide, Version D, Release 0 
and equivalent NCPDP Batch Standard Implementation Guide, Version 1, 
Release 2 (collectively, Version D.0) in place of the NCPDP 
Telecommunication Standard Implementation Guide, Version 5, Release 1 
and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 
1, Release 1 (collectively, Version 5.1), for the following retail 
pharmacy drug transactions: health care claims or equivalent encounter 
information; eligibility for a health plan; referral certification and 
authorization; and coordination of benefits.
    Therefore, for consistency with the current HIPAA transaction 
standards, and the need for covered entities (prescribers and 
dispensers) to comply with HIPPA, we propose to revise Sec.  
423.160(b)(3), to--(1) Update Version 4010/4010A with Version 5010; (2) 
adopt the NCPDP Telecommunication Standard Implementation Guide, 
Version D, Release 0 (Version D.0) and equivalent NCPDP Batch Standard 
Implementation Guide, Version 1, Release 2 (Version 1.2); and (3) 
retire NCPDP Telecommunication Standard Implementation Guide, Version 
5, Release 1 (Version 5.1) and equivalent NCPDP Batch Standard 
Implementation Guide, Version 1, Release 1 (Version 1.1), for 
transmitting eligibility inquiries and responses between dispensers and 
Part D sponsors with an effective date of January 1, 2012.
    Contact: Andrew Morgan, 410-786-2543.
5. Physical and Occupational Therapist Qualifications (Sec.  440.110)
    Current regulations detail provider qualifications for a `qualified 
physical therapist' under Medicaid at 42 CFR 440.110(a)(2). Section 
440.110(b)(2) details the provider qualifications for a `qualified 
occupational therapist' under Medicaid. These current regulations 
contain outdated terminology referencing several professional 
organizations. Also some of the current qualification requirements do 
not address individuals who have been trained outside of the United 
States, or refer to outdated requirements, which could unintentionally 
exclude otherwise qualified therapists resulting in diminished access 
to care for Medicaid beneficiaries.
    Medicare regulations at Sec.  484.4 were updated through a November 
27, 2007 final rule (72 FR 66406), effective January 1, 2008. While 
these personnel qualifications are detailed under home health services, 
we indicated in the preamble to the November 27, 2007 final rule, that 
therapy services must be provided according to the same standards and 
policies in all settings, to the extent possible and consistent with 
statute, and revised multiple regulations to cross-reference the 
personnel qualifications for therapists in Sec.  484.4 to the personnel 
requirements in many other sections.
    We are proposing at Sec.  440.110 to remove the outdated personnel 
qualifications language in the current Medicaid regulations and instead 
cross reference the updated Medicare personnel qualifications for 
physical therapists and occupational therapists under Sec.  484.4. This 
proposal has the potential to broaden the scope of providers that may 
be able to provide PT and OT services, by streamlining the 
qualifications so that certain providers are not excluded from 
providing services under Medicaid. In addition, it strengthens the 
consistency of standards across Medicare and Medicaid.
    Contact: Adrienne Delozier, 410-786-0278.

[[Page 65917]]

6. Definition of Donor Document (Sec.  486.302)
    Section 486.302 includes the following definition: ``Donor document 
is any documented indication of an individual's choice in regard to 
donation that meets the requirements of the governing State law.'' In 
recent years, the concept of the donor document and the opportunities 
for individuals to express their wishes concerning organ and/or tissue 
donation have changed. An individual can indicate his or her wishes not 
only on a driver's license through a State's Department of Motor 
Vehicles, but also on various registries or even in separate documents. 
Therefore, we believe that our definition in Sec.  486.302 should be 
updated. Moreover, the focus on patient rights has increased over the 
last several years. For example, we published a final rule on November 
19, 2010 entitled, ``Changes to the Hospital and Critical Access 
Hospital Conditions of Participation to Ensure Visitation Rights for 
All Patients'' (CMS-3228-F). In light of this increased focus, we 
believe that the current definition, does not fully allow for the 
various ways individuals can express their choices in the donor 
process. In addition, we believe it is important to emphasize that the 
decision to donate organs and/or tissue before death is the decision of 
the individual.
    We propose replacing the current definition of ``donor document'' 
in Sec.  486.302 with the following definition, ``[D]onor document 
means any documented indication of an individual's choice that was 
executed by the patient, in accordance with any applicable State law, 
before his or her death, and that states his or her wishes regarding 
organ and/or tissue donation.'' This new definition modifies the 
current definition in two ways. First, while the current definition 
refers to ``an individual's choice'' it does not recognize the right of 
the individual to identify their wishes more specifically. Donor 
documents may simply allow for the choice of whether or not to be an 
organ and/or tissue donor, however, some individuals may choose to use 
documents that allow them to express their wishes in more detail. For 
example, some people may choose to be an organ donor, but not a tissue 
donor. Others may not want to consent to the donation of specific 
organs. Therefore, we believe our proposed definition should cover 
documents or other ways for individuals to express their wishes more 
specifically, and we have modified the definition accordingly.
    Second, we also believe that it is important to include the 
requirement that the donor document be ``executed by the patient.'' 
While this may appear self-evident, we want to emphasize that the 
decision by a living person to donate organs and/or tissue after his or 
her death is always a voluntary decision. Therefore, we have modified 
the definition to account for this.
    These changes to the definition of the donor document only affect 
the documentation of an individual's wishes concerning organ and/or 
tissue donation while they are alive and can legally make those 
decisions. In the absence of a valid donor document, the donation 
decisions would rest with the individual who is legally responsible for 
making these decisions, usually the person's next of kin.
    Contact: Jacqueline Morgan, 410-786-4282.
7. Administration and Governing Body (Sec.  486.324)
    On May 31, 2006, we published a final rule in the Federal Register 
(71 FR 30982) entitled, ``Conditions for Coverage for Organ Procurement 
Organizations (OPOs).'' The final rule established several 
requirements, for OPOs at Sec.  486.324, including a number of 
requirements related to the administration and governing body of an 
OPO. Due to an error in publishing the final rule, paragraph (e) was 
inadvertently inserted twice (71 FR 31052).
    We are proposing to remove the duplicate paragraph (e), which 
appears immediately after Sec.  486.324(d). It does not alter or change 
the legal requirement, nor does it create a change in information 
collection requirements or other regulatory burden.
    Contact: Jacqueline Morgan, 410-786-4282.
8. Requirement for Enrolling in the Medicare Program (Sec.  424.510)
    We have identified an incorrect reference in Sec.  424.510(a), due 
to a typographic error. We are proposing to replace the incorrect 
reference to paragraph (c) (the effective date for reimbursement for 
providers and suppliers seeking accreditation from a CMS-ap