[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Notices]
[Pages 32659-32661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12950]
[[Page 32659]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-367, CMS-10279, CMS-10483, CMS-301, CMS-317,
CMS-319, CMS-10178 and CMS-10307]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: The
necessity and utility of the proposed information collection for the
proper performance of the agency's functions; the accuracy of the
estimated burden; ways to enhance the quality, utility, and clarity of
the information to be collected; and the use of automated collection
techniques or other forms of information technology to minimize the
information collection burden.
1. Type of Information Collection Request: Extension without change
of a currently approved collection. Title of Information Collection:
Medicaid Drug Program Monthly and Quarterly Drug Reporting Format; Use:
Labelers transmit drug data to CMS within 30 days after the end of each
calendar month and quarter. We calculate the unit rebate amount (URA)
for each National Drug Code and distribute to all state Medicaid
agencies. States use the URA to invoice the labeler for rebates. The
monthly data is used to calculate Federal Upper Limit prices for
applicable drugs and for states that opt to use this data to establish
their pharmacy reimbursement methodology. Form Number: CMS-367 (OCN:
0938-0578); Frequency: Monthly and quarterly; Affected Public: Private
sector (business or other for-profits); Number of Respondents: 590;
Total Annual Responses: 9,440; Total Annual Hours: 139,712. (For policy
questions regarding this collection contact Cindy Bergin at 410-786-
1176. For all other issues call 410-786-1326.)
2. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Ambulatory Surgical Center Conditions for Coverage; Use:
The Ambulatory Surgical Center (ASC) Conditions for Coverage (CfCs)
focus on a patient-centered, outcome-oriented, and transparent
processes that promote quality patient care. The CfCs are designed to
ensure that each facility has properly trained staff to provide the
appropriate type and level of care for that facility and provide a safe
physical environment for patients. The CfCs are used by federal or
state surveyors as a basis for determining whether an ASC qualifies for
approval or re-approval under Medicare. We, along with the healthcare
industry, believe that the availability to the facility of the type of
records and general content of records, which this regulation
specifies, is standard medical practice and is necessary in order to
ensure the well-being and safety of patients and professional treatment
accountability. Form Number: CMS-10279 (OCN: 0938-1071); Frequency:
Annual; Affected Public: Business or other for-profit, Not-for-profit
institutions; Number of Respondents: 5,300; Total Annual Responses:
5,300; Total Annual Hours: 206,700. (For policy questions regarding
this collection contact Jacqueline Leach at 410-786-4282. For all other
issues call 410-786-1326.)
3. Type of Information Collection Request: New Collection (Request
for a new control number); Title of Information Collection: Evaluation
of the Multi-Payer Advanced Primary Care Practice (MAPCP)
Demonstration: Conduct Beneficiary Experience with Care Surveys; Use:
On September 16, 2009, the Department of Health and Human Services
announced the establishment of the Multi-payer Advanced Primary Care
Practice (MAPCP) Demonstration, under which Medicare joined Medicaid
and private insurers as a payer participant in state-sponsored patient-
centered medical home (PCMH) initiatives. We selected eight states to
participate in this demonstration: Maine, Vermont, Rhode Island, New
York, Pennsylvania, North Carolina, Michigan, and Minnesota.
We are conducting a survey to assess the care experiences of
beneficiaries involved in the MAPCP Demonstration. We have chosen to
measure patient experience using a validated, standardized survey
questionnaire, the PCMH version of the Consumer Assessment of
Healthcare Providers and Systems (PCMH-CAHPS). The PCMH-CAHPS is a
validated, federally developed instrument that measures patient
experience in 6 domains (access to care, provider communication, office
staff interactions, attention to medical/emotional health, health care
support, and medication decisions). Form Number: CMS-10483 (OCN: 0938-
NEW); Frequency: Annually; Affected Public: Individuals and households;
Number of Respondents: 10,038; Total Annual Responses: 10,038; Total
Annual Hours: 3,313. (For policy questions regarding this collection
contact Suzanne Goodwin at 410-786-0226. For all other issues call 410-
786-1326.)
4. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection:
Certification of Medicaid Eligibility Quality Control (MEQC) Payment
Error Rates; Use: We conduct these to determine whether or not the
sampled cases meet applicable state Title XIX or XXI eligibility
requirements when applicable. The reviews are also used to assess
beneficiary liability, if any, and to determine the amounts paid to
provide Medicaid services for these cases. In the Medicaid Eligibility
Quality Control (MEQC) system, sampling is the only practical method of
validating eligibility of the total caseload and determining the dollar
value of eligibility liability errors. Any attempt to make such
validations and determinations by reviewing every case would be an
enormous and unwieldy undertaking. During each 6-month review period
states are required to collect data on eligibility payment error
dollars and paid claims dollars for each case in the sample. States
must also identify cases for which a review cannot be conducted. At the
conclusion of the 6-month review period, states must complete the
Payment Error Rate form which contains aggregate data on sample size,
number of sampled cases dropped, and number of sampled cases listed in
error. These data, along with the calculated eligibility payment error
rate and lower limit are certified by the State Medicaid Director (or
designee) and submitted to the Regional Office. The collection of
information is also necessary to implement provisions from the
Children's Health Insurance Program Reauthorization Act of 2009
(CHIPRA) (Pub. L. 111-3) with regard to the MEQC and Payment Error Rate
Measurement (PERM) programs. Form Number: CMS-301 (OCN: 0938-0246);
Frequency: Semi-Annually; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 51; Total Annual Responses: 102;
Total Annual Hours: 16,446. (For policy questions regarding this
collection contact Monetha Dockery at 410-786-0155. For all other
issues call 410-786-1326.)
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5. Type of Information Collection Request: Reinstatement of
previously approved collection; Title of Information Collection: State
Medicaid Eligibility Quality Control (MEQC) Sample Plans; Use: The
Medicaid Eligibility Quality Control (MEQC) system is based on monthly
state reviews of Medicaid and Medicaid expansion under Title XXI cases
by states performing the traditional sampling process identified
through statistically reliable statewide samples of cases selected from
the eligibility files. These reviews are conducted to determine whether
or not the sampled cases meet applicable state Title XIX or XXI
eligibility requirements when applicable. The reviews are also used to
assess beneficiary liability, if any, and to determine the amounts paid
to provide Medicaid services for these cases. In the MEQC system,
sampling is the only practical method of validating eligibility of the
total caseload and determining the dollar value of eligibility
liability errors. Any attempt to make such validations and
determinations by reviewing every case would be an enormous and
unwieldy undertaking. In 1993, CMS implemented MEQC pilots in which
states could focus on special studies, targeted populations, geographic
areas or other forms of oversight with CMS approval. States must submit
a sampling plan, or pilot proposal to be approved by CMS before
implementing their pilot program. The Children's Health Insurance
Program Reauthorization Act (CHIPRA) was enacted February 4, 2009.
Sections 203 and 601 of the CHIPRA relate to MEQC. Section 203 of the
CHIPRA establishes an error rate measurement with respect to the
enrollment of children under the express lane eligibility option. The
law directs states not to include children enrolled using the express
lane eligibility option in data or samples used for purposes of
complying with the MEQC requirements. Section 601 of the CHIPRA, among
other things, requires a new final rule for the Payment Error Rate
Measurement (PERM) program and aims to harmonize the PERM and MEQC
programs and provides states with the option to apply PERM data
resulting from its eligibility reviews for meeting MEQC requirements
and vice versa, with certain conditions. CMS reviews, either directly
or through its contractors, of the sampling plans helps to ensure
states are using valid statistical methods for sample selection. The
collection of information is also necessary to implement provisions
from the Children's Health Insurance Program Reauthorization Act of
2009 (CHIPRA) (Pub. L. 111-3) with regard to the MEQC and Payment Error
Rate Measurement (PERM) programs. Form Number: CMS-317 (OCN: 0938-
0148); Frequency: Semi-Annually; Affected Public: State, Local, or
Tribal Governments; Number of Respondents: 10; Total Annual Responses:
20; Total Annual Hours: 480. (For policy questions regarding this
collection contact Monetha Dockery at 410-786-0155. For all other
issues call 410-786-1326.)
6. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection: State
Medicaid Eligibility Quality Control (MEQC) Sample Selection Lists;
Use: The Medicaid Eligibility Quality Control MEQC system is based on
monthly state reviews of Medicaid and Medicaid expansion under Title
XXI cases by states performing the traditional sampling process
identified through statistically reliable statewide samples of cases
selected from the eligibility files. These reviews are conducted to
determine whether or not the sampled cases meet applicable state Title
XIX or XXI eligibility requirements when applicable. The reviews are
also used to assess beneficiary liability, if any, and to determine the
amounts paid to provide Medicaid services for these cases. In the MEQC
system, sampling is the only practical method of validating eligibility
of the total caseload and determining the dollar value of eligibility
liability errors. Any attempt to make such validations and
determinations by reviewing every case would be an enormous and
unwieldy undertaking. At the beginning of each month, state agencies
still performing the traditional sample are required to submit sample
selection lists which identify all of the cases selected for review in
the states' samples. The sample selection lists contain identifying
information on Medicaid beneficiaries such as: State agency review
number, beneficiary's name and address, the name of the county where
the beneficiary resides, Medicaid case number, etc. The submittal of
the sample selection lists is necessary for regional office validation
of state reviews. Without these lists, the integrity of the sampling
results would be suspect and the regional offices would have no data on
the adequacy of the states' monthly sample draw or review completion
status. The authority for collecting this information is Section
1903(u) of the Social Security Act. The specific requirement for
submitting sample selection lists is described in regulations at 42 CFR
431.814(h). Regional Office staff review the sample selection lists to
determine that states are sampling a sufficient number of cases for
review. Form Number: CMS-319 (OCN: 0938-0147); Frequency: Monthly;
Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 10; Total Annual Responses: 120; Total Annual Hours: 960.
(For policy questions regarding this collection contact Monetha Dockery
at 410-786-0155. For all other issues call 410-786-1326.)
7. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection:
Medicaid and Children's Health Insurance (CHIP) Managed Care Claims and
Related Information; Use: The Payment Error Rate Measurement (PERM)
program measures improper payments for Medicaid and the State
Children's Health Insurance Program (SCHIP). The program was designed
to comply with the Improper Payments Information Act (IPIA) of 2002 and
the Office of Management and Budget (OMB) guidance. Although OMB
guidance requires error rate measurement for SCHIP, 2009 SCHIP
legislation temporarily suspended PERM measurement for this program and
changed to Children's Health Insurance Program (CHIP) effective April
01, 2009. Please see Children's Health Insurance Program
Reauthorization Act of 2009 (CHIPRA) Public Law 111-3 for more details.
There are two phases of the PERM program, the measurement phase and the
corrective action phase. The PERM measures improper payments in
Medicaid and CHIP and produces state and national-level error rates for
each program. The error rates are based on reviews of Medicaid and CHIP
fee-for-service (FFS) and managed care payments made in the federal
fiscal year under review. States conduct eligibility reviews and report
eligibility related payment error rates also used in the national error
rate calculation. We created a 17 state rotation cycle so that each
state will participate in PERM once every three years. Following is the
list of states in which CMS will measure improper payments over the
next three years in Medicaid. We need to collect capitation payment
information from the selected states so that the federal contractor can
draw a sample and review the managed care capitation payments. We will
also collect state managed care contracts, rate schedules and updates
to the contracts and rate schedules. This information will be used by
the federal contractor when conducting the managed care claims reviews.
Sections 1902(a)(6) and
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2107(b)(1) of the Social Security Act grants CMS authority to collect
information from the States. The IPIA requires CMS to produce national
error rates in Medicaid and CHIP fee-for-service, including the managed
care component. The state-specific Medicaid managed care and CHIP
managed care error rates will be based on reviews of managed care
capitation payments in each program and will be used to produce
national Medicaid managed care and CHIP managed care error rates. Form
Number: CMS-10178 (OCN: 0938-0994); Frequency: Occasionally; Affected
Public: State, Local, or Tribal Governments; Number of Respondents: 34;
Total Annual Responses: 2040; Total Annual Hours: 28,050. (For policy
questions regarding this collection contact Monetha Dockery at 410-786-
0155. For all other issues call 410-786-1326.)
8. Type of Information Collection Request: Reinstatement with
change of a previously approved information collection; Title of
Information Collection: Medical Necessity and Claims Denial Disclosures
under MHPAEA; Use: The Paul Wellstone and Pete Domenici Mental Health
Parity and Addiction Equity Act of 2008 (MHPAEA) (P.L.110-343) requires
that group health plans and group health insurance issuers offering
mental health or substance use disorder (MH/SUD) benefits in addition
to medical and surgical (med/surg) benefits ensure that that they do
not apply any more restrictive financial requirements (e.g., co-pays,
deductibles) and/or treatment limitations (e.g., visit limits) to MH/
SUD benefits than those requirements and/or limitations applied to
substantially all med/surg benefits.
Medical Necessity Disclosure Under MHPAEA
The MHPAEA section 512(b) specifically amends the Public Health
Service (PHS) Act to require plan administrators or health insurance
issuers to provide, upon request, the criteria for medical necessity
determinations made with respect to MH/SUD benefits to current or
potential participants, beneficiaries, or contracting providers. The
interim final rules Under the Paul Wellstone and Pete Domenici Mental
Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2,
2010) set forth rules for providing criteria for medical necessity
determinations. CMS oversees non-federal governmental plans or related
health insurance.
Claims Denial Disclosure Under MHPAEA
The MHPAEA section 512(b) specifically amends the Public Health
Service (PHS) Act to require plan administrators or health insurance
issuers to supply, upon request, the reason for any denial of payment
for MH/SUD services to the participant or beneficiary involved in the
case. The interim final rules Under the Paul Wellstone and Pete
Domenici Mental Health Parity and Addiction Equity Act of 2008 (75 FR
5410, February 2, 2010) implement 45 CFR 146.136(d)(2), which sets
forth rules for providing reasons for denial of payment. We oversee
non-federal governmental plans or related health insurance, and the
regulation provides a safe harbor such that plans or issuers are deemed
to comply with requirements of paragraph (d)(2) of 45 CFR 166.136 if
they provide the notice in a form and manner consistent with ERISA
requirements found in 29 CFR 2560.503-1. Form Number: CMS-10307 (OMB
Control No. 0938-1080); Frequency: On Occasion; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 20,300; Number of
Responses: 509,600; Total Annual Hours: 2,200. (For policy questions
regarding this collection, contact Usree Bandyopadhyay at 410-786-6650.
For all other issues call (410) 786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995,
or Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected], or call
the Reports Clearance Office on (410) 786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by July 30, 2013:
1. Electronically. You may submit your comments electronically to
http://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number --------, Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
Dated: May 28, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-12950 Filed 5-30-13; 8:45 am]
BILLING CODE 4120-01-P