Roster of Pending Health-related Federal Regulations – as of 10/14/2015


Skilled Nursing Facility PPS and Consolidated Billing



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Skilled Nursing Facility PPS and Consolidated Billing

CMS-10387

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-10-02/pdf/2015-25109.pdf


Released: 10/2/2015
Due date: 11/2/2015

1. Type of Information Collection Request: Reinstatement of a previously approved collection; Title: Skilled Nursing Facility (SNF) Prospective Payment System and Consolidated Billing; Use: CMS seeks approval of a reinstatement of a Change of Therapy OMRA for Skilled Nursing Facilities (SNFs). As described in CMS-1351-F, CMS finalized the assessment effective October 1, 2011. SNFs must submit this assessment. The COT OMRA includes a subset of resident assessment information developed for use by SNFs to satisfy a Medicare payment requirement. The burden associated with this involves the SNF staff time required to complete the COT OMRA, SNF staff time to encode the data, and SNF staff time spent in transmitting the data. SNFs must complete a COT OMRA when a resident receives a sufficient level of rehabilitation therapy to qualify for an Ultra High, Very High, High, Medium, or Low Rehabilitation category and when the intensity of therapy (as indicated by the total reimbursable therapy minutes (RTM) delivered and other therapy qualifiers, such as number of therapy days and disciplines providing therapy) changes to such a degree that it would no longer reflect the RUG-IV classification and payment assigned for a given SNF resident based on the most recent assessment used for Medicare payment. The COT OMRA, a type of required PPS assessment, uses the same item set as the End of Therapy (EOT) OMRA.
















Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs

CMS-10110

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-10-02/pdf/2015-25109.pdf


Released: 10/2/2015
Due date: 11/2/2015

2. Type of Information Collection Request: Reinstatement of a previously approved collection; Title: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals; Use: In accordance with section 1847A of the Social Security Act (Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the average sales price (ASP) of the drug or biological, beginning in calendar year (CY) 2005. The ASP data reporting requirements appear in section 1927 of the Act. CMS uses the reported ASP data to establish the Medicare payment amounts. CMS revised the reporting template in CY 2011 to facilitate accurate collection of ASP data. CMS also created an accompanying user guide with instructions on the template and an explanation of the data elements in the template.

10/2/2015: Paperwork Reduction Act notice. No comments recommended.















Home Health Agency Cost Report

CMS-1728-94

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-04/pdf/2015-22033.pdf


Released: 9/4/2015
Due date: 11/3/2015

1. Type of Information Collection Request: Revision of a currently approved collection; Title: Home Health Agency Cost Report; Use: Providers of Services participating in the Medicare program must, under sections 1815(a), 1833(e) and 1861(v)(1)(A) of the Social Security Act, submit annual information to achieve settlement of costs for health care services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and 413.24 require adequate cost data and cost reports from providers on an annual basis. CMS needs the form CMS-1728-94 cost report to determine a reasonable cost incurred by a provider in furnishing medical services to Medicare beneficiaries and reimbursement due to or from the provider.

9/9/2015: Paperwork Reduction Act notice. No comments recommended.















Statement of Deficiencies and Plan of Correction

CMS-2567

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-04/pdf/2015-22033.pdf


Released: 9/4/2015
Due date: 11/3/2015

2. Type of Information Collection Request: Extension without change of a currently approved collection; Title: Statement of Deficiencies and Plan of Correction Supporting Regulations; Use: Section 1864(a) of the Social Security Act requires that the HHS Secretary use state survey agencies to conduct surveys to determine whether health care facilities meet Medicare and Clinical Laboratory Improvement Amendments participation requirements. Form CMS-2567 serves as the means by which the survey findings are documented. This section of the law further requires making compliance findings resulting from these surveys available to the public within 90 days of such surveys. Form CMS-2567 serves as the vehicle for this disclosure. Health care facilities also use the form to document their plan of correction, and CMS, states, facilities, purchasers, consumers, advocacy groups, and the public use the form as a source of information about quality of care and facility compliance.

9/9/2015: Paperwork Reduction Act notice. No comments recommended.















Off-Cycle Submission of Summaries of Model of Care Changes

CMS-10565

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-10-05/pdf/2015-25212.pdf


Released: 10/5/2015
Due date: 11/4/2015

Type of Information Collection Request: New collection; Title: Off-Cycle Submission of Summaries of Model of Care Changes; Use: All Medicare Advantage (MA) special needs plans (SNPs) must receive approval from the National Committee for Quality Assurance (NCQA). SNPs must submit Models of Care (MOC) as a component of the Medicare Advantage application process. NCQA bases its approval on an evaluation of SNPs using MOC scoring guidelines. Based on their scores, SNPs receive an approval for a period of 1, 2, or 3 years. CMS has developed an MOC off-cycle revision process so that SNPs can revise the MOC to modify their processes and strategies for providing care during their MOC approval period. CMS will require that SNPs submit summaries of their MOC revisions for NCQA evaluation when an SNP makes significant changes to its MOC as described in the annual Announcement of Medicare Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call letter for CY 2015 and CY 2016. NCQA will review the summary of changes to verify that the revisions comport with the acceptable, high quality standards as included in the original approved MOC. CMS has revised this information collection package subsequent to the publication of the 60-day notice in the June 17, 2015, Federal Register (80 FR 34647).
















Nondiscrimination in Health Programs and Activities

HHS OCR (RIN 0945-AA02)

AGENCY: HHS OCR
Nondiscrimination in Health Programs and Activities
http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-22043.pdf

Released: 9/8/2015
Due date: 11/9/2015

Section 1557 of ACA prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of ACA authorizes the HHS Secretary to promulgate regulations to implement the nondiscrimination requirements of Section 1557. In addition, the HHS Secretary can prescribe regulations for department governance, conduct, and performance of its business, including, as addressed in this proposed rule, how HHS will apply the standards of Section 1557 to department-administered health programs and activities. This proposed rule applies to health programs and activities administered by CMS, HRSA, CDC, IHS, and SAMHSA. Examples include tribal hospitals and clinics operated by IHS (about 876 hospitals and clinics) and the National Health Service Corps.

9/9/2015: This proposed rule may have a significant impact on how Indian-specific provisions are enforced and/or permitted.















Medicare Enrollment Application--DMEPOS Suppliers

CMS-855S

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-11/pdf/2015-22944.pdf


Released: 9/11/2015
Due date: 11/10/2015

Type of Information Collection Request: Revision of a currently approved collection; Title: Medicare Enrollment Application--Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Suppliers; Use: The CMS-855S Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) supplier enrollment application gathers from a supplier information that tells CMS its name, whether it meets certain qualifications of a health care supplier, where it renders its services or supplies, the identity of the owners of the enrolling entity, and information necessary to establish correct claims payment.
This revision of CMS-855S seeks to simplify and clarify the current data collection and to remove obsolete and/or redundant questions. CMS has corrected grammar and spelling errors and has added limited informational text within the application form and instructions in conjunction with links to Web sites when greater detail is needed by the supplier. To clarify current data collection differentiations and to comport with accreditation coding, CMS has updated Section 3D (“Products and Services Furnished by This Supplier”). This revision does not offer any new material data collection.


9/15/2015: Paperwork Reduction Act Notice. No comments recommended.















Cost-Sharing Reduction Reconciliation

CMS-10526

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-14/pdf/2015-22959.pdf



Released: 9/14/2015
Due date: 11/13/2015

Type of Information Collection Request: Revision of a currently approved collection; Title: Cost-Sharing Reduction Reconciliation; Use: Under established HHS regulations, qualified health plan (QHP) issuers will receive estimated advance payments of cost-sharing reductions throughout the year. Each issuer will then complete a reconciliation process at the end of the benefit year to ensure that HHS reimburses each issuer only for actual cost sharing. This revised collection eliminates some data elements and requires summary plan level reporting and reporting in the 2016 reconciliation cycle on the dollar amount of 2014 cost-sharing reductions used in calculations for medical loss ratio and risk corridors programs reporting.
Analysis: At the present time, there are no documents available for review on the PRA Notice, except the Federal Register notice.
On 4/30/2013, tribal organizations submitted comments in response to CMS-9964-IFC, which included an alternative, optional methodology for calculating the value of cost-sharing reductions provided for the purpose of reconciliation of advance payments of cost-sharing reductions and created a transition period permitting the use of this alternative. A summary of the recommendations from tribal organizations, as well as the responses from CMS, appear below.


  1. Transition Period: CMS should limit the transition period to two years and require issuers that elect the alternative/simplified methodology to use the underlying payment methodology for an equivalent length of time (i.e., two years) after the transition period before moving to any new payment approach the agency might propose.


Response: Accepted in part. CMS stated, “To allow QHP issuers adequate time to develop their systems to support the standard methodology, we are establishing a three-year transition period during which QHP issuers may use the simplified methodology, provided that they choose the simplified methodology prior to the start of benefit year 2014. We are modifying §156.430(c)(3) to specify that the option to use the simplified methodology will extend only through benefit year 2016.” [78 FR 65071]


  1. Data Collection: To evaluate the operation of the program, CMS should ensure the collection of a robust amount of data on the actual payments made by issuers under the Indian-specific cost-sharing variations and ensure the collection of data is representative of the experiences of all health plans, with consideration to factors such as the service areas of plans, the degree of I/T/U penetration in the service areas, the percentage of AI/ANs enrolled in a plan, plan size and market concentration, and whether plans provided protections under the limited or zero cost-sharing variations.


Response: Accepted in part. CMS stated, “To ensure that QHP issuers using either the standard or simplified methodology submit accurate information for cost-sharing reduction payment reconciliation, we are finalizing cost-sharing reduction oversight standards in §156.480 of this final rule. …
We are also clarifying in this final rule the standards for reporting information on the effective cost-sharing parameters. Specifically, we are renumbering the paragraph on reporting as paragraph (c)(4)(iv), and specifying that a QHP issuer using the simplified methodology must submit to HHS, in the manner and timeframe established by HHS, the effective cost-sharing parameters, calculated pursuant to paragraph (c)(4)(iii), for each standard plan offered by the QHP issuer in the individual market through the Exchange for each set of circumstances described in paragraph (c)(4)(ii). … We will provide guidance on the manner and timeframe of this submission in the future.
As discussed in the interim final rule, we recognize that because the effective pre- and post-deductible coinsurance rates are calculated based on the average experience of the enrollees in the standard plan, low enrollment in the standard plan could lead to inaccurate effective coinsurance rates. Therefore, we provided additional standards related to the simplified methodology in §156.430(c)(4)(iv) to address credibility concerns that may result from low enrollment in the standard plan.” [78 FR 65075 ]


  1. Primary Payment Methodology: CMS should continue to use as the primary payment methodology a mechanism based on actual (and not estimated) payments made by issuers for the cost-sharing protections provided to AI/ANs under the limited and zero cost-sharing variations and propose to transition to an alternative payment mechanism only after demonstrating such an alternative would not create counter-productive financial incentives.


Response: Accepted in part. According to CMS, all QHP issuers will have to use the standard methodology, which relies on actual cost-sharing reduction payments, after 2016 (see #1 above). However, CMS stated it “will continue to consider alternative approaches for reimbursing QHP issuers for the future, including a capitated payment system.” [78 FR 65071]


  1. Administrative Costs--If administrative costs to issuers are an impediment to processing requests for reimbursement based on actual costs, CMS should consider providing an appropriate administrative fee to the issuers for the effort involved in reconciling the initial, estimated payments received from the agency with the actual amounts expended on cost-sharing protections.


Response: Not accepted. CMS said it believes that “both methods of calculating the value of cost-sharing reductions provided will be accurate so that QHP issuers are adequately compensated for providing cost-sharing reductions to all populations.” [78 FR 65071]

9/15/2015: Paperwork Reduction Act Notice. No comments recommended.


9/15/2015: Note that Tribal reps submitted comments previously on the topic of the reconciliation of cost-sharing reductions by QHP issuers. Please see notes to the left.















Emergency and Foreign Hospital Services

CMS-1771

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-21/pdf/2015-23528.pdf



Released: 9/21/2015
Due date: 11/20/2015

Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title: Emergency and Foreign Hospital Services; Use: Section 1866 of the Social Security Act (Act) states that any provider of services must qualify to participate in the Medicare program and qualify for payments under Medicare if it files an agreement with the HHS Secretary to meet the conditions outlined in this section of the Act. Section 1814(d)(1) of the Act and 42 CFR 424.100 allow payment of Medicare benefits for a Medicare beneficiary to a nonparticipating hospital that does not have an agreement in effect with CMS. These payments can occur if such services were emergency services and if CMS would have to make the payment if the hospital had an agreement in effect and met the conditions of payment. This form is used in connection with claims for emergency hospital services provided by hospitals that do not have an agreement in effect under Section 1866 of the Act. As specified in 42 CFR 424.103(b), before a non-participating hospital can receive payment for emergency services rendered to a Medicare beneficiary, it must submit a statement sufficiently comprehensive to support that an emergency existed. Form CMS-1771 contains a series of questions relating to the medical necessity of the emergency. The attending physician must attest to the need for the hospitalization under the regulatory emergency definition and give clinical documentation to support the claim.


9/15/2015: Paperwork Reduction Act notice. No comments recommended.
















CY 2017 Plan Benefit Package Software and Formulary Submission

CMS-R-262

AGENCY: CMS
PRA Request for Comment
http://www.gpo.gov/fdsys/pkg/FR-2015-09-24/pdf/2015-24263.pdf

Released: 9/24/2015
Due date: 11/23/2015

Type of Information Collection Request: Revision of a currently approved collection; Title: Contract Year 2017 Plan Benefit Package (PBP) Software and Formulary Submission; Use: CMS requires that Medicare Advantage and Prescription Drug Plan organizations submit a completed PBP and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval. CMS publishes beneficiary education information using a variety of formats. The specific education initiatives that utilize PBP and formulary data include Web application tools on www.medicare.gov and the plan benefit insert in the Medicare & You handbook. In addition, organizations utilize the PBP data to generate their Summary of Benefits marketing information.

9/25/2015: Paperwork Reduction Act Notice. No comments recommended.















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