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



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Released: 9/28/2015
Due Date: None



CMS conducts Periodic Data Matching (PDM) in the Marketplace to help ensure consumers enrolled in Medicaid or CHIP coverage also are not enrolled in a Marketplace plan with advance payments of the premium tax credit (APTC) or cost-sharing reductions (CSRs). If consumers enrolled in Medicaid or CHIP coverage also are enrolled in a Marketplace plan with APTC or CSRs, the tax filers likely will have to pay back all or some of the APTC received for the Marketplace plan for the months following their Medicaid or CHIP eligibility determination.
CMS will conduct periodic and regularly scheduled data matches to identify these consumers and will send them a notice instructing them to act immediately to end their Marketplace coverage with APTC or CSRs if they are enrolled in Medicaid or CHIP coverage.
This document answers frequently asked questions to help inform state Medicaid and CHIP agencies about the technical and operations aspects of PDM. CMS will update this document as necessary to reflect changes in the PDM process.
















Medicare Inpatient Psychiatric Facilities PPS for FY 2015

CMS-1606-CN

AGENCY: CMS
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Fiscal Year Beginning October 1, 2014 (FY 2015); Correction
http://www.gpo.gov/fdsys/pkg/FR-2015-10-01/pdf/2015-24998.pdf


Released: 10/1/2015
Due Date: None



This document corrects technical errors that appeared in the final rule published in the August 6, 2014, Federal Register and titled “Inpatient Psychiatric Facilities Prospective Payment System--Update for Fiscal Year Beginning October 1, 2014 (FY 2015); Final Rule.”
The inpatient psychiatric facilities prospective payment system (IPF PPS) includes a comorbidity payment adjustment. In Table 7 of the final rule, CMS converted the 17 comorbidity categories defined using ICD-9-CM codes to ICD-10-CM codes (79 FR 45953). This document corrects eight typographic errors in ICD-10-CM codes or code ranges listed in Table 7.
Additionally, in response to a request from IPF providers and software companies to make the table more user-friendly by listing each ICD-10-CM code individually, rather than showing the ICD-10-CM code ranges, CMS has republished Table 7 in its entirety to make this change, after incorporating the eight corrections noted above. CMS has posted Table 7 on the IPF PPS Web site, under the “Tools and Worksheets” link, at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/tools.html.

10/2/2015: No comments requested or recommended.















FFM and Federally-Facilitated SHOP Enrollment Manual

CCIIO (no reference number)

AGENCY: CCIIO
Federally-Facilitated Marketplace and Federally-Facilitated Small Business Health Options Program Enrollment Manual
https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Updated_Enrollment_Operations_Policy-and_Guidance_Final_9-30-2015_mb.pdf


Released: 10/1/2015
Due Date: None



ACA created new competitive private Health Insurance Exchanges, or Marketplaces, that enable qualified individuals (QIs) to shop for, select, and enroll in high quality, affordable private health plans. Marketplaces also allow individuals to obtain an eligibility determination or eligibility assessment for coverage under Medicaid and/or CHIP. In addition, ACA created Small Business Health Options Program (SHOP) Marketplaces that enable qualified employers to provide health plans to their employees. QIs and qualified employers have obtained coverage from private health insurance companies through the Marketplaces since January 1, 2014.
This manual, which provides guidance on enrollment in Federally-Facilitated Marketplaces and Federally-Facilitated SHOP Marketplaces, will go into effect as of October 1, 2015. Processing of all enrollments made on or after this date should occur in accordance with the operational requirements set forth in this manual. CMS intends to update this manual regularly and publish clarifying bulletins between updates. This manual supersedes all previous versions of any incorporated bulletins into this document.
This manual includes several Indian-specific provisions, outlined below.


  • 2.5.1 Premium Payment Due Date: In this section, regarding third-party premium payments, CCIIO notes, “Under 45 CFR §156.1250, issuers offering individual market QHPs must accept premium and cost-sharing payments made on behalf of QHP enrollees by Indian tribes, tribal organizations, urban Indian organizations, and state and federal government programs or grantees, such as the Ryan White HIV/AIDS programs. If an enrollee notifies the QHP issuer of coordinated premium payment with one of the third party entities described in 45 CFR §156.1250, issuers should allow for timely premium payment to prevent termination of enrollments for non-payment. CMS may take enforcement action against QHP issuers that fail to comply with this requirement.”

  • 4.2 GUIDELINES FOR SPECIFIC QI SCENARIOS: In this section, regarding Marketplace applicants found eligible for enrollment in a QHP and eligible for APTCs or CSRs, CCIIO states that the “Enrollment Partner must allow applicants to select the amount of APTCs they want to apply towards the reduction of their share of the premiums in the plan selection process, and should only display the CSRs plan variation for which an applicant is found eligible, for any of the QHP issuer’s silver-level plans (or American Indian/Alaskan Native CSRs variations, as appropriate).”

  • 4.4 QHP DISPLAY GUIDANCE: In this section, regarding requirements for the QHP issuer Enrollment Partner Web site, CCIIO states the site must “provide a way for applicants to select their APTC amount up to the maximum for which they are eligible as set forth in 45 CFR §156.1230(a)(1)(v), and subsequently update the net premium for the displayed QHPs,” adding, “If an applicant is eligible for CSRs, QHP issuer Enrollment Partners should only display the CSRs plan variation that an individual is found eligible for, any of the QHP issuer’s second lowest cost silver-level plans, or American Indian/Alaskan Native CSRs variations as appropriate.”

  • 5.1 AVAILABILITY AND LENGTH OF SEPS: In section, regarding the eligibility of QIs/enrollees for a special enrollment period, CCIIO states that a QI/enrollee might qualify if he or she is an “American Indian/Alaska Native, as defined by Section 4 of the Indian Health Care Improvement Act, which permits the enrollee to enroll in a QHP or change from one QHP to another one time per month.” CCIIO also notes in a footnote that, in addition to the “eligibility requirements established by 45 CFR §155.420(d), an Indian (as defined by Section 4 of the Indian Health Care Improvement Act) may enroll in a QHP or change from one QHP to another one time per month.”

10/2/2015: No comments requested or recommended.


Document provides detailed information on CCIIO requirements on the FFM, QHP issuers, and others with regard to enrollment and disenrollment in/from the Marketplace.













Hospice Wage Index and Payment Rate Update for FY 2016, et al.

CMS-1629-CN

AGENCY: CMS
Medicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements; Correction
http://www.gpo.gov/fdsys/pkg/FR-2015-10-05/pdf/2015-25267.pdf

Released: 10/5/2015
Due Date: None



This document corrects technical errors that appeared in the final rule published in the August 6, 2015, Federal Register (80 FR 47142) and titled “Medicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.”

Final version.















IPPS for Acute Care Hospitals and PPS for LTCHs for FY 2016, et al.

CMS-1632-CN

AGENCY: CMS
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals; Correction

http://www.gpo.gov/fdsys/pkg/FR-2015-10-05/pdf/2015-25269.pdf




Released: 10/5/2015
Due Date: None



This document corrects technical and typographical errors that appeared in the final rule and interim final rule with comment period published in the August 17, 2014, Federal Register (80 FR 49325) and titled “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals.”

Final version.















PPS and Consolidated Billing for Skilled Nursing Facilities for 2016, et al.

CMS-1622-CN

AGENCY: CMS
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2016, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and Staffing Data Collection; Correction

http://www.gpo.gov/fdsys/pkg/FR-2015-10-05/pdf/2015-25268.pdf



Released: 10/5/2015
Due Date: None


This document corrects technical errors that appeared in the final rule published in the August 4, 2015, Federal Register ( 80 FR 46389) and titled “Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) for FY 2016, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and Staffing Data Collection.”

Final version of rule.















Early Reinsurance Payments for the 2015 Benefit Year

CCIIO (no reference number)

AGENCY: CCIIO
Early Reinsurance Payments for the 2015 Benefit Year

https://www.cms.gov/CCIIO/Programs-and-Initiatives/Premium-Stabilization-Programs/Downloads/Early-Reinsurance-Guidance-FInal-10-09-15.pdf



Released: 10/9/2015
Due Date: None


This guidance announces that CMS will make an early payment under the transitional reinsurance program for the 2015 benefit year to issuers of reinsurance-eligible plans. CMS anticipates making this early payment in March 2016. CMS will pay out reinsurance funds not paid out through this early payment in late 2016, as part of the standard reinsurance data submission, validation, calculation, and payment process.

10/12/2015: No comments requested or recommended.















2015 Edition Health Information Technology Certification Criteria, et al.

HHS ONC (RIN 0991-AB93)

AGENCY: HHS ONC
2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification

https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-25597.pdf



Released: 10/6/2015
Due Date: None
Published: 10/16/2015 (expected)



This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or “2015 Edition”) and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the HHS ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition establishes the capabilities and specifies the related standards and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs.

Final version of rule.



Health-related Agency Actions Pending at OMB

Medicare Secondary Payer and “Future Medicals” (CMS-6047-P)

Received at OMB: 8/1/2013



















Influenza Vaccination Standard for Certain Participating Providers and Suppliers (CMS-3213-F)

Received at OMB: 9/27/2013

This final rule requires certain Medicare and Medicaid providers and suppliers to offer all patients an annual influenza vaccination, unless medically contraindicated or unless patients or their representative or surrogate declined vaccination. This final rule seeks to increase the number of patients receiving annual vaccination against seasonal influenza and to decrease the morbidity and mortality rate from influenza. This final rule also requires certain providers and suppliers to develop policies and procedures that will allow them to offer vaccinations for pandemic influenza in case of a future pandemic influenza event for which a vaccine might become available.
Approved by OMB on 4/18/2014 but not yet released by the agency.
















CY 2015 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8056-N)

Received at OMB: 9/18/2014

This annual notice announces the inpatient hospital deductible and the hospital and extended care service coinsurance amounts for services furnished in calendar year 2015 under the Medicare Hospital Insurance Program (Part A). The Medicare statute specifies the formula used to determine these amounts.
















CY 2015 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8057-N)

Received at OMB: 9/18/2014

This annual notice announces the premiums for CY 2015 under the Medicare Hospital Insurance Program (Part A) for the uninsured aged and for certain disabled individuals who have exhausted other entitlement.
















CY 2015 Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible (CMS-8058-N)

Received at OMB: 9/18/2014

No detail provided.
















Pre-Existing Condition Insurance Plan Program Updates (CMS-9995-IFC4)

Received at OMB: 2/3/2015

No detail provided.
















Revisions to Requirements for Discharge Planning for Hospitals, Inpatient Rehabilitation Facilities, Long-Term Care Hospitals, Home Health Agencies, and Critical Access Hospitals (CMS-3317-P)

Received at OMB: 7/22/2015

This proposed rule would revise the discharge planning requirements that hospitals, inpatient rehabilitation facilities, long-term care hospitals, home health agencies, and critical access hospitals must meet to participate in the Medicare and Medicaid programs. This proposed rule also would enact the discharge planning requirements of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT).
















Covered Outpatient Drugs (CMS-2345-F)

Received at OMB: 8/4/2015

This final rule revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of ACA. This final rule also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program.
On April 2, 2012, tribal organizations made the following recommendations on the proposed version of this rule:


  1. Tribal Consultation: CMS should consider in its decisions regarding the final rule all comments received during tribal consultation, although the agency would not have received these comments until after the April 2, 2012, deadline.

  2. Payment Methodologies: Proposed § 447.518 requires the State plan to describe the payment methodology for prescription drugs, including those dispensed by I/T/U pharmacies, provided that the allowable methodologies include reimbursement on the same basis as retail pharmacies and the OMB encounter rate already approved by CMS in a number of State plans; CMS should retain this provision in the final rule but provide clarification regarding allowable methodologies to ensure that states do not mistakenly believe that current reimbursement models, such as encounter rates, are not permitted.

  3. Dispensing Fee Calculations: CMS should retain in the final rule the proposed requirement that dispensing fee calculations take into account special circumstances of I/T/U pharmacies.

8/6/2015: CMS issued the proposed rule version of this rule on 2/2/2012, and NIHB filed comments on 4/2/2012 (see column to the left).


See additional notes in entry under Priority Roster items above.













Prior Authorization Process for Certain Durable Medical Equipment, Prosthetic, Orthotics, and Supplies (DMEPOS) Items (CMS-6050-F)

Received at OMB: 8/19/2015

This final rule establishes a prior authorization process for certain DMEPOS items frequently subject to unnecessary utilization and adds the contractor decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.
















Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health (CMS-2348-F)

Received at OMB: 9/8/2015

This final rule revises the Medicaid home health service definition as required by section 6407 of ACA to add a requirement that physicians document the existence of a face-to-face encounter (including through the use of telehealth) with the Medicaid-eligible individual within reasonable timeframes. In addition, this rule amends home health services regulations to clarify the definitions of included medical supplies, equipment and appliances, and clarify that states cannot limit home health services to services delivered in the home, or to services furnished to individuals who are homebound.
















Medicare Shared Savings Program; Final Waivers (CMS-1439-F)

Received at OMB: 9/9/2015

This final rule establishes waivers of the application of the Physician Self-Referral Law, the federal anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified financial arrangements involving accountable care organizations (ACOs) under the Medicare Shared Savings Program. ACA authorizes the HHS Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Social Security Act (the Medicare Shared Savings Program).
















Methods for Assuring Access to Covered Medicaid Services (CMS-2328-FC)

Received at OMB: 9/11/2015

This rule creates a standardized, transparent process for states to follow as part of their broader efforts to “assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area,” as required by section 1902(a)(30)(A) of the Social Security Act (Act). This rule also recognizes, as states have requested, electronic publication as an optional means of communicating State Plan Amendments (SPAs) and proposed rate-setting policy changes to the public.
















Medicaid Mechanized Claims Processing and Information Retrieval Systems (CMS-2392-F)

Received at OMB: 9/11/2015

This final rule revises Medicaid regulations for Federal Funding for Medicaid Eligibility Determination and Enrollment Activities and Mechanized Claims Processing and Information Retrieval Systems. Specifically, this rule modifies CMS regulations to make enhanced Federal Financial Participation (FFP) available, under certain circumstances, for the design, development, installation, or enhancement of eligibility determination systems on an ongoing basis. It also makes enhanced FFP available, under certain circumstances, for maintenance and operations of such systems. In addition to lifting the time limit that currently applies to the availability of such funding, this rule finalizes changes to the standards and conditions for Medicaid IT to access enhanced funding, as well as new approaches to systems development, acquisition approvals, and formal certification.
















Basic Health Program; Federal Funding Methodology for Program Year 2017 (CMS-2396-PN)

Received at OMB: 9/16/2015

No detail provided.
















Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-P)

Received at OMB: 9/29/2015

No detail provided.
















CY 2017 Notice of Benefit and Payment Parameters (CMS-9937-P)

Received at OMB: 10/9/2015

This proposed rule would set forth payment parameters and provisions related to the risk adjustment programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-Facilitated Exchanges. It also would provide additional standards for several other Affordable Care Act programs.
















CY 2016 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-FC)

Received at OMB: 10/13/2015

This annual proposed final rule revises payment polices under the Medicare physician fee schedule and makes other policy changes to payment under Medicare Part B. These changes will apply to services furnished beginning January 1, 2016.
















CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-FC)

Received at OMB: 10/13/2015

This annual final rule revises the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from continuing CMS experience with this system. This final rule describes changes to the amounts and factors used to determine payment rates for services. In addition, this final rule makes changes to the ambulatory surgical center payment system list of services and rates.
















CY 2016 Home Health Prospective Payment System Refinements and Rate Update (CMS-1625-F)

Received at OMB: 10/13/2015

This annual final rule updates the 60-day national episode rate based on the applicable home health market basket update and case-mix adjustment. It also updates the national per-visit rates used to calculate low utilization payment adjustments (LUPAs) and outlier payments under the Medicare prospective payment system for home health agencies. These changes will apply to services furnished during home health episodes beginning on or after January 1, 2016.
















CY 2016 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1628-F)

Received at OMB: 10/13/2015

This annual final rule will update the bundled payment system for ESRD facilities by January 1, 2016. This final rule also updates the quality incentives in the ESRD program and establishes the methodology for adjusting DMEPOS fee schedule payment amounts.




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