Alston & Bird Healthcare Week in Review, April 14, 2017

I. Regulations, Notices, & Guidance

• On April 9, 2017, the Office of Management and Budget (OMB) received a proposed rule from the Centers for Medicare & Medicaid Services (CMS) entitled, CY 2018 Home Health Prospective Payment System Rate Update; Value-Based Purchasing Model; and Quality Reporting Requirements. The proposed rule would update the 60-day national episode rate, 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.
• On April 11, 2017, the Centers for Disease Control and Prevention (CDC) issued a final rule entitled, Possession, Use, and Transfer of Select Agents and Toxins – Addition of Bacillus cereus Biovar anthracis to the HHS List of Select Agents and Toxins. The final rule finalizes the interim final rule that added Bacillus cereus Biover anthracis to the list of Department of Health and Human Services (HHS) select agents and toxins as a Tier 1 select agent.
• On April 11, 2017, CMS issued a notice entitled, Medicare Program; Funding in Support of the Pennsylvania Rural Health Model - Cooperative Agreement. The notice announces the issuance of the January 12, 2017 single-source cooperative agreement funding opportunity announcement to begin the Pennsylvania Rural Health Model’s implementation activities, entitled, Funding in Support of the Pennsylvania Rural Health Model Cooperative Agreement (the “Funding Opportunity”). According to CMS, The Funding Opportunity is available solely to the Commonwealth of Pennsylvania acting through the Pennsylvania Department of Health (the “Commonwealth”).
• On April 12, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Medical Devices; Exemptions from Premarket Notification: Class I Devices. The notice identifies a list of class I devices that are now exempt from premarket notification requirements, subject to certain limitations. The notice represents the FDA’s final determination with respect to the class I devices included in this document. According to the FDA, the action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.
• On April 12, 2017, OMB received a proposed rule from CMS entitled, CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates. The proposed rule would revise the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from our continuing experience with this system. The proposed rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the ambulatory surgical center payment system list of services and rates.
• On April 13, 2017, the National Institute for Occupational Safety and Health (NIOSH) issued a notice entitled, Issuance of Final Guidance Publications. The notice announces the availability of the following final 14 IDLH Value Profiles: Iron Pentacarbonyl, Acrylonitrile, 1,1- Dichloro-1-Fluoroethane (HCFC-141b), Chloroacetyl Chloride, Chlorine Pentafluoride, Furan, Hexafluoroacetone, n-Butyl Acrylate, Benzontrile, Methyl Isocyanate, Bromine Pentafluoride, 1,3-Butadiene, Diketene and Butane.
• On April 13, 2017, CMS issued a final rule entitled, Patient Protection and Affordable Care Act; Market Stabilization. According to CMS, the final rule finalizes changes that will help stabilize the individual and small group markets and affirm the traditional role of State regulators. The final rule amends standards relating to special enrollment periods, guaranteed availability, and the timing of the annual open enrollment period in the individual market for the 2018 plan year; standards related to network adequacy and essential community providers for qualified health plans; and the rules around actuarial value requirements. The final rule is effective on 60 days after the date of publication in the Federal Register, which is scheduled for April 18, 2017.
• On April 14, 2017, CMS issued a proposed rule entitled, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices. The proposed rule would revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of the proposed changes would implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. Comments are due by June 13, 2017.

• May 3, 2017: HHS announced a meeting of the National Committee on Vital and Health Statistics (NCVHS), Standards Subcommittee. The purpose of this NCVHS Standards Subcommittee meeting is to seek further input from the health care industry for disposition and next steps of the health plan identifier (HPID) for health plans.
• May 3 – 4, 2017: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). May 3, 2017, will be dedicated to the topic of Infection Prevention and Control for Animal Health. The three working groups on Incentives for Diagnostics, Therapeutics/Anti-Infectives, and Vaccines, will report their preliminary findings to the full Advisory Council for deliberation on the second day of the public meeting; no vote will be held.
• May 8 – 9, 2017: The FDA announced a public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The committee will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain 7 compounding facilities. In addition, the committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A Bulks List. The FDA will discuss the following nominated bulk drug substances: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin.
• June 6 -7, 2017: HHS announced a meeting of the National Vaccine Advisory Committee (NVAC). During the June 2017 NVAC meeting, sessions will include an update on the Secretary of HHS’ report on vaccine innovation to Congress in response to the 21st Century Cures Act; presentations on immunization information systems and inter-jurisdictional data exchange; and an update on vaccine confidence-related projects.

II. Congressional Legislation & Committee Action

• The Senate has adjourned and will reconvene on Monday, April 24, 2017.

• The House has adjourned and will reconvene on Tuesday, April 25, 2017.

• On April 10, 2017, the Government Accountability Office (GAO) released a report entitled, Medicare Provider Education: Oversight of Efforts to Reduce Improper Biller Needs Improvement. The report found that Medicare administrative contractors (MAC) process Medicare claims, identify areas vulnerable to improper billing, and develop general education efforts focused on these areas. MAC officials state that their provider education departments focus their educational efforts on areas vulnerable to improper billing; however, oversight and requirements for these efforts are limited.

• On April 13, 2017, CMS released a report entitled, Gender Disparities in Health Care in Medicare Advantage. The report provides data regarding 8 patient experience measures and 24 clinical care measures. The patient experience data was collected from a national survey of Medicare beneficiaries, known as the Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey.

IV. Other Health Policy News

• On April 13, 2017, CMS issued key dates for calendar year 2017. The key dates relate to the timeline for Qualified Health Plan (QHP) Certification in the Federally Facilitated Exchanges (FFM).

• On April 13, 2017, CMS issued guidance to States on review of Qualified Health Plan Certification standards in FFMs for Plan Years 2018 and later. The guidance amends the previously released 2018 Letter to Issuers in the FFMs by outlining areas where CMS will rely, starting with plan year 2018, on state reviews of QHP certification standards for states with FFMs, including states with FFMs that perform plan management functions in partnership with CMS.

• On April 13, 2017, CMS issued the revised Final 2018 Actuarial Value Calculator Methodology. The document announces the revised Actuarial Value Calculator Methodology since the releasing of the final rule entitled, Patient Protection and Affordable Care Act; Market Stabilization.

• On April 13, 2017, CMS issued a revised guidance on Unified Rate Review Timeline: Revised Timing of Submission and Posting of Rate Filing Justifications for the 2017 Filing Year for Single Risk Pool Coverage; Revised Timing of Submission for Qualified Health Plan Certification Application.

• On April 13, 2017, CMS issued a FAQ document on compliance standards for issuers in FFMs. According to CMS, they will not use formal enforcement remedies for non-compliance with QHP certification standards when QHP issuers participating in the FFMs in PY 2018 act in good faith and make reasonable efforts to address concerns in an appropriate time frame.

• Insurers, hospitals and employers are increasing pressure on the Trump Administration and Congress to take decisive action on the ACA cost-sharing reduction (CSR) payments because the window for issuers to price their 2018 plans closes soon. Those industries jointly sent a letter warning that slashing the subsidies would lead to higher premiums, which could drive out middle-class Obamacare customers who do not receive financial assistance, and increase costs for taxpayers. The groups also warn that if fewer individuals have coverage, uncompensated care at hospitals will increase. The letter is signed by America's Health Insurance Plans (AHIP), Blue Cross Blue Shield Association (BCBSA), the Federation of American Hospitals (FAH), the American Hospital Association, American Medical Association, Academy of Family Physicians, American Benefits Council and the U.S. Chamber of Commerce.

V. ACA Repeal News

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