Alston & Bird Healthcare Week in Review, April 27, 2018

I. Regulations, Notices, & Guidance

• On April 23, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals; Draft Guidance for Industry; Availability. The purpose of this guidance is to provide information to assist sponsors in the design of an appropriate program of nonclinical studies for the development of pharmaceuticals used to treat patients with severely debilitating or life-threatening hematologic disorders (SDLTHDs). While FDA has guidance for oncology indications (most of which are considered severely debilitating or life-threatening diseases) and for rare diseases (which include some SDLTHD conditions), FDA has no guidance to facilitate nonclinical development specifically for pharmaceuticals used to treat non-oncology patients with SDLTHDs. A streamlined approach to drug development is necessary to allow patients with SDLTHDs earlier and continued access to new and potentially effective therapies.
• On April 24, 2018, the Centers for Medicare and Medicaid Services (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 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs)Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims. CMS is proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from CMS’s experience with these systems for FY 2019. Some of these proposed changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. CMS also is proposing to make changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, CMS is proposing to provide the market basket update that would apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2019. CMS is proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2019. In addition, CMS is proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). CMS is also proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, CMS is proposing changes to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. CMS is proposing to update policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. CMS is proposing to make changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.
• On April 24, 2018, CMS issued a notice entitled, Extension of Payment Adjustment for Low-volume Hospitals and the Medicare-dependent Hospital Program under Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals for Fiscal Year 2018. This notice announces changes to the payment adjustment for low volume hospitals and to the Medicare-dependent Hospital (MDH) Program under the hospital IPPS for FY 2018 in accordance with the Bipartisan Budget Act of 2018.
• On April 25, 2018, the Department of Health and Human Services (HHS) issued a notice entitled, Request for Nominations: National Clinical Care Commission. The notice announces the establishment of the National Clinical Care Commission (Commission) pursuant to the National Clinical Care Commission Act. The Commission will consist of representatives of specific federal agencies and non-federal individuals and entities who represent diverse disciplines and views. The Commission will evaluate and make recommendations to the HHS Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases. The notice is also requesting nominations of individuals who are interested in being considered for appointment to the Commission.
• On April 26, 2018, the FDA issued a notice entitled, Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff. This draft guidance provides FDA's regulatory approach for products with multiple functions, including at least one device function, in accordance with the 21st Century Cures Act. This draft guidance is not final nor is it in effect at this time.
• On April 27, 2018, CMS issued a proposed rule entitled, FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements. This proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2019. The rule also proposes to make conforming regulations text changes to recognize physician assistants as designated hospice attending physicians effective January 1, 2019. Finally, the rule proposes changes to the Hospice Quality Reporting Program.
• On April 27, 2018, CMS issued a proposed rule entitled, FY 2019 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2018 (FY 2019). This proposed rule would update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. These changes would be effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2018 through September 30, 2019 (FY 2019). This rule also proposes to update the IPF labor-related share, to update the IPF wage index for FY 2019, update the International Classification of Diseases 10th Revision, Clinical Modification (ICD-10-CM) codes for FY 2019, make technical corrections to the IPF regulations, and update quality measures and reporting requirements under the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program. In addition, it would update providers on the status of IPF PPS refinements. Finally, this proposed rule includes a Request for Information related to health information technology.
• On April 27, 2018, CMS issued a proposed rule entitled, Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019. This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2019. As required by the Social Security Act, this proposed rule includes the classification and weighting factors for the IRF prospective payment system’s (PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2019. CMS is also proposing to alleviate administrative burden for IRFs by removing the Functional Independence Measure (FIM™) instrument and associated Function Modifiers from the IRF Patient Assessment Instrument (IRF-PAI) and revising certain IRF coverage requirements to reduce the amount of required paperwork in the IRF setting. In addition, CMS is soliciting comments on removing the face-to-face requirement for rehabilitation physician visits and expanding the use of non-physician practitioners (that is, nurse practitioners and physician assistants) in meeting the IRF coverage requirements. For the IRF Quality Reporting Program (QRP), we are proposing to adopt a new measure removal factor, remove two measures from the IRF QRP measure set, and codify in our regulations a number of requirements.
• On April 27, 2018, CMS issued a proposed rule entitled, Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Proposed Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting Program. This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019. This proposed rule also proposes to replace the existing case-mix classification methodology, the Resource Utilization Groups, Version IV (RUG-IV) model, with a revised case-mix methodology called the Patient-Driven Payment Model (PDPM) effective October 1, 2019. It also proposes revisions to the regulation text that describes a beneficiary’s SNF “resident” status under the consolidated billing provision and the required content of the SNF level of care certification. The proposed rule also includes proposals for the SNF Quality Reporting Program (QRP) and the Skilled Nursing Facility Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs.

Event Notices

• May 3, 2018: The FDA announced a public meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee. The general function of the committees is to provide advice and recommendations for the FDA on regulatory issues.
• May 3, 2018: The Department of Health and Human Services (HHS) announced a public meeting of the National Vaccine Advisory Committee.  The public meeting will be dedicated to the deliberation of various recommendations to the Director of the National Vaccine Program.
• May 9, 2018: The FDA announced a public workshop entitled, Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation. The purpose of the public workshop is to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity when approving a product with a tissue agnostic indication.
• May 14-16, 2018: The Center for Medicare and Medicaid Services (CMS) announced the public meetings on the Healthcare Common Procedure Coding System (HCPCS) for 2018. The public meetings will cover CMS’ preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments.
• May 17, 2018: The FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The VRBPAC will discuss approaches from demonstrating effectiveness in certain vaccines intended for use in pregnant women.
• May 22, 2018: The FDA announced a public meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss the new drug application for buprenorphine sublingual spray that would treat moderate-to-severe acute pain.
• May 24, 2018: The FDA announced a public workshop entitled, FY 2018 Generic Drug Regulatory Science Initiatives. The purpose of the workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on the initiatives.
• June 25, 2018: The CMS announced the Annual Laboratory Public Meeting. The meeting will gather public input on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HSPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule for calendar year 2019.
• June 25-26, 2018: The FDA announced a public symposium to discuss scientific topics related to the regulation of biologics and to highlight science conducted at the Center for Biologics Evaluation and Research. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.

II. Congressional Legislation & Committee Action

U.S. Senate

• On April 24, 2018, the Senate Health, Education, Labor and Pensions Committee held a markup for health-related bills, including S. 2680, S. 2315, S. 2597, and S. 382.
• On April 24, 2018, the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing to entitled, To Review the FY 2019 Budget Request for the Food & Drug Administration. FDA Commissioner Scott Gottlieb was the only witness.             

House of Representatives

• On April 25, 2018, the House Energy and Commerce Committee Health Subcommittee held a markup on numerous opioid-related bills. The Subcommittee advanced 57 bills to the full Committee.
• On April 26, 2018, the House Ways and Means Committee held a hearing entitled, Identifying Innovative Practices and Technology in Health Care. Witnesses present, included Matthew S. Philip, M.D., Physician, Breakthrough Care Center, DuPage Medical Group (DMG) joined by Paul F. Merrick, M.D., President, DMG; Oliver Kharraz, M.D., Chief Executive Officer (CEO) and Founder, Zocdoc; Becki Hafner-Fogarty, M.D., Senior Vice President, Policy and Strategy, Zipnosis, Inc.; Dan Paoletti, CEO, The Ohio Health Information Partnership; and Sean Cavanaugh, Chief Administrative Officer, Aledade and Former Deputy Administrator and Director, Center for Medicare, Centers for Medicare & Medicaid Services.

III. Reports, Studies, & Analyses

• On April 26, 2018, CMS Administrator Verma announced that the agency will make Medicare Advantage encounter data available to researchers.

IV. Other Health Policy News

• On April 23, 2018, the Journal of the American Medical Association issued a research letter entitled, Conflicts of Interest of Public Speakers at Meetings of the Anesthetic and Analgesic Drug Products Advisory Committee. The publication found that five percent of public speakers had an undisclosed financial association with a drug sponsor.