General Publications July 6, 2018

Alston & Bird Healthcare Week in Review, July 6, 2018

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news. 

I. Regulations, Notices, & Guidance

  •  On July 2, 2018, Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations. This proposed rule would update the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2019. It also proposes updates to the HH PPS case-mix weights for calendar year (CY) 2019 using the most current, complete data available at the time of rulemaking; discusses CMS efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CYs 2014 through 2017; proposes a rebasing of the HH market basket (which includes a decrease in the labor-related share); proposes the methodology used to determine rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the Bipartisan Budget Act of 2018 hereinafter referred to as the “BBA of 2018”; proposes regulations text changes regarding certifying and recertifying patient eligibility for Medicare home health services; and proposes to define “remote patient monitoring” and recognize the cost associated as an allowable administrative cost. Additionally, it proposes case-mix methodology refinements to be implemented for home health services beginning on or after January 1, 2020, including a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the BBA of 2018; includes information on the implementation of temporary transitional payments for home infusion therapy services for CYs 2019 and 2020, as required by section 50401 of the BBA of 2018; solicits comments regarding payment for home infusion therapy services for CY 2021 and subsequent years; proposes health and safety standards for home infusion therapy; and proposes an accreditation and oversight process for home infusion therapy suppliers. This rule proposes changes to the Home Health Value-Based Purchasing (HHVBP) Model to remove two OASIS-based measures, replace three OASIS-based measures with two new proposed composite measures, rescore the maximum number of improvement points, and reweight the measures in the applicable measures set. Also, the Home Health Quality Reporting Program provisions include a discussion of the Meaningful Measures Initiative and propose the removal of seven measures to further the priorities of this initiative. In addition, the HH QRP offers a discussion on social risk factors and an update on implementation efforts for certain provisions of the IMPACT Act. This proposed rule clarifies the regulatory text to note that not all OASIS data is required for the HH QRP. Finally, it would require that accrediting organization surveyors take CMS-provided training.
  • On July 2, 2018, the Food and Drug Administration (FDA) issued a guidance entitled, Abbreviated New Drug Application Submissions--Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Guidance for Industry; Availability. This guidance finalizes the October 2017 draft guidance for industry "ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA." This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application's review goal dates. The guidance also describes how FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II review goals.
  • On July 5, 2018, CMS issued a notice entitled, Medicaid Program: Final FY 2016 and Preliminary FY 2018 Disproportionate Share Hospital Allotments, and Final FY 2016 and Preliminary FY 2018 Institutions for Mental Diseases Disproportionate Share Hospital Limits. This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2016 and the preliminary federal share DSH allotments for FY 2018. This notice also announces the final FY 2016 and the preliminary FY 2018 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states’ FY DSH allotments.
  • On July 6, 2018, the FDA issued a guidance entitled, Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products--Content and Format; Draft Guidance for Industry; Availability. This guidance is intended to assist applicants in writing the Indications and Usage section of labeling. The recommendations in this draft guidance are intended to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.

Event Notices

  • July 9, 2018: The FDA announced a public meeting on “Patient-Focused Drug Development for Chronic Pain.” The meeting will provide patients with an opportunity to present FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments.
  • July 25, 2018: The CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The meeting will focus on obtaining the MEDCAC’s appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements, trans-catheter aortic valve replacements and percutaneous coronary interventions for hospitals.
  • July 30, 2018: The Department of Health and Human Services (HHS) announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council will spend the majority of the July meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations in the afternoon will include a presentation on a recent study by RAND on the health care infrastructure, the CDC/Alzheimer’s Association’s joint Healthy Brain Initiative Roadmap, federal workgroup updates, and updates on work by the non-federal members.
  • August 1, 2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The CSAT NAC will discuss substance use disorder spending estimates and the opioid epidemic.
  • August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.
  • August 21, 2018: The FDA announced a public work shop entitled, Development of Non-Traditional Therapies for Bacterial Infections. The purpose of the workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
  • September 12, 2018: The FDA announced a public hearing to solicit comments on FDA’s Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review.

II.Congressional Legislation & Committee Action

U.S. Senate

  • No health-related hearings this week.

House of Representatives

  •  No health-related hearings this week.

III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • On July 2, 2018, CMS released three reports that provide information on the current condition of the Federal and State-based Exchanges and state individual health insurance markets. According to CMS, the reports show that state markets are increasingly failing to cover people who do not qualify for federal subsidies even as the Exchanges remain relatively stable. Further information on the reports is available here.
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