Health Care Week in Review November 22, 2019

Alston & Bird Health Care Week in Review, November 22, 2019

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

On November 19, CMS announced that the Fiscal Year 2019 Medicare Fee-For-Service improper payment rate is at its lowest point since Fiscal Year 2010. Read more about this announcement and other news below.

I. Regulations, Notices, & Guidance

  • On November 18, 2019, the Department of Health and Human Services (HHS) issued a final rule entitled, Nonenforcement of Grants Regulation. This notification is to inform the public that HHS has determined that the rulemaking that resulted in the regulatory provisions promulgated on December 12, 2016, regarding HHS’s grant regulations, raises significant concerns about compliance with the Regulatory Flexibility Act. The provisions will not be enforced pending a repromulgation that complies with the Act.
  • On November 18, 2019, HHS issued a proposed rule entitled, Health and Human Services Grants Regulation. This rule would repromulgate or revise certain regulatory provisions of the HHS, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards.
  • On November 20, 2019, the Food and Drug Administration issued guidance entitled, Transdermal and Topical Delivery Systems—Product Development and Quality Considerations. This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Specifically, the guidance discusses FDA’s current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues, such as adhesion failure and the impact of applied heat on drug delivery.
  • On November 21, 2019, HHS issued a rule entitled, HHS Policy for the Protection of Human Research Subjects. The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), HHS, excepts two categories of research from the required use of a single institutional review board (IRB) to review cooperative research under the HHS regulations for the protection of human subjects. This determination is specific to research conducted or supported by HHS.
  • On November 21, 2019, CMS issued an interim final rule with comment period entitled, Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States. The rule further delays the inclusion of the U.S. territories (American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands) in the definitions of “States” and “United States” from April 1, 2020 until April 1, 2022, in relation to the Medicaid Drug Rebate Program (MDRP). Based on further discussions with the U.S. Territories, CMS found that while the territories are making progress, only one territory would be prepared to implement the MDRP program by April 1, 2020. This interim final rule with comment period will provide the U.S. territories with the additional time needed to develop systems so as to ensure interested territories are able to fully participate in MDRP.
  • On November 22, 2019, FDA issued guidance entitled, Certificates of Confidentiality. This draft guidance is intended to explain FDA implementation of the revised statutory provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) amended the statutory provisions relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom sensitive and identifiable information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding to disclose identifiable sensitive information about the research participant, created or compiled for the research. As amended, a CoC prohibits a researcher from disclosing such information unless a specified exception applies.

Event Notices

  • December 5, 2019: FDA announced a public meeting entitled, Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program. The purpose of the public meeting is to help ensure that as standard core sets of clinical outcome assessments (COAs) are developed as part of the FDA pilot grant program, the identified concepts, COAs, and endpoints reflect what is most important to patients and relevant to regulatory and potentially other stakeholder decision making. To facilitate this, stakeholders—including patients, care partners, FDA reviewers, drug developers, other government and academic researchers, health care providers, health technology assessors and health payers—are encouraged to attend the meeting.
  • December 5-6, 2019: The National Institute of Health (NIH) announced a public workshop entitled, National Center for Advancing Translational Sciences. This workshop is being held to discuss challenges around finding new uses for drugs that are already on the market but lack commercial and regulatory incentives for research and development.
  • December 6, 2019: FDA announced a public meeting entitled, Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making. The purpose of this meeting is to discuss incorporating clinical outcome assessments into endpoints for regulatory decision making. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act) and as part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Amendments (PDUFA VI).
  • December 10, 2019: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee. The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED); including updates on the following focus areas: data, access and engagement, treatment and recovery, justice, and finance; and discussion on pediatric behavioral health federal work.
  • December 16-17, 2019: CMS announced a town hall meeting entitled, Medicare Program; Town Hall Meeting on the FY 2021 Applications for New Medical Services and Technologies Add-On Payments. CMS is holding this meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss Fiscal Year (FY) 2021 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system. Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2021 new medical services and technologies applications meet the substantial clinical improvement criterion.

II. Congressional Hearings

House of Representatives

  • On November 19-20, 2019, the House Committee on Energy and Commerce held a markup of 18 bills. Health-related legislation included: H.R. 2339, Reversing the Youth Tobacco Epidemic Act of 2019; H.R. 4995, Maternal Health Quality Improvement Act of 2019; and H.R. 4996, Helping Medicaid Offer Maternity Services (MOMS) Act of 2019. The three bills were favorable reported to the full House.
  • On November 19, 2019, the House Judiciary Committee held a hearing entitled, The Patent Trial and Appeal Board and the Appointments Clause: Implications of Recent Court Decisions. Witnesses present included: John F. Duffy, Samuel H. McCoy II Professor of Law, University of Virginia School of Law; Robert A. Armitage, Consultant, IP Strategy & Policy; John M. Whealan, Intellectual Property Advisory Board Associate Dean for Intellectual Property law Studies, George Washington University Law School; and Arti K. Rai, Elvin R. Latty Professor of Law and Faculty Directory, The Center for Innovation Policy, Duke University School of Law.
  • On November 20, 2019, the House Judiciary Committee held a markup of five bills. Health-related legislation included: H.R. 3991, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; and H.R. 5133, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Both bills were favorably reported to the full House.


  • On November 20, 2019, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing on the Nomination of Dr. Stephen M. Hahn, MD, to serve as FDA Commissioner. Members of the HELP Committee took turns questioning Dr. Hahn to determine whether he would be a good fit for the role.
  • On November 20, 2019, the Senate Committee on Finance held a hearing entitled, Alzheimer’s Awareness: Barriers to Diagnosis, Treatment and Care Coordination. Witness present included: Dr. Jason Karlawish, Professor of Medicine, Medical Ethics and Health Policy, and Neurology, and Co-Director, Penn Memory Center, University of Pennsylvania; Janet Tomcavage, Chief Nursing Executive, Geisinger; Marc A. Cohen, Professor, Department of Gerontology, Co-Director, LeadingAge LTSS Center, and Research Director, Center for Consumer Engagement in Health Innovation, UMass Boston and Community Catalyst; and Lauren Kovach, Alzheimer’s Advocate.

III. Reports, Studies, & Analyses

  • On November 18, 2019, RAND Corporation published a report entitled, Medicare for 50-to-60-Year-Olds: Assessing the Effects of Allowing Older Adults to Buy Into the Medicare Program. In this report, the authors analyze how allowing adults ages 50 and older to buy into the Medicare program could affect health insurance coverage, individual market premiums, and federal health care spending. They consider a base buy-in scenario that assumes 50-to-64-year-olds are eligible for the buy-in, advance premium tax credits and cost-sharing reductions are available on the buy-in, and—like traditional Medicare—the buy-in has no out-of-pocket maximum. They then estimate eight alternative scenarios that vary based on assumptions about the design of the buy-in and consumers' response to the program. The findings presented in this report suggest that a Medicare buy-in could offer significantly more affordable coverage to older adults while potentially leading to higher premiums for the pool of people remaining on the individual market.
  • On November 21, 2019, Kaiser Family Foundation published an issue brief entitled, Insurer Participation on ACA Marketplaces, 2014-2020. Since the Affordable Care Act marketplaces opened in 2014, there have been many changes in insurer participation as companies entered and exited states or changed their footprint within states. A number of insurers are entering the market or expanding their service area for 2020. This year, 18 states are seeing a total of 26 new entrants (see Table 1) and an additional 54 insurers are expanding their service areas within states. There will be an average of 4.5 insurers per state in 2020, up from 4.0 in 2019 and 3.5 in 2018, but down from a peak of 6.0 in 2016. The map and charts in this issue brief show how insurer participation has changed from 2014–2020 in every county in the United States.

IV. Other Health Policy News

  • On November 18, 2019, HHS and the American Society of Nephrology (ASN) launched the second phase of KidneyX: Redesign Dialysis, a prize competition that seeks to transform kidney care. Redesign Dialysis is part of a series of KidneyX prize competitions to catalyze the development of innovative solutions that can prevent, diagnose, and treat kidney diseases. Read more about this competition here.
  • On November 19, 2019, CMS announced that the Fiscal Year (FY) 2019 Medicare Fee-For-Service (FFS) improper payment rate is at its lowest point since FY 2010. The reduction in improper payments represent considerable savings for the American public. The Medicare FFS estimated improper payment rate decreased to 7.25 percent in FY 2019, from 8.12 percent in FY 2018, the third consecutive year the Medicare FFS improper payment rate has been below the 10 percent threshold for compliance established in the Improper Payments Elimination and Recovery Act of 2010. Read more about the announcement here.

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