Alston & Bird Healthcare Week in Review

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Below is Alston & Bird’s Healthcare 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 7, CMS issued the first annual update to the Medicaid and Children’s Health Insurance Program (CHIP) Scorecard. Read more about the update below.


I. Regulations, Notices, & Guidance

  • On November 4, 2019, the Department of Health and Human Services (HHS) issued a rule entitled, Annual Civil Monetary Penalties Inflation Adjustment. HHS is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, and is making a technical change to correct an error in the regulation.
  • On November 7, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff. This document sets forth risk-based principles by which FDA conducts ongoing postmarketing safety surveillance for human drug and biological products. The main topics this document addresses include: a multidisciplinary, life-cycle approach to the management of drug and biologic safety; general considerations that inform the frequency and extent of systematic drug and biologic safety monitoring; additional considerations based on specific product types and patient populations; safety signal identification based on screening and data mining of the adverse event (AE) reporting system and other data sources; a multidisciplinary, comprehensive evaluation of the identified safety signal that integrates the cumulative data gathered from all available sources; an assessment of the causal association between the identified AE and the product; and an overview of regulatory and other actions that can be taken in response to identified safety signals.
  • On November 8, 2019, FDA reopened the comment period on its proposed rule entitled, Tobacco Products; Required Warnings for Cigarette Packages and Advertisements. The proposed rule, which appeared in the Federal Register of August 16, 2019, would establish new required cigarette health warnings for cigarette packages and advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. This proposed rule, once finalized, would specify the color graphics that must accompany the new textual warning statements. FDA is proposing to take this action to promote greater public understanding of the negative health consequences of cigarette smoking. Comments will be due 15 days after the proposed rule is published in the Federal Register.
  • On November 8, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled, Medicare Program; CY 2020 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts. This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2020 under Medicare Part A. The Medicare statute specifies the formulae used to determine these amounts. For CY 2020, the inpatient hospital deductible will be $1,408. The daily coinsurance amounts for CY 2020 will be: $352 for the 61st through 90th day of hospitalization in a benefit period; $704 for lifetime reserve days; and $176 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
  • On November 8, 2019, CMS issued a notice entitled, Medicare Program; CY 2020 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement. This annual notice announces the Medicare Part A premium for uninsured enrollees in calendar year (CY) 2020. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2020 for these individuals will be $458. The premium for certain other individuals as described in this notice will be $252.
  • On November 8, 2019, CMS issued a notice entitled, Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2020. This notice announces the monthly actuarial rates for aged and disabled beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2020. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2020, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2020 are $283.20 for aged enrollees and $343.60 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2020 is $144.60, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00 repayment amount required under current law. (The 2019 standard premium rate was $135.50, which included the $3.00 repayment amount.) The Part B deductible for 2020 is $198.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, 80, or 85 percent of the total cost of Part B coverage plus a repayment amount of $4.20, $6.00, $7.80, $9.60, or $10.20 respectively.

Event Notices

  • November 12, 2019: FDA announced a public workshop entitled, Advancing the Development of Pediatric Therapeutics: Pediatric Clinical Trial Endpoints for Rare Diseases with a Focus on Pediatric Patient Perspectives. The purpose of this workshop is to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases. In this workshop, FDA will obtain the pediatric patient perspective on their disease/condition and what is most important to consider when designing rare disease trials. There will also be discussion regarding patients’ thoughts on clinical endpoints that are currently being used in clinical trials, potential areas of innovation, and how to create processes that might include pediatric patients and their caregivers as collaborators in endpoint development in early stages of medical product development (e.g., protocol design).
  • November 13-14, 2019: FDA announced a public meeting entitled, Immunology Devices Panel of the Medical Devices Advisory Committee. The committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam.
  • November 6-7, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Clinical Laboratory Improvement Advisory Committee. The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will focus on a follow up on CLIAC recommendations; an update on the clinical laboratory workforce; improving integration of laboratory information systems with electronic health records; and future CLIAC topics. There will be an extended public comment session focusing on emerging technologies and the clinical laboratory. Agenda items are subject to change as priorities dictate.
  • November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.
  • November 13, 2019: FDA announced a public meeting entitled, Endocrinologic and Metabolic Drugs Advisory Committee. The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.
  • November 13-14, 2019: HHS announced a public meeting entitled, Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. The purpose of the meeting is to discuss issues related to the President’s initiative on “Ending the HIV Epidemic: A Plan for America,” building community capacity, strategies for engaging people with HIV who are out of care, models of clinical care, workforce issues, pre-exposure prophylaxis services in community health centers, and pending committee reports.
  • November 21, 2019: FDA announced a public meeting entitled, Pediatric Stakeholder Meeting. The purpose of the meeting is to solicit input from patient/parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).
  • November 22, 2019: FDA announced a public meeting entitled, Blood Products Advisory Committee. The committee will meet in open session to discuss scientific considerations for cold stored platelet products intended for transfusion, including product characterization, duration of storage and clinical indications for use. The committee will hear presentations on available characterization and functional studies of cold stored platelets, clinical studies, and the potential role of cold stored platelets in clinical care in military and civilian patient populations. The committee will also discuss the clinical studies needed to support the indications for use of cold stored platelet products stored beyond 3 days.
  • 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 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

There were no health-related hearings this week.

III. Reports, Studies, & Analyses

  • On November 4, the Kaiser Family Foundation (KFF) published an issue brief examining the amount Medicare beneficiaries spend out-of-pocket on health care. The analysis presents the most current data on out-of-pocket health care spending by Medicare beneficiaries, both overall and among different groups of beneficiaries. The analysis addresses how much, on average, Medicare beneficiaries spend out-of-pocket in total on health care premiums and health-related services; how much Medicare beneficiaries spend out-of-pocket on different types of health-related services; and what share of income Medicare beneficiaries spend on out-of-pocket health care costs. The issue brief can be found here.
  • On November 7, KFF published an issue brief examining how Affordable Care Act (ACA) marketplace premiums are changing by county in 2020. The analysis found that premiums for ACA Marketplace benchmark silver plans are decreasing on average across the U.S. in 2020. However, premium changes vary widely by location and by metal level, including premium increases in a number of counties and plans. Additionally, the amount an exchange enrollee actually pays in premiums depends largely on their income – as most enrollees receive significant premium subsidies – and the difference in cost between the benchmark (second-lowest silver plan) and the premium for the plan they choose. The issue brief can be found here.
  • On November 7, the Organization for Economic Cooperation and Development (OECD) published the 2019 edition of Health at a Glance. This publication compares key indicators for population health and health system performance across OECD members, candidate, and partner countries. It highlights how countries differ in terms of the health status and health-seeking behavior of their citizens; access to and quality of health care; and the resources available for health. Analysis is based on the latest comparable data across 80 indicators, with data coming from official national statistics, unless otherwise stated. Alongside indicator-by-indicator analysis, an overview chapter summarizes the comparative performance of countries and major trends, including how much health spending is associated with staffing, access, quality and health outcomes. This edition also includes a special focus on patient-reported outcomes and experiences, with a thematic chapter on measuring what matters for people-centered health systems.

IV. Other Health Policy News

  • On November 6, CMS announced the approval of a first-of-its-kind Medicaid demonstration project that broadens treatment services available to Medicaid beneficiaries living in the District of Columbia (“the District”) diagnosed with serious mental illness (SMI) and/or serious emotional disturbance (SED).  At the same time, CMS is approving the District’s request to begin providing new services for its beneficiaries diagnosed with substance use disorder (SUD). Read more about the demonstration project here.
  • On November 6—on behalf of HHS—the United States filed a complaint in federal district court against Gilead Sciences, Inc. and Gilead Sciences Ireland UC (collectively, Gilead) seeking damages for Gilead’s infringement of HHS patents related to pre-exposure prophylaxis (or PrEP) for HIV prevention. Despite attempts by HHS to license its patents, Gilead has refused. In the complaint, HHS claims that Gilead has willfully and deliberatively induced infringement of the HHS patents. The complaint further alleges that, as a result of such infringement, Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale of Truvada® and Descovy®. Read more about the lawsuit here.
  • On November 7, CMS issued the first annual update to the Medicaid and Children’s Health Insurance Program (CHIP) Scorecard. The Scorecard enables American taxpayers to see how Medicaid and CHIP programs improve beneficiaries’ lives, ensures efficient use of taxpayer dollars to strengthen program integrity and accountability. The update promotes greater transparency and accountability by including additional data points, measures and enhanced functionality, and ensuring taxpayers’ dollars are being used efficiently on the $600 billion programs which serve nearly 73 million children and adults. Read more about this action here. Part of this update includes the release of the Transformed Medicaid Statistical Information System (T-MSIS) data, a robust and evolving collection of Medicaid and CHIP data files.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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