Alston & Bird Health Care Week in Review - December 2020 #2

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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:

This week, HHS issued a final rule intended to govern the administrative dispute process in the 340B Drug Pricing Program. Read more about the rule and other news below.


I. Regulations, Notices & Guidance

  • On December 8, 2020, the Food & Drug Administration (FDA) issued guidance entitled, Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. This draft guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The draft guidance also describes the framework FDA uses in evaluating proposed proprietary names for nonprescription drug products, which is available to sponsors to use before marketing a nonprescription drug product bearing a particular proprietary name. This draft guidance is issued in response to industry stakeholders' requests to specifically address the approaches for naming of human nonprescription drug products.
  • On December 8, 2020, FDA issued guidance entitled, Best Practices in Developing Proprietary Names for Human Prescription Drug Products. This document provides guidance to sponsors on the development and selection of proposed proprietary names. This guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the FD&C Act and its implementing regulations and provides a voluntary framework for evaluating proposed proprietary names before submitting them for FDA review.
  • On December 10, 2020, the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), issued a final rule entitled, 340B Drug Pricing Program; Administrative Dispute Resolution Regulation. This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The final rule sets forth the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process.
  • On December 10, 2020, HHS released a notice of proposed rulemaking (NPRM) entitled, Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement. This proposed rule is intended to modify the Standards for the Privacy of Individually Identifiable Health Information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). These modifications address standards that may impede the transition to value-based health care by limiting or discouraging care coordination and case management communications among individuals and covered entities (including hospitals, physicians, and other health care providers, payors, and insurers) or posing other unnecessary burdens. The proposals in this NPRM address these burdens while continuing to protect the privacy and security of individuals’ protected health information.
  • On December 10, 2020, the Centers for Medicare & Medicaid Services (CMS) and HHS released a proposed rule entitled, Patient Protection and Affordable Care Act; Reducing Provider and Patient Burden by Improving Prior Authorization Processes, and Promoting Patients’ Electronic Access to Health Information for Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-facilitated Exchanges; Health Information Technology Standards and Implementation Specifications. This proposed rule would place new requirements on state Medicaid and CHIP fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of health care data, and streamline processes related to prior authorization, while continuing CMS’ drive toward interoperability, and reducing burden in the health care market. In addition, on behalf of HHS, the Office of the National Coordinator for Health Information Technology (ONC) is proposing the adoption of certain specified implementation guides (IGs) needed to support the proposed Application Programming Interface (API) policies included in this rule. Each of these elements plays a key role in reducing overall payer and provider burden and improving patient access to health information.
  • On December 11, 2020, FDA issued guidance entitled, Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway. This guidance provides performance criteria for spinal plating systems in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for spinal plating systems will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
  • On December 11, 2020, FDA issued guidance entitled, Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway. This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for non-spinal metallic bone screws and washers will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
  • On December 11, 2020, FDA issued guidance entitled, Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway. This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
  • On December 11, 2020, HHS issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. This final rule amends the Substance Abuse and Mental Health Services Administration’s (SAMHSA) regulation governing the Confidentiality of Substance Use Disorder Patient Records, to clarify one of the conditions under which a court may authorize disclosure of confidential communications made by a patient to a part 2 program as defined in this regulation. This change to the regulation is intended to clarify that a court has the authority to permit disclosure of confidential communications when the disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, such as one that directly threatens loss of life or serious bodily injury, where the extremely serious crime was allegedly committed by either a patient or an individual other than the patient.
  • On December 11, 2020, HHS issued a final rule entitled, Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. This document includes final rules regarding grandfathered group health plans and grandfathered group health insurance coverage that amend current rules to provide greater flexibility for certain grandfathered health plans to make changes to certain types of fixed-amount cost-sharing requirements without causing a loss of grandfather status under the Patient Protection and Affordable Care Act (ACA).

Event Notices  

  • December 15, 2020: FDA announced a public meeting entitled, Meeting of the Cardiovascular and Renal Drugs Advisory Committee. The committee will discuss supplemental new drug application (sNDA) 207620-S18, for the angiotensin receptor-neprilysin inhibitor, ENTRESTO (sacubitril and valsartan) tablets, submitted by Novartis Pharmaceuticals Corp., for the proposed indication of heart failure with preserved ejection fraction (HFpEF)
  • December 15-16, 2020: CMS announced a town hall entitled, Meeting on the FY 2022 Applications for New Medical Services and Technologies Add-On Payments. The purpose of the meeting is to discuss FY 2022 applications for add-on payments for new medical services and technologies under the IPPS.
  • December 16, 2020: FDA announced a public meeting entitled, Meeting of the Cardiovascular and Renal Drugs Advisory Committee. The committee will discuss spironolactone for the proposed treatment of heart failure with preserved ejection fraction, a serious and often fatal condition for which no drug is approved to improve outcomes.
  • January 7, 2020: CMS announced a public meeting entitled, Town Hall Meeting on Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) Implementation. This notice announces a virtual Town Hall meeting for CMS to share updates on the Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) policy considerations and for stakeholders to provide feedback on those MVP considerations for future implementation. Clinicians, professional organizations, third party vendors, stakeholders, and other interested parties are invited to this meeting to present their individual views on MVP design and implementation.

II. Congressional Hearings

U.S. Senate

  • On December 8, 2020, the Senate Committee on Homeland Security and Governmental Affairs held a hearing entitled, Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, Part II. Witnesses present included: Dr. Ramin Oskoui, Vice President of Medica Staff, Sibley Memorial Hospital and CEO, Foxhall Cardiology; Dr. Jean-Jacques Rajter, Pulmonologist, Broward Health Medical Center; Dr. Pierre Kory, Associate Professor of Medicine, St. Luke’s Aurora Medical Center; Dr. Armand Balboni, CEO, Appili Therapeutics, Inc.; Dr. Jane Orient, Executive Director, Association of American Physicians and Surgeons; and Dr. Jayanta Bhattacharya, Professor of Medicine, Stanford University, and Senior Fellow, Stanford Institute for Economic Policy Research.
  • On December 10, 2020, the Senate Committee on Commerce, Science, and Transportation held a hearing entitled, The Logistics of Transporting a COVID-19 Vaccine. Witnesses present included: Dr. Rachel Levine, Secretary of Health for the Commonwealth of Pennsylvania and President of the Association of State and Territorial Health Officers; Mr. Richard Smith, Regional President of the Americas and Executive Vice President, FedEx Express; and Mr. Wesley Wheeler, President of Global Healthcare, United Parcel Service.

III. Reports, Studies & Analyses

  • On December 7, 2020, the Government Accountability Office (GAO) published a report entitled, Medicaid: CMS Needs More Information on States' Financing and Payment Arrangements to Improve Oversight. GAO was asked to review the sources of funds states used for Medicaid and the types of payments made to providers. This report describes states’ reliance on provider and local government funds for these arrangements; the estimated effect of these arrangements on the federal share of net Medicaid payments; and the extent to which CMS collects information on these arrangements.
  • On December 8, 2020, the Kaiser Family Foundation (KFF) published an table entitled, Potential Health Policy Administrative Actions Under President Biden. This table includes potential administrative actions under the incoming Biden Administration, based on campaign pledges, and actions that would reverse or modify controversial regulations or guidance issued by the Trump Administration. The table also describes actions Biden could take as president that have received a great deal of attention from other prominent Democrats or are generally consistent with his campaign proposals, and that may therefore be priorities in Biden’s Administration.
  • On December 8, 2020, KFF published a report entitled, Options to Make Medicare More Affordable For Beneficiaries Amid the COVID-19 Pandemic and Beyond. This report analyzes several policy options that could help make health care more affordable for people covered by Medicare, including: (1) adding an out-of-pocket limit to Medicare Part A and Part B; (2) adding a hard cap on out-of-pocket drug spending under Medicare Part D; (3) expanding Medicare premium and cost-sharing assistance to low-income Medicare beneficiaries through the Medicare Shared Savings Program; and (4) expanding Part D premium and cost-sharing assistance to low-income Medicare beneficiaries through the Part D Low-Income Subsidy Program.
  • On December 10, 2020, KFF published an issue brief entitled, Estimates of the Initial Priority Population for COVID-19 Vaccination by State. This analysis provides new national and state-level estimates of the number of health care workers and long-term care residents who are expected to be part of the group first in line to receive the COVID-19 vaccine to gain insight into how this initial priority population varies across states. These estimates are based on KFF’s analysis of the 2019 American Community Survey (ACS) and Certification and Survey Provider Enhanced Reports (CASPER) data.

IV. Other Health Policy News

  • On December 7, 2020, HHS, through the HRSA, announced it will distribute $523 million in second round performance payments to over 9,000 nursing homes. These nursing homes are being rewarded for successfully reducing COVID-19 related infections and deaths between September and October. More information about this announcement can be found here.
  • On December 7, 2020, HHS released new hospital COVID-19 capacity data at the facility level. Previously released data about hospital capacity that had been released was aggregated at the state level. This new, more granular, data release aggregates daily hospital reports into a "week at a time" picture to protect patient privacy, while providing a view of how COVID-19 is impacting hospitals and local communities across the country. More information about this data can be found here.
  • On December 10, 2020, the U.S. Supreme Court unanimously ruled in favor of an Arkansas law that regulates how much pharmacy benefit managers (PBMs) can pay pharmacies, clearing the way for the more than 40 states with similar laws that aim to use PBM regulation to control drug prices. The ruling can be found here.

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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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