Alston & Bird Health Care Week in Review, December 4, 2020

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, CMS issued its Medicare Outpatient Prospective Payment System and Physician Fee Schedule final rules. Read more about these rules and other news below.

I. Regulations, Notices & Guidance

• On November 30, 2020, the Food & Drug Administration (FDA) issued guidance entitled, Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications. This draft guidance focuses on specific recommendations pertinent to gastric pH-dependent drug-drug interaction (DDI) assessment and describes the FDA's recommendations regarding when clinical DDI studies with acid-reducing agents (ARAs) are needed; design of the clinical studies; interpretation of study results; and communicating findings and options for managing pH-dependent DDIs in product labeling.
• On November 30, 2020, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations. This proposed rule sets forth payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for federally facilitated Exchanges and State-based Exchanges on the Federal platform. It includes proposed changes related to special enrollment periods; Navigator program standards; direct enrollment entities; the administrative appeals processes with respect to health insurance issuers and non-federal governmental group health plans; the medical loss ratio program; acceptance of payments by issuers of individual market Qualified Health Plans; and other related topics. It proposes clarifications to the regulation imposing network adequacy standards with regard to Qualified Health Plans that do not use provider networks. It proposes changes to the regulation requiring the reporting of certain prescription drug information by qualified health plans or their pharmacy benefit managers. It also proposes a new direct enrollment option for federally facilitated Exchanges and State Exchanges. This proposed rule also proposes changes related to section 1332 State Innovation Waivers.
• On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare Program: CY 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc. This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; Medicaid Promoting Interoperability Program requirements for Eligible Professionals; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; Medicare enrollment of Opioid Treatment Programs; payment for office/outpatient evaluation and management services; Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan and Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy. This final rule also finalizes certain provisions of the interim final rules with comment period that CMS issued on March 31, 2020, May 8, 2020, and September 2, 2020 in response to the Public Health Emergency (PHE) for COVID-19. This rule also establishes coding and payment for virtual check-in services and for personal protective equipment (PPE) on an interim final basis.
• On December 3, 2020, HHS issued a final rule entitled, Department of Health and Human Services Good Guidance Practices. These regulations will help to ensure that the public receives appropriate notice of new guidance and that HHS guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them.
• On December 4, 2020, CMS issued a final rule entitled, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; etc. This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2021 based on CMS’ continuing experience with these systems. In this final rule with comment period, CMS describes the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this final rule with comment period establishes and updates the Overall Hospital Quality Star Rating beginning with the CY 2021; removes certain restrictions on the expansion of physician-owned hospitals that qualify as “high Medicaid facilities,” and clarifies that certain beds are counted toward a hospital’s baseline number of operating rooms, procedure rooms, and beds; adds two new service categories to the Hospital Outpatient Department (OPD) Prior Authorization Process; provides notice of the closure of two teaching hospitals and the opportunity to apply for available slots for purposes of indirect medical education (IME) and direct graduate medical education (DGME) payments; and revises the Clinical Laboratory Date of Service (DOS) policy. This interim final rule with comment period modifies the Radiation Oncology Model (RO Model) Model performance period for CY 2021, and establishes new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) for tracking of COVID-19 therapeutic inventory and usage and for tracking of the incidence and impact of Acute Respiratory Illness (including, but not limited to, Seasonal Influenza Virus, Influenza-like Illness, and Severe Acute Respiratory Infection) during the ongoing COVID-19 PHE.
• On December 4, 2020, FDA issued guidance entitled, Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency. FDA is issuing this guidance to provide FDA’s enforcement policy regarding certain quality standards requirements under the Mammography Quality Standards Act of 1992 (MQSA) and also to provide general considerations to facilities that may have temporarily ceased performing mammography or that may be continuing to perform mammography while facing difficulty in complying with certain quality standards requirements during the public health emergency. The MQSA is part of United States Code Title 42 - Public Health and Welfare, and is implemented in FDA’s regulations at 21 CFR part 900. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of HHS on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
• On December 4, 2020, FDA issued guidance entitled, FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency. FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 PHE. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.
• On December 4, 2020, FDA issued guidance entitled, Requesting FDA Feedback on Combination Products. The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics.  These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER)  and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER,  or through Combination Product Agreement Meetings (CPAMs),  as appropriate.

Event Notices   

• December 8-9, 2020: FDA announced a public meeting entitled, The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security. The purpose of the public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA and provide input on strategies and issues related to the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) and the results of FDA’s DSCSA Pilot Project Program.
• December 11, 2020: FDA announced a public workshop entitled, Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes—Exploring the Path Forward for Assessment. The purpose of the public workshop is to obtain scientific input on methods to evaluate the Opioid Analgesics Risk Evaluation and Mitigation Strategy (OA REMS) education program. To assist in the workshop discussion, FDA is making available an issues paper that provides a brief overview of the REMS background and challenges with evaluating the REMS education intervention.
• 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

There were no health-related Congressional hearings this week.

III. Reports, Studies & Analyses

• On November 30, 2020, the Government Accountability Office (GAO) published a report entitled, COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal Response. This report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic, and makes 11 new recommendations to federal agencies and raises one new matter for congressional consideration. Areas covered include medical supply shortages, COVID-19 testing, COVID-19 vaccines and therapeutics, nursing home care, assistance to individuals and businesses, and program integrity.
• On November 30, 2020, GAO published a report entitled, Public Health: Federal Programs Provide Screening and Treatment for Breast and Cervical Cancer. According to the Centers for Disease Control and Prevention (CDC), tens of thousands of people die each year from breast or cervical cancer. Early screening and detection, followed by prompt treatment, can improve outcomes and, ultimately, save lives. Federal programs, like CDC’s Early Detection Program, are intended to improve access to these services. GAO was asked to examine the implementation of the Early Detection Program and the states’ use of Medicaid under the Treatment Act. This report provides information on the number of people who were (1) screened through the Early Detection Program and (2) enrolled in Medicaid under the Treatment Act.
• On December 1, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Growth in Medicaid MCO Enrollment during the COVID-19 Pandemic. This brief looks at state Medicaid managed care enrollment data through September 2020 to assess the impact of the COVID-19 pandemic and economic crisis on Medicaid enrollment. Data collected for 30 states show Medicaid managed care enrollment increased to 11.3 percent from March 2020 through September 2020. The rate accelerated from the 4.1 percent reported for 27 states from March 2020 through May 2020 and reversed trends from March 2019 to March 2020 when aggregate growth declined. These trends mirror national enrollment trends that show enrollment growth has been accelerating post-pandemic.
• On December 3, 3030, KFF published an issue brief entitled, Addressing Racial Equity in Vaccine Distribution. This brief provides an overview of barriers to vaccination that disproportionately affect people of color and discusses how current national recommendations and state vaccine allocation plans address racial equity.

IV. Other Health Policy News

• On December 3, 2020, HHS released a new plan and announced a partnership to reduce maternal deaths and disparities that put women at risk prior to, during, and following pregnancy. In the newly released plan, HHS provides a roadmap for addressing risk factors before and during pregnancy, improving the quality of and access to maternity and postpartum care, and supporting a research agenda to fill gaps in current evidence. More information about the announcement can be found here.
• On December 3, 2020, HHS issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19. Among other things, the amendment authorizes healthcare personnel using telehealth to order or administer Covered Countermeasures, such as a diagnostic test that has received an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA), for patients in a state other than the state where the healthcare personnel are already permitted to practice. More information about the amendment can be found here.
• On December 3, 2020, CMS announced a new voluntary payment model that builds on CMS’ focus to deliver Medicare beneficiaries value through better care and improved quality. The Geographic Direct Contracting Model will test an approach to improving health outcomes and reducing the cost of care for Medicare beneficiaries in multiple regions and communities across the country. Through the model, participants will take responsibility for beneficiaries’ health outcomes, giving participants a direct incentive to improve care across entire geographic regions. Within each region, organizations with experience in risk-sharing arrangements and population health will partner with health care providers and community organizations to better coordinate care. More information about the model can be found here.

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