Alston & Bird Health Care Week in Review, October 30, 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 several rules, including an interim final rule in response to the COVID-19 public health emergency and a final rule on price transparency. Read more about these rules and other news below.

I. Regulations, Notices & Guidance

• On October 27, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date. FDA is issuing this guidance to revise its compliance policy regarding the deadline for filing premarket approval (PMA) applications for previously cleared accessories necessary to the operation of automated external defibrillator (AED) systems.
• On October 27, 2020, FDA issued guidance entitled, Referencing Approved Drug Products in Abbreviated New Drug Application Submissions. Any person is permitted to submit an abbreviated new drug application (ANDA) in order to seek approval to market a generic version of a previously approved drug product. The purpose of this guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an ANDA submission.
• On October 27, 2020, FDA issued guidance entitled, Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. This draft guidance provides information intended to assist applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product application (MRTPA), a premarket tobacco product application (PMTA), or a substantial equivalence (SE) report. The draft guidance is intended to discuss a variety of scientific issues applicants may want to consider as they design and conduct TPPI studies.
• On October 28, 2020, FDA issued guidance entitled, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products. This document provides guidance about the nonclinical information FDA recommends to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. This guidance finalizes the draft guidance of the same name issued August 6, 2018.
• On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) released an interim final rule with comment period (IFC) entitled, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. This IFC discusses CMS’s implementation of section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136), which established Medicare Part B coverage and payment for COVID-19 vaccines and their administration. This IFC implements requirements in the CARES Act that providers of COVID-19 diagnostic tests make public their cash prices for those tests and establishes an enforcement scheme to enforce those requirements. This rule also establishes an add-on payment for cases involving the use of new COVID-19 treatments under the Medicare Inpatient Prospective Payment System (IPPS). This IFC provides for separate payment for new COVID-19 treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for COVID-19 when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service. This rule also interprets and implements the requirement to maintain Medicaid beneficiary enrollment in order to receive the temporary increase in federal funding in the Families First Coronavirus Response Act (FFCRA). This IFC modifies policies of the Comprehensive Care for Joint Replacement (CJR) model and adds technical changes to accommodate these policy changes. Specifically, CMS is extending Performance Year (PY) 5 by adding 6 months, creating an episode-based extreme and uncontrollable circumstances COVID-19 policy, providing two reconciliation periods for PY 5, and adding DRGs 521 and 522 for hip and knee procedures. This rule also amends regulations regarding coverage of preventive health services to implement section 3203 of the CARES Act, which shortens the timeframe within which non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage must begin to cover without cost sharing qualifying coronavirus preventive services, including recommended COVID-19 immunizations. This IFC also revises regulations to set forth flexibilities in the public notice requirements and post award public participation requirements for State Innovation Waivers under section 1332 of the Patient Protection and Affordable Care Act (PPACA) during the public health emergency for COVID-19.
• On October 29, 2020, CMS released a final rule entitled, Transparency in Coverage. The final rule sets forth requirements for group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information upon request to a participant, beneficiary, or enrollee (or his or her authorized representative), including an estimate of the individual’s cost-sharing liability for covered items or services furnished by a particular provider. Under the final rule, plans and issuers are required to make this information available on an internet website and, if requested, in paper form, thereby allowing a participant, beneficiary, or enrollee (or his or her authorized representative) to obtain an estimate and understanding of the individual’s out-of-pocket expenses and effectively shop for items and services. The final rule also requires plans and issuers to disclose in-network provider negotiated rates, historical out-of-network allowed amounts, and drug pricing information through three machine-readable files posted on an internet website, thereby allowing the public to have access to health coverage information that can be used to understand health care pricing and potentially dampen the rise in health care spending. HHS also finalized amendments to its medical loss ratio (MLR) program rules to allow issuers offering group or individual health insurance coverage to receive credit in their MLR calculations for savings they share with enrollees that result from the enrollees shopping for, and receiving care from, lower-cost, higher-value providers.
• On October 29, 2020, FDA issued guidance entitled, Providing Regulatory Submissions in Electronic Format—Standardized Study Data. This guidance and the technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act. In accordance with section 745A(a), following the issuance of a final guidance on this topic, study data contained in the submission types identified in this guidance must be submitted electronically in a format that FDA can process, review, and archive.
• On October 29, 2020, CMS issued a final rule entitled, CY 2021 Home Health Prospective Payment System Rate Update, Home Health Quality Reporting Program Requirements, and Home Infusion Therapy Services and Supplier Enrollment Requirements; and Home Health Value-Based Purchasing Model Data Submission Requirements. This final rule updates the home health prospective payment system (HH PPS) payment rates and wage index for calendar year (CY) 2021. This final rule also implements the changes to the home health regulations regarding the use of telecommunications technology in providing services under the Medicare home health benefit as described in the “Medicare and Medicaid Programs, Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” interim final rule with comment period (March 2020 COVID-19 IFC). In addition, this rule implements the permanent home infusion therapy services benefit and supplier enrollment requirements for CY 2021 and finalizes conforming regulations text changes excluding home infusion therapy services from coverage under the Medicare home health benefit. This rule also finalizes a policy to align the Home Health Value-Based Purchasing (HHVBP) Model data submission requirements with any exceptions or extensions granted for purposes of the Home Health Quality Reporting Program (HH QRP) during the COVID-19 PHE and also finalizes a policy for granting exceptions to the New Measures data reporting requirements during the COVID-19 PHE, as described in the “Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program” interim final rule with comment period (May 2020 COVID-19 IFC).
• On October 29, 2020, CMS issued a proposed rule entitled, Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues and Level II of the Healthcare Common Procedure Coding System (HCPCS). This proposed rule would establish methodologies for adjusting the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule amounts using information from the Medicare DMEPOS competitive bidding program for items furnished on or after April 1, 2021, or the date immediately following the duration of the emergency period described in section 1135(g)(1)(B) of the Social Security Act, whichever is later; application evaluation processes and other procedures related to Healthcare Common Procedure Coding System (HCPCS) Level II code applications; and procedures for making benefit category and payment determinations for new items and services that are durable medical equipment (DME), prosthetic devices, orthotics and prosthetics, therapeutic shoes and inserts, surgical dressings, or splints, casts, and other devices used for reductions of fractures and dislocations under Medicare Part B. In addition, this rule proposes to classify continuous glucose monitors (CGMs) as DME under Medicare Part B and establish fee schedule amounts for these items and related supplies and accessories. Also, this proposed rule would expand the scope of the Medicare Part B benefit for DME by revising the interpretation of the “appropriate for use in the home” requirement in the definition of DME specifically for certain drugs or biologicals infused in the home using an external infusion pump. This proposed rule would also make conforming changes to the regulations related to implementation of section 106 of the Further Consolidated Appropriations Act, 2020.
• On October 29, 2020, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Implementation of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment. The SUPPORT Act, which became law on October 24, 2018, amended the Controlled Substances Act to expand the conditions a practitioner must meet to provide medication-assisted treatment and expand the options available for a physician to be considered a qualifying physician. The SUPPORT Act removed the time period for a nurse practitioner or physician assistant to be considered a qualifying other practitioner, and revised the definition of a qualifying practitioner. The SUPPORT Act also allows a pharmacy to deliver prescribed controlled substances to a practitioner’s registered location for the purpose of maintenance or detoxification treatment to be administered under certain conditions by a practitioner. The DEA amends its regulations to make them consistent with the SUPPORT Act and implement its requirements.
• On October 30, 2020, CMS issued a proposed rule entitled, Basic Health Program: Federal Funding Methodology for Program Year 2022. This document proposes the methodology and data sources necessary to determine Federal payment amounts to be made for program year 2022 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.

Event Notices 

• November 5, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following HICPAC workgroups: The Healthcare Personnel Guideline Workgroup; the Long-term Care/Post-acute Care Workgroup; and the Neonatal Intensive Care Unit Workgroup.
• November 6, 2020: FDA announced a public meeting entitled, Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease.
• November 9, 2020: FDA announced a public meeting entitled, Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The committee will discuss, make recommendations and vote on information regarding the PMA for the VisAbility Micro Insert sponsored by Refocus Group, Inc.
• November 16, 2020: FDA announced a public meeting entitled, Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs. The purpose of the meeting is to obtain early input from the public on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with the use of antimicrobial drugs in animals. FDA is seeking public input on a potential revised process for ranking antimicrobials according to their relative importance in human medicine, on the potential criteria for their ranking, and on the resulting ranked list of antimicrobial drugs.
• November 19, 2020: FDA announced a public meeting entitled, Reauthorization of the Biosimilar User Fee Act. The purpose of this public meeting is to hear stakeholder views on the Biosimilar User Fee Act (BsUFA) as the FDA considers elements to propose, update, or discontinue in the next BsUFA.
• November 20, 2020: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Breast Cancer in Young Women (ACBCYW). The agenda will include discussions on current topics related to breast cancer in young women. These will include Mental/Behavioral Health, Sexual Health, Genetics and Genomics, and Provider Engagement.
• 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 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.

II. Congressional Hearings

There were no health-related Congressional hearings this week.

III. Reports, Studies & Analyses

• On October 29, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, More Than Half of All People on Medicare Do Not Compare Their Coverage Options Annually. Each year, people with Medicare have the opportunity to review their coverage options and change plans during the open enrollment period (October 15 to December 7). Previous KFF analysis shows that only a small share of Medicare beneficiaries voluntarily switch plans. This may indicate that beneficiaries are satisfied with their current coverage, but it may also indicate that many people on Medicare find it difficult to compare plans, are unaware of the open enrollment period, or are not confident in their ability to select a better plan. This analysis builds on previous KFF work by examining beneficiaries’ knowledge and behavior related to the Medicare open enrollment period, based on an analysis of the 2018 Medicare Current Beneficiary Survey.
• On October 29, 2020, KFF published an issue brief entitled, Medicare Part D: A First Look at Medicare Prescription Drug Plans in 2021. During the Medicare open enrollment period each year, beneficiaries can enroll in a plan that provides Part D drug coverage, either a stand-alone prescription drug plan (PDP) as a supplement to traditional Medicare, or a Medicare Advantage prescription drug plan (MA-PD), which covers all Medicare benefits, including drugs. Among the 46 million Part D enrollees in 2020, 20.2 million (44%) are in PDPs and 19.3 million (41%) are in MA-PDs (excluding the 7.0 million (15%) in employer-only group PDPs and MA-PDs). This issue brief provides an overview of Medicare Part D drug plans that will be available in 2021 and key trends over time.
• On October 29, 2020, KFF published an issue brief entitled, Medicare Advantage 2021 Spotlight: First Look. Over the last decade, Medicare Advantage has taken on a larger role in the Medicare program. In 2020, more than 24 million Medicare beneficiaries are enrolled in a Medicare Advantage plan. This brief provides an overview of the Medicare Advantage plans that are available for 2021 and key trends over time.

IV. Other Health Policy News

• On October 28, 2020, the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced it will distribute approximately $333 million in first round performance payments to over 10,000 nursing homes. These nursing homes are being recognized for demonstrating significant reductions in COVID-19 related infections and deaths between August and September. More information about these performance payments can be found here.
• On October 30, 2020, HHS published the final 2020-2025 Federal Health IT Strategic Plan. The Plan outlines federal health information technology (health IT) goals and objectives, with a focus on individuals’ access to their electronic health information. More information about this plan can be found here.
• On October 30, 2020, HHS and the American Society of Nephrology (ASN) launched the KidneyX Artificial Kidney Prize to accelerate the development of artificial kidneys toward human clinical trials. This multiphase competition is KidneyX’s first fully dedicated effort toward artificial kidney advancement, with initial phases offering up to $10 million in prizes. Phase 1 seeks solutions that enable and advance the functionality, effectiveness, and/or reliability of artificial kidneys. More information about this prize can be found here.
• On October 30, 2020, FDA published a list of medicines and medical products needed to prepare the country for infectious disease outbreaks as well as chemical, biological, radiological and nuclear threats. More information about the list can be found here.

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