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 published an interim final rule extending the compliance dates for meeting certain information blocking and Health IT Certification requirements. Read more about this rule and other news below.
I. Regulations, Notices & Guidance
- On November 2, 2020, the Department of Health and Human Services (HHS) issued an interim final rule with comment period (IFC) entitled, Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency. This IFC gives health IT developers and health care providers flexibilities to effectively respond to the public health threats posed by the spread of COVID-19. Recognizing the urgency of this situation, and understanding that caring for patients with COVID-19 is of utmost importance, ONC is issuing this IFC to extend certain compliance dates and timeframes adopted in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule), including compliance and applicability dates for the information blocking provisions, certain 2015 Edition health IT certification criteria, and Conditions and Maintenance of Certification requirements under the ONC Health IT Certification Program (Program). In this IFC, ONC is also making programmatic changes to the Program by updating standards. In addition, ONC is making corrections and clarifications to the ONC Cures Act Final Rule, which was published in the Federal Register on May 1, 2020.
- On November 2, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program. This final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2021. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rule updates requirements for the ESRD Quality Incentive Program (QIP).
- On November 4, 2020, HHS issued a proposed rule entitled, Securing Updated and Necessary Statutory Evaluations Timely. The Regulatory Flexibility Act (RFA) requires agencies to publish plans to conduct periodic reviews of certain of their regulations. Multiple Executive Orders also require agencies to submit plans for periodic reviews of certain regulations. To further comply with the RFA and Executive Orders, and to ensure the Department’s regulations have appropriate impacts, HHS is issuing this notice of proposed rulemaking to set expiration dates for its regulations (subject to certain exceptions), unless the Department periodically assesses the regulations to determine if they are subject to the RFA, and if they are, performs a review that satisfies the criteria in the RFA.
- On November 6, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Insanitary Conditions at Compounding Facilities. Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients. FDA is issuing this guidance to help compounding facilities and State regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health. These examples are intended to help compounding facilities take action to prevent the occurrence of these and other insanitary conditions, as well as to implement appropriate corrective actions when such conditions already exist.
- 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 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: The Centers for Disease Control and Prevention (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.
- November 20, 2020: HHS announced a public meeting entitled, Meeting of the Advisory Committee on Minority Health. The purpose of this meeting is to finalize recommendations for improving access to and utilization of clinical preventive services among racial and ethnic minority populations. The recommendations will be given to the Deputy Assistant Secretary for Minority Health to inform efforts for removing barriers to achieving health equity.
- 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.
II. Congressional Hearings
There were no health-related Congressional hearings this week.
III. Reports, Studies & Analyses
- On November 2, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, State Variation in Seasonal Flu Vaccination: Implications for a COVID-19 Vaccine. As states consider the logistics of what will likely be an unprecedented vaccination campaign, analysis of routine vaccination rates by state may help to shed light on differential uptake across the country as well as inform where more targeted efforts might be needed. Specifically, this brief analyzed seasonal flu vaccination rates for the 2019-2020 flu season by state, as well as across states by age, race/ethnicity, and health risk status. Data were obtained from the CDC’s 2019-20 Influenza Season Vaccination Coverage Dashboard and are also available at KFF’s State Health Facts.
- On November 5, 2020, JAMA published a study entitled, Changes in Health Services Use Among Commercially Insured US Populations During the COVID-19 Pandemic. This study examined how health service use among commercially insured populations changed during the initial phase of the COVID-19 pandemic in the U.S. This cross-sectional study with a claims-based analysis of 6.8 million commercially insured individuals found that during the initial phase of the COVID-19 epidemic in March and April of 2020, patients significantly reduced use of preventive and elective care and increased use of telemedicine but not enough to offset reductions in in-person care. Racial/ethnic and income disparities were seen in changes in use of in-person care and telemedicine.
- On November 6, 2020, KFF published an issue brief entitled, Key Facts about the Uninsured Population. This issue brief describes trends in health coverage prior to the pandemic, examines the characteristics of the uninsured population in 2019, and summarizes the access and financial implications of not having coverage.
IV. Other Health Policy News
- On November 2, 2020, CMS released its Long-term Services and Supports (LTSS) Rebalancing Toolkitto support states in their efforts to expand and enhance home and community-based services (HCBS) and to rebalance, or recalibrate, LTSS from institutional to community-based systems. The toolkit advances CMS’s long-standing priority to support state flexibility to develop a broad range of HCBS; to reinforce the delivery of high quality and person-centered care; and to facilitate progress toward community integration of older adults and individuals with disabilities. By using this toolkit, states and other key stakeholders can help to accelerate the use of HCBS over institutional services, especially as states seek strategies and solutions to address the high rates of COVID-19 infection and death among nursing facility residents. More information about the toolkit can be found here.
- On November 6, 2020, HHS and the American Society of Nephrology (ASN) launched the KidneyX COVID-19 Kidney Care Challenge. The $300,000 challenge seeks solutions that reduce the transmission of coronavirus among people with kidney disease and/or reduce the risk of kidney damage among people who contract the virus. More information about this program can be found here.
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