Alston and Bird Healthcare Week Review – May 2021 # 3 | Alston and Bird


Below is Alston & Bird Healthcare Week Review, which provides a synopsis of the latest news in health regulations, advice and advice; federal legislation and the work of congressional committees; reports, studies and analyzes; and other health policy news.


Weekly review Highlight of the week:

This week, the Senate Finance Committee discussed creating permanent flexibilities for COVID-19, including those related to telehealth. See the hearing and other news below.


I. Regulations, notices and guidelines

  • On May 19, 2021, the Food and Drug Administration (FDA) released a draft guidance titled, Clinical feasibility studies of certain medical devices intended to improve glycemic control in patients with type 2 diabetes mellitus. The draft guidelines provide recommendations for clinical studies of the feasibility and early feasibility of certain medical devices intended to improve glycemic control in patients with type 2 diabetes mellitus. These medical devices are intended to therapeutically reduce hemoglobin glycated in patients with type 2 diabetes mellitus regardless of the administration of drugs (eg, insulin). The draft guidelines are not final and are not in force at this time.
  • On May 21, 2021, the FDA released a draft guidance titled, Adjustment of covariates in randomized clinical trials for drugs and biologics. The draft guidelines, when finalized, will represent the FDA’s current thinking on adjusting covariates in randomized clinical trials for drugs and biologics. The guide revises the draft guideline “Adjusting Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Results” that was published on April 25, 2019. This revision provides more detailed recommendations for the use of linear models for covariate fit and also includes recommendations for covariate fit using nonlinear models.

Event notice

  • May 28, 2021: The Department of Health and Human Services (HHS) ad a public meeting entitled, COVID-19 Health Equity Working Group Meeting. The purpose of this meeting is to review the interim recommendations specific to discrimination and xenophobia
  • June 9, 2021: FDA ad a public workshop entitled, Models of informed drug development approaches for immunogenicity assessments. The purpose of this public workshop is to discuss best practices and future directions for quantitative methods for predicting the immunogenicity of biologicals.
  • June 16-17, 2021: HHS ad a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During this meeting, NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines and immunization equity.
  • June 23, 2021: FDA ad a public workshop entitled, Generic Drugs Research and Science Initiatives for Fiscal Year 2021 Workshop. The purpose of the public workshop is to provide an overview of the status of generic drug science and research initiatives and the opportunity to engage the public on these initiatives.
  • June 24, 2021: CMS ad a public meeting regarding the new and reconsidered clinical diagnostic laboratory test codes for the clinical laboratory fee schedule for the calendar year (CY) 2022. This notice announces a public meeting to receive comments and recommendations (including the data on which the recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Common Healthcare Procedures Coding System codes contemplated for Medicare payment under the Schedule of Clinical Laboratory Fee (CLFS) for CY 2022. This meeting also provides a forum for those who have submitted certain reconsideration requests regarding final decisions made last year on new test codes and for the public to comment on the requests.
  • June 29-30, 2021: HHS ad a public meeting entitled, Meeting of the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria. This meeting will be devoted to board deliberations and voting on two reports to be forwarded to the HHS Secretary, the first from the Disparities in Antibiotics Access and Use Working Group, and the second from the Antimicrobial Resistance Working Group (AMR ) in inter-vocational training. The remainder of the two-day public meeting will include an update on the state of the antibiotic development pipeline and an open board discussion on the provocative issues of antimicrobial resistance (no recommendations will be made), in addition presentations by subject matter experts on Operationalizing One. Health and environmental dimensions of antimicrobial resistance.
  • July 28-29, 2021: CMS ad a public meeting entitled, Medicare Advisory Group Meeting on Clinical Diagnostic Laboratory Tests. The purpose of the group is to advise the Secretary of HHS and the Administrator of CMS on matters related to clinical diagnostic laboratory testing.

II. Congressional hearings

US senate

  • On May 18, 2021, the Senate Finance Committee held a hearing entitled: Financing and Financing Options to Strengthen U.S. Infrastructure. Witnesses in attendance included: Joseph Kile, Ph.D., director of microeconomic analysis, Congressional Budget Office; Victoria Sheehan, president, American Association of State Highway Transportation Officials; Heather Buch, Subcommittee Chair, Transportation Steering Committee, National Association of Counties; and Shirley Bloomfield, CEO, NTCA – The Rural Broadband Association.
  • ON May 19, 2021, the Senate Finance Committee held a hearing entitled: COVID-19 Healthcare Flexibilities: Perspectives, Experiences and Lessons. Witnesses in attendance included: Jessica Farb, Director of Health Care, United States Government Accountability Office; Kisha Davis, MD, MPH, Member, Commission on Federal and State Policy, American Academy of Family Physicians; Linda DeCherrie, MD, Clinical Director, Mount Sinai at Home and Professor, Geriatrics and Palliative Medicine, Icahn School of Medicine, Mount Sinai; Narayana Murali, MD, executive director and board member, American Physician Groups, Marshfield Clinic; and Robert Berenson, MD, Institute Fellow, Urban Institute.
  • On May 19, 2021, the Senate Judiciary Subcommittee on Competition Policy, Antitrust Laws and Consumer Rights held a hearing titled: Applied Antitrust: Hospital Consolidation Problems and Solutions. Witnesses present included: Professor Martin Gaynor, Professor of Economics and Public Policy at EJ Barone University, Carnegie Mellon University; Ms. Beth McCracken, Pittsburgh, PA; Michael Cannon, director of health policy studies, Cato Institute; Dr. Rodney Hochman, president, president of the American Hospital Association; Ahmer Qadeer, Director of Strategic Initiatives, International Union of Service Employees; Dr Brian Miller, Assistant Professor of Medicine, John Hopkins School of Medicine.
  • On May 19, 2021, the Senate Committee on Homeland Security and Government Affairs held a hearing entitled: COVID-19 Part II: Assessment of the Medical Supply Chain and Pandemic Response Gaps. Witnesses in attendance included: Shereef Elnahal, MD, President and CEO, University Hospital; Robert Handfield, Ph.D., professor, Poole College of Management, North Carolina State University; Stephen Schondelmeyer, Professor, College of Pharmacy, Co-Principal Investigator, Resilient Drug Supply Project, University of Minnesota; and Kimberly Glas, President and CEO, National Council of Textile Organizations.
  • On May 20, 2021, the Senate Committee on Health, Education, Labor and Pensions held a hearing entitled: A serious shortage in the exploitation of the tax code for infrastructure investments. Witnesses in attendance included: David Skorton, MD, President and CEO, Association of American Medical Colleges; Leon McDougle, MD, MPH, president, National Medical Association; Shelley Spiers, Executive Director, Albany Area Primary Health Care; and James Herbert, Ph.D., president, University of New England.

United States House of Representatives

  • On May 19, 2021, the House Ways and Means Committee held a hearing entitled: Leverage the tax code for infrastructure investments. Witnesses present included: Khalil Shahyd, Senior Policy Advisor, National Resource Defense Council; Michael Novogradac, Managing Partner, Novogradac; Rachael Eubanks, Treasurer, State of Michigan; Stephen Lewis, Governor, Gila River Indian Community; and Adrian Moore, vice president of policy, Reason Foundation.

III. Reports, studies and analyzes

  • On May 17, 2021, the Office of the Inspector General of the Department of Health and Human Services (HHS OIG) released a report titled: Comparison of Average Selling Prices and Average Prices of Manufacturers: Fourth Quarter 2020 Results. By law, the OIG must notify the Secretary of HHS if the Average Sales Price (PMA) of a particular drug exceeds the Manufacturer’s Average Price (PMA) of the drug by five percent or more. If this threshold is reached, the secretary may disregard the drug’s ASP when setting the reimbursement amount and replace the payment amount with the lesser of the widely available market price or 103% of the AMP. . In the fourth quarter of 2020, the OIG found that some drug codes met CMS price substitution criteria, however, the drug codes were identified as being in short supply.

IV. More news on health policy

  • On May 17, 2021, the HHS agency responsible for administering the 340B Drug Pricing Program letters sent to six pharmaceutical manufacturers claiming that manufacturers’ policies limiting the prices of 340B in contract pharmacies have resulted in additional costs and are in direct violation of Law 340B. HRSA’s announcement states that the final rule of the 340B ceiling price and civil monetary penalties (CMP) (82 Fed. Reg. 1210, 1230 (January 5, 2017)) provides for penalties of $ 5,000 for each occurrence of overload when a manufacturer participating in the 340B knowingly and intentionally charges a covered entity more than the ceiling price of a covered outpatient drug. The letters state that “failure to always provide the 340B price to covered entities using contract pharmacies” may result in CMPs as described in the CMP final rule, in addition to reimbursements owed to covered entities, and requires an update. status day of compliance with the letter. to June 1.
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