Washington Healthcare Update

December 20, 2021

Pardon Our Dust

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This week in Washington: President Biden acknowledges that the Build Back Better Act might not pass Congress this year.

Congress 

House

Senate

Administration

Proposed Rules

Final Rules

Courts

Reports

  

Congress

The House and Senate are in recess.

House

On Dec. 14, the House and Senate passed the debt ceiling increase, averting a default.

Senate

Senate Passes the Methamphetamine Response Act of 2021

On Dec. 13, the Senate voted to pass the Methamphetamine Response Act of 2021, which was introduced by Sens. Dianne Feinstein (D-CA) and Chuck Grassley (R-IA). The bill would designate methamphetamine as an emerging drug threat and require the Office of National Drug Control Policy (ONDCP) to implement a plan to address its use.

Sens. Baldwin and Cassidy Introduce Bill to Improve Medical Device Safety

On Dec. 14, Sens. Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduced the Medical Device Integrity Act, which would increase the Food and Drug Administration’s (FDA) access to information about device manufacturers in an attempt to improve pandemic preparedness and device safety.

The bill text can be found here.

Republican Senators Introduce Bill to Limit Medicaid 1115 Waiver Denials

On Dec. 15, Sens. Marsha Blackburn (R-TN), Mike Braun (R-IN), Todd Young (R-IN), Mitt Romney (R-UT), Bill Hagerty (R-TN) and Jim Inhofe (R-OK) introduced the Let States Innovate Under Medicaid Act. The bill would prevent the Centers for Medicare and Medicaid Services (CMS) from denying a Section 1115 Medicaid demonstration waiver due to the work or community engagement requirements. 

The bill can be found here.

Administration

Biden Administration Issues Executive Order to Improve Government Service Delivery

On Dec. 13, the Biden administration issued an executive order titled “Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in the Government,” which aims to improve the delivery of government services and reduce barriers for people relying on safety net programs. The executive order details commitments to improve delivery of services across 17 agencies.

The order says that Medicare beneficiaries should have a more streamlined enrollment experience and enhanced online tools to manage and support their healthcare. In addition, the order calls for automated access to prenatal, birth and postpartum health records, strengthening maternal health quality requirements and allowing people eligible for the Special Supplemental Nutrition Program for Women, Infants, and Children to shop online.

The executive order can be found here.

HHS Says It Will Give 60-Days’ Notice Before Ending PHE Declaration 

On Dec. 16, a representative from the Department of Health and Human Services (HHS) stated that the department would provide 60 days of notice before allowing the public health emergency (PHE) declaration to lapse. This means that the PHE declaration with its related flexibilities will last at least through mid-March.

HRSA to Distribute $9 Billion in Provider Relief Payments  

On Dec. 14, the Department of Health and Human Services (HHS) announced that it would be distributing $9 billion of the Provider Relief Fund (PRF) Phase 4 payments to 69,000 providers that lost revenue and incurred expenses due to the COVID-19 pandemic. Providers started receiving the payments on Dec. 16.

CMS Releases National Health Expenditures Report

On Dec. 15, the Centers for Medicare and Medicaid Services (CMS) published its 2020 National Health Expenditures (NHE) Report. The NHE report has been published annually since 1960 and contains estimates for U.S. health spending by measuring annual spending by type of good or service, payer and sponsor. The 2020 report finds that the COVID-19 pandemic contributed to a 9.7 percent increase in national healthcare spending, taking the total to $4.1 trillion. The report noted that healthcare spending growth in 2020 was driven by federal spending through the Provider Relief Fund ($122 billion), the Paycheck Protection Program ($53 billion) and federal spending on vaccine development, health facility preparedness and COVID-19 testing. Federal spending on healthcare in 2020 represented an increase of 36 percent. Despite the high amount of federal healthcare spending in 2020, the national health expenditure growth was only 1.9 percent due to reduced healthcare due to the pandemic. The report also found that the number of uninsured Americans decreased from 31.8 million to 31.2 million. 

The CMS press release on the report can be found here.

The 2020 NHE data can be found here.

FDA Loosens REMS Restrictions on Mifepristone

On Dec. 16, the Food and Drug Administration (FDA) announced it would be loosening the Risk Evaluation and Mitigation Strategy (REMS) restrictions on the abortion pill mifepristone to facilitate access and delivery via mail and pharmacy. Mifepristone can be administered at home and is approved to terminate a pregnancy of up to 10 weeks. Prior to the announcement, REMS restrictions required mifepristone to be administered under the direct supervision of a certified prescriber and it could not be dispensed by retail pharmacies.

FDA Approves Drug to Prevent Graft Versus Host Disease

On Dec. 15, the Food and Drug Administration (FDA) approved the first drug to prevent graft versus host disease (aGVHD). The drug, Orencia (abatacept), can be used in adults and children over two years of age undergoing bone marrow or stem cell transplantation from an unrelated donor. Graft versus host disease occurs when, following a stem cell transplant, the donor’s immune cells (graft) view the recipient body as foreign and the donated cells attack the recipient’s body. Acute graft versus host disease is potentially fatal.

The FDA press release on the approval can be found here.

CDC’s Vaccine Advisors Vote to Recommend mRNA COVID-19 Vaccine Over J&J Vaccine

On Dec. 16, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend the mRNA COVID-19 vaccine over Johnson & Johnson’s (J&J) adenovirus vector vaccine. This decision comes after reported deaths from thrombosis with thrombocytopenia syndrome (TTS), a rare condition associated with the J&J vaccine. On Dec. 14, the Food and Drug Administration (FDA) added a contraindication to the J&J vaccine for people with a history of TTS.

Proposed Rules

VA Publishes Notice to Update Its Reasonable Charges Calculation

On Dec. 17, the Department of Veterans Affairs (VA) published a notice titled “Reasonable Charges for Outpatient Medical Care or Services; v4.225, Calendar Year (CY) 2022 Update and National Average Administrative Prescription Drug Charge Update.” The notice includes an update to the Reasonable Charges collected by VA for medical care provided by the VA. The notice also updates the National Average Administrative Prescription Costs for calculating the cost of prescription drugs that were provided by the VA but not administered during treatment.

The change will be effective on Jan. 1, 2022.

The notice can be found here.

CMS Publishes Draft Guidance for Antisense Oligonucleotide Drug Products for Severe Diseases

On Dec. 8, the Food and Drug Administration (FDA) published a draft guidance document for industry titled “Investigational New Drug (IND) Submissions for Individualized Antisense Oligonucleotide (ASO) Drug Products for Severely Debilitating or Life-Threatening (SDLT) Diseases: Clinical Recommendations.” The guidance is intended to help sponsor-investigators interested in developing ASO products for rapidly progressive SDLT genetic diseases with clinical recommendations for IND applications.

Comments will be accepted until Feb. 4, 2022.

The guidance can be found here.

FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions

On Nov. 3, the Food and Drug Administration (FDA) published new draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The guidance provides information on documentation sponsors need to submit for FDA’s evaluation of the safety and effectiveness of device software functions. When final, the guidance will replace prior guidance issued in 2005.

Public comments will be accepted until Feb. 2, 2022.

The draft guidance can be found here.

HHS Issues Proposed Rule to Withdraw the SUNSET Rule

On Oct. 29, the Department of Health and Human Services (HHS) issued a proposed rule that would withdraw the January 2021 final rule titled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The SUNSET final rule required HHS regulations with a significant economic impact to be reviewed every 10 years, with regulations automatically expiring if they were not reviewed. This would have impacted more than 17,000 HHS regulations and required a review process considerably faster than HHS ever conducted.

The rule would have gone into effect in March 2021, but HHS issued a delay following a lawsuit.

Comments will be accepted until Dec. 28, 2021.

The proposed rule can be found here.

FDA Issues Draft Industry Guidance on Real-World Data Standards

On Oct. 22, the Food and Drug Administration (FDA) announced industry draft guidance titled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” The guidance includes recommendations to help sponsors comply with the Federal Food, Drug and Cosmetic Act when submitting study data from real-world data sources.

Public comments will be accepted until Dec. 21, 2021.

The draft guidance can be found here.

FDA Issues Proposed Rule on Over-the-Counter Hearing Aids

On Oct. 20, the Food and Drug Administration (FDA) issued a proposed rule titled “Medical Devices: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.” The proposed rule would establish a new category of over-the-counter (OTC) hearing aids that could be sold to consumers directly without a medical exam or audiologic hearing. The proposed rule comes after President Biden’s July Executive Order aimed at promoting competition in the economy directed the FDA to increase access to OTC hearing aids.

Public comments will be accepted until Jan. 18, 2022.

The proposed rule can be found here.

Final Rules

FDA Issues Final Rule to Amend Laboratory Food Testing Requirements

On Dec. 1, the Food and Drug Administration (FDA) issued a final rule titled “Laboratory Accreditation for Analyses of Foods.” The rule amends FDA regulations to establish a program for accredited laboratories to test food under certain circumstances.

The final rule will go into effect on Feb. 1, 2022.

The final rule can be found here.

CMS Issues Final Rule for End-Stage Renal Disease Prospective Payment System

On Oct. 29, the Centers for Medicare and Medicaid Services (CMS) published a final rule titled “End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model.” The final rule updates payment rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services starting Jan. 1, 2022. The rule also updates the acute kidney injury (AKI) dialysis payment rate for renal dialysis services and the ESRD Treatment Choices (ETC) Model.

The final rule will go into effect on Jan. 1, 2022.

The final rule can be found here. The CMS fact sheet on the final rule can be found here.

CMS Issues CY 2022 Medicare Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems Final Rule

On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) released a Final Rule titled “Calendar Year (CY) Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center (ASC) Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model.” CMS is required by the January 2021 Hospital Price Transparency Final Rule to update Medicare payment policies for Outpatient Prospective Payment System (OPPS) hospitals and ASCs on an annual basis. The changes in the final rule aim to strengthen enforcement of hospital price transparency requirements and will stop the phased elimination of the Inpatient Only (IPO) list for surgical procedures. CMS will increase the penalty for hospitals that do not comply with the Hospital Price Transparency Rule starting on Jan. 1, 2022. The final rule also halts the elimination of the IPO list. In addition, the rule updates the OPPS payment rates for hospitals that meet quality reporting requirements by 2.0 percent. The final rule also details the Radiation Oncology Model, which is set to begin on Jan. 1, 2022, and last for five years.

The final rule will go into effect on Jan. 1, 2022.

The final rule can be found here. The CMS fact sheet on the final rule can be found here.

CMS Issues CY 2022 Medicare Physician Fee Schedule Final Rule

On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) issued a final rule titled “Calendar Year (CY) 2022 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-payment Medical Review Requirements.” The rule includes policy changes for Medicare payments under the Physician Fee Schedule (PFS) and would continue the coverage of Medicare telehealth services and finalize changes to the Medicare Diabetes Prevention Program (MDPP) expanded model, among other things. The CY 2022 PFS conversion factor is $33.59, a decrease from the CY 2021 factor of $34.89.

The final rule will go into effect on Jan. 1, 2022.

The final rule can be found here. The CMS fact sheet on the final rule can be found here.

CMS Issues 2022 Home Health Prospective Payment System Rate Final Rule

On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Calendar Year (CY) 2022 Home Health Prospective Payment System Rate Final Rule.” The rule will expand the Home Health Value-Based Purchasing (HHVBP) Model. In addition, the rule updates the Medicare Home Health Prospective Payment System (HH PPS) and the home infusion therapy services payment rates for CY 2022. In addition, the proposed rule makes permanent changes to the home health Conditions of Participation (CoP) implemented during the COVID-19 public health emergency.

The final rule will go into effect on Jan. 1, 2022.

The final rule can be found here. The CMS fact sheet on the final rule can be found here.

Courts

Eighth Circuit Court Denies Biden Administration Request to Lift Vaccine Mandate Injunction

On Dec. 13, the Eighth Circuit Court denied the Biden administration’s request to lift a preliminary injunction that blocked the Centers for Medicare and Medicaid Services’ (CMS) Interim Final Rule mandating COVID-19 vaccination for healthcare workers. This decision means that hold continues as the Biden administration continues to appeal the lower court ruling.

Reports

GAO Report on COVID-19 Relief Funding for Behavioral Health in Higher-Risk Populations

On Dec. 10, the Government Accountability Office (GAO) published a report titled “Behavioral Health and COVID-19: Higher-Risk Populations and Related Federal Relief Funding.” The report states that certain populations may be at higher risk for exacerbated behavioral health symptoms or conditions related to the COVID-19 pandemic. The populations at higher risk include children and adolescents who faced disruptions to school-based behavioral health services. The GAO notes that the federal government has awarded $8 billion in COVID-19 relief funding for behavioral health, which could serve the higher-risk populations mentioned above.

The full report can be found here.

GAO Report on Support Services Provided During the COVID-19 Pandemic

On Dec. 15, the Government Accountability Office (GAO) published a report titled “COVID-19: Selected States Modified Meal Provision and Other Older Americans Act Services to Prioritize Safety.” The report says that support services for older Americans were important during the COVID-19 pandemic. The GAO found that states used a majority of their supplemental COVID-19 funding from the Older Americans Act to provide meals, and spent much less to provide other services, such as in-home services.

The full report can be found here.

GAO Report on Agency Use of Defense Production Act Authorities

On Dec. 16, the Government Accountability Office (GAO) published a report titled “COVID-19: Agencies Are Taking Steps to Improve Future Use of Defense Production Act Authorities.” The report says that federal agencies faced challenges using Defense Production Act (DPA) authorities to address medical supply needs during the COVID-19 public health emergency. The GAO said that the Departments of Health and Human Services (HHS), Defense and the Office of Management and Budget (OMB) established new procedures and practices to manage DPA authorities, and additional actions are expected through 2025 as agencies use American Rescue Plan funding.

The full report can be found here.

HHS OIG Report on Medicare Beneficiaries With Opioid Use Disorder

On Dec. 15, the Health and Human Services’ (HHS) Office of the Inspector General (OIG) published a report on Medicare beneficiaries with opioid use disorder. The report notes that while 1 million Medicare beneficiaries were diagnosed with opioid use disorder (OUD) in 2020, less than 16 percent of beneficiaries received medicated treatment. In addition, less than half of the Medicare beneficiaries that received medication to treat their OUD also received behavioral health services. This raises concern that Medicare beneficiaries are facing challenges to accessing treatment. The HHS OIG recommends that the Centers for Medicare and Medicaid Services (CMS) reach out to beneficiaries to increase awareness of Medicare coverage of OUD treatments, work to increase the number of providers and treatment programs for Medicare beneficiaries with OUD and take steps to increase the utilization of behavioral health services, among other things.

The full report can be found here.

Our next newsletter will be in January. We wish you a happy holiday and a happy new year.

If you have any questions, contact the following individuals atMcGuireWoods Consulting:

Stephanie Kennan, Senior Vice President
Alexandra Gale, Research Associate

Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.

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