This week in Washington: Congress makes agreement on pathway forward to raise the debt ceiling.

Congress

Upcoming Hearings/Markups

House

• House Passes 15 Health Bills
• Reps. Griffith and Latta Introduce Bill to Permanently Schedule Fentanyl-related Substances
• House Oversight and Reform Committee Releases Report on Drug Pricing and Pharmaceutical Practices
• Reps. Bucshon and Buchanan Lead 100 Republican Members in Letter Opposing Federal Vaccine Mandate
• 25 Congressional Tri-Caucus Members Write Speaker Pelosi to Express Concern Regarding Medicare Reimbursement Cuts in the PFS Rule
• Rep. Devin Nunes to Retire at the End of the Year

Senate

• Senate and House Pass Bill to Phase in Medicare Sequester Cuts
• Senate Passes Bill Opposing Biden Administration Vaccine Mandate

Administration

• White House Marks the First Maternal Health Day of Action
• FDA Approves COVID-19 Boosters for 16- and 17-Year-Olds
• FDA Issues Emergency Use Authorization for AstraZeneca’s Monoclonal Antibody Treatment
• CMS Announces 4.6 Million Enrolled in Affordable Care Act Plans
• CMS Announces Updated Medicaid and CHIP Scorecard
• Lawrence Tabak to Serve as NIH Acting Director
• MACPAC Announces Retirement of Executive Director Anne Schwartz

Proposed Rules

• FDA Issues Final Industry Guidance on Tobacco Product User Fees
• CMS Publishes Draft Guidance for Antisense Oligonucleotide Drug Products for Severe Diseases
• FDA Issues Draft Guidance on Premarket Submissions for Device Software Functions
• HHS Issues Proposed Rule to Withdraw the SUNSET Rule
• FDA Issues Draft Industry Guidance on Real-World Data Standards
• FDA Issues Proposed Rule on Over-the-Counter Hearing Aids
• FDA Issues Guidance on Continuous Manufacturing of Drug Substances and Products
• FDA Issues Guidance Updating Unique Device Identification Policy

Final Rules

• FDA Issues Final Rule to Amend Laboratory Food Testing Requirements
• CMS Issues Final Rule to Delay VBP Reporting and the Inclusion of U.S. Territories
• CMS Issues Final Rule Rescinding Medicare Coverage of Innovative Technology and “Reasonable and Necessary” Final Rule
• CMS Issues Final Rule for End-Stage Renal Disease Prospective Payment System
• CMS Issues CY 2022 Medicare Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems Final Rule
• CMS Issues CY 2022 Medicare Physician Fee Schedule Final Rule
• CMS Issues 2022 Home Health Prospective Payment System Rate Final Rule

Courts

• Supreme Court Allows Texas Abortion Challenge to Proceed but Declines to Block Law
• Hospital and Doctor Groups Sue the Administration Regarding the Surprise Billing Rule

Reports

• GAO Report on ONDCP Grant Posting Practices

Upcoming Hearings/Markups

December 14

Senate Health, Education, Labor and Pensions (HELP) Committee Hearing: “Nomination of Dr. Robert Califf to be Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services”
10:00 a.m.

For more information, click here.

House Select Subcommittee on the Coronavirus Crisis Hearing: “A Global Crisis Needs a Global Solution: The Urgent Need to Accelerate Vaccinations Around the World”
2:00 p.m.

For more information, click here.

Congress

House

Reps. McMorris Rodgers and Comer Request Information on Biden Administration Compliance With COVID-19 Vaccine Mandates

On Nov. 23, Reps. Cathy McMorris Rodgers (D-WA-5) and James Comer (R-KY-1) wrote to the Acting Director of the Office of Management and Budget (OMB) Shalanda Young requesting an update on the Biden administration’s compliance with recent COVID-19 vaccination requirements for federal employees.

The full letter can be found here.

House Passes 15 Health Bills

On Dec. 8, the House voted to pass 15 health bills. The bills, with a brief summary, can be found below.

• The Accelerating Access to Critical Therapies for ALS Act (R. 3537) would award grants to certain small pharmaceutical companies to cover the costs of expanding ALS clinical trial access.
• The Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2021 (R. 5487) would authorize states to collect data related to stillbirth risk factors and carry out education efforts.
• The Early Hearing Detection and Intervention Act of 2021 (R. 5561) would reauthorize the Early Hearing Detection and Intervention (EHDI) programs at the Health Resources and Services Administration (HRSA).
• The Improving the Health of Children Act (R. 5551) would reauthorize the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention (CDC).
• The Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act (R. 1193) would authorize a grant program to study valvular heart disease.
• The Dr. Lorna Breen Health Care Provider Protection Act (R. 1667) would require the Department of Health and Human Services (HHS) to disseminate best practices to improve the mental health resiliency and prevent suicide among healthcare providers.
• The Oral Health Literacy and Awareness Act of 2021 (R. 4555) would require HRSA to establish a public education campaign to increase oral health literacy.
• The Opioid Prescription Verification Act of 2021 (R. 2355) would develop trainings to help pharmacists verify the identities of people receiving controlled substance prescriptions.
• The Synthetic Opioid Danger Awareness Act (R. 2364) would require the CDC to carry out a public education campaign on synthetic opioids.
• The Supporting the Foundation for the National Institutes of Health and the Regan-Udall Foundation for the Food and Drug Administration (FDA) Act (R. 3743) would increase the FDA’s and NIH’s transfer authority to fund their supporting research foundations.
• The Collecting and Analyzing Resources Integral and Necessary for Guidance (CARING) for Social Determinants Act of 2021 (R. 3894) would require the HHS Secretary to provide assistance and guidance on how to address social determinants of health within the Medicaid and the Children’s Health Insurance Program (CHIP).
• The Social Determinants of Health Data Analysis Act of 2021 (R. 4026) would require the Government Accountability Office (GAO) to report on social determinants of health.
• The Immunization Infrastructure Modernization Act (R. 550) would allocate $400 million in grants to improve immunization information systems.
• The Maternal Vaccination Act (R. 951) would require the CDC to increase their efforts on maternal vaccinations.
• The Promoting Resources to Expand Vaccination, Education and New Treatments (PREVENT) for HPV Cancers Act of 2021 (R. 1550) would reauthorize a CDC program that works to promote awareness of HPV.

Reps. Griffith and Latta Introduce Bill to Permanently Schedule Fentanyl-related Substances

On Dec. 8, Reps. Morgan Griffith (R-VA) and Bob Latta (R-OH) introduced the Halt Lethal Trafficking (HALT) Fentanyl Act (H.R. 2366), which would permanently place fentanyl-related substances on Schedule 1 of the Controlled Substance Act.

House Oversight and Reform Committee Releases Report on Drug Pricing and Pharmaceutical Practices

On Dec. 10, the House Oversight and Reform Committee released the final staff report summarizing findings of a three-year investigation into pharmaceutical pricing and business practices. The investigation was launched in January 2019 by the late Committee Chair Elijah E. Cummings. Chair Carolyn Maloney said the committee investigation found that pharmaceutical companies raise prices to meet revenue targets, target the U.S. markets for higher prices and use the patent system to suppress competition, among other things.

The staff report can be found here.

Reps. Bucshon and Buchanan Lead 100 Republican Members in Letter Opposing Federal Vaccine Mandate

On Dec. 6, Reps. Larry Bucshon (R-IN) and Vern Buchanan (R-FL) led a group of 100 Republican House members in writing a letter to the Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure. In the letter, the members state their opposition to the Biden administration’s COVID-19 vaccine mandate for Medicare and Medicaid service providers. In the letter, members cited concerns that the mandate will contribute to a worsening healthcare workforce shortage.

The letter can be found here.

25 Congressional Tri-Caucus Members Write Speaker Pelosi to Express Concern Regarding Medicare Reimbursement Cuts in the PFS Rule

On Dec. 6, a group of 25 members of the Congressional Tri-Caucus, led by Rep. Bobby Rush (D-IL), Danny Davis (D-IL) and Tony Cárdenas (D-CA), wrote to Speaker Nancy Pelosi (D-CA) to express their concern regarding Medicare reimbursement reductions in the 2022 Physician Fee Schedule (PFS) Final Rule. The final rule was released on Nov. 2, 2022, by the Centers for Medicare and Medicaid Services (CMS) and would cut Medicare reimbursement for office-based services by 20 percent or more. The members express concern that this would negatively impact health equity.

The letter can be found here.

Rep. Devin Nunes to Retire at the End of the Year

On Dec. 8, Rep. Devin Nunes (R-CA) announced that he would leave his seat in Jan. 2022 to lead former President Trump’s new media company. He has been in Congress since 2003. Rep. Nunes had been in line to be the most senior Republican member of the House Ways and Means Committee.

Senate

Senate and House Pass Bill to Phase in Medicare Sequester Cuts

On Dec. 7, the House passed the Protecting Medicare and American Farmers from Sequester Cuts Act. On Dec. 9, the Senate passed the same legislation. Specifically, the bill would:

• Extend the 2 percent Medicare sequester moratorium until March 31, 2022, re-implementing 1 percent cuts in the second quarter of 2022 and reinstating the 2 percent cut subsequently, funded by backend increased sequester cuts in fiscal year 2030;
• Adjust the Medicare Physician Fee Schedule conversion factor by 3 percent in calendar year 2022;
• Delay Protecting Access to Medicare Act (PAMA)-related cuts to clinical laboratory services and the next round of private payer data reporting by one year;
• Delay implementation of the Medicare Radiation Oncology Model until 2023; and
• Delay application of 4 percent cuts to Medicare and other federal programs resulting from statutory Pay-As-You-Go Act requirements until calendar year 2023.

Senate Passes Bill Opposing Biden Administration Vaccine Mandate

On Dec. 8, the Senate voted 52-48 to block the Biden administration’s COVID-19 vaccine and testing requirements for private employers. Two Democrats, Reps. Joe Manchin (D-WV) and Jon Tester (D-MT), sided with Republican senators on the vote. The resolution was brought under the Congressional Review Act, which allows Congress to void federal agency rules within a certain time frame with a majority vote in the House and Senate.

Administration

White House Marks the First Maternal Health Day of Action

On Dec. 7, Vice President Kamala Harris marked the first White House Maternal Health Day of Action. The Vice President announced commitments the Biden administration has made related to maternal health, which include $3 billion in Build Back Better funding, encouraging states to expand postpartum coverage and creating Centers for Medicaid and Medicare Services (CMS)-designated “Birthing-Friendly” hospitals.

The White House fact sheet on the initiative can be found here.

FDA Approves COVID-19 Boosters for 16- and 17-Year-Olds

On Dec. 9, the Food and Drug Administration (FDA) announced the approval of COVID-19 booster doses of Pfizer’s COVID-19 for adolescents aged 16 and 17 who have completed their primary two-dose regimen at least six months prior.

FDA Issues Emergency Use Authorization for AstraZeneca’s Monoclonal Antibody Treatment

On Dec. 8, the Food and Drug Administration (FDA) announced it had issued an emergency use authorization (EUA) for AstraZeneca’s monoclonal antibody treatment for pre-exposure prevention of COVID-19 in certain adults and children. The treatment, called Evusheld, consists of tixagevimab administered with cilgavimab. Authorization requires individuals to have moderately to severely compromised immune systems or a history of severe adverse reactions to the COVID-19 vaccine or vaccine components.

The press release can be found here.

CMS Announces 4.6 Million Enrolled in Affordable Care Act Plans

On Dec. 9, the Centers for Medicare and Medicaid Services (CMS) announced that nearly 4.6 million Americans signed up for coverage through healthcare.gov or a state-based exchange since open enrollment began on Nov. 1.

CMS Announces Updated Medicaid and CHIP Scorecard

On Dec. 8, the Centers for Medicare and Medicaid Services (CMS) released the annual update to its Medicaid and Children’s Health Insurance Program (CHIP) Scorecard.

The scorecard can be found linked here.

Lawrence Tabak to Serve as NIH Acting Director

On Dec. 9, Health and Human Services (HHS) Secretary Xavier Becerra announced that Lawrence Tabak, deputy director of the National Institutes of Health (NIH), will serve as the NIH Acting Director starting on Dec. 20, 2021. Current NIH Director Francis Collins announced in October his plans to retire at the end of the year. Tabak has been principal deputy director and deputy ethic counselor of the NIH since 2010.

MACPAC Announces Retirement of Executive Director Anne Schwartz

On Dec. 10, the Medicaid and CHIP Payment and Access Commission (MACPAC) announced that Executive Director Anne Schwartz would be retiring in the spring of 2022.

Proposed Rules

FDA Issues Final Industry Guidance on Tobacco Product User Fees

On Dec. 9, the Food and Drug Administration (FDA) announced the availability of final industry guidance, titled “Tobacco Product User Fees: Responses to Frequently Asked Questions.” The guidance answers frequently asked questions about tobacco product user fees under the Federal Food, Drug, and Cosmetic Act.

The guidance 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.

FDA Issues Guidance on Continuous Manufacturing of Drug Substances and Products

On Oct. 12, the Food and Drug Administration issued a draft guidance document titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products,” which was prepared with the support of the International Council for Harmonisation (ICH). The draft guidance provides clarification on the development and operation of continuous manufacturing and builds on prior guidelines Q7-Q10.

Comments will be accepted until Dec. 13, 2021.

The guidance can be found here.

FDA Issues Guidance Updating Unique Device Identification Policy

On Oct. 14, the Food and Drug Administration (FDA) issued a draft guidance titled “Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.” The guidance revises the 2020 Unique Device Identification Guidance. The updated guidance explains there are certain class I devices for which the FDA will not enforce the Global Unique Device Identification Database (GUDID) submission requirements, and also states how a class I device labeler can determine if the device is in the scope of compliance policy.

Comments will be accepted until Dec. 13, 2021.

The guidance 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 to Delay VBP Reporting and the Inclusion of U.S. Territories

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing (VBP) Arrangement; Delay of Inclusion of Territories in Definition of States and United States.” The final rule delays the best price provisions and reporting related to VBP arrangements as part of the Medicaid Drug Rebate Program (MDRP) from Jan. 1, 2022, to July 1, 2022. In addition, the rule also delays the inclusion of five U.S. territories in the MDRP’s regulatory definition of “states” from April 1, 2022, to Jan. 1, 2023.

The regulations will be effective on Dec. 20, 2021.

The final rule can be found here.

CMS Issues Final Rule Rescinding Medicare Coverage of Innovative Technology and “Reasonable and Necessary” Final Rule

On Nov. 12, the Centers for Medicare and Medicaid Services (CMS) released a final rule to rescind the Trump administration’s “Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” (MCIT/R&N) Final Rule. The final rule was published on Jan. 14, 2021, and would have gone into effect on Dec. 15, 2021. The rule would have granted up to four years of expedited Medicare coverage for certain designated “breakthrough” devices that receive market authorization. CMS states that the rule did consider the differences in devices and the potential safety impact on Medicare patients.

The final rule can be found here. A CMS press release on 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

Supreme Court Allows Texas Abortion Challenge to Proceed but Declines to Block Law

On Dec. 10, the Supreme Court declined to block Texas’s law that severely limits abortions and relies on private citizen enforcement, allowing the law to proceed. The court did say that state court could take action to block the law.

Hospital and Doctor Groups Sue the Administration Regarding the Surprise Billing Rule

On Dec. 9, the American Hospital Association, the American Medical Association and several other providers filed a lawsuit in the U.S. District Court for the District of Columbia regarding the administration’s Surprise Billing Rule. The hospital groups say that the interim final rule unfairly favors insurers and have asked the district court to vacate the section of the rule that directs arbitrators to consider the qualifying payment amount (QPA) when determining a payment dispute. The Texas Medical Association and the Association of Air Medical Services previously sued the administration, taking issue with the QPA language as well.

Reports

GAO Report on ONDCP Grant Posting Practices

On Dec. 8, the Government Accountability Office (GAO) published a report titled “Drug Control Grants: ONDCP Should Document Its Process for Identifying Duplication, Overlap, and Fragmentation.” The report states that the Office of National Drug Control Policy (ONDCP) posts drug control grant information to its website and collects information from federal agencies annually. The GAO report notes that some grant programs did not have their information posted to the ONDCP website. The GAO also noted that it is not clear if the ONDCP assesses whether or not grants are duplicative.

The full report can be found here.