This week in Washington: Reconciliation negotiations continue.
Congress
Upcoming Hearings/Markups
House
- House Passes Four Public Health Bills
- House Energy and Commerce Committee’s Subcommittee on Health to Discuss Legislation
- CBO Releases Score of Healthcare Provisions of the House Reconciliation Bill
Senate
- Senate Appropriations Labor-H Released
- Sen. Wyden Requests Review of Pharmacy Closures
Administration
- White House Announces COVID-19 Vaccine Rollout for Children Aged 5-11
- HHS Secretary Becerra Renews Public Health Emergency Determination
- FDA Authorizes Mixed Regimens, Moderna and Johnson & Johnson COVID-19 Boosters
- FDA Advisory Committee to Discuss EUA of Pfizer COVID-19 Vaccine for Children Aged 5-11
- FDA to Withdraw the Approval of 216 Abbreviated New Drug Applications
- FDA Extends Public Comment Deadline for Biosimilar User Fee Act Reauthorization Meeting
- CMS Innovation Center Releases Strategic Plan for Next Decade
- CMS Announces that Medicare Promoting Interoperability Payment Adjustment Reconsideration Applications are Due Dec. 3
- CDC Supports Moderna and Johnson & Johnson Boosters
Proposed Rules
- FDA Issues Draft Industry Guidance on Real-World Data Standards
- FDA Issues Proposed Rule on Over-the-Counter Hearing Aids
- HHS Issues Proposed Rule to Repeal Two Trump-Era HHS Final Rules
- FDA Issues Guidance on Continuous Manufacturing of Drug Substances and Products
- FDA Issues Guidance Updating Unique Device Identification Policy
Final Rules
- HHS Issues Final Rule to Rescind Trump-Era “Gag Rule” on Title X Grantees
- FDA Issues Final Rules for Premarket Review of New Tobacco Products
- FDA Issues Final Rule on De Novo Pathway for Medical Devices
- HHS Issues Final Rule to Rescind 2020 Rule on Insulin and Epinephrine
Courts
- Supreme Court to Hear Challenges to Texas Abortion Law But Declines to Block Enforcement
Reports
- GAO Report on Rare Diseases Costs
Upcoming Hearings/Markups
October 26
House Education and Labor Committee, Subcommittee on Workforce Protections and the Subcommittee on Civil Rights and Human Services Hearing: “Protecting Lives and Livelihoods: Vaccine Requirements and Employee Accommodations”
10:15 a.m.
For more information, click here.
House Energy and Commerce Committee, Health Subcommittee Hearing: “Caring for America: Legislation to Support Patients, Caregivers, and Providers”
10:30 a.m.
For more information, click here.
House Veterans Affairs Committee, Subcommittee on Technology Modernization Hearing: “Next Steps: Examining Plans for the Continuation of the Department of Veterans Affairs Electronic Health Record Modernization Program”
2:00 p.m.
For more information, click here.
October 27
House Appropriations Committee, Subcommittee on State, Foreign Operations, and Related Programs Hearing: United States Global COVID-19 Response: Actions Taken and Future Needs”
10:00 a.m.
For more information, click here.
House Veterans Affairs Committee, Subcommittee on Health Hearing: “Lessons Learned? Building a Culture of Patient Safety Within the Veterans Health Administration”
10:00 a.m.
For more information, click here.
Congress
House
House Passes Four Public Health Bills
On Oct. 20, the House voted to pass four public health bills. The first, the Strengthening America’s Strategic National Stockpile Act (H.R. 3635), aims to secure medical supply chains and would allow the Department of Health and Human Services (HHS) to transfer supplies from the strategic national stockpile to other federal agencies or departments under specific conditions. In addition, the bill would require HHS to maintain reserves of certain critical supplies.
The second bill, the National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act (H.R. 4369), would allow the Food and Drug Administration (FDA) to designate educational institutions as National Centers of Excellence in Continuous Pharmaceutical Manufacturing.
The third bill, the Drug-Free Communities Pandemic Relief Act (H.R. 654), would waive a federal grantee’s matching requirements for grantees that cannot meet the Drug-Free Communities Support Program match during the COVID-19 pandemic.
The fourth bill, the State Opioid Response Grant Authorization Act (H.R. 2378), would authorize the State Opioid Response (SOR) Grant Authorization Program and align the program’s grants with Substance Abuse and Mental Health Services Administration (SAMHSA) funding.
House Energy and Commerce Committee’s Subcommittee on Health to Discuss Legislation
On Oct. 26, the House Energy and Commerce Committee’s Subcommittee on Health will hold a hearing titled “Caring for America: Legislation to Support Patients, Caregivers, and Providers” to discuss legislation. The bills to be discussed are listed below.
- H.R. 1474, the Alzheimer’s Caregiver Support Act
- H.R. 1667, the Dr. Lorna Breen Health Care Provider Protection Act
- H.R. 3297, the Public Health Workforce Loan Repayment Act of 2021
- H.R. 3320, the Allied Health Workforce Diversity Act of 2021
- H.R. 5583, the Helping Enable Access to Lifesaving Services Act or the HEALS Act
- H.R. 5594, the Enhancing the Community Health Workforce Act
- H.R. 5602, the Bolstering Infectious Outbreaks Preparedness Workforce Act of 2021 or the BIO Preparedness Workforce Act of 2021
CBO Releases Score of Healthcare Provisions of the House Reconciliation Bill
On Oct. 19, the Congressional Budget Office (CBO) wrote to Rep. Jason Smith (R-MO) providing additional information and cost estimates on the health provisions in the House reconciliation legislation. While the CBO has not scored the Build Back Better Act in its entirety, it did study the potential impact of increasing the premium tax credits and cost-sharing reductions established under the Affordable Care Act (ACA).
The letter, with more detailed information and cost estimates, can be found here.
Senate
Senate Appropriations Labor-H Released
On Oct. 18, the Senate Appropriations Committee released the nine remaining fiscal year 2022 appropriations bills. The Labor, Health and Human Services (HHS), and Education and related agencies bill text can be found here, the explanatory statement here and the bill summary here.
Sen. Wyden Requests Review of Pharmacy Closures
On Oct. 20, Sen. Ron Wyden (D-OR) wrote to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure requesting that the agency review pharmacy closures. Specifically, Sen. Wyden voiced his concern that Medicare Part D plan fees and pharmacy benefit managers are contributing to pharmacy closures, many of which have occurred in rural areas.
The letter can be found here.
Administration
White House Announces COVID-19 Vaccine Rollout for Children Aged 5-11
On Oct. 20, the White House announced its plans to roll out Pfizer’s COVID-19 vaccine to children aged 5-11 once it is approved by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The plan was announced in anticipation of the FDA’s Oct. 26 advisory committee meeting and the CDC’s Nov. 2-3 advisory committee meeting.
The White House Fact Sheet with additional information can be found here.
HHS Secretary Becerra Renews Public Health Emergency Determination
On Oct. 15, Health and Human Services (HHS) Secretary Xavier Becerra announced that the public health emergency determination would be renewed on Oct. 18, 2021. The public health emergency declaration was first issued on Jan. 27, 2020, and this marks the seventh renewal.
FDA Authorizes Mixed Regimens, Moderna and Johnson & Johnson COVID-19 Boosters
On Oct. 20, the Food and Drug Administration (FDA) authorized COVID-19 vaccine booster doses of Moderna and Johnson & Johnson for specific populations. In addition, the FDA also authorized a heterologous (mix-and-match) regimen for COVID-19 booster shots. This means that people who are eligible for booster shots can get either the Johnson & Johnson, Moderna or Pfizer booster regardless of what vaccine they received for their primary dose.
FDA Advisory Committee to Discuss EUA of Pfizer COVID-19 Vaccine for Children Aged 5-11
On Oct. 26, the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee will meet to discuss amending Pfizer’s Emergency Use Authorization (EUA) to allow the Pfizer COVID-19 vaccine to be administered to children aged 5-11.
The meeting will be broadcast to the public. For more information, click here.
FDA to Withdraw the Approval of 216 Abbreviated New Drug Applications
On Oct. 22, the Food and Drug Administration (FDA) published a notice that detailed the agency’s decision to withdraw approval of 216 abbreviated new drug applications (ANDAs) from multiple holders. The FDA stated that this decision was taken since some ANDA holders have repeatedly failed to submit the required annual reports.
Approval will be withdrawn within 30 days.
The notice can be found here.
FDA Extends Public Comment Deadline for Biosimilar User Fee Act Reauthorization Meeting
The Food and Drug Administration (FDA) extended comment deadline in advance of its Nov. 2 virtual public meeting to discuss recommendations for the Biosimilar User Fee (BsUFA) reauthorization. Public comments will be accepted until Oct. 26.
CMS Innovation Center Releases Strategic Plan for Next Decade
On Oct. 20, the Centers for Medicare and Medicaid Services (CMS) Innovation Center released a strategic plan for the next decade. The five strategic objectives outlined in the plan include: driving accountable care, advancing health equity, supporting innovation, addressing affordability and partnering to achieve system transformation.
The complete strategic plan can be found here.
CMS Announces that Medicare Promoting Interoperability Payment Adjustment Reconsideration Applications are Due Dec. 3
CMS stated that participants in the Medicare Promoting Interoperability Program can apply for payment adjustment reconsideration by Dec. 3, 2021. Participating critical access hospitals (CAHs) and eligible hospitals (EHs) that were informed they would be subject to a negative payment adjustment and believe this determination is incorrect are encouraged to apply for reconsideration.
The application forms for CAHs can be found here and applications for EHs can be found here.
CDC Supports Moderna and Johnson & Johnson Boosters
On Oct. 21, the Centers for Disease Control and Prevention (CDC) recommended a booster COVID-19 dose of Moderna or Johnson & Johnson vaccines for certain populations and approved the use of a mixed booster schedule. This recommendation comes after the agency’s vaccine advisory committee voted unanimously in favor and aligns with the Food and Drug Administration’s (FDA) recent authorization.
Proposed Rules
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.
HHS Issues Proposed Rule to Repeal Two Trump-Era HHS Final Rules
On Oct. 20, the Department of Health and Human Services (HHS) issued a proposed rule to repeal two final rules: the Dec. 7, 2020, rule titled “Department of Health and Human Services Good Guidance Practices” and the Jan. 14, 2021, rule titled “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions.” HHS stated that the 2020 Good Guidance rule conflicts with the Food and Drug Administration’s (FDA) good guidance regulations and complicates the Centers for Medicare and Medicaid Services’ (CMS) issuing of Medicaid and Children’s Health Insurance Program (CHIP) guidance.
Public comments will be accepted until Nov. 19, 2021.
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 are 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
HHS Issues Final Rule to Rescind Trump-Era “Gag Rule” on Title X Grantees
On Oct. 7, the Department of Health and Human Services (HHS) issued a final rule that would rescind a 2019 Trump-era rule that prevented Title X grantees from referring patients for abortion, often referred to as the “gag rule.” The Biden administration had announced its intention to roll back the rule in an April 14 rulemaking, stating that it had decreased the number of Title X grantees by 25 percent and could have led to 181,477 unintended pregnancies.
The rule will go into effect on Nov. 7, 2021.
The final rule can be found here.
FDA Issues Final Rules for Premarket Review of New Tobacco Products
On Oct. 4, the Food and Drug Administration (FDA) issued two final rules related to the premarket review of new tobacco products. The rules provide information for the content and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports, two pathways commonly used to receive FDA marketing authorization. Both rules will be effective Nov. 4, 2021.
The final rule titled “Premarket Tobacco Product Applications and Recordkeeping Requirements” can be found here.
The final rule titled “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports” can be found here.
The FDA press release on the rules can be found here.
FDA Issues Final Rule on De Novo Pathway for Medical Devices
On Oct. 4, the Food and Drug Administration (FDA) published a final rule titled “Medical Device De Novo Classification Process,” which establishes requirements for the medical device De Novo classification process. The final rule also provides information on how medical device markers can pursue marketing authorization via the De Novo pathway for low- and moderate-risk devices with no existing predicate comparison device. Although the De Novo pathway has existed since 1997, this rule will be the first to explain the FDA procedures for reviewing De Novo applications and specify what needs to be included in an application.
The rule goes into effect Jan. 3, 2022.
The final rule can be found here.
HHS Issues Final Rule to Rescind 2020 Rule on Insulin and Epinephrine
On Oct. 1, the Department of Health and Human Services (HHS) issued a final rule to rescind a December 2020 final rule titled “Implementation of Executive Order on Access to Affordable Life-Saving Medications.” The Trump-era rule required health centers to pass on 340B discounts for insulin and injectable epinephrine to patients. Health centers had opposed the rule. In its rule to rescind the Trump administration rule, HHS stated that the 2020 rule had excessive administrative costs and burdens for health centers that would have resulted in reduced resources for critical services for patients who use insulin and epinephrine. The rule states that HHS is exploring nonregulatory options to implement the executive order.
The rule is effective Nov. 1, 2021.
The final rule can be found here.
Courts
Find a comprehensive look at “The Courts and Healthcare Policy” here.
Supreme Court to Hear Challenges to Texas Abortion Law But Declines to Block Enforcement
On Oct. 22, the Supreme Court agreed to hear arguments on S.B. 8, the Texas law that bans abortion after six weeks of pregnancy but decided against halting enforcement of the law as litigation proceeds. The Court will hear two challenges to S.B. 8 on Nov. 1. The announcement comes after the Department of Justice (DOJ) filed a request Oct. 18 asking the Supreme Court to restore a preliminary injunction that would halt the enforcement of S.B. 8.
Reports
GAO Report on Rare Diseases Costs
On Oct. 18, the Government Accountability Office (GAO) published a report titled “Rare Diseases: Although Limited, Available Evidence Suggests Medical and Other Costs Can Be Substantial.” The report states that the diagnosis of rare disease can be complicated, and people who are undiagnosed, misdiagnosed or remain untreated face negative outcomes. People with rare diseases face substantial costs that include a combination of medical, nonmedical and indirect costs. Indirect costs include loss of income and decreased quality of life.
The full report can be found here.
