Jun 13, 2022
Washington Healthcare Update
This Week in Washington: House Passes FDA User Fee Reauthorization Package
Senate Health, Education, Labor and Pensions Committee Executive Session: “RISE and SHINE Act, H.R. 1193, S. 4053, S. 4348 and S. 958”
House Energy and Commerce Committee Hearing: “Protecting American Consumers: Bipartisan Legislation to Strengthen Data Privacy and Security”
House Committee on Veterans Affairs, Subcommittee on Economic Opportunity Hearing: “Reviewing President Biden’s Strategy to Reduce Veteran Suicide by Addressing Economic Risk Factors”
Senate Committee on Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights Hearing: “Baby Formula and Beyond: The Impact of Consolidation on Families and Consumers”
House Committee on Energy and Commerce Subcommittee on International Trade, Customs, and Global Competitiveness Hearing: “Supply Chain Resiliency: Alleviating Backlogs and Strengthening Long-Term Security”
Senate Health, Education, Labor and Pensions Committee Hearing: “An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning”
House Committee on Veterans Affairs Subcommittee on Oversight and Investigations Hearing: “Ensuring Independence and Building Trust: Considering Reforms to Whistleblower Protections at VA”
House to Consider the ARPA-H Act
On June 20, the House will consider H.R. 5585, the Advanced Research Projects Agency-Health (ARPA-H) Act. The bill would establish ARPA-H, a new biomedical research agency, within the Department of Health and Human Services (HHS). The bill would also require ARPA-H to coordinate with the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on product and coverage decisions, and would allocate $5 million to fund the agency. The ARPA-H Act would override HHS’s recent decision to place ARPA-H in the National Institutes of Health (NIH).
House Passes FDA User Fee Reauthorization Package
On June 8, the House voted 392-28 to pass the Food and Drug Amendments of 2022, which would reauthorize the Food and Drug Administration (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs. The legislation would require sponsors to begin post-approval studies before drugs go on the market and for manufacturers to develop a clinical trial diversity action plan. In addition, the legislation would extend additional hiring flexibility to the FDA.
Reps. Hoyer and Clyburn Call in Op-Ed for Preserving American Rescue Plan Premium Tax Credits
On June 7, House Majority Leader Steny Hoyer (D-MD-05) and Majority Whip James Clyburn (D-SC-06) wrote an op-ed in The Hill titled “Congress must not forget about protecting access to affordable health coverage.” In the article, Reps. Hoyer and Clyburn stressed the importance of preserving the American Rescue Plan premium tax credits.
Rep. Jacobs Introduces Bill to Protect Reproductive Health Data
On June 2, Rep. Sara Jacobs (D-CA-35) introduced the My Body, My Data Act. The bill would create a national standard to protect personal reproductive health data, enforced by the Federal Trade Commission. The bill would prevent reproductive health data that is collected from being disclosed or misused. This bill is introduced amid concerns that reproductive health data could be used to target people if the Supreme Court overturns Roe v. Wade.
Senate HELP Committee to Discuss Four Bills
On June 14, the Senate Health, Education, Labor and Pensions (HELP) Committee will hold an executive session to discuss four bills. The bills can be found below.
- 4353, Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg (RISE and SHINE) Act
- R. 1193, Cardiovascular Advances in Research and Opportunities Legacy Act
- 4052, Early Hearing Detection and Intervention Act of 2022
- 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act
- 958, Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act
Sen. Barrasso Leads 25 Senators in a Letter to HHS Calling for Clarification on PHE Unwinding
On June 10, Sen. John Barrasso (R-WY) and 24 other senators sent a letter to Secretary of Health and Human Services (HHS) Xavier Becerra calling for HHS to clarify its plans for transitioning out of the COVID-19 public health emergency (PHE).
Sen. Wyden and Rep. Pallone Call on CMS To Ensure Provider Choice for Medicaid Beneficiaries
On June 8, Sen. Ron Wyden (D-OR) and Rep. Frank Pallone (D-NJ) wrote to the Administrator of the Centers for Medicare and Medicaid Services (CMS) Chiquita Brooks-LaSure expressing their concern about state efforts to exclude Planned Parenthood and other family planning providers from Medicaid. Sen. Wyden and Rep. Pallone note that this violates federal law, and called on CMS to take measures to ensure that Medicaid beneficiaries can access services from the providers they choose.
Sens. Leahy and Cornyn Call on Patent and Trade Office to Address Patent Thickets
On June 8, Sens. Patrick Leahy (D-VT) and John Cornyn (R-TX) led six senators in a letter to the U.S. Patent and Trademark Office (USPTO). In the letter, the senators call for the USPTO to address patent thickets, which is defined as a large number of patents that cover a single product, extending patent protections for longer. The senators raised concerns that patent thickets were negatively impacting competition in the pharmaceutical sector.
18 Members of Congress Write to FDA Expressing Concern with Method of Authorizing COVID-19 Vaccines for Children
On June 7, Sens. Ron Johnson (R-WI) and Ted Cruz (R-TX), along with Rep. Bill Posey (R-FL) and Rep. Louie Gohmert (R-TX), led a group of 18 members of Congress in a letter to the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). In the letter, the members raise concerns about the Centers for Disease Control and Prevention (CDC) and the FDA’s approach to emergency use authorizations of COVID-19 vaccines for children under five.
Sens. Rosen and Young Introduce Bill to Improve Medical Device Cybersecurity
On June 3, Sens. Jacky Rosen (D-NV) and Todd Young (R-IN) introduced the Strengthening Cybersecurity for Medical Devices Act. The bill would require the Food and Drug Administration (FDA) to update medical device cybersecurity guidelines to better protect devices from possible cyberattacks.
Agencies Release Social Security and Medicare Trustees Reports
On June 2, the Department of the Treasury, Health and Human Services and Labor, the Centers for Medicare and Medicaid Services (CMS) and the Social Security Administration released the annual Social Security and Medicare Trustees Reports. The reports project that the Medicare Part A trust fund will be insolvent in 2028, two years later than what was predicted in last year’s report. It should be noted that the Congressional Budget Office (CBO) recently predicted that the trust fund would be insolvent in 2030.
HHS Launches Website with Resources and Guidances for Families Impacted by the Baby Formula Shortage
On June 2, the Health and Human Services (HHS) Department launched a website to make information on baby formula more accessible to families. The website contains a list in several languages of of resources and guidance for families.
CMS Releases HCPCS Codes for Vaccine Counseling
On June 8, the Centers for Medicare and Medicaid Services (CMS) released the Medicaid and Children’s Health Insurance Program (CHIP) vaccine counseling Healthcare Common Procedure Coding System (HCPCS) codes. Providers can use these codes to bill for stand-alone vaccine counseling for Medicaid and CHIP beneficiaries.
CMS Publishes FAQs on Agent and Broker Compensation During Special Enrollment Periods
On June 7, the Centers for Medicare and Medicaid Services (CMS) posted a Frequently Asked Questions (FAQs) document on agent and broker compensation during open special enrollment periods or open enrollment periods. In the document, CMS notes that some issuers have reduced or eliminated commissions brokers and agents’ commissions during special enrollment periods.
CMS Announces Advisory Panel on Outreach and Education Public Meeting
On June 6, the Centers for Medicare and Medicaid Services (CMS) announced that its Advisory Panel on Outreach and Education (APOE) would meet on June 23, 2022, from 8:30 a.m. to 5:00 p.m. APOE advises the Department of Health and Human Services and CMS on consumer education strategies for Medicare, Medicaid, the Children’s Health Insurance Program (CHIP) and the Health Insurance Marketplace. The meeting will be open to the public.
CMS Extends Spending Deadline for States to Expand HCBS for Medicaid Beneficiaries
On June 3, the Centers for Medicare and Medicaid Services (CMS) announced that states now have until March 31, 2026, to use American Rescue Plan funding to expand home- and community-based services (HCBS) for Medicaid beneficiaries.
CMS Outlines its Behavioral Health Strategy
On June 1, the Centers for Medicare and Medicaid Services (CMS) outlined its plan to strengthen behavioral healthcare in a Health Affairs article. CMS’s behavioral health strategy aims to improve equity, quality and access to behavioral healthcare, increase access to substance use disorder prevention and treatment, ensure effective pain treatment and use data to inform actions and measure impact.
CMS Releases Tool for States to Help Prepare for PHE Unwinding
On June 2, the Centers for Medicare and Medicaid Services (CMS) announced a new tool for states to use in preparation for the end of the COVID-19 public health emergency (PHE) and a resumption of normal eligibility and enrollment. The tool details 10 fundamental actions that states need to take to be ready for unwinding.
CMS Releases Latest Medicare, Medicaid and CHIP Enrollment Figures
On May 31, the Centers for Medicare and Medicaid Services (CMS) released the most recent enrollment figures for Medicare, Medicaid and the Children’s Health Insurance Program.
FDA Advisory Panel Votes in Favor of Authorizing Novavax’s COVID-19 Vaccine
On June 7, the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 21-0 to authorize Novavax’s COVID-19 vaccine for individuals aged 18 and older. The Novavax COVID-19 vaccine is a two-dose recombinant protein vaccine, and FDA officials stated that the vaccine may appeal to individuals concerned or unwilling to take approved mRNA vaccines. The FDA has released documents stating that the Novavax vaccine may be linked to cases of myocarditis and pericarditis, but Novavax has argued that there is not enough evidence to demonstrate a direct link.
CDC Vaccine Advisory Committee to Discuss and Vote on Pediatric COVID-19 Vaccines
On June 7, the Centers for Disease Control and Prevention (CDC) announced that its Advisory Committee on Immunization Practices will meet on June 17 and 18 to discuss and vote on pediatric COVID-19 vaccines.
HRSA Announces Competition to Promote Innovation in Technical Assistance to Health Centers
On June 9, the Health Resources and Services Administration (HRSA) announced a national competition titled “Building Bridges to Better Health: A Primary Health Care Challenge.” The competition is an effort to encourage innovation in health center technical assistance. $1 million in cash prizes will be offered as part of the competition.
HRSA Allocates $15 Million to Address Stimulant Use in Rural Communities
On June 8, the Health Resources and Services Administration (HRSA) announced that $15 million in funds would be allocated to address psychostimulant misuse in rural communities. Psychostimulants include methamphetamine, cocaine, ecstasy and prescription stimulants to treat ADHD or depression.
HRSA Releases Framework Document with Recommendations to Improve Care for Children with Special Healthcare Needs
On June 1, the Health Resources and Services Administration (HRSA) published an document titled “The Blueprint for Change: A National Framework for a System of Services for Children and Youth with Special Health Care Needs” in the journal Pediatrics. The document describes a national framework to improve care for children with special healthcare needs. The framework’s principles include a focus on reducing health disparities, making services easy to navigate and reducing barriers to access.
FTC Launches Inquiry into PBMs
On June 7, the Federal Trade Commission (FTC) announced the launch of an inquiry into six pharmacy benefit managers (PBMs). The inquiry will investigate the impact of vertically integrated PBMs on access and cost of prescription drugs. Specifically, the inquiry will focus on the following areas:
- Fees charged to unaffiliated pharmacies,
- Methods to influence patients towards pharmacies owned by PBMs,
- Potentially unfair independent pharmacy audits,
- Lack of transparency in determining pharmacy reimbursement,
- The amount of prior authorization and administrative restrictions,
- The use of specialty drug lists, and
- The effect of rebates and fees from manufacturers on formulary design and prescription drug cost.
CMS Publishes Proposed Rule on Funding Methodology and Changes to Basic Health Program Regulations
On May 25, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule titled “Basic Health Program; Federal Funding Methodology for Program Year 2023 and Proposed Changes to Basic Health Program Regulations.” The proposed rule includes information on how federal payment amounts for states establishing a Basic Health Program under the Affordable Care Act will be determined in program year 2023.
Public comments will be accepted until June 24, 2022.
CMS Releases FY 2023 Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System Rule
On April 18, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule titled “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year (FY) 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation.” The proposed rule, which is referred to as the FY 2023 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) rule, updates the Medicare fee-for-service payment rates for long-term care hospitals (LTCHs). The rule also establishes new requirements for hospitals and critical access hospitals participating in the Medicare Promoting Interoperability Program. In addition, the proposed rule adds three health equity measures to hospital quality programs.
A CMS fact sheet on the proposed rule can found here.
Public comments will be accepted until June 17, 2022.
FDA Announces Request for Public Comments for Adding Maximum Daily Exposure Information to Inactive Ingredient Database
On March 22, the Food and Drug Administration (FDA) issued a notice titled “Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database” to establish a public docket and request public comment. The public comments will help the FDA determine how to best prioritize maximum daily exposure (MDE) information for inactive ingredients that are not currently included in the Centers for Drug Evaluation and Research’s Inactive Ingredient Database, as well as if the database should be restructured by removing dosage form information.
Public comments will be accepted until June 21, 2022.
HHS Issues Final Rule Withdrawing SUNSET Rule
On May 27, the Department of Health and Human Services (HHS) published a final rule to withdraw the “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET)” Final Rule of 2021. The SUNSET rule was originally set to go into effect on March 22, 2021, but was delayed until September 22, 2022, following a lawsuit. The SUNSET rule would have required HHS to review every rule to determine if it was still applicable after 10 years, and any rules not reviewed within that time frame would be automatically eliminated. In its withdrawal of the SUNSET rule, HHS stated that the rule faced significant opposition from stakeholders and would not expedite rulemaking.
The rule is effective immediately.
CMS Releases Reassignment of Medicaid Provider Claims Final Rule
On May 12, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Medicaid Program; Reassignment of Medicaid Provider Claims.” The final rule authorizes states to make payments to third parties on behalf of individual Medicaid practitioners for whom Medicaid is their primary source of revenue. The rule allows payments for health insurance, skills training and other benefits typical for employees. The rule will go into effect on June 15, 2022.
CMS Releases Notice of Benefit and Parameters for 2023 Final Rule
On April 28, the Centers for Medicare and Medicaid Services (CMS) announced the 2023 Notice of Benefit and Payment Parameters Final Rule, which aims to strengthen plan coverage offered on the federal Marketplace. The final rule will require healthcare.gov plans to offer a standardized version of each product an issuer sells in each metal tier for plan year 2023. The final rule also finalizes exchange user fees, updates quality improvement standards related to health equity and reduces the number of verification requirements for special enrollment periods.
A CMS fact sheet on the final rule can be found here.
CMS Releases Final Rule for Medicare Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing
On April 14, the Centers for Medicare and Medicaid Services (CMS) released a final rule titled “Medicare Program; Maximum Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing Standards.” The rule finalizes the maximum out-of-pocket (MOOP) limits for Medicare Parts A and B services and cost sharing limits for Medicare Parts A and B services. CMS is also requesting public comment on new ways to update cost sharing limits in the future. The regulations go into effect on June 13, 2022.
Final Rule to Change Qualifications for Products to be Considered “Made in America” Released
On March 4, the Department of Defense, the General Services Administration and the Aeronautics and Space Administration announced a final rule that would increase manufacturing of critical supplies in the U.S. as part of President Biden’s “Made in America” policy. The final rule would require pharmaceutical companies that want their products to qualify as being “Made in America” for federal procurement purposes to increase the percentage of drug ingredients made in the U.S. from 55 percent to 75 percent in the next seven years. Specifically, the final rule would increase the threshold to 60 percent in 2022, 65 percent in 2024 and 75 percent in 2029. In addition, the rule will allow the government to apply price preferences to select drug products and components that will support the expansion of the domestic supply chain. The final rule will go into effect on Oct. 25, 2022.
The White House Fact Sheet on the final rule can be found here.
Supreme Court Allows Florida to Recoup Medicaid Payments in Gallardo Injury Case
On June 6, the U.S. Supreme Court ruled 7-2 in favor of the state of Florida, allowing it to recoup Medicaid payments it made to Gianinna Gallardo, a teenager who suffered a catastrophic brain injury after being hit by a pickup trick when she was getting off a school bus. The Supreme Court’s decision affirmed the 11th Circuit’s June 2020 decision, which asserted that federal Medicaid law does not preempt Florida’s state policies which allow the state to receive Medicaid reimbursements from personal injury lawsuit settlements. This ruling clarifies the type of Medicaid reimbursements states can pursue from injured plaintiffs.
CBO Report on Work Requirements and Supports for TANF, SNAP and Medicaid Participants
On June 9, the Congressional Budget Office (CBO) released a report titled “Work Requirements and Work Supports for Recipients of Means-Tested Benefits.” The report analyzes the impact of work requirements and supports on employment and income of people participating in Temporary Assistance for Needy Families (TANF), the Supplemental Nutrition Assistance Program (SNAP) and Medicaid.
CBO Releases Cost Estimates of Four Healthcare Bills
On June 6, the Congressional Budget Office (CBO) released the cost estimates of four healthcare bills. The cost estimates can be found below.
NASEM Report on the Need to Study the Health Effects of Low-Dose Radiation Exposure
On June 2, the National Academies of Sciences, Engineering and Medicine (NASEM) released a report titled “Leveraging Advances in Modern Science to Revitalize Low-Dose Radiation Research in the United States.” The report recommends that the U.S. establish a new program to research the effects of low doses to radiation on human health. NASEM recommends that $100 million be allocated annually for 15 years to carry out this effort.
KFF Report on Expected Medical Loss Ratio Rebates
On June 1, the Kaiser Family Foundation (KFF) released an analysis titled “Data Note: 2022 Medical Loss Ratio Rebates.” In the analysis, KFF states that private insurers will likely need to pay consumers around $1 billion in September because of an Affordable Care Act (ACA) medical loss ratio provision. The medical loss ratio provision requires plans to refund consumers if spending is below a specific threshold.
HHS OIG Report States Medicare Improperly Paid Durable Medical Equipment Suppliers for Power Mobility Device Repairs
On May 31, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report titled “Medicare Improperly Paid Durable Medical Equipment Suppliers and Estimated $8 Million of the $40 Million Paid for Power Mobility Device Repairs.” The report summarizes the findings of a OIG audit of payments made from Oct. 1, 2018, to Sept. 30, 2019. The audit found that during the audit period, not all suppliers complied with Medicare requirements when billing for Power Mobility Device (PMD) repairs for Medicare beneficiaries. The report estimates that $7.9 million of the $40.1 million paid for PMD in the audit period was improperly paid.
GAO Report on DOD Electronic Health Records System
On June 8, the Government Accountability Office (GAO) published a report titled “Electronic Health Records: Additional DOD Actions Could Improve Cost and Schedule Estimating for New System.” The report notes that the Department of Defense (DOD) started replacing its health record systems in 2017, however the cost and schedule estimates for the new electronic health record system are not reliable. The GAO recommended that DOD develop new and more reliable cost and schedule estimates for the new electronic health system.
GAO Report on Open Recommendations for HHS
On June 2, the Government Accountability Office (GAO) published a report titled “Priority Open Recommendations: Department of Health and Human Services.” The report outlines 56 priority recommendations for the Department of Health and Human Services (HHS) that are currently open.
GAO Report on Limited Short-Term Plan Data During the COVID-19 Pandemic
On May 31, the Government Accountability Office (GAO) published a report titled “Private Health Insurance: Limited Data Hinders Understanding of Short-Term Plans' Role and Value During the COVID-19 Pandemic.” The report states that short-term plans were utilized by many Americans who lost employer-sponsored insurance during the COVID-19 pandemic. However, the GAO notes that there is limited data on the use of short-term plans, which leads to an incomplete understanding of the role they played during the COVID-19 pandemic and consumer perceptions of these plans.