Health Care Watch: June 7, 2021
The following Health Care Watch provides a summary of legislative and regulatory health care activities from May 31 – June 6. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On June 2, a bipartisan group of 26 House members, led by Reps. Terri Sewell (D-AL) and Adrian Smith (R-NE), sent a letter to the Centers for Medicare & Medicaid Services’ (CMS) Center for Medicare & Medicaid Innovation (CMMI) Director Liz Fowler requesting that she share her plans for making CMMI more transparent and how models will be developed that focus on measurable cost savings, address beneficiary health, and reduce health disparities. The letter also called for CMMI to use real-time data to make quicker decisions about a demonstration’s value.
On June 2, 11 Blue Dog Democrats called for investment to expand access to high-speed internet in rural areas with the highest need and ensure high speed internet access to these areas in the next infrastructure package.
On June 2, Ways & Means Oversight Subcommittee Chair Bill Pascrell (D-NJ) sent a letter to the Government Accountability Office (GAO) requesting they analyze the relationship between private equity investments and subsequent bankruptcies or closures of health care facilities over the past 10 to 15 years.
The House will hold committee business the week of June 7 – 11, 2021. The House will return for session on June 14.
Senate
On June 2, Senate Finance Committee Chairman Ron Wyden (D-OR) launched an investigation into AbbVie’s international tax practices and intellectual property rights of Humira and other products sold by the company.
On June 4, Senator Elizabeth Warren (D-MA) of the Finance Committee invited Daniel O’Day, CEO of Gilead Sciences to testify at a hearing of the Senate Finance’s subcommittee on Fiscal Responsibility and Economic Growth entitled, “Promoting Domestic Competition and International Competitiveness.” The subcommittee hearing is tentatively scheduled for Wednesday afternoon, June 16.
The Senate will return to Washington, D.C. for session June 7.
NON-CORONAVIRUS REGULATORY UPDATE
On May 28, the Federal Trade Commission (FTC) sent a report to Congress about the effects that “rebate walls” have on competition in pharmaceutical markets. The report notes that rebate walls may give payers strong incentives to block patient access to lower-priced drugs, whereas absent rebates a lower-priced, equally effective product would tend to take sales from the higher priced incumbent product. FTC Acting Chairwoman Rebecca Kelly Slaughter called for Congress to help address concerns about anticompetitive practices throughout the pharmaceutical supply and payment chain.
On June 1, Biomedical Advanced Research and Development Authority (BARDA) partnered with the Global Health Investment Corporation (GHIC) to accelerate the development and commercialization of technologies and medical products needed to respond to or prevent public health emergencies and other health security threats. BARDA intends to provide GHIC with a minimum of $50 million over five years with potential for up to $500 million over 10 years.
On June 2, the Administration for Children and Families announced$166.6 million to launch the Low-Income Household Water Assistance Program to expand access to more affordable water and help low-income households affected by the COVID-19.
On June 3, Food & Drug Administration (FDA) issued two guidance documents and made available two draft guidance documents to help ensure that prescription drugs are identified and traced properly as they move through the supply chain. The documents include:
Product Identifiers Under the Drug Supply Chain Security Act (DSCSA), Questions and Answers;
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification;
Definitions of Suspect Product and Illegitimate Product for Verification Obligation under DSCSA; and
Enhanced Drug Distribution Security at the Package Level under DSCSA.
On June 3, CMMI Director Fowler spoke at a Health Affairs event signaling that the Biden Administration is exploring mandatory models to increase savings and commitment to value-based care models. Fowler also indicated that CMMI will consider concepts in the Trump-era “Most Favored Nation” demonstration that ties Medicare payments to prices abroad but added “I don’t know that it will take that form.” On drug pricing reform, she indicated that CMMI would likely first look to see if Congress can make progress before undertaking any major demonstration: “Let's see what Congress can do because it’s a lot easier to make progress on this issue there. But if that's not possible, I think we stand ready to work with them and look and see how far we can get.”
On June 3, CMS Administrator Chiquita Brooks-LaSure sent a letter to Georgia Governor Brian Kemp (R) requesting more analysis of the Georgia State Innovation Waiver.
On June 4, CMS issued the 2021 Navigator Notice of Funding Opportunity, making $80 million in grant funding available to Navigators in states with a Federally-Facilitated Marketplace for the 2022 plan year.
The National Clinical Care Commission will hold a meeting on June 1, to evaluate and make recommendations regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
FDA will hold a virtual public meeting on June 18 to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act and Generic Drug User Fee Amendments.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
House
None of note.
Senate
None of note.
Regulatory
On June 2, the National Institute of Allergy & Infectious Diseases launched a study on mixing COVID-19 vaccines to strengthen immunity and combat COVID-19 variants.
On June 3, the Department of Agriculture announced a partnership with National Rural Health Association, the Health Action Alliance, the Covid Collaborative, the American Farm Bureau Federation, the National League of Cities, and other groups to launch a vaccine education campaign aimed at rural Americans and work with rural community leaders and businesses to promote vaccines.
On June 4, FDA authorized a lower dose of Regeneron's COVID-19 antibody therapy of casirivimab and imdevimab, from 1200 mg of each drug to 600 mg of each drug.
FDA Vaccines and Related Biological Products Advisory Committee will hold a virtual meeting June 10 to discuss the approach to issuing EUAs for children to receive COVID-19 vaccines.
White House
On June 2, the White House launched the following initiatives to boost COVID-19 vaccination rates and reach the Administration’s goal of having 70% of American adults vaccinated by July 4:
Promoting extended hours at vaccination sites during the month of June, including 24-hour availability every Friday;
Partnering with KinderCare, Learning Care Group, Bright Horizons, and hundreds of YMCAs for free childcare while parents are getting vaccinated;
Launching another national vaccination tour featuring Administrative officials to encourage people to get vaccinated;
Working with the Black Coalition Against COVID and other organizations to launch Shots at the Shop, leveraging Black-owned barbershops and beauty salons to increase vaccine education;
Promoting National Canvassing Weekend where volunteers will go door to door and encourage their communities to get vaccinated;
Launching the City Vaccination Challenge to see which city can grow its vaccination rate the most by July 4th; and
Working with employers to set up on-the-job vaccination clinics.
On June 3, the Administration announced that the U.S. will send 25 million doses to countries overseas, 19 million doses of which will be sent to COVAX.
On June 4, President Biden rejected the Senate Republican infrastructure package offer of $928 billion. The two sides will continue to talk.
Other
On May 31, the World Health Organization (WHO) announced a new naming system for COVID-19 variants. The variant identified from the U.K. is named Alpha and the variant identified from India is named Delta. WHO Director-General Tedros Adhanom Ghebreyesus also advocated for a global pandemic treaty to support global health security and empower the WHO.
On June 1, Moderna submitted the company’s COVID-19 vaccine to the FDA for full Biologics License Application (BLA) approval for people 18 and older.
On June 1, WHO approved China’s Sinovac COVID-19 vaccine for emergency use.
On June 2, Moderna and UNICEF signed a long-term agreement for up to 34 million COVID-19 vaccine doses on behalf of the COVAX Facility to be delivered in the fourth quarter 2021 and up to 466 million doses in 2022. All doses were offered at Moderna’s lowest tiered price.
On June 2, COVAX secured $2.4 billion for COVID-19 vaccine procurement, reaching a total of $9.6 billion for the initiative.
On June 4, the EU proposed an alternative plan to waive intellectual property rights for COVID-19 vaccines to the World Trade Organization, instead favoring limiting export restrictions and supporting the expansion of production.
As of June 6, over 170 million people have received the first dose of COVID-19 vaccines (more than 138 million have received both doses) and more than 371 million doses have been distributed, according to the CDC COVID Data Tracker.
As of June 6, the U.S. had more than 33 million confirmed COVID-19 cases resulting in 597,377 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1751); Proposed Rule; Received 3/30/21
CY 2022 Home Health Prospective Payment System Rate Update, Home Infusion Therapy Services, and Quality Reporting Requirements (CMS-1747); Proposed Rule; Received 4/30/21
CY 2022 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1749); Proposed Rule; 5/3/21
CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1753); Proposed Rule; 5/11/21
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Final Rule; 5/12/21
HHS-FDA
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability; Notice; 5/11/21
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; 5/11/21
Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Guidance for Industry; Availability; Notice; 5/11/21
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; 5/11/21
Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Prerule; 5/26/21
HHS-HRSA
Rescission of the Final Rule “Implementation of Executive Order on Access to Affordable Life-Saving Medications”; Proposed Rule; 5/10/21
REPORTS
Health & Human Services (HHS) Office of Inspector General (OIG)
On June 1, OIG released a report entitled Gateway Community Action Partnership Claimed Unallowable Costs, Did Not Comply With Federal Regulations on Construction and Major Renovations, and Did Not Accurately Account for Grant Funds. The report found that Gateway did not account for HHS grant funds in accordance with Federal requirements, resulting in $932,607 of unallowable costs. Some expenditures were not properly allocated and documentation was not always consistent and accurate. OIG recommended that Gateway refund the unallowable costs, ensure compliance with Federal requirements and the accuracy of information submitted to HHS Administration for Children and Families, and verify submitted information to support Gateway's grant award applications. Gateway did not agree to all the recommendations. A summary of the report is available here.
On June 1, OIG released a report entitled Medicare Home Health Agency Provider Compliance Audit: Caretenders of Jacksonville, LLC. The report found that Caretenders did not comply with Medicare billing requirements for all of the home health claims OIG reviewed, resulting in an estimated $4.4 million of overpayments. OIG found that Caretenders incorrectly billed Medicare for services provided to beneficiaries who were not homebound, services provided to beneficiaries who did not require skilled services, and claims that were assigned with incorrect Health Insurance Prospective Payment System (HIPPS) payment codes. OIG recommended that Caretenders identify, report, and return any overpayments; ensure that the homebound status of Medicare beneficiaries are verified and continually monitored and the specific factors qualifying beneficiaries as homebound are documented; ensure that beneficiaries are receiving only reasonable and necessary skilled services, and that the correct HIPPS payment codes are billed. Caretenders disagreed with some of the findings and the recommendations. A summary of the report is available here.
On June 3, OIG released a report entitled New Mexico Did Not Bill Manufacturers for Some Rebates for Physician-Administered Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations. The report found that New Mexico did not bill for and collect from manufacturers rebates for 70,131 claim lines totaling at least $1.5 million for physician-administered drugs. OIG recommended that New Mexico bill for and collect manufacturers' rebates for the overlooked claim lines; work with CMS to determine whether the other claim lines were eligible for rebates and, if so, determine the rebates due and refund the Federal share of rebates collected; and work with CMS to determine whether the other physician-administered drugs were eligible for rebates. New Mexico partially concurred with our findings. A summary of the report is available here.
On June 4, OIG released a report entitled University of Michigan Health System: Audit of Medicare Payments for Polysomnography Services. The report found that University of Michigan submitted Medicare claims for some polysomnography services that did not comply with Medicare billing requirements, resulting in at least $12,520 in overpayments. OIG recommended that the University of Michigan refund the estimated overpayment for claims that it incorrectly billed and implement policies and procedures to ensure that Medicare claims for polysomnography services comply with Medicare requirements. The University of Michigan disagreed with OIG’s findings. A summary of the report is available here.
Government Accountability Office (GAO)
On June 1, the GAO released a report entitled National Health Service Corps: Program Directs Funding to Areas with Greatest Provider Shortages. The report found that for FY 2020, about 14,000 recipients of National Health Service Corps scholarships and loan repayments to primary, dental, or mental health care providers provided care at about 7,000 sites. Providers were most commonly nurse practitioners, physicians, and licensed clinical social workers and about 57% of new applicants received funding. A summary of the report is available here.
On June 2, GAO announced appointments and reappointments for the Medicare Payment Advisory Commission (MedPAC):
Newly appointed members include Stacie Dusetzina, Associate Professor of Health Policy, Ingram Associate Professor of Cancer Research, Vanderbilt University Medical Center, and Lynn Barr, Founder, Executive Chairwoman, Caravan Health. Their terms began in May 2021 and will expire in April 2024.
Reappointed members include Marjorie Ginsburg; Jonathan Jaffery, MD, Professor of Medicine, University of Wisconsin School of Medicine and Public Health; Jonathan Perlin, MD, President of Clinical Services, Chief Medical Officer, HCA; and Jaewon Ryu, MD, President, CEO, Geisinger Health System. Their terms will expire in April 2024.
On June 3, GAO released a report entitled Science & Tech Spotlight: Digital Vaccine Credentials. The report found that digital vaccine credentials that certify that a person has been vaccinated or tested for COVID-19 can be a tool to mitigate COVID-19 transmission, however, challenges related to data protection, interoperability, and equity may limit their use and potential public health benefits.
HEARINGS
House
Ways and Means Committee
The President's Proposed FY2022 Budget with the Department of Health and Human Services
June 8, 10:00 a.m.
Witness: HHS Secretary Xavier Becerra
Senate
Budget Committee
The President's Fiscal Year 2022 Budget Proposal
June 8, 11:00 a.m., Room SD-608
Witness: OMB Acting Director Shalanda Young
Health, Education, Labor and Pensions Committee
June 8, 10:00 a.m., Room SD-430
Finance Committee
The President’ FY 2022 HHS Budget
June 10, 10:00 a.m., Room SD-215
Witness: HHS Secretary Becerra
Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee
FY2022 Budget Request for the Food and Drug Administration
June 10, 10:00 a.m., Room SD-124
Witness: FDA Acting Commissioner Janet Woodcock
Finance Fiscal Responsibility and Economic Growth Subcommittee
Promoting Domestic Competition and International Competitiveness
June 16, 2:30 p.m.
OTHER HEALTH POLICY NEWS
On June 1, District Court for the District of New Jersey rejected motions for administrative stays filed by Sanofi-Aventis and Novo Nordisk to delay the deadline to respond to the HHS advisory opinion mandating the companies implement 340B drug discounts to contract pharmacies. In a separate suit, Lilly secured an extension on the deadline.
On June 1, a study published in JAMA found that individuals who are privately insured are more likely to report worse access to care, higher medical costs and lower satisfaction than those on public insurance programs.
On June 2, Kentucky Attorney General Daniel Cameron (R) filed a lawsuit accusing CVS Health of fueling the opioid crisis in the state.