Health Care Watch: August 30, 2021
The following FHP Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 23 – August 29. 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 August 24, the House passed the $3.5 trillion budget resolution in a 220-212 party line vote. The measure also set a September 27 deadline for a House vote on the Senate’s $1 trillion bipartisan infrastructure package. Committees have until September 15 to assemble the $3.5 trillion budget reconciliation. Democrats are discussing health priorities to be included in the package, including:
Expanding Medicare to cover vision, dental, and hearing;
Closing the Medicaid "coverage gap” in non-expanded states;
Tying Medicare drug reimbursements to a domestic benchmark;
Extending premium subsidies to purchase coverage through the Affordable Care Act (ACA) insurance marketplaces; and
Funding for home and community-based services.
The package is not expected to include a provision to lower Medicare’s eligibility age.
On August 24, Energy & Commerce Committee Ranking Member Cathy McMorris Rodgers (R-WA), Health Subcommittee Brett Guthrie (R-KY), and Oversight & Investigations Subcommittee Ranking Member Morgan Griffith (R-VA) requested information from the National Institutes of Health (NIH) on the National Institute of Allergy and Infectious Diseases (NIAID) grant awarded to the Wuhan Institute of Virology (WIV) pre-COVID-19. Specifically, they voiced concerns that the NIH failed to oversee biosafety concerns at the WIV, that may have led to COVID-19 being released from the lab.
On August 25, Reps. Annie Kuster (D-NH) and David McKinley (R-WV) sent a letter to the Centers for Medicare & Medicaid Services (CMS) urging the Agency to implement policies that would increase access to generics and biosimilars. Specifically, they request that CMS limit the newly established, lower cost-sharing, preferred specialty tier in Part D to only generics and biosimilars; and set a co-insurance percentage for the newly established preferred specialty tier that is meaningfully lower than the co-insurance for the non-preferred specialty tier.
On August 27, 38 Representatives called for Speaker Pelosi, Senate Majority Leader Chuck Schumer (D-NY), House Budget Committee Chairman John Yarmuth (D-KY), Senate Budget Chairman Bernie Sanders (I-VT), House Ways & Means Chairman Richard Neal (D-MA), and Senate Finance Chairman Rob Wyden (D-OR) to make the advance premium tax credit expansion that was included in the American Rescue Plan permanent.
The House will return from recess on September 20.
Senate
On August 23, Sens. Maggie Hassan (D-NH), Chuck Grassley (R-IA), Sheldon Whitehouse (D-RI), Edward Markey (D-MA), Joe Manchin (D-WV), and Elizabeth Warren (D-MA) requested information about the Food & Drug Administration’s (FDA) past work with McKinsey & Co. and potential conflicts of interest relating to advising opioid manufacturers and avoiding regulatory oversight. The Senators asked for more information from the FDA by September 20.
On August 25, Peter Fise joined the Finance Committee as a health counsel focusing on Medicare Part B, telehealth, delivery and payment of mental health care and chronic care in the fee-for-service program, and other provider issues.
On August 26, Finance Committee Ranking Member Mike Crapo (R-ID) called for the Government Accountability Office (GAO) to monitor the progress of the Social Security and Medicare Trustees Report, following the lack of sufficient response from his letter to Treasury Secretary Janet Yellen regarding the report. Treasury Secretary Yellen noted that the 2021 Trustees Reports should be signed on August 31. As per statute, the report should have been published no later than April 1.
The Senate will return from recess on September 13. It is expected to bypass Committee markups and consider the $3.5 trillion reconciliation package on the floor the week of October 4.
NON-CORONAVIRUS REGULATORY UPDATE
On August 23, the CMS Advisory Panel on Hospital Outpatient Payment held a meeting to advise the Agency on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights.
On August 23, the FDA published its Prescription Drug User Fee Act reauthorization performance goals and procedures for fiscal years (FY) 2023-2027. The FDA will hold a public meeting to discuss the proposed recommendations on September 28.
On August 24, CMS announced data from the Next Generation Accountable Care Organizations (NGACO) Model for Performance Years 1-3. The NGACO Beneficiary RIF contains enrollment data for beneficiaries in the NGACO Model and the NGACO Provider RIF contains identifying information about the providers participating in the NGACO Model.
On August 25, CMS released performance data from Accountable Care Organizations (ACOs) in the Medicare Shared Savings Program, finding that the program saved Medicare nearly $1.9 billion in 2020.
On August 27, CMS awarded $80 million in grants to expand the number of Navigator organizations to help people enroll in coverage through the Marketplace, Medicaid, or the Children’s Health Insurance Program (CHIP) in 30 states with a Federally-Facilitated Marketplace.
On August 27, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced $74.2 million in grants to strengthen the structures that serve the mental health needs for youths.
On August 27, the Health Resources and Services Administration (HRSA) announced $10.7 million in funding through the Pediatric Mental Health Care Access Program to expand pediatric mental health care access by integrating telehealth services into pediatric care.
On August 27, CMS issued a notice announcing its phased expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports will resume on December 1. The demonstration was halted for nine months due to the COVID-19 pandemic.
The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will hold a public meeting on September 22 to examine relevant health outcomes in studies for cerebrovascular disease treatment, with a particular focus on new technologies of interest to CMS.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) rescheduled their August 24 meeting to August 30. The Agenda for this meeting is available here. The Committee will also hold a meeting on September 29 and 30 to review and revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children program.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
House
On August 21, Rep. Troy Nehls (R-TV) announced that he tested positive for COVID-19, despite being vaccinated.
Senate
Nothing of note.
Regulatory
On August 22, the FDA updated the Emergency Use Authorization (EUA) to extend the shelf-life of the Pfizer COVID-19 vaccine from 6 months to 9 months. On August 23, the FDA granted full approval to Pfizer's COVID-19 vaccine for people 16 and older. The vaccine is now named Comirnaty.
On August 24, the Department of Agriculture announced $300 million to conduct surveillance of COVID-19 and other emerging diseases in animals by building an early warning system to prevent or limit future pandemics.
On August 24, CMS announced that health care providers can receive increased payment for administering at-home COVID-19 vaccines by $35 per vaccination when the shots are administered to multiple residents in one home setting or communal home setting. Medicare currently reimburses providers $40 for each dose of a COVID-19 vaccine, and an additional $35 for each dose administered in the home. The new enhanced payment would give providers an additional $35 when administered to multiple residents in one home setting or communal home setting. As an example, CMS notes that if a provider administers a COVID-19 vaccine dose to two beneficiaries in the same home on the same day, Medicare would pay the provider $150 (i.e., $40 for each COVID-19 vaccine, plus the $35 rate for the in-home vaccine administration, plus the additional $35 for administering to multiple residents).
On August 24, the CDC released two studies finding that COVID-19 immunity may be decreasing due to the Delta variant. One study of frontline health care workers found that COVID-19 vaccines that have been given EUA are 80% effective against preventing COVID-19 and 66% effective against the delta variant. The other study of Los Angeles residents found that COVID-19 infection and hospitalization rates, specifically during the rise of the Delta variant, of partially vaccinated people were 4.9 times higher than fully vaccinated people, and infection and hospitalization rates of unvaccinated people were 29.2 times higher than fully vaccinated people. The study also found that from May to July 2021, 25% of new COVID-19 infections were in fully vaccinated individuals and 71% were in unvaccinated people.
On August 24, NIH Director Francis Collins predicted that the FDA will likely not authorize COVID-19 vaccines for children under the age of 12 before late 2021. On the same day, however, NIH National Institute of Allergy and Infectious Diseases Director Anthony Fauci predicted that COVID-19 vaccines may be available by mid-late fall or early winter for children under 12.
On August 25, Defense Secretary Lloyd Austin announced a COVID-19 vaccine mandate for all troops.
On August 25, CMS’ Center for Clinical Standards and Quality Deputy Director Jean Moody-Williams announced that CMS will implement a phased-in penalty process for nursing homes that do not meet the recent federal mandate requiring nursing homes to require that all staff to be fully vaccinated against COVID-19 as a condition of participating in the Medicare and Medicaid programs.
On August 26, the Federal Communications Commission announced $41.98 million in funding for telehealth services through the COVID-19 Telehealth Program to assist hotspot, low income, and unfunded areas by supporting health care workers in providing telecommunications services, information services, and connected devices necessary to enable telehealth during COVID-19.
On August 27, Office of the U.S. Trade Representative issued a notice and request for comments entitled Request for Comments on Certain Products Exclusions Related to COVID-19: China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation. The office will consider whether to continue to exclude certain medical-care products made in China needed to address COVID-19 from the tariffs from the former Trump Administration on a "case-by-case" basis. The tariff exclusions are set to expire on September 30.
On August 27, the NIH launched a study to assess the antibody response to a COVID-19 vaccine booster shot in people with autoimmune disease who did not respond to an original COVID-19 vaccine.
White House
On August 23, President Biden urged businesses and public leaders to implement COVID-19 vaccine mandates, as the Pfizer COVID-19 vaccine received full FDA approval. Following this announcement, Delta Airlines announced that it will require employees to receive the COVID-19 vaccine or submit to weekly testing and a $200 monthly surcharge for health insurance.
On August 25, Vice President Kamala Harris announced that the U.S. will provide an additional 1 million COVID-19 vaccine doses to Vietnam.
Other
On August 23, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus urged countries with high vaccination rates to delay administering booster shots for two months, to prioritize under-vaccinated countries and prevent additional COVID-19 variants.
State and local leaders have continued to implement COVID-19 vaccine and mask mandates. On August 23, New Jersey and New York City announced COVID-19 vaccine mandates for teachers and education staff. On August 24, Oregon Governor Kate Brown (D) announced a statewide outdoor mask mandate in the state, regardless of vaccination status, to help stop spread of the Delta variant. On the other hand, Texas Governor Greg Abbott (R) expanded the ban on COVID-19 vaccine mandates, regardless of their approval status. On August 26, Illinois Governor J.B. Pritzker (D) announced a vaccine mandate for health care workers, educators and college students must or submit to testing.
On August 25, Johnson & Johnson released interim data from two Phase I/IIa studies that have not yet been peer reviewed that found that a second dose of its COVID-19 vaccine given six months after the first dose generated a strong immune response. The studies found that antibody levels increased nine times after a second dose, compared to one month after their first dose.
On August 25, a U.K. study found that Pfizer’s and AstraZeneca’s COVID-19 vaccines decrease in efficacy within six months. Pfizer’s vaccine effectiveness decreased to 74% within five to six months and AstraZeneca’s vaccine effectiveness decreased to 67% after four to five months.
On August 25, the WHO announced the Scientific Advisory Group for the Origins of Novel Pathogens to advise the WHO regarding the origins of potential emerging and re-emerging pathogens that could lead to epidemics and pandemics, including COVID-19.
On August 25, Pfizer announced that it has initiated FDA approval of its COVID-19 vaccine booster dose for people 16 years and older.
On August 25, Moderna announced that it submitted its COVID-19 vaccine to the FDA for full approval.
On August 25, a study published in the New England Journal of Medicine found that the risk of myocarditis is much higher with contracting COVID-19 than with receiving the Pfizer COVID-19 vaccine. The study also found that the risk of other serious adverse events was substantially higher after COVID-19 infection, compared to receiving the Pfizer COVID-19 vaccine.
On August 26, New York Governor Kathy Hochul (D) said the state had 12,000 more COVID-19 deaths than were publicized by the Cuomo administration. The system under the Cuomo Administration collected data from hospitals, nursing homes and adult care facilities and excluded people who died at home, in hospice, in prisons or at state-run homes for people with disabilities, which accounts for the disparity.
On August 26, the Institute for Clinical and Economic Review (ICER) announced it will conduct a comparative review of five COVID-19 treatments for mild to moderate cases. The assessment will be finalized in April 2022.
On August 25, Becton Dickinson announced that FDA granted an EUA to its at-home rapid antigen COVID-19 test.
On August 27, the WHO, the International Monetary Fund, the World Bank, and the World Trade Organization urged countries that have large vaccine supplies to share doses with COVAX and the African Vaccine Acquisition Trust first.
On August 27, a study published in the British Medical Journal found that the risk of blood clots after contracting COVID-19 is many times larger than the risk of blood clots associated with the AstraZeneca or Pfizer vaccine.
As of August 29, nearly 204 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 173 million have received both doses) and nearly 440 million doses have been distributed, according to the CDC COVID Data Tracker.
As of August 27, the U.S. had more than 38.7 million confirmed COVID-19 cases resulting in 637,258 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
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Final Rule; Received 5/12/21
Reporting Requirements Related to Air Ambulance and Agent and Broker Services and HHS Enforcement Provisions; Proposed Rule; 7/7/21
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; Received 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
Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations; Proposed Rule; 8/18/21
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 8/18/21
Patient Protection and Affordable Care Act; Updating Payment Parameters and Improving Health Insurance Markets for 2022 and Beyond (CMS-9906); Final Rule; 8/19/21
Department of Labor-Employee Benefits Security Administration
Requirements Related to Surprise Billing, Part 2; Interim Final Rule; 8/2/21
REPORTS
HHS Office of Inspector General (OIG)
On August 16, OIG released a report entitled Oklahoma's Oversight of Medicaid Outpatient Services for Opioid Use Disorder (OUD) Was Generally Effective. OIG found that Oklahoma's oversight of Medicaid OUD drugs and outpatient services was generally effective. OIG identified areas that could be improved, including increasing access to outpatient counseling services because Oklahoma does not emphasize counseling in conjunction with OUD drugs, and expanding behavioral health contract reviews by Oklahoma Department of Mental Health and Substance Abuse Services (ODMHSAS) to Medicaid beneficiaries. OIG recommended that Oklahoma consider whether more of an emphasis on counseling could improve OUD outcomes and take steps to increase the appropriate use of counseling with OUD drugs in outpatient OUD treatment, and develop policies and procedures to ensure that Medicaid behavioral health services are reviewed on an ongoing basis. Oklahoma agreed with the recommendations and described actions it is taking or may take to address the findings and recommendations. Oklahoma also said that it recognizes that individuals who receive medication assisted treatment drugs should receive therapy and other appropriate health services because providing both medication and therapeutic treatment is a best practice. A summary of the report is available here.
On August 24, OIG released a report entitled Although CDC Implemented Our Prior Audit Recommendations, Its Corrective Actions Did Not Effectively Address Findings Related to 3 of Our 13 Recommendations. The report found that CDC implemented the 13 recommendations from the prior OIG audit. On the other hand, OIG found that the CDC did not comply with one or more HHS or CDC policies when awarding President's Emergency Plan for AIDS Relief (PEPFAR) funds, did not perform cost analyses before issuing some of the grant awards, and issued several Notices of Award (NOAs) with missing or incorrect reporting requirements. OIG recommended that CDC develop and implement a written policy requiring periodic internal review of PEPFAR award files for compliance with HHS and CDC policies; fully implement its Cost Analysis Standard Operating Procedure (SOP) by establishing a formal date of effectiveness, updating the SOP periodically, and enforcing its use through regular compliance testing as part of the internal reviews of PEPFAR award files; and establish a policy requiring periodic reviews of, and updates to, the NOA link to ensure functionality, accuracy, and relevance of the content. CDC officials agreed with the recommendations. A summary of the report is available here.
On August 26, OIG released a report entitled CMS Needs To Issue Regulations Related to Phlebotomy Travel Allowances. The report found that some Medicare Administrative Contractors (MACs) that paid providers for phlebotomy travel allowances did not comply with Medicare guidance. Errors were related to incorrect prorated mileage, incorrect payment rates, and inadequate documentation, resulting in $2.7 million in phlebotomy travel allowance payments that were not in accordance with Medicare guidance. As of June 2020, CMS had not begun the notice and comment rulemaking process to clarify provider guidance related to prorating mileage on claims for phlebotomy travel allowances or issue further guidance. OIG recommended that CMS work with the MACs to educate providers about the documentation requirements for phlebotomy travel allowances, instruct the MACs to identify and adjust any paid claims that incorrectly used the previous year's rate, and issue regulations related to phlebotomy travel allowances. CMS agreed with the first two recommendations. A summary of the report is available here.
On August 26, OIG released a report entitled CGS Administrators, LLC, Claimed Some Unallowable Medicare Excess Plan Costs Through Its Incurred Cost Proposals. The report found that CGS received $29,022 in unallowable Medicare Excess Plan costs on its Incurred Cost Proposals (ICPs) for calendar years (CYs) 2015 and 2016, due to CGS using an incorrect allocable Excess Plan cost when calculating the indirect cost rates. OIG recommended that CGS work with CMS to ensure that its final settlement of contract costs reflects the correct decrease in Medicare Excess Plan costs. CGS said that it would work with CMS to ensure that its final settlement of contract costs is appropriate. A summary of the report is available here.
On August 27, OIG released a report entitled CGS Administrators, LLC, Claimed Some Unallowable Medicare Postretirement Benefit (PRB) Costs Through Its Incurred Cost Proposals. The report found that CGS claimed $2.2 million in unallowable Medicare PRB costs on its ICPs for CYs 2012 through 2016, due to CGS using an incorrect allocable PRB cost when calculating the indirect cost rates. OIG recommended that CGS work with CMS to ensure that its final settlement of contract costs reflects the decrease in Medicare PRB costs. CGS said that it would work with CMS to ensure that its final settlement of contract costs is appropriate. A summary of the report is available here.
On August 27, OIG released a report entitled Foreign Assistance to Combat HIV/AIDS, Tuberculosis, and Malaria: Fiscal Year 2022 Inspectors General Coordinated PEPFAR Oversight. OIG announced that it plans to conduct PEPFAR program integrity and fraud prevention activities for the FY 2022 coordinated oversight plan. For FY 2022, OIG has four ongoing audits to complete, two planned audits to start, and fraud prevention training to conduct. A summary of the plan is available here.
Congressional Budget Office (CBO)
On August 26, CBO released a report entitled CBO's Simulation Model of New Drug Development: Working Paper 2021-09. The simulation model builds on the previous CBO report on this topic and estimates the number of drugs entering the various stages of human clinical trials depending on the reduction of profits caused by legislation. The report predicts that if implemented, the Lower Drug Costs Now Act (H.R. 3), would result in eight fewer new drugs coming to market in the next decade. CBO predicts that early-stage drugs will be most affected but expects more new drugs to be introduced over the next decade under H.R. 3. A summary of the report is available here.
UPCOMING CONGRESSIONAL HEARINGS
House
House Committees are expected to markup their reconciliation bills the week of September 6 and 13.
Senate
None of note.
OTHER HEALTH POLICY NEWS
On August 23, a report published by the Urban Institute found that the uninsured rate stayed steady at 11% between March 2019 and April 2021. The rate of those with employer-sponsored coverage decreased from 65% to 62.3%, or about 5.5 million people, due to layoffs during COVID-19.
On August 24, the U.S. Preventive Services Task Force recommended that those who are overweight or obese should begin to get screened for Type 2 diabetes and abnormally high blood sugar levels beginning at 35 years old, five years earlier than their previous recommendations.
On August 25, the U.S. Chamber of Commerce withdrew its lawsuit against HHS and other agencies regarding the HHS Transparency in Coverage rule requiring group health plans and insurance issuers to publicly disclose cost-sharing estimates, negotiated rates, prescription drugs, and other price information that was implemented during the former Trump Administration.
On August 27, the Medicare Payment Advisory Commission (MedPAC) released the agenda for its September 2-3 meeting. The meeting will include sessions discussing: