Health Care Watch: October 11, 2021
The following FHP Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 4 – October 9. 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
Senate
On October 4, Majority Leader Chuck Schumer (D-NY) called for the debt ceiling to be raised and warned his colleagues that the Senate may have to remain in session over this weekend and possibly through the recess. On October 6, Democratic leaders delayed the scheduled cloture vote to suspend the debt limit through December 2022. After Democrats discussed altering the filibuster for the debt ceiling, Minority Leader Mitch McConnell (R-KY) proposed temporarily raising the debt ceiling to a fixed dollar amount to cover current spending levels into December, presumably to provide more time for Democrats to settle on a reconciliation bill that would include the debt ceiling increase. On October 7, the Senate passed a short-term suspension of the debt limit, coinciding with the December 3 date where government funding will expire, by a 50-48 party line vote. The House will return from recess on October 12 to consider a two-month debt limit extension.
On October 7, the Commerce, Science and Transportation Communications, Media, and Broadband Subcommittee held a hearing entitled State of Telehealth: Removing Barriers to Access and Improving Patient Outcomes. Witnesses included: Sterling Ransone, Jr., MD, Fellow, President, American Academy of Family Physicians; Sanjeev Arora, MD, Founder, Project ECHO; Distinguished Professor of Medicine, University of New Mexico; Deanna Larson, President, Avel eCARE; and Brendan Carr, Commissioner, Federal Communications Commission.
Democrats are continuing to consider ways to trim the price tag of the $3.5 trillion reconciliation bill, including means-testing the proposed new Medicare dental, vision, and hearing benefits and cross-program funding reductions. The White House is seriously entertaining the idea of across-the-board haircuts to most items in President Biden’s $3.5 trillion social spending package. Rep. Pramila Jayapal (D-WA) stated that she would like the package to end up closer to $3 trillion rather than the $2 trillion ballpark referenced by President Biden.
House
Democratic leaders are hoping to pass the bipartisan infrastructure bill and the reconciliation package by October 31, before certain transportation programs expire again.
NON-CORONAVIRUS REGULATORY UPDATE
On October 4, the Centers for Medicare & Medicaid Services (CMS) announced that Kentucky, Maine, and New Mexico will transition from HealthCare.gov to their own State-based Marketplaces for the 2022 plan year. Open enrollment begins on November 1.
On October 4, CMS announced that 275,000 Missourians are now eligible for Medicaid following the state successfully expanding the program through ballot initiative, and has received over 17,000 applications since they began accepting applications in August 2021.
On October 5, National Institutes of Health (NIH) Director Francis Collins announced he will retire by the end of the year. Collins is the longest serving presidentially-appointed NIH director, having served over more than 12 years.
On October 5, the U.S. Department of Health & Human Services (HHS) issued a request for comment on the Draft Department Strategic Plan for Fiscal Year (FY) 2022-2026.
On October 5, the White House Office of Management & Budget (OMB) concluded its review of the notice from the Food & Drug Administration (FDA) entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.
On October 6, the FDA issued revised guidance entitled Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs under theFederal Food, Drug, and Cosmetic Act. A summary of the guidance is available here.
On October 7, OMB received a final rule from CMS entitled CY 2022 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1749).
On October 7, OMB received a final rule from CMS entitled CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1753)
On October 7, HHS Secretary Xavier Becerra swore in Melanie Egorin as Assistant Secretary for Legislation.
On October 8, Agency for Healthcare Research and Quality issued a notice entitled Supplemental Evidence and Data Request on Telehealth for Women.
On October 8, CMS released the 2022 Star Ratings for Medicare Advantage and Medicare Part D prescription drug plans. A fact sheet on the 2022 Star Ratings is available here.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
House
None of note.
Senate
None of note.
Regulatory
On October 4, the Department of Defense announced that all civilian employees must be fully vaccinated by November 22.
On October 4, the FDA issued an emergency use authorization (EUA) for ACON Laboratories over-the-counter at-home COVID-19 antigen test.
On October 4, CMS released updated FAQs that employer group health plans cannot deny benefits to unvaccinated beneficiaries but plans can offer premium discounts to customers who are vaccinated. Plans that increase premiums for unvaccinated beneficiaries will have the increase count toward whether that coverage is determined to be affordable under the Affordable Care Act (ACA).
On October 4, OMB released guidance for workers to be fully vaccinated and specific medical exemptions.
On October 5, the HHS Office of the Assistant Secretary for Planning and Evaluation releaseda report that found that COVID-19 vaccinations were linked to a reduction of approximately 265,000 COVID-19 infections, 107,000 hospitalizations, and 39,000 deaths among Medicare beneficiaries between January and May 2021. A summary of the report is available here.
On October 6, the NIH published a study that found that those who are vaccinated with substance use disorders may be at higher risk of COVID-19 breakthrough infection, compared to vaccinated people without substance use disorders. The study also found that co-occurring health conditions and adverse socioeconomic determinants of health, which are more common in people with substance use disorders, appear to be largely responsible for the increased risk of COVID-19 breakthrough infections.
On October 8, OMB received an interim final rule from CMS entitled Omnibus COVID-19 Health Care Staff Vaccination (CMS-3415).
The FDA Vaccines and Related Biological Products Advisory Committee will hold a public meeting on October 14-15 to discuss Moderna’s and Johnson & Johnson’s (J&J) COVID-19 booster shots. The Committee will also hold a public meeting on October 26 to discuss Pfizer's request for EUA for its COVID-19 vaccine for kids 5 to 11.
The Centers for Disease Control and Prevention (CDC) Independent Advisory Committee on Vaccines will hold a public meeting on October 20-21 to discuss Moderna’s and J&J COVID-19 booster shots. The Committee will also meet on November 2-3 to evaluate and discuss Pfizer's request for EUA for its COVID-19 vaccine for kids 5 to 11.
White House
On October 6, White House Coronavirus Response Coordinator Jeff Zients announced that the U.S. will purchase an additional 180 million rapid, at-home COVID-19 tests over the next year for $1 billion.
On October 7, the White House released a report entitled Vaccination Requirements Are Helping Vaccinate More People, Protect Americans from COVID-19, and Strengthen the Economy. The report found that vaccination requirements by health care systems, educational institutions, public-sector agencies, and private businesses increase vaccination rates by more than 20 percentage points, with organizations increasing their percentage of vaccinated workers to 90%. Vaccination requirements have already helped cut the rate of unvaccinated Americans by one-third and higher vaccination rates lead to lower COVID-19 rates and a stronger economy, the report claims. About 25% of businesses, 40% of hospitals, and colleges and universities serving 37% of all graduate and undergraduate students have vaccination requirements.
Other
On October 4, the European Medicines Agency’s Human Medicines Committee recommended Pfizer’s and Moderna’s COVID-19 vaccine boosters six months after the second dose for those with severely weakened immune systems.
On October 4, Pfizer published a study in The Lancet that found that the effectiveness of the Pfizer COVID-19 vaccine against delta variant infections declined to 53% after 4 months and effectiveness against other variants declined to 67% at 4–5 months. The vaccine maintained 93% effectiveness against hospital admissions with the delta variant for up to 6 months.
On October 4, a study published in JAMA Internal Medicine found 5.8 cases per million of myocarditis in men with an average age of 25 years, following a second dose of both Pfizer’s and Moderna’s COVID-19 vaccine, an increase from 0.8 cases per million after the first dose. The risk of myocarditis is still extremely low.
On October 5, J&J announced it has submitted COVID-19 booster data to the FDA for EUA.
On October 4, a study published in JAMA found that convalescent plasma was not associated with clinical improvement in critically ill COVID-19 patients.
On October 5, AstraZeneca submitted a request to the FDA for EUA for its long antibody COVID-19 treatment for the prevention of symptomatic COVID-19.
On October 6, Los Angeles approved an ordinance in a 11-2 vote to require proof of COVID-19 vaccination for indoor restaurants, shopping malls, movie theaters, hair and nail salons, gym or sporting venues, and many other indoor venues beginning in early November.
On October 7, Pfizer submitted its COVID-19 vaccine to the FDA for EUA for children ages 5 to 11.
As of October 9, more than 216 million people in the U.S. (65.2%) have received the first dose of COVID-19 vaccines (nearly 187 million received both doses – 56.3%) and more than 485 million doses have been distributed, according to the CDC COVID Data Tracker.
As of October 9, the U.S. had nearly 44.3 million confirmed COVID-19 cases resulting in 712,698 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Request for Information: Transplant System Modernization (CMS-3409); Notice; 9/21/21
Prescription Drug and Health Care Spending (CMS-9905); Interim Final Rule; 9/24/21
CY 2022 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1749); Final Rule; 10/7/21
CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1753); Final Rule; 10/7/21
Omnibus COVID-19 Health Care Staff Vaccination (CMS-3415); Interim Final Rule; 10/8/21
HHS-FDA
Medical Device De Novo Classification Process; Final Rule; 6/28/21
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
HHS-Office of the Secretary
Securing Updated and Necessary Statutory Evaluations Timely; Proposed Rule; 8/31/21
Streamlining HHS Guidance Practices; Proposed Rule; 6/28/21
REPORTS
HHS Office of Inspector General (OIG)
On October 5, OIG released a report entitled Medicare Overpaid $636 Million for Neurostimulator Implantation Surgeries. The report found that more than 40% of the providers in this OIG audit did not comply with Medicare requirements when they billed for neurostimulator implantation surgeries. OIG estimated that during calendar years (CY) 2016 and 2017, providers received $636 million in unallowable Medicare payments associated with neurostimulator implantation surgeries and beneficiaries paid $54 million in related unnecessary copays and deductibles. OIG noted that CMS published a final rule that requires prior authorizations for implanted spinal neurostimulators during the audit, however, the rule does not include claims for Parkinson's disease or seizure disorders. OIG recommended that CMS instruct the Medicare contractors to recover Medicare potential overpayments for incorrectly billed claims; instruct providers to refund beneficiary coinsurance amounts; and notify providers with potential overpayments, so they can exercise reasonable diligence to identify, report, and return any overpayments in accordance with the 60-day rule. OIG also recommended that CMS conduct provider outreach and education regarding the Medicare coverage requirements for neurostimulator implantation surgeries and require prior authorization for neurostimulator implantation surgeries for Parkinson's disease and seizure disorders. CMS agreed with the recommendations. A summary of the report is available here.
On October 5, OIG released a report entitled SAMHSA's Oversight Generally Ensured That the Commission on Accreditation of Rehabilitation Facilities Verified That Opioid Treatment Programs Met Federal Opioid Treatment Standards. The report found that SAMHSA's oversight generally ensured that Commission on Accreditation of Rehabilitation Facilities (CARF) verified that opioid treatment programs (OTPs) met federal standards and ensured that CARF's survey teams met federal requirements. OIG recommended that SAMHSA update its policies and procedures to require verification that accreditation bodies maintain records that contain sufficient detail to support each accreditation decision. SAMHSA agreed with the recommendation. A summary of the report is available here.
On October 8, OIG released a report entitled Minnesota Medicaid Managed Care Entities Used a Majority of Medicaid Funds Received for Medical Expenses and Quality Improvement Activities. The report found that Minnesota managed care entities used the majority of funds received for medical expenses and quality improvement activities, during CY 2017. OIG estimated that the Minnesota Medicaid program could have saved $82,427 in CY 2017 if Minnesota required its Medicaid managed care entities to meet the minimum 85% medical loss ratios (MLRs) standard for each Medicaid managed care contract and required remittances when Medicaid managed care entities did not meet the MLR standard. Minnesota incorporated a remittance requirement for contracts beginning CY 2018 if Medicaid Managed Care Organizations do not meet an MLR of at least 85%, therefore, OIG had no recommendations. A summary of the report is available here.
Congressional Budget Office (CBO)
On October 9, CBO released a report entitled Monthly Budget Review: September 2021.CBO estimated that the federal budget deficit was $2.8 trillion in FY 2021, which is $362 billion less than the deficit recorded in FY 2020. A summary of the report is available here.
UPCOMING CONGRESSIONAL HEARINGS
House
Energy & Commerce Committee
October 20, time TBD
Legislative hearing on public health bills
Senate
None of note.
OTHER HEALTH POLICY NEWS
On October 4, a study published in Health Affairs found that recently acquired rural hospitals were more likely to shut down maternal, neonatal and surgical care services, compared to those that remained independent.
On October 6, a study published in JAMA Network estimated that the cost of cancer care for the 15 most prevalent cancers for privately insured adults in the US was $156.2 billion in 2018. Drug treatments drove this cost, with the expenses for breast, lung, lymphoma, and colorectal cancers driving the highest drug costs.
On October 7, PhRMA released a report that 41% of Americans who take prescription drugs have skipped a dose at least once over the last year, over half of whom had high-deductible health plans. Two-thirds of respondents said they prefer to pay lower out-of-pocket costs for prescriptions versus paying a lower premium each month.
On October 7, the Medicaid and CHIP Payment and Access Commission (MACPAC) releasedan issue brief entitled An Updated Look at Rates of Churn and Continuous Coverage in Medicaid and CHIP. The brief found that about 8% of full-benefit Medicaid and CHIP beneficiaries disenrolled and reenrolled within a year, which is higher than MACPAC's previous estimates. The report found varied rates of churn and average lengths of coverage between states, due to state policy differences.
On October 7-8, the Medicare Payment Advisory Commission (MedPAC) held its October meeting. The meeting included sessions discussing:
· Addressing high prices of pharmaceutical products (and other technologies) covered under Medicare;
· Data on Medicare's net prices for prescription drugs and other drug pricing metrics;
· Congressional request: Vulnerable Medicare beneficiaries' access to care (final report);
· Exploring features of Medicare's alternative payment models
· Improving Medicare Advantage risk adjustment by limiting the influence of outlier predictions; and
· Medicare hospital wage index.