The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 19 - October 25. 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 October 19, 229 House members urged Speaker Nancy Pelosi (D-CA) and Minority Leader Kevin McCarthy (R-CA) to address proposed rate cuts to physician specialty services in the 2021 Medicare Physician Fee Schedule. Representatives voiced their concern that the proposed cuts would further strain the health care system, as it is dealing with COVID-19.
On October 20, Ways & Means Chairman Richard Neal (D-MA), Energy & Commerce Chairman Frank Pallone (D-NJ), and Senate Finance Ranking Member Ron Wyden (D-OR) raised additional concerns to Health and Human Services (HHS) Secretary Alex Azar regarding the legality of the Trump Administration’s plan to deliver $200 drug discount cards to Medicare beneficiaries. The letter builds on the two letters they sent last week requesting the Government Accountability Office (GAO) review the drug card plan and requesting additional information from HHS regarding the legality of the plan and how Centers for Medicare & Medicaid Services (CMS) would administer the program. The most recent letter references the leaked HHS General Counsel Robert Charrow memo that warned the drug cards could violate election law. The $7.9 billion drug card plan would send beneficiaries enrolled in a Part D plan and not receiving the program’s low-income subsidies, a $200 card to be used exclusively for prescription drugs. On October 21, 25 House Democrats called for CMS to abandon the drug card plan.
On October 20, the Ways & Means Oversight Subcommittee held a hearing entitled Maximizing Health Coverage Enrollment Amidst Administration Sabotage. Chairman Bill Pascrell (D-NJ) discussed the pending Supreme Court legal case against the Affordable Care Act (ACA). Ranking Member Mike Kelly (R-PA) highlighted the expanded choice of plans Americans have, including short term health plans. Witnesses included: Marlene Caride, Commissioner, New Jersey Department of Banking and Insurance; Kevin Patterson, Chief Executive Officer, Connect for Health Colorado; Andy Slavitt, Board Chair, United States of Care; and Chris Pope, Senior Fellow, Manhattan Institute.
On October 21, Ways & Means Committee Chairman Neal and Energy & Commerce Committee Chairman Pallone expressed their strong concerns to CMS Administrator Seema Verma with the CMS proposal to modify the regulatory framework that currently limits the expansion of Physician Owned Hospitals.
The House is scheduled to return on November 18.
House Democrats plan to hold leadership elections on November 18 and 19.
Senate
On October 22, the Judiciary Committee voted to advance the nomination of Amy Coney Barrett to be an Associate Justice of the Supreme Court to the Senate floor 12-0. Senate Democrats boycotted the vote in an act of protest. Senate Majority Mitch McConnell (R-KY) scheduled to bring the nomination to the Senate floor on October 26.
NON-CORONAVIRUS REGULATORY UPDATE
On October 19, CMS released a report entitled Plan Year 2021 Qualified Health Plan Choice and Premiums in HealthCare.gov States. The report estimated that premiums will decrease and issuer participation will increase for HealthCare.gov in 2021, for the third consecutive year. A summary of the report is available here.
On October 21, CMS approved Nebraska's Medicaid Section 1115 demonstration, entitled Heritage Health Adult, to expand the state’s Medicaid program and provide vision, dental, and over-the-counter drug benefits. In order to receive enhanced benefits, enrollees must have an annual health visit, complete a health risk assessment, and not miss more than three scheduled appointments within a half-year. A work requirement for the program will take effect in April 2022. The expansion is expected to expand Medicaid coverage to an additional 90,000 people.
On October 21, the Department of Justice (DOJ) announced an $8.3 billion settlement with Purdue Pharma to resolve criminal and civil investigations for the company’s role in the opioid crisis, including defrauding the U.S. and two anti-kickback-related charges. The settlement also includes a $225 million resolution of its civil investigation into the Sackler family. The settlement agreement does not prevent family members or company executives from being prosecuted in the future. Purdue Pharma will be dissolved and won't exist in its current form, pending bankruptcy court approval.
On October 21, CMS announced that the start date of the Radiation Oncology Model will be delayed from January 1, 2021 to July 1, 2021, in response to stakeholder concerns.
On October 21, CMS Administrator Seema Verma sent a letter to the editor for The Hill, highlighting the Administration’s accomplishments in lowering drug prices, including capping the price of insulin as part of the Part D Senior Savings Model, progress on reducing drug list prices (citing insulin as an example), and implementing a real-time benefit tool in Part D.
2021 Medicare Open Enrollment is open and will run through December 7, 2020.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
Legislative
On October 19, 14 Democratic Senators called for free COVID-19 tests for all Capitol Hill staff after multiple Congress members and staff test positive.
On October 21, the Senate failed to advance S.178, the Delivering Immediate Relief to America’s Families, Schools and Small Businesses Act, the GOP’s $500 billion targeted relief package, that included expanded unemployment benefits, new Paycheck Protection Program money, more than $100 billion for schools, funding for testing and tracing, money for Operation Warp Speed (OWS) to produce a vaccine, and funding to distribute it. No Democrats voted for the package.
Speaker Pelosi and Treasury Secretary Steve Mnuchin continued to meet over a larger package but Speaker Pelosi announced October 21 that an agreement will not happen before the election. There is also some doubt regarding Congress passing a relief package after the election, including Sen. Roy Blunt (R-MO) who voiced skepticism regarding Congress’s productivity post-election.
On October 22, Homeland Security & Governmental Affairs Committee Ranking Member Gary Peters (D-MI) released a report entitled Road to Recovery: Administration Must Build Public Trust and Ensure Safe, Effective, and Free Coronavirus Vaccines. The report identifies gaps in current federal vaccine preparedness measures and recommends actions to strengthen the nation’s response, including making a safe and effective COVID-19 vaccine free and widely available and giving additional aid to state and local governments to assist with vaccine distribution and administration.
Regulatory
On October 19, the Food & Drug Administration (FDA) released the Technology Modernization Action Plan to modernize the FDA’s technical infrastructure and operations; enhance the FDA’s capabilities to develop technology products; and communicate and collaborate with external stakeholders to drive technological progress that is interoperable and delivers value to consumers and patients.
On October 19, HHS Secretary Azar said that states do not need additional funding for COVID-19 vaccine distribution because states received $200 million through the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Contrary to these statements, state officials and the Association of State and Territorial Health Organizations have stressed the need for additional funding and direction regarding COVID-19 vaccine administration and distribution.
On October 20, the Centers for Disease Control and Prevention (CDC) released a report estimating that 299,028 more deaths occurred between late January and October 3, compared to previous years, with 66% of the deaths due to COVID-19.
On October 20, GAO announced that the office will investigate whether Administration officials improperly interfered with the CDC and the FDA’s COVID-19 response, including communications and guidance. GAO warned that the investigation would not begin for three months. The investigation comes after Sens. Elizabeth Warren (D-MA), Gary Peters (D-MI), and Patty Murray (D-WA) formally requested for the GAO to pursue this audit on October 8.
On October 21, the CDC updated its COVID-19 guidance, expanding the definition of “close contact” to “someone who was within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period,” from a definition of 15 consecutive minutes of exposure being “close contact.” This change will impact contract tracing efforts and considerations for who should be tested.
On October 21, HHS Secretary Azar predicted a timeline for COVID-19 vaccines: a vaccine should be authorized and available for “the most vulnerable individuals” by the end of the year; available for all seniors, health care workers, and first responders by the end of January 2021; and available for all Americans by the end of March to early April. This is slightly different than other proposed COVID-19 vaccine distribution plans that prioritize health care workers for the first round of vaccines.
On October 21, OWS advisor Moncef Slaoui said that AstraZeneca and Johnson & Johnson’s (J&J) COVID-19 vaccine clinical trials could restart as soon as this week. AstraZeneca’s U.S. clinical trials have been on hold since September 6, after a participant experienced a potential adverse reaction, but trials have continued elsewhere. J&J paused the company’s clinical trials on October 12, due to a participant experiencing an unexplained illness.
On October 21, HHS issued revised guidance authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines, and COVID-19 tests. The guidance clarifies that the pharmacy intern must be authorized by the State or board of pharmacy, but this authorization need not take the form of a license from, or registration with, the State board of pharmacy.
On October 22, the FDA Vaccines and Related Biological Products Advisory Committee held the committee’s first COVID-19 vaccine meeting. The Committee discussed the development and authorization of COVID-19 vaccines and advised that clinical trials should continue even after a vaccine candidate is authorized for emergency use; emphasized the importance of racial, age, and risk factor diversity in clinical trials; and raised the issue of public confidence affecting uptake of an eventual vaccine.
On October 22, the FDA approved remdesivir for the treatment of hospitalized COVID-19 patients, through the FDA Fast Track and Priority Review designations. Remdesivir is the first drug to receive full approval for treating COVID-19.
On October 22, HHS announced that state and local governments will use a system developed by Palantir Technologies, the company that created HHS Protect, to track hospital data related to COVID-19 patients, to track the production, administration and distribution of COVID-19 vaccines.
On October 22, the Health Resources & Services Administration announced that the Provider Relief Fund (PRF) Phase III application has been expanded to include additional provider applicants, including residential treatment facilities, chiropractors, and eye and vision providers that have not yet received PRF distributions. HHS also broadened use of the funding.
On October 22, the FDA amended previous guidance for PRF reporting requirements, adjusting the formula required for providers to account for lost revenue, after stakeholder pushback.
On October 22, HHS Secretary Azar released an op-ed in Fox Business entitled Why OWS is a Made-in-America story. Secretary Azar highlighted the ability for OWS to assist in accelerating the COVID-19 vaccine development and manufacturing timelines.
DOJ-identified “anarchist jurisdictions,” including New York; Portland, OR; D.C.; and Seattle, WA could lose federal COVID-19 and other health-related funding as part of the Memorandum on Reviewing Funding to State and Local Government Recipients That Are Permitting Anarchy, Violence, and Destruction in American Cities, originally released on September 2. HHS has identified 200 health programs that could face cuts, as part of the directive. On October 22, New York, Seattle, and Portland filed a joint complaint in the U.S. District Court of the Western District of Washington seeking to block the loss of federal funds.
White House
On October 24, the office of Vice President Mike Pence released a statement confirming that his chief of staff Marc Short tested positive for COVID-19. Reports indicate that Marty Obst, a senior adviser to Pence who is not a government employee, and another aide in Pence’s office also tested positive for the virus. According to the statement, Vice President Pence and Mrs. Pence have both tested negative for COVID-19. The statement also notes that while Pence is considered a “close contact” with Short, “in consultation with the White House Medical Unit, the Vice President will maintain his schedule in accordance with the CDC guidelines for essential personnel.”
Other
On October 19, CVS Health announced that the company is hiring 15,000 employees to prepare for an expected rise in COVID-19 and flu cases and to administer a potential COVID-19 vaccine.
On October 19, Avalere released a report finding that 94% of Medicare Advantage (MA) plans will offer telehealth benefits for Medicare Part B covered services in 2021. The report also finds that one in three MA plans will start offering new supplemental benefits related to COVID-19, including COVID-19 relief packages with masks, hand sanitizer, and thermometers.
On October 19, Kaiser Family Foundation (KFF) released a report entitled Trends in Overall and Non-COVID-19 Hospital Admissions. The report found that, though hospital admissions dropped to as low as 68.6% of predicted admissions in April, admission volume has mostly stabilized to 90.8% of predicted levels in August. For non-COVID-19 admissions, admissions for people age 65 and older have stabilized at approximately 80-85% of predicted levels in late July and early August.
On October 19, DNA Genotek, a subsidiary of OraSure Technologies, received FDA Emergency Use Authorization (EUA) for the company’s COVID-19 diagnostic test, OMNIgene®·ORALb. This is the first EUA that allows unsupervised use of the diagnostic test at-home or in a healthcare setting when used as part of an approved or validated at-home test kit.
On October 19, Moderna Chief Executive Stéphane Bancel announced the company could see interim results from its COVID-19 vaccine clinical trial in November and could seek EUA as early as December. Bancel warned that if the company doesn't get sufficient interim results earlier, authorization may not happen until early 2021.
On October 19, California announced it will independently review COVID-19 vaccines for safety and vaccines distribution plans. California joins New York, Michigan, West Virginia, D.C. and potentially others in creating review boards for COVID-19 vaccines.
On October 19, the American Health Care Association (AHCA) and the National Center for Assisted Living released a report that COVID-19 cases in nursing homes are beginning to trend upwards, though COVID-19 related deaths in nursing homes are currently on the decline.
On October 20, KFF released a report entitled Distributing a COVID-19 Vaccine Across the U.S. - A Look at Key Issues.The report identifies challenges regarding vaccine distribution, including: resource and funding constraints for state and local health departments; supply, logistics, and monitoring issues; overlapping and unclear federal, state, and local authority distinctions over vaccination requirements leading to differential access to vaccines and varying levels of success in controlling COVID-19; limitations and gaps in insurance coverage and out-of-pocket costs; racial and ethnic disparities in vaccinations and COVID-19 impact; and issues of public confidence and concerns about politicization of vaccine approval and distribution.
On October 20, the Service Employees International Union; the American Federation of State, County, and Municipal Employees; and the American Federation of Teachers released a joint statement that the groups would not take or promote a COVID-19 vaccine without independent experts verifying the approval process, due to recent politicization of public health.
On October 20, a study published in JAMA Internal Medicine found that the immune modulator used to treat rheumatoid arthritis, tocilizumab, may reduce mortality among critically ill COVID-19 patients. Researchers call for further research from randomized clinical trials to validate tocilizumab use as a COVID-19 treatment.
On October 20, 25 health researchers and advocates called for vaccine transparency measures from the federal government and vaccine manufacturers, including publishing clinical trial design methodology and making Data and Safety Monitoring Board charters public.
On October 21, the American Hospital Association, American Medical Association, AHCA, and National Association for Home Care and Hospice sent a letter to congressional leadership seeking an extension of relief from the Medicare sequestration cuts.
On October 21, Columbia University’s National Center for Disaster Preparedness released a study estimating that between 130,000 and 210,000 COVID-19 related deaths could have been avoided with earlier policy interventions and more robust federal coordination and leadership.
On October 21, Federal Reserve Governor Lael Brainard warned that without additional fiscal aid from Congress, economic recovery will be slower, especially for small businesses and the labor market.
On October 21, KFF and the Peterson Center on Healthcare released a report entitled The pandemic’s effect on the widening gap in mortality rate between the U.S. and peer countries. The report predicted that the existing mortality rate gap between the U.S. and peer countries will increase due to COVID-19.
On October 21, a volunteer in AstraZeneca’s COVID-19 vaccine clinical trial in Brazil died. The AstraZeneca vaccine trials did not identify any safety concerns and will not pause clinical trials.
On October 21, Former New Jersey Governor Chris Christie released an op-ed in the Wall Street Journal urging people to wear masks, saying that he should have worn a mask during the White House nomination event for Judge Amy Coney Barrett. Christie was admitted to an intensive-care unit with COVID-19 after this event.
On October 22, Roche announced a $350 million partnership with Atea Pharmaceuticals to develop and distribute Atea’s COVID-19 direct-acting antiviral treatment, AT-527, currently in Phase II clinical trials.
On October 22, Moderna completed the enrollment of 30,000 participants for the Phase III clinical trial of the company’s COVID-19 vaccine candidate, mRNA-1273.
On October 22, the Association of American Medical Colleges (AAMC) called for a coordinated national testing strategy to identify, track, and help curtail the spread of COVID-19. AAMC presented recommendations include: implementing a transparent national strategic, risk-based testing program with federal standards for diagnostic and screening testing; ensuring transparent government action by publicizing the use of the Defense Production Act for testing supplies; and creating a partnership between the federal government, state health authorities, academic institutions, and industry to fund and accelerate screening and surveillance testing for COVID-19.
On October 23, the U.S. set a new single-day record for coronavirus infections (83,010). COVID-related hospitalizations are up 20% in the past two weeks.
On October 23, a study published in the British Medical Journal found that convalescent plasma did not improve patients’ progression to severe COVID-19 or improve mortality.
As of October 24, the U.S. had 8,568,625 confirmed COVID-19 cases resulting in 224,771 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center. COVID-19 is now the third leading cause of death in the U.S., according to Scientific American.
RULES AT THE WHITE HOUSE OMB
Pending Review
HHS-CMS
Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payments (CMS-3337-P); Received 6/6/19
International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/19
Medicaid & CHIP Managed Care (CMS-2408-F); Final Rule; Received 9/26/2019
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Payment Policies for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-1738); Proposed Rule; Received 4/28/20
Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720); Final Rule; Received 7/21/20
Revisions to Medicare Part A Enrollments (CMS-4194) Proposed Rule; Received 9/9/20
Transparency in Coverage (CMS-9915); Final Rule; Received 9/11/20
Advance Notice of Methodological Changes for Calendar Year (CY) 2022 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies – Part II; Notice; Received 9/21/20
Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and PACE (CMS-4190); Final Rule; Received 9/28/20
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Proposed Rule; Received 9/29/20
CY 2021 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1730); Final Rule; 10/5/20
CY 2021 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1732); Final Rule; 10/8/20
HHS-FDA
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Guidance for Industry; Notice; Received 5/28/2020
HHS-OCR
HIPAA Privacy: Changes To Support, and Remove Barriers to, Coordinated Care and Individual Engagement; Proposed Rule; Received 7/31/20
HHS-OIG
Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement; Final Rule; Received 7/21/20
REPORTS
HHS Office of Inspector General (OIG)
On October 23, OIG released a report entitled Medicare Home Health Agency Provider Compliance Audit: Gem City Home Care, LLC. The report found that Gem City did not comply with Medicare billing requirements for some home health claims, resulting in an estimated $2.67 million in overpayments. OIG recommended that Gem City refund overpayments for incorrectly billed claims and strengthen procedures to ensure that the homebound statuses of Medicare beneficiaries are verified and continually monitored, the specific factors qualifying beneficiaries as homebound are documented, and beneficiaries are receiving only reasonable and necessary skilled services. A summary of the report is available here.
Government Accountability Office (GAO)
On October 19, the GAO announced the appointment of Carrie Colla and Dr. Terry Mills, Jr., to the Physician-Focused Payment Model Technical Advisory Committee. Colla is a professor at The Dartmouth Institute for Health Policy and Clinical Practice and part of the Geisel School of Medicine at Dartmouth College. Dr. Mills is the Senior Vice President and Chief Medical Officer of CommunityCare.
On October 19, the GAO released a report entitled Fair Labor Standards Act: Observations on the Effects of the Home Care Rule. The report found that some states made changes to minimum wage and overtime protections for home care workers in their Medicaid programs. GAO found that the rule led some states to limit home care workers' hours in their Medicaid programs to avoid overtime costs but some states did not make any major changes to their Medicaid programs' home care services. GAO also found that home care workers were more likely to work full-time but did not earn significantly higher earnings following the Home Care Rule, when compared to occupations with similar education and training requirements. A summary of the report is available here.
On October 19, GAO released a report entitled Tax Administration: Opportunities Exist to Improve Oversight of Hospitals' Tax-Exempt Status. The report outlined the requirements to obtain and maintain a nonprofit tax exemption for hospitals and highlighted that though the ACA created requirements to better ensure hospitals are serving their communities, the law is unclear about what community benefit activities hospitals should be engaged in to justify their tax exemption. The Internal Revenue Service (IRS) identified factors that can demonstrate community benefits, but they are not requirements, because the IRS does not have authority to specify activities hospitals must undertake. GAO recommends that Congress specify in the Internal Revenue Code what services and activities Congress considers sufficient community benefit. GAO also recommends that the IRS establish a well-documented process to ensure hospitals' community benefit activities are being reviewed, and to create codes to track audit activity related to hospitals' community benefit activities. A summary of the report is available here.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On October 19, Pioneer Health released a white paper entitled Antimicrobial Resistance: Learning from the current global health crisis to prevent another one. The report calls attention to the impact of drug resistant infections, estimating that drug resistance could lead to a cumulative $100 trillion of lost economic output by 2050. Pioneer Health recommends that Congress incentivize antibiotic development by passing the DISARM Act, that would create higher Medicare reimbursement for new antibiotics and require hospitals that receive the increased payments to use the drugs appropriately.
On October 22, Democratic Presidential nominee Joe Biden and President Trump participated in the second and final presidential debate. Biden referenced his proposed health care plan, “Bidencare,” described as a revamped ACA, with a public option, ACA marketplace subsidies, allowing Medicare to directly negotiate with drug companies, and lowering Medicare eligibility from 65 to 60. President Trump called for the complete replacement of the ACA and touted the elimination of the individual mandate but did not offer any specifics of his own health plan.