HealthCare Roundtable e-News – August 1, 2022

 

Top News

Senate Democrats Reveal New Reconciliation Package, Includes ARP Extensions, Drug Pricing Measures

On Wednesday night, Senate Majority Leader Chuck Schumer (D-NY) and Sen. Joe Manchin (D-WV) agreed to a bill that includes energy, health, and tax policy after weeks of negotiation. The bill, which has been deemed “The Inflation Reduction Act of 2022,” now includes a $369.75 billion investment in climate and energy security, and reduces the deficit by $300 billion. The package includes another nearly $64 billion to cover three years of subsidies for Affordable Care Act premiums, marking an increase over the two-year extension Sen. Manchin originally agreed to. On Thursday night, Sen. Schumer said Democrats are adding insulin-affordability measures to the government price control part of the package. It is unclear which provisions are being added. However, the version of the legislation posted Wednesday night does not single out insulin products, meaning their eligibility would be determined like other products based on their time on the market and cost to Medicare. Once the legislation comes back from the Senate Parliamentarian, we will have a better idea of what the official package looks like. The bill does not close the Medicaid gap, but advocates have noted that this will be their focus once Congress passes the reconciliation package.

 

NY Attorney General Sues CVS for Violating Antitrust Laws, Diverting Millions From Underserved Communities

On Friday, New York Attorney General Letitia James sued CVS Health Corporation for violating antitrust laws and hurting state safety net hospitals and clinics. CVS required New York safety net hospitals and clinics, which provide for underserved communities in the state, to exclusively use CVS-owned Wellpartner to process and obtain federal subsidies on prescriptions fulfilled at CVS pharmacies. For years, CVS prevented safety net hospitals and clinics from using the company of their choice to obtain subsidies on prescriptions filled at CVS pharmacies through the contested 340B federal program. This program allows hospitals to purchase certain drugs at a discount from pharmaceutical companies and use the saving for patient care. Attorney General James is seeking injunctive relief and equitable monetary relief for the revenue loss and additional costs safety net providers incurred, as well as civil penalties for CVS’s actions. Additionally, Attorney General James hopes to require CVS to inform all safety net health care providers that they are not limited to Wellpartner.

Administrative Action

  • The Department of Health and Human Services (HHS) announced a proposed rule that would ban discrimination on the basis of sex, including sexual orientation and gender identity, and would also clarify that “discrimination on the basis of sex includes discrimination on the basis of pregnancy or related conditions, including ‘pregnancy termination.’ The Department of Health and Human Services (HHS or the Department) is issuing this proposed rule on Section 1557 of the Affordable Care Act (ACA) (Section 1557). The rule is expected to face legal challenges.
  • Last week, the Congressional Budget Office (CBO) and the Joint Committee on Taxation (JCT) released its analysis on the effects of making the enhanced premium tax credit structure provided in section 9661 of the American Rescue Plan Act of 2021 (ARPA) permanent. Under the May 2022 baseline, CBO and JCT estimate that if the enhancements became permanent, federal deficits would increase by $247.9 billion over the 2023-2032 period. Additionally, the report detailed the effects of a proposed regulation concerning the affordability of employment-based coverage for family members. CBO and JCT estimate that, if the proposed regulation is made final, the number of people enrolled in nongroup coverage would increase, on average, by 900,000 in each year over the 2023-2032 period.

Regulatory Action

The Centers for Medicare and Medicaid Services (CMS) issued three final rules related to Medicare payment policies and rates on Wednesday. The Inpatient Rehabilitation Facility (IRF) Prospective Payment System Final Rule (fact sheetfull rule text) updates IRF payment rates based on the IRF market basket update and a productivity adjustment, places a permanent cap on year-to-ear wage index decreases, and codifies IRF teach status adjustment policies. The Inpatient Psychiatric Facility (IPF) Prospective Payment System Final Rule (fact sheetfull rule text) is consistent with the legal requirement to update payment policies for IPF on an annual basis. Additionally, the Hospice Payment Rate Update (fact sheetfull rule text) updates Medicare hospice payments and aggregate cap amount and established a permanent mitigation policy to smooth out the impacts of hospice wage index changes over time. 

Congressional Action

  • Late Wednesday evening, the House voted 416-12 in favor of legislation to extend telehealth flexibilities through 2024. The legislation allows Medicare, federally qualified health centers, and rural health clinics to cover telehealth or audio-only telehealth visits. These flexibilities were initially authorized under the Trump administration at the beginning of the pandemic, and renewed by Congress in March 2020 as part of the CARES Act. The Senate will now review the legislation, where it is expected to have enough votes for passage.
  • The House Ways and Means Committee voted unanimously to send an amended H.R. 3173 “Improving Seniors’ Timely Access to Care Act of 2021,” to the floor of the House. The included amendment would require a Medicare Advantage plan to authorize or deny services within 24 hours for emergency services, and 7 days for all other services. The bill, cosponsored by 306 representatives, would automate the prior authorization process for physicians and patients under Medicare Advantage plans, and aims to reduce provider burden and create better health outcomes. A previous report done by the Office of Inspector General under The Department of Health and Human Services displayed increased burden and negative health outcomes as a result of the current prior authorization process.
  • The Congressional Budget Office (CBO) recently released the estimated budgetary effect of Sen. Jeanne Shaheen’s proposed Improving Needed Safeguards for Users of Lifesaving Insulin Now Act, which caps the out-of-pocket cost of insulin and other related products. The bill imposes private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA). CBO estimates that the annual average cost to comply would exceed the private-sector threshold established under UMRA of $184 million in 2022.
  • Senators Sherrod Brown (D-OH) and Rob Portman (R-OH) introduced the bipartisan Comprehensive Care for Dual Eligible Individuals Act of 2022, legislation which would amend the Social Security Act to create a new optional state-administered program for those dually eligible for both Medicare and Medicaid. In states that elect to establish the program, dually eligible beneficiaries would be able to choose a single program that provides integrated care for their medical, long-term care, social, and behavioral needs. Medicaid and Medicare each have their own set of administrative rules and processes, which can lead to fragmented care and poorer health outcomes. More than 12 million Americans are dually eligible for both programs.

Medicaid

  • CMS released their Maternity Care Action Plan in support of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. The action plan seeks to use expanded equity measurements and collaboration to increase quality of care from pregnancy to the postpartum period, and reduce disparities particularly among vulnerable populations. The report details plans to improve coverage and access to care, enhance data collection and utilization, prioritize quality of care, grow the workforce, and provide social supports.
  • The California Health Care Foundation released a study today that found greater investment in primary care is associated with better quality care, patient experience, and plan rating. The study highlights the important opportunity to improve health equity through greater emphasis on primary care. California and several other states are currently pushing for requirements that primary care teams, including physicians nurse practitioners, physician assistants, community health workers, behavioral health staff, and others, play a greater role in the health care delivery system.

Medicare

  • The Centers for Medicare and Medicaid Services (CMS) released a Request for Information seeking public comment on the Medicare Advantage program. CMS is soliciting input on how the agency can enhance health equity through MA, strengthen beneficiary access to health services, drive innovation to promote person-centered care, support affordability and sustainability of the program, and better engage stakeholders to improve the program. The RFI is a part of CMS’s efforts to prioritize increased engagement with stakeholders in the policy development and implementation process.
  • KFF published a brief illustrating the potential scope of the drug price negotiation proposal in the Build Back Better Act (BBBA). The analysis highlights which 20 drugs covered under Medicare Part B and Part D, in addition to all insulin products, would be subject to negotiation under the BBA if the proposal is implemented this year. Additionally, the brief shows which of the current top-spending drugs covered in Part B and Part D could be subject to price negotiation, and in what years.

Litigation

  • Last week, the United States Court of Appeals for the Second Circuit found that Pfizer’s proposed program to provide charitable assistance to some Medicare beneficiaries with a rare heart condition would violate the Anti-Kickback Statute (AKS). According to the appeals court, the New York-based federal district properly concluded that providing $13,000 per year to some Medicare beneficiaries to help them afford Pfizer’s drug Tafamidis would violate the AKS because the intent of the program is to increase the number of beneficiaries who purchase the drug.  Broadly, this ruling may have an effect on other similar charity or co-pay assistance programs offered by pharmaceutical companies to cover the cost of an expensive medication for Medicare beneficiaries.
  • A group of Texas residents and employers are challenging (subscription required) provisions under the Affordable Care Act (ACA) that require insurance coverage for preventative services, including STD screenings, HIV prevention drugs, depression checks, and flu shots. This week, Judge Reed O’Connor heard oral arguments in Kelley v. Becerra, which could determine whether insurance companies are allowed to deny coverage or charge higher co-pays for common preventative care. The challenge was filed in March of 2020 and argues that the ACA’s preventative care mandates violate the Religious Freedom Restoration Act. The plaintiffs also argue that Congress did not authorize civil servants and outside advisers at the Department of Health and Human Services (HHS) to compile a list of preventative health services that all insurance plans must cover. On Monday, the Urban Institute released an analysis that concluded a ruling against ACA coverage could threaten coverage of preventative services for nearly 168 million people on employer health insurance and on Obamacare’s individual market.

Roundtable Reminders

SAVE THE DATE – November 9-11, 2022
Annual Conference Returns to Alexandria, VA

After two years of virtual meetings, the Roundtable is planning an in-person Annual Conference for this November. We will return to The Alexandrian Hotel in Old Town Alexandria, Virginia for our annual policy conference from Wednesday, November 9 to Friday, November 11, 2022.

Details will be released later this year. For now, save the dates!