HealthCare Roundtable e-News – February 6, 2023

 

Roundtable Welcomes Newest Member

Texas Association of Counties Health & Employee Benefits Pool

The Texas Association of Counties Health & Employee Benefits Pool (TAC HEBP) is one of the oldest, largest and most successful public-sector benefit pools in the nation. The program enables counties and county-related entities to combine, or pool, their purchasing power, increasing contract control and decreasing costs.

For more information click here.

SAVE THE DATE

New Congress, New Policies & Possibilities: Public Sector Purchaser Priorities in 2023

Tuesday, February 14th at 2:00 PM (EST)

With newly elected members of congress, committee leaders, and an expanded Democratic majority in the U.S. Senate and Republican takeover in the U.S. House, the landscape for federal health care policy has changed dramatically in a few short weeks. Join us on Tuesday, February 14th at 2:00pm ET to hear from the Public Sector HealthCare Roundtable senior policy team who will provide a legislative and regulatory policy and political forecast for public sector purchaser priorities in the 118th Congress and second half of the Biden Presidency. 

Register Today


Top News

Senate Judiciary Committee Set to Mark Up Five Bipartisan Bills on Drug Pricing Reform

This week, the Senate Judiciary Committee will mark up five bipartisan bills that aim to improve competition against brand drugs. Each bill passed out of committed by a voice vote last Congress. The bills aim to:

  • Coordinate between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (PTO)
  • Direct the Federal Trade Commission (FTC) to study the role of pharmacy benefit managers (PBMs) in the supply chain
  • Limit pay-for-delay agreements
  • Deter use of citizen petitions that aim to delay competition

Last Thursday, Sens. John Cornyn (R-TX) and Richard Blumenthal (D-CT) reintroduced their bipartisan bill, the Affordable Prescriptions for Patients Act, which aims to improve competition by placing limits on the number of patents biologic manufacturers can assert during the “patent dance.” This term refers to part of the biosimilar approval process when manufacturers of the biologic and biosimilar can exchange information and resolve disagreements over intellectual property. The bill has support from stakeholders such as the Pharmaceutical Care Management Association (PCMA), which is the national organization representing pharmacy benefit managers (PBMs).

 

U.S. Court of Appeals Sides With Drugmakers in 340B Drug Discount Case

The United States Court of Appeals for the Third Circuit, ruled in favor of pharmaceutical manufacturer Sanofi Aventis that providers cannot use the 340B drug discount program through an unlimited number of contract pharmacies. The case stems from a Department of Health and Human Services (HHS) policy stating that hospitals are allowed to receive discounts from an unlimited number of contract pharmacies. The Court rejected this claim and stated only Congress is allowed to set terms of the 340B Program per statute. However, the Court also suggested drug companies would be required under the law to allow the discounts for at least one contract pharmacy where no other options are available. Hospitals and providers will look to future appeals for more favorable rulings.

 

Sen. Wyden Asks CMS for Information on Implementation of Inflation Rebates

Last Wednesday, Senate Finance Committee Chair Ron Wyden (D-OR) sent a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure asking for information on the enforcement of the Inflation Reduction Act’s inflation rebate requirements for Medicare Parts B and D. Specifically, he asked how Medicare will calculate the rebates and what enforcement mechanisms CMS will use to notify drugmakers of the required rebates. According to Sen. Wyden, the Finance Committee will pay close attention to how the inflation rebate provisions lower prices for Medicare beneficiaries. The inflation rebates went into effect in Parts B and D on January 1.

 

Sens. Sanders and Cassidy Lay out HELP Committee Agenda

Yesterday, the Senate finally made committee assignments official, naming Sens. Bernie Sanders (I-VT) and Bill Cassidy (R-LA) as Chair and Ranking Member, respectively, of the Senate Committee on Health, Education, Labor, and Pensions. In interviews with STAT news (subscription required), both senators outlined their top priorities for the committee and where there is an opportunity for bipartisan collaboration. Both senators cited addressing the national shortage of nurses as a potential area for bipartisanship. Chairman Sanders also highlighted expanding access to community health centers and improving dental coverage as issues where democrats and republicans can find agreement. Ranking Member Cassidy highlighted mental health care legislation and investigating the implementation of the No Surprises Act as potential areas of bipartisan cooperation. On the issue of drug pricing, Chairman Sanders named slashing drug prices as a top priority and stated that the Inflation Reduction Act provisions that allowed Medicare to negotiate drug prices did not go far enough. In contrast, Ranking Member Cassidy was critical of drug price negotiation and voiced concern that it could harm innovation.

 

Texas Medical Association Files Fourth Lawsuit Against No Surprises Act

Last Monday, the Texas Medical Association (TMA) filed its fourth lawsuit in the U.S. District Court for the Eastern District of Texas, challenging a hike in administrative fees for those seeking a surprise billing federal dispute resolution under the No Surprises Act (NSA). The Departments of Health and Human Services (HHS), Labor, and the Treasury, and the U.S. Office of Personnel Management established in their interim final rules a nonrefundable administrative fee all parties must pay to enter the federal independent dispute resolution (IDR) process in the event of a payment disagreement between an out-of-network provider and a health plan.

The federal agencies set the initial administrative fee at $50 and announced in October 2022 it would remain at $50 for 2023. However, they later increased the fee to $350 beginning January 2023. The agencies noted this was due to supplemental data analysis and increasing expenditures in carrying out the federal IDR process. TMA contends the steep jump in fees will dramatically curtail many providers’ ability to seek arbitration when a health plan offers insufficient payment for care. On December 12, 2022, the Roundtable and 58 other stakeholders sent a letter to the Secretaries of HHS, Labor, and the Treasury, urging the Departments to stand firm against efforts to strike down the NSA.

Executive Action

  • On Monday, President Biden announced to Congress his plans to end the COVID-19 Public Health Emergency (PHE) on May 11. The announcement came in response to resolutions brought to the floor this week by House Republicans to immediately end the PHE. This also comes on the heels of an announcement by the World Health Organization, which also declared that COVID-19 continues to constitute a public health emergency of international concern. Certain flexibilities tied to the PHE will conclude, including telehealth parity with in-office visits, eased rules for prescribing controlled substances without an in-person physician visit, and more.

  • Recently, on the one-year anniversary of the reignition of the Cancer Moonshot, the Biden Administration announced actions that will build on measures taken in the past year. In addition to new activity, President Biden announced his intent to appoint six members to the National Cancer Advisory Board, which will help guide the Director of the National Cancer Institute (NCI) in setting the course for the research program.

Administrative Action

Last Monday, HHS and the Departments of Labor and the Treasury proposed to expand and strengthen access to birth control coverage under the Affordable Care Act (ACA). The rules would also establish a new pathway, called the individual contraceptive arrangement, that individuals enrolled in plans or coverage by objecting entities that are not eligible for or have not opted for the existing accommodation may use to obtain contraceptive services at no cost directly from a willing provider or facility that furnishes contraceptive services. In the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the proposed rule aims to ensure broader access to contraceptive services by enabling individuals enrolled in plans offered by objecting entities to still access contraceptive services directly. 

Congressional Action

On Wednesday, Rep. Larry Bucshon (R-IN) called (subscription required) for oversight hearings on Medicare physician payment reform as he works through stakeholders’ comments on flaws in the system set up by the Medicare Access and CHIP Reauthorization Act. This is consistent with a range of provider groups representing more than a million clinicians urging lawmakers to move on comprehensive reforms. Rep. Bucshon mentioned that the partial mitigation included in last year’s spending bill isn’t enough for physicians or to protect Medicare beneficiaries’ access to care.

Medicare

  • Last week, CMS released a final rule (press releasefact sheet) on changes to the Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) program, which CMS uses to recover improper risk adjustment payments made to MA plans. Through RADV audits, a sample of beneficiary medical records are provided by MA plans, and CMS reviews those records to verify that diagnoses reported for risk adjusted payments are accurate and supported in the medical record. Risk adjustment discrepancies can be aggregated to determine an overall level of payment error, which can then be extrapolated.

  • On Wednesday, CMS released the Advancing Interoperability and Improving Prior Authorization Processes proposed rule that outlines the Agency’s goals to advance interoperability and to improve overall prior authorization processes to enhance communication between patients, providers, and payers. Significant policies addressed in this rule include changes to prior authorization processes, interoperability standards for patient and provider access APIs, and payer-to-payer data exchange on FHIR. The proposed rule also includes requests for information on adopting standards related to social risk data, advancing an electronic data exchange among behavioral health providers, the electronic exchange of information in Medicare FFS, advancing the Trusted Exchange Framework and Common Agreement, and improving interoperability and prior authorization processes for maternal health. A detailed summary of the proposed rule can be accessed here.

  • On Wednesday, CMS released the Calendar Year (CY) 2024 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS will accept comments on the CY 2024 Advance Notice through March 3, 2023, before publishing the final Rate Announcement by April 3, 2023. 

Medicaid

CMS issued new guidance and frequently asked questions (FAQ) on a temporary special enrollment period for individuals disenrolled from Medicaid and CHIP due to the unwinding of the COVID-19 maintenance of effort requirement. States will begin Medicaid and CHIP eligibility redeterminations over the coming months for all individuals who were enrolled in the programs during the COVID-19 public health emergency (PHE). Individuals who no longer meet the eligibility criteria for Medicaid or CHIP will be eligible for a new Marketplace Unwinding Special Enrollment Period (SEP) between March 31, 2023 and July 31, 2024. 

Research

  • On Tuesday, the Commonwealth Fund released their updated cross-national comparison of health care systems to assess U.S. health spending, outcomes, status, and service use relative to other high income countries. The data from this analysis uses the Organization for Economic Co-operation and Development (OECD) and reflects the impact of the COVID-19 pandemic. Among other outcomes, the Commonwealth Fund found that while the U.S. spends more on health care than any other high-income country, the nation often performs worse on measures of health and health care.

  • MedPAC and MACPAC released their annual update to the dually eligible beneficiary data book. The data book provides an overview on populations that are dually eligible for both Medicaid and Medicare benefits, health care utilization and expenditures across both programs, and key trends. Dually eligible individuals are a relatively small proportion of either program, but they continue to account for a disproportionate share of both Medicare and Medicaid expenditures.