Health Policy Report (2/14)

Capitol Hill Update

The Senate will reconvene for legislative business today eyeing action on legislation that would implement a series of reforms to the U.S. Postal Service. Specifically, the Postal Service Reform Act (H.R. 3076) would, among other things: (1) provide USPS with $50 billion in additional funding over 10 years; (2) require future retirees to enroll in Medicare; and (3) establish a Postal Service Health Benefits program for USPS employees and retirees. While the House-passed bill is expected to clear the Senate with strong bipartisan support, timing on a final vote could slip due to a last-minute disagreement between leadership and Sen. Rick Scott (R-FL) over a technical change to the legislation.

Senators are also slated to vote on a continuing resolution (CR) (text; summary) that would keep the government funded beyond Friday’s deadline. However, it is possible that the Senate’s vote on the stopgap falls closer to February 18 due to a hold placed on the measure by Sen. Marsha Blackburn (R-TN). Specifically, Sen. Blackburn has been critical over language contained in the Substance Abuse and Mental Health Service Administration’s (SAMHSA) Harm Reduction Grant program that could be perceived as directly funding certain drug paraphernalia. It is unclear whether a clarifying statement issued by Health and Human Services (HHS) Secretary Xavier Becerra and Office of National Drug Control Policy (ONDCP) Director Dr. Rahul Gupta is enough to ease the Senator’s concerns.

Meanwhile, appropriations leaders are expected to continue their negotiations on a fiscal year (FY) 2022 omnibus spending deal after reaching an agreement on a “framework” for government funding last week. While the agreement will allow appropriators to begin writing each of the 12 appropriations bills, leadership has yet to formally unveil the 302(b) subcommittee funding allocations for each of the spending measures. Reports out of Capitol Hill suggest that appropriators are expected to support a funding level for defense spending that exceeds authorization levels established in the FY 2022 National Defense Authorization Act (NDAA). The forthcoming omnibus legislation is also likely to include scores of congressionally-directed spending items (House; Senate).

Califf Teed Up to Receive Official Confirmation Vote

After putting Robert Califf’s nomination on ice while Senate and White House leadership worked to whip votes, Senate Majority Leader Chuck Schumer (D-NY) filed cloture on a vote on Califf’s confirmation to lead the Food and Drug Administration (FDA). This move likely signals that Schumer is confident in the Senate’s ability to confirm Califf, with a vote expected as soon as tomorrow. The White House has been making the rounds on Capitol Hill — including calls from White House COVID coordinator Jeff Zients and Chief Medical Advisor Anthony Fauci — to drum up support for Califf amid concerns about this candidacy on both sides of the aisle.

Califf participated in over 50 interviews this past week to assuage Senators’ concerns, and some members are still on the fence. On the Republican side, Sens. Rob Portman (R-OH), Thom Tillis (R-NC), Rick Scott (R-FL), and Pat Toomey (R-PA) are still weighing Califf’s merits, but Senate Majority Whip Dick Durbin (D-IL) is fairly confident that he has a sufficient number of his Republican colleagues on board. Califf also secured support from Sens. Michael Bennet (D-CO) and Ron Wyden (D-OR), though Sens. Richard Blumenthal (D-CT), Maggie Hassan (D-NH), and Joe Manchin (D-WV) remain opposed to Califf’s nomination.

Biden Gives Speech on Drug Pricing Reform

On Thursday, President Joe Biden took to the road in a campaign-style speech (TRP analysis) aimed at selling the drug pricing proposalsincluded in his signature Build Back Better (BBB) agenda. Less than 24 hours after Sen. Bernie Sanders (I-VT) attempted to ignite the issue on the Senate floor by seeking unanimous consent (UC) on a new, more aggressive legislative proposal, the President doubled down on policies included in the BBB Act. In his address, the President spoke to his desire to “hold drug companies accountable” by allowing Medicare to negotiate drug prices, imposing mandatory rebates for drugs that rise faster than inflation, capping the amount seniors pay for prescription drugs at $2,000 per year, and improving transparency at pharmacies. 

While President Biden’s remarks served to underscore the areas of consensus on drug pricing among Democrats in Washington, he strayed from Sen. Sanders’s sentiments. Sanders recommended a plan that would go significantly further than the Democratic party’s consensus approach, including calling on Medicare to lower drug prices down to the levels paid by the Department of Veterans’ Affairs. Senator Sanders’ approach has also put him at odds with Senate Majority Leader Chuck Schumer (D-NY), who has resisted his calls to bring stand-alone drug pricing legislation to the floor. 

Tensions Rise Over 1115 Waivers, Medicaid Premiums

As the Biden administration continues to push for Medicaid expansion and increase enrollment, the White House is moving to eliminate premiums. While premiums are generally not permitted in the Medicaid program, some states charge premiums through their 1115 waivers. Specifically, the Biden administration’s efforts from late 2021 direct Arkansas, Georgia, and Montana to phase out premiums by the end of 2022. Now, the administration may also follow suit in the other five states that charge premiums under their waivers: Arizona, Indiana, Iowa, Michigan, and Wisconsin.

States and the federal government have long struggled for power over Medicaid policy, and this tension has been exacerbated by 1115 wavier disagreements. Biden’s efforts to withdraw previously approved waivers are especially frustrating for those states, as waivers can take years to approve and are now at risk of rescission before they expire. The heated debate is driving some stakeholders to revisit the traditionally Republican concept of implementing Medicaid block grants instead of waiver programs. They argue that waivers add a layer of uncertainty to states’ Medicaid programs, given the unpredictability of policy shifts due to changes in administrations. Additionally, advocates of block grants note that waivers can dissuade non-expansion states from expanding their programs.

Legislators Release Telehealth Legislation

As uncertainly around the extension of the public health emergency (PHE) grows, telehealth advocates are growing more restless. The PHE designation enabled telehealth flexibilities to increase accessibility, and there has been bipartisan support to retain some of those flexibilities. Most recently, the Department of Health and Human Services (HHS) extended the COVID-19 PHE for 90 days, until April 16, 2022. Absent another extension of the PHE, however, Medicare beneficiaries would be slated to lose access to telehealth services.

In an attempt to rectify this situation, Sens. Catherine Cortez Masto (D-NV) and Todd Young (R-IN) introduced the Telehealth Extension and Evaluation Act (text; press release; section-by-section), which would provide for a two-year: (1) extension of telehealth services under Medicare; (2) modification of payment structures for high-cost durable medical equipment (DME) and laboratory tests ordered via telehealth; and (3) addition of a special payment rule for telehealth services provided by federally-qualified health centers (FQHC) and rural health clinics.

If passed, the legislation would aid in avoiding an abrupt termination of telehealth access for Medicare beneficiaries at the conclusion of the PHE, as is set to take place currently. Meanwhile, stakeholders have been pushing for an extension of certain telehealth flexibilities to ride on a potential omnibus spending deal for fiscal year (FY) 2022, though, at this time, it is too early to tell if this path forward is realistic. While extension legislation was introduced in the Senate last week, its House companion — the Telehealth Extension Act of 2021 (H.R. 6202) — was released by Rep. Lloyd Doggett (D-TX) in December 2021.

CDC Releases Highly-Anticipated Draft Guidance for Opioid Prescribing

Last week, the Centers for Disease Control and Prevention (CDC) released the long-anticipated notice of its draft 2022 Clinical Practice Guideline for Prescribing Opioids (TRP summary). The draft guidance updates the CDC’s 2016 guidance and is intended for the use of clinicians providing outpatient pain care for patients 18 years or older with acute pain, subacute pain, or chronic pain. The 2022 draft guidance includes a detailed summary of findings that informed the CDC’s recommendations. Specifically, the clinical practice guideline addresses: (1) determination process of initiating opioid treatment; (2) opioid selection and dosage; (3) treatment duration and follow-up; and (4) assessing harms of opioid use. CDC notes that its final guidance will not apply to pain stemming from sickle cell disease, cancer, palliative care, or end-of-life care.

CDC currently provides guidance to clinicians in the realm of pain care primarily through the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. In that guidance document, CDC noted that it would update guidance accordingly as new evidence and research is developed. Since 2016, the CDC has reviewed noninvasive, nonpharmacological, and nonopioid treatments. The updated 2022 guidance is intended to reflect this research.

These clinical practice guidelines are intended to function as a tool to improve patient-provider communication and are not a law or regulation. In developing the guidelines, CDC collaborated closely with the Opioid Working Group (OWG) and the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC/ NCIPC). Notably, this updated guidance no longer recommends that doctors “avoid increasing dosage” to 90 morphine milligram equivalents (MME). The new guidance also removed language that suggests limits for acute pain prescriptions.