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.