Wynne Health Group (WHG) has compiled a chart that delineates a comprehensive set of temporary flexibilities pursuant to the COVID-19 public health emergency (PHE). Under current PHE conditions, the U.S. Department of Health and Human Services (HHS) is authorized under section 1135 of the Social Security Act to waive a range of Medicare and Medicaid requirements as a means for... Read More
Impact Health - Overview of the Pharmacy Benefit Manager Regulatory and Legislative Landscape
While legislative momentum for drug pricing reform has waned since the Build Back Better (BBB) Act stalled, regulators and legislators have continued to focus on pharmacy benefit managers (PBMs) and their role in the pharmaceutical supply chain. As this recent attention has been spread across different agencies and between the federal and state legislatures, the Wynne Health Group has compiled... Read More
Impact Health - Weekly, April 4-8
Ahead of the two-week congressional recess, the Senate will have a busy week continuing to negotiate a bipartisan COVID-19 supplemental package and advancing the nomination of Ketanji Brown Jackson to the U.S. Supreme Court. Tomorrow, former President Barack Obama will return to the White House for an event celebrating the Affordable Care Act (ACA). President Biden is also expected to... Read More
Impact Health - Weekly, March 28-April 1
Today, President Biden is slated to release his fiscal year (FY) 2023 budget request, officially kicking off the appropriations process for the next fiscal year beginning on October 1, 2022. Throughout the week, committees in both chambers will hold hearings on various health policy priorities, including universal health coverage, behavioral health care, Food and Drug Administration (FDA) user fees, and... Read More
Impact Health - Weekly, March 21-25
This week, the Senate Judiciary Committee will hold four days of confirmation hearings on President Biden’s nomination of Ketanji Brown Jackson to serve on the Supreme Court of the United States. Last year, three Republican senators (Sens. Susan Collins (R-ME), Lisa Murkowski (R-AK), and Lindsey Graham (R-SC)) voted with Democrats to confirm Judge Jackson to the U.S. Court of Appeals... Read More
Impact Health - Weekly, March 14-18
This week, House leaders plan to vote on a standalone $15.6 billion COVID supplemental package (H.R. 7007) that was pulled from the fiscal year (FY) 2022 appropriations omnibus due to pushback from some Democrats over the offsets. Nearly identical to the original version, this new bill includes $9.85 billion to procure therapeutics and vaccines, $750 million to develop vaccines against... Read More
Impact Health - Possible CMMI Action on Drug Pricing
Following the collapse of the Build Back Better Act (BBBA), it remains unclear whether Congress will pass drug pricing legislation. While it is still possible for Congress to act on separate components of the BBBA (including drug pricing) via reconciliation, there is less insight into how exactly Democrats plan to move forward on these legislative priorities. It has remained WHG’s... Read More
Impact Health - Weekly, March 7-11
The deadline to fund the government for fiscal year (FY) 2022 is this Friday, March 11. Democrats are pushing to include COVID-19 supplemental funding in the FY 2022 appropriations omnibus, along with Ukraine assistance. “Democrats have made a reasonable global offer to Republicans and it is my hope that we will reach an agreement very soon so that we can... Read More
Impact Health - Weekly, February 28-March 4
This week’s main event is President Biden’s first State of the Union address tomorrow evening. While the President’s remarks will have a significant focus on national security, we anticipate his speech will also touch on the Biden Administration’s COVID-19 response and health care priorities. Biden may provide some direction to lawmakers on which health policies of the Build Back Better... Read More
Impact Health - Weekly, February 22-25
With Congress in recess this week, we look ahead to what is underway on the administrative front – including changes to electronic prior authorization, Medicare payment updates, Medicare Advantage (MA) and Part D Advance Notice, and modifications to Medicare enrollment. Additionally, we highlight key activities and dates related to the unwinding of the Medicaid continuous coverage requirement... Read More
Impact Health - Weekly, February 14-18
Senate Votes A third continuing resolution (CR) appears to be the charm for fiscal year (FY) 2022 appropriations. On the heels of an agreed-to “bipartisan appropriations framework,” the Senate is expected to pass the House-approved (272-162) stopgap funding extension before the current CR expires on February 18. Lawmakers will then have until March 11 to negotiate and finalize all 12... Read More
Impact Health - Roundup of Recent Telehealth Policy
Federal attention on telehealth continues to mount. This is true especially as uncertainty builds around when the COVID-19 public health emergency (PHE) will end, which would mark the end of many telehealth flexibilities absent further congressional action (though the Administration may allow any flexibilities to persist for up to an additional 60 days following the end of the PHE). The... Read More
Impact Health - Weekly, February 7-11
Without an agreement on a fiscal year (FY) 2022 spending, and with the February 18 deadline of the second continuing resolution (CR) approaching, top appropriators are considering a third CR with a March 11 expiration. The protracted bipartisan talks over topline spending numbers have stalled the finalization of all 12 appropriations bills. The House is expected to vote on a... Read More
Impact Health - Weekly, January 31-February 4
While congressional Democrats continue to negotiate a scaled down version of the Build Back Better Act (BBBA), lawmakers are homing in on other key legislative priorities. This week, committees in both chambers will hold hearings on an array of health policy issues – including mental health, Medicare financing, Food and Drug Administration’s (FDA) user fee programs, public health, and broadband... Read More
Impact Health - Weekly, January 24-28
With major health care legislation on hold as congressional Democrats figure out how to pass “big chunks” of the Build Back Better Act (BBBA), we look ahead to statutory cliffs and potential legislative vehicles to watch as well as anticipated rulemaking from the Biden Administration in 2022. A fuller account of WHG’s 2022 Legislative & Regulatory Outlook is available here... Read More
Impact Health - 2022 Legislative and Regulatory Outlook - Excel Version
As a companion tool to our Legislative and Regulatory Outlook, WHG has also developed an excel-based version that allows for greater sortability across a range of variables (including by agency and health policy area)... Read More
Impact Health - 2022 Legislative and Regulatory Outlook
WHG has developed its Legislative and Regulatory Outlook for 2022, based largely on changes reflected in the Administration's recently released Fall 2021 Unified Agenda. As in previous versions of our annual outlook, we provide a comprehensive line-up of key federal health care policy developments we expect to see throughout the course of the coming year and their approximate timing. We... Read More
Impact Health - Weekly, January 18-21
With the expiration of the continuing resolution (P.L. 117-70) funding the federal government one month away (February 18), top congressional appropriators appear to be nearing a deal on a fiscal year (FY) 2022 omnibus government funding bill. Whether a COVID-19 supplemental package will be bundled with the FY 2022 funding bill remains an open question, as congressional Democrats wait for... Read More
Impact Health - Weekly, January 10-14
COVID-19 The Biden Administration faces a crucial week, as President Biden and top health officials try to ensure public confidence in the administration’s COVID-19 response, especially as the Centers for Disease Control and Prevention (CDC) faces harsh criticism over its new isolation and quarantine guidelines for the general population and schools. The President is scheduled to deliver remarks on the... Read More
Impact Health - Weekly, January 3-7, 2022
Congressional Democrats return with the same to-do list but with a more tenuous political landscape. Following Sen. Joe Manchin’s (D-WV) announcement that he will not support the Build Back Better Act (BBBA) as currently proposed, Democrats will work to revise the package to a more pared down version that may possibly exclude some of its more contentious elements. As another... Read More
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