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Federal Health Policy Updates for the Week of January 4, 2021

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Yesterday is gone
And what matters – what is next
Depends on today


With the swearing in of a new Congress and administration, our newsletter will continue to serve as a resource for you and will report on the notable happenings in Washington, D.C. as well as issues that directly affect the Duke Health mission.

Point of Personal Privilege
The events at the Capitol building on Wednesday afternoon remain fresh in our minds as we publish our first newsletter of the new year. For our team, who have spent a considerable amount of time on those grounds throughout our careers working in a congressional office and now meeting with staff and Members of Congress, those images were especially poignant and personal. We are grateful for the safety of staff and members of the North Carolina congressional delegation.

We remember in everything we do that words matter, not just in their meaning but also their cadence, tone, and purpose. This is true of our elected officials, and it is as true and important for us in how we choose to occupy and report in this space. We will continue to bring you the latest news with some color and creativity (and occasional irreverence), but please be assured just how seriously we take that privilege. If you are looking for even the slightest trace of cynicism, you won’t find it here.

Why? As aware as we are of the shortcomings of our political and governmental institutions, we’ve also seen firsthand what they can be. What is portrayed on our screens as part of the show often belies the truth behind the scenes where deeply committed groups of people actively fight for progress to outweigh ideology. Recognizing this disconnect is important, but so is honoring and highlighting dedicated service.

What’s next? Over the coming weeks, we will have more to report on the developing agenda of the incoming Biden administration and the 117th Congress that will now be led by Democrats, albeit narrowly, in both the House and Senate. Today we reaffirm our own commitment of service to you and this institution and invite you to join us – whenever possible and appropriate – to lend your voice in support of Duke Health’s priorities.

Federal Updates

Any landing from which you can walk away…
Before the end of the session, Congress managed to pass key COVID relief and spending policies, but the closing days of the 116th Congress were not without drama. The first few days of the 117th Congress have proved to be even more eventful as special elections in Georgia have shifted the balance of power in the Senate, and President-elect Joe Biden and Vice President-elect Kamala Harris are now “Congress-official” to take their oaths of office on January 20th.

117th Congress takes shape
Democrats now have majority control of the Senate following a January 5 special election run-off for both Senate seats in Georgia. Rev. Raphael Warnock (D) defeated Senator Kelly Loeffler (R), while Jon Ossoff (D) defeated Senator David Perdue (R). The Senate is split evenly between Republicans and Democrats, and Vice President-elect Harris will serve as the tie-breaking vote. Senator Chuck Schumer (D-NY) will become the Senate Majority Leader while Senator Mitch McConnell (R-KY) will take over the post of Senate Minority Leader.

While final committee leadership posts are not yet official, Senator Patty Murray (D-WA) is expected to chair the Senate Health, Education, Labor, and Pensions (HELP) Committee, Senator Ron Wyden (D-OR) is expected to chair the Senate Finance Committee, which has jurisdiction over Medicare, and Senator Pat Leahy (D-VT) is expected to chair the Senate Appropriations Committee.

The House, which will also be under Democratic control, elected Rep. Nancy Pelosi (D-CA) to serve another, and possibly final, term as Speaker of the House. Rep. Steny Hoyer (D-MD) will serve as House Majority Leader, and Rep. Kevin McCarthy (R-CA) will serve as House Minority Leader.

COVID-19 relief, stimulus, and federal funding
On December 21, 2020, Congress approved a combined spending package that included $1.4 trillion in discretionary spending to fund the federal government through September 30, 2021, and $900 billion in COVID relief and stimulus. Among its provisions, the omnibus spending package provided $42.9 billion for the National Institutes of Health (NIH) in FY 2021, which is an increase of $1.25 billion or 3 percent above the FY 2020 level. Within the funding for NIH, the bill provided $40 million to be evenly divided among the 12 Regional Biocontainment Labs, including Duke.

The COVID-19 relief portion of the bill provided $1.25 billion to the NIH for research and clinical trials related to the long-term effects of COVID-19 ($1.15 billion), as well as continuing support for Rapid Acceleration of Diagnostics ($100 million for RADx). In addition, it provided $3 billion for the Provider Relief Fund, eliminated the $4 billion in Medicaid DSH cuts scheduled to occur in FY 2021, and created 1000 new Medicare Graduate Medical Education slots for the first time in 25 years.

President-elect Biden, as well as Democratic leadership in the House and Senate, have made clear that they view the most recent round of COVID-19 relief and stimulus as a down payment on a more expansive effort being eyed shortly after Biden takes office later this month. Among the priorities discussed for another relief package include additional funding support and assistance for small businesses and individuals, provider relief, some state and local government funding, liability protections for businesses and universities, a potential FMAP increase, and emergency funding to further strengthen the research enterprise. With Democrats in control of the Congress and White House, most observers expect a relatively quick introduction of another COVID relief package in the $1 trillion range, but it is unclear what conditions or provisions Senate Republicans may request in exchange for their support to clear procedural hurdles.

As Congress begins to examine FY 2022 spending priorities, and possible additional COVID relief, Duke Health Government Relations will continue to advocate that funding for biomedical research be strengthened, including for the NIH and Departments of Defense and Veterans Affairs medical research. In addition, we will continue to promote Duke Health priorities.

What’s next?
The House and Senate are both recessed through January 19th, when they are expected to return for the week of the presidential inauguration. As noted, among the first pieces of business may be a follow up COVID-19 relief effort, while President-elect Biden has also signaled he will use his executive authority to walk back as many Trump administration Executive Orders and policies as possible, including those released in the latter months of 2020 and on immigration.

HHS rebukes 340B drug manufacturers
Over the past year, several drug major manufacturers began limiting the drugs sold to hospitals at a steep discount under the 340B program, while others sent requests to covered entities demanding claims data that go beyond the scope of the 340B statute.

On December 30, the Department of Health and Human Services (HHS) Office of the General Counsel released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Program on covered outpatient drugs when community pharmacies are acting as agents of 340B covered entities. The Duke Health Government Relations office has urged Congress to give the Health Resources and Services Administration more authority to enforce the law and protect 340B hospitals from these actions by certain drug companies.