Health Policy Report (12/2)

The Week Ahead

Lawmakers will return to Washington this week to begin an end-of-the-year legislative blitz. Funding the government for fiscal year (FY) 2020 will be the top priority for the December work session after House Appropriations Committee Chairwoman Nita Lowey (D-NY) and Senate Appropriations Chairman Richard Shelby (R-AL) reportedly struck an agreement on funding allocations earlier last week. In addition to appropriations, legislative movement could happen on big-ticket priorities such as the United States-Mexico-Canada Agreement, prescription drug pricing, and tax extenders before the end of this year.

On the floor Senators will return this afternoon to consider of Dan Brouillette’s nomination to be Secretary of Energy. Meanwhile, House lawmakers will return tomorrow to consider a bill that would amend the Securities Exchange Act to prohibit certain securities trading and related communications by those who possess material, nonpublic information. Later in the week, the lower chamber will also take up a bipartisan, bicameral measure that seeks to combat illicit robocalls.

Azar, Verma Reportedly at Odds Over Health Reform

Department of Health and Human Services (HHS) Secretary Alex Azar is reportedly “increasingly at odds” with Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma, according to an expose published last week in Politico. Among the central issues to the rift are reportedly differences over everything from the Affordable Care Act (ACA) to drug pricing to who would travel with President Trump when rolling out major administration initiatives. For example, the article suggests that after Administrator Verma spent “about six months” developing a Trump administration alternative to the ACA, Secretary Azar “nix[ed] the proposal before it could be presented to Trump this summer, sending the administration back to the drawing board.”

In another notable dispute, the article reports that the officials sparred last month over the announcement of a plan to help health care providers better coordinate patient care. “When Azar heard that Verma was set to lead the announcement, he insisted on being included,” according to the report. “The White House then pushed to be included in the rollout as well, prolonging an agency turf war by days.”

DeGette, Upton Release RFI On Cures 2.0

The lead authors of 21^st Century Cures are soliciting feedback on a second iteration of the legislation, which they say will focus on issues such as digital health, coverage of innovative treatments, the use of real-world evidence (RWE), and improving education for caregivers. The lawmakers vision of so-called Cures 2.0 legislation is laid out in a new request for information (RFI) from Reps. Diana DeGette (D-CO) and Fred Upton (R-MI), who are soliciting feedback by December 16 on ideas that should be considered as part of a redux of their landmark bipartisan initiative. While the Department of Health and Human Services (HHS) is still fulfilling provisions of the original law, enacted in 2016, Rep. Upton recently indicated that at least part of the focus of Cures 2.0 will be on “how to make the law work better.”

The bipartisan pair of Reps. DeGette and Upton launched a public campaign for the 21st Century Cures Act five years ago with a similar request for ideas and support and spent two years crafting the bill, which was enacted in December 2016. The legislation, signed by President Barack Obama in the final weeks of his presidency, was aimed at speeding research and therapies for patients. It bolstered aid to the NIH, gave FDA new powers and responsibilities, and required more information sharing.

White House Presses Congress to Pass Surprise Billing Legislation

The White House is pressing lawmakers to move on surprise billing legislation and ignore outside interest groups’ influence on the debate. White House Domestic Policy Council Director Joe Grogan argued in a recent USA Today op-ed that if Republicans do not end surprise billing quickly by approving the Senate health committee and House Energy & Commerce Committee’s bills, Democrats may gain more support for Medicare for All. “[P]rivate equity is exploiting situations where patients have no meaningful opportunity to choose their provider, then we are just providing fodder for the radical socialists who say the only solution is to throw in the towel on private markets altogether,” Director Grogan wrote.

Lawmakers still hope to pass surprise billing legislation by the end of the year, but the competing interests between insurers and providers have complicated the process. Director Grogan says that President Donald Trump would like to soon sign surprise billing legislation, but Congress needs to act. He encourages conservatives to ignore private equity-funded surprise billing ads when they are home for the holidays and come back in December to vote for the surprise billing policies the House and Senate are already considering.

FDA Guidance Addresses Approval Process for Biosimilar Insulins

The Food & Drug Administration (FDA) announced new draft guidance intended to facilitate the development of biosimilar and interchangeable insulin products. In a statement, Acting FDA Commissioner Brett Giroir highlighted that the FDA is committed to increasing market competition among insulin products in the effort to lower prices and improve patient access. The draft guidance — “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products” — seeks to better inform product developers intending to prove interchangeability for approved insulin products and describes circumstances in which comparative studies may not be necessary.

As of March 2020, FDA will begin regulating insulins as biologics. This change in the regulatory approval pathway for insulins will allow developers to seek licensure for subsequent-entry insulins under the biosimilar approval pathway. In May 2019, FDA issued final guidance which offers developers an understanding of the research studies and considerations needed in order to develop products that meet the current “statutory interchangeability standard of the Public Health Service Act (PHS Act).” Last week’s draft guidance incorporates stakeholder feedback on the topic provided at a public hearing held last May.

CMS Announces Additional Reorganization Plans for Central Office

The Centers for Medicare & Medicaid Services (CMS) released additional updates to their reorganization plan last week, including plans to further streamline authorities within the CMS Central Office (CO). CMS has previously taken steps to consolidate authority within CMS’s Central Office, specifically within CMCS where regional employees were integrated into a single operating unit. Last week’s update establishes a new office of Office of Program Operations and Local Engagement (OPOLE) to replace the Consortium for Medicare Health Plan Operations (CMHPO) and the Consortium for Financial Management and Fee for Service Operations (CFMFFSO).

Last February, CMS announced the merger of two of its groups that administer the Medicaid and CHIP programs. The Consortium for Medicaid and Children’s Health Operations (CMCHO) and the Center for Medicaid and CHIP Services (CMCS) were consolidated, bringing CMCHO’s functions under the umbrella of CMCS. CMS explained that the reorganization will spur consistent policy implementation and improve communication between the states and the federal government. CMS also created the Regional Management Office (RMO) under CMCS to take up the work with states that was undertaken by CMCHO, and CMS also created a new Division of Health Information Technology for Economic and Clinical Health and Medicaid Management Information System.