Congressional:

Government Shutdown Enters Fourth Week

The government shutdown, which began on October 1, is on its 31st day. At the heart of the shutdown is a disagreement between Congressional Republicans and President Trump, who have pushed for a clean continuing resolution (CR) to fund the government on a short-term basis, and Democratic leaders have insisted that any funding deal include an extension of Affordable Care Act (ACA) enhanced advanced premium tax credits (APTCs), which are set to expire this year. 

On Wednesday, President Trump proposed working with Democrats to find an alternative to the Affordable Care Act (ACA), stating, "We can do something with Democrats better than Obamacare. That's something that I think can come out of this with Democrats.” Trump added that the ACA "never worked. It never will work. And we can do something—work with the Democrats—much better than Obamacare. Less money and better health care." On Thursday, President Trump also called for Senate Republicans to end the partial government shutdown by eliminating the legislative filibuster.

In the Senate, Majority Leader John Thune (R-SD) told reporters Thursday that he expects bipartisan talks focused on breaking the logjam to continue into the weekend. Thune also reiterated that he is open to giving Democrats a vote on legislation to extend the APTCs as part of an agreement to reopen the government. In the House, Majority Leader Steve Scalise (R-LA) stated that he is working with the Energy and Commerce, Ways and Means, and Education and Workforce Committees on ideas to lower health care premiums.

Adding to the shutdown pressure is the halting of Supplemental Nutrition Assistance Program (SNAP) benefits on November 1 due to funding and the increasingly frequent air traffic delays at major hubs across the United States.

Senate HELP Committee Holds Hearing on Biotech

On Wednesday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the future of biotech in the U.S. During the hearing, Committee Chairman Bill Cassidy (R-LA) talked about the need for investments in U.S. medical research and warned of the encroachment of the Chinese biotechnology industry on U.S. dominance in medical research. Ranking Member Bernie Sanders (I-VT) stated that he agreed with Cassidy on the desire for the U.S. to be a biotechnology leader but faulted the pharmaceutical industry for charging unaffordable drug prices, preventing Americans from accessing life-saving drugs. Read Mehlman’s hearing summary here.

Senate Finance Committee Holds Nomination Hearing for HHS Inspector General Nominee

On Wednesday, the Senate Finance Committee held a nomination hearing to consider Thomas Bell's nomination to serve as the Department of Health and Human Services (HHS) Inspector General. Bell currently serves as general counsel for the House Committee on Administration and previously served as chief of staff of the Office of Civil Rights during the First Trump administration. During the hearing, Bell told the Committee that he believes federal agencies have become more concerned with their own interests than with what Congress originally intended and wants to change that. Republicans broadly supported Bell’s nomination, highlighting his extensive career in health care policy. In contrast, Ranking Member Ron Wyden (D-OR) stated that Bell is a "dangerous" choice for the job and that President Trump has “unlawfully fired nearly two dozen inspectors general across the government, including in HHS." Read Bell’s testimony here. 

Notable Bills Introduced:

Senators Murkowski, Whitehouse, Tillis, and Warner Reintroduce Bipartisan Legislation to Expand Telehealth Access

On Tuesday, Senators Lisa Murkowski (R-AK), Sheldon Whitehouse (D-RI), Thom Tillis (R-NC), and Mark Warner (D-VA) reintroduced the Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act. The legislation would address regulatory hurdles to accessing telehealth services for opioid use disorder by making permanent the expansion of coverage for healthcare providers to prescribe medication to treat opioid addiction via audio-only or audio-visual telehealth appointments. Read the press release here and the bill here.

Representatives Cammack, Dingell Unveil Bipartisan Bill to Advance Women's Healthcare Coverage & Care for Breast Cancer Survivors

Late last week, on Friday, Representatives Kat Cammack (R-FL) and Debbie Dingell (D-MI) introduced the Advancing Women’s Health Coverage Act to modernize the Women’s Health and Cancer Rights Act of 1998 (WHCRA) and ensure every person diagnosed with breast cancer has access to comprehensive, up-to-date reconstructive care. The legislation would expand coverage to include all recognized breast reconstruction options. Read the press release here and the bill here. 

Executive Branch:

FDA Moves to Accelerate Biosimilar Development

On Wednesday, the Food and Drug Administration (FDA) announced plans to ease requirements for biosimilar manufacturers to lower drug prices and bring more drugs to market. The FDA released draft guidance outlining how biosimilar developers can avoid comparative studies, which could speed up the approval process. The FDA will also issue final guidance in the next three to six months explaining when companies can bypass "switching studies," a requirement that biosimilars must meet to be deemed interchangeable with the branded drug. Read the press release here and the draft guidance here.

CMS Names Dan Brillman as New Medicaid and CHIP Director

On Tuesday, the Centers for Medicare & Medicaid Services (CMS) announced that Dan Brillman has been appointed CMS Deputy Administrator and Director of the Center for Medicaid and the Children’s Health Insurance Program (CHIP) Services. Brillman is the former CEO at Unite Us. Outgoing Acting Director Caprice Knapp will transition to the role of Principal Deputy Director. 

Legal & Other:

Judge Extends Block on Government Shutdown Layoffs

On Tuesday, Judge Susan Illston of the U.S. District Court for the Northern District of California issued a preliminary injunction blocking the Trump administration from implementing a mass Reduction in Force (RIF) of 2,500 federal workers during the government shutdown, stating in part that those terminations were intended for "political retribution.” The injunction is expected to remain in place while the case is pending, but it could be appealed. Illston previously issued a temporary restraining order in the case to block the layoffs, finding that the labor groups were likely to succeed on claims that actions from the Office of Personnel Management and the Office of Management and Budget to authorize layoffs during the shutdown violated administrative law. Read the order here.