Health Policy Report

The Week in Review

Both chambers of Congress were out of town for a brief Thanksgiving recess.

The Week Ahead

The Senate is slated to return to action today as leadership looks to clear a slew of presidential nominations. When the upper chamber returns this afternoon, senators will vote to invoke cloture and end debate on the nomination of Stephen Vaden to be General Counsel of the Department of Agriculture. Meanwhile, the House will reconvene tomorrow to begin consideration of 29 bills under suspension of the rules.

Off the floor, House Democrats are set to continue a contentious debate over the speaker’s gavel for the 116^th Congress. House Minority Leader Nancy Pelosi (D-CA) — the presumed favorite for the speakership in the 116th Congress — is facing pushback from a host of incumbent and incoming Democrats who claim they have the votes to block her path to victory. Leader Pelosi is also facing dissent from some members of the centrist Problem Solvers Caucus, who are pushing for an endorsement of their proposed House rule changes for the next Congress in exchange for their support. Despite the intraparty opposition, a clear challenger to Leader Pelosi has yet to emerge after Rep. Marcia Fudge (D-OH) announced she would not seek the speakership last week. 

CMS Approves Kentucky Work Requirements for Second Time

Five months after a federal judge blocked Kentucky’s 1115 waiver application to implement work requirements as a condition of Medicaid enrollment for certain populations, the Trump administration last week approved the waiver for a second time. The waiver, which takes effect April 1, 2019, will require the population covered by Kentucky’s Medicaid expansion to work or engage in a related activity for at least 80 hours per month. Beneficiaries found to not be in compliance with the requirements would be subject to a six-month lockout period.

CMS’s decision comes after the Medicaid and CHIP Payment and Access Commission (MACPAC) — a congressionally-chartered body that advises Congress and CMS on Medicaid issues — sent a letter to Health and Human Services Secretary Alex Azar, M.D. advising the cessation of work requirement-related disenrollments in Arkansas and a halt to approvals of new waivers authorizing work requirements. The MACPAC letter may provide ammunition to an incoming Democratic majority in the House of Representatives, which appears eager to investigate CMS’s approvals of work requirements. In September, current Committee on Oversight and Government Reform Ranking Member Elijah Cummings (D-MD) and Subcommittee on Health Care, Benefits, and Administrative Rules Ranking Member Raja Krishnamoorthi (D-IL) sent a letter to Committee Chairman Trey Gowdy (R-SC) laying out their concerns with the approval process for the waivers and requesting that Chairman Gowdy subpoena CMS documents and communications related to the analysis and approval of the waivers. Ranking Member Cummings is expected to take the gavel of the Oversight Committee in January.

FDA Announces New Goal for Medical Device Monitoring

Last Tuesday, the Food and Drug Administration (FDA) announced that it would take additional steps to evaluate post-market safety of medical devices through surveillance and presented new goals for medical device safety. FDA Commissioner Scott Gottlieb, M.D. and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, M.D. said in a statement that the FDA would pursue the goal of being “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”

Specifically, FDA has indicated its plans to bolster the capabilities of the National Evaluation System for Health Technology (NEST) by providing additional funding to the program and ensuring that electronic health data contain information that will help the FDA quickly identify underperforming devices and to take corrective actions. NEST has not yet been completed, but it currently brings together information from patient registries, Medicare claims, and electronic medical records to give a more complete picture of medical device performance and to quickly identify signals about device safety. The FDA is also strengthening its Women’s Health Technologies Coordinated Registry Network (WHT-CRN), which brings together data from multiple sources to aggregate the most comprehensive available evidence.

The FDA is targeting WHT-CRN for $3 million of additional funding, which so far has generated and harmonized data on stress urinary incontinence (SUI), pelvic floor disorders, uterine fibroids, and long-acting reversible contraception and sterilization. NEST, a larger program that the FDA says will improve the breadth and quality of accessible and analyzable evidence, is allotted an additional $46 million in the President’s Fiscal Year 2019 budget in part to facilitate a more rapid full rollout of the system. NEST also brings in funding from user fees, and Commissioner Gottlieb and Director Shuren indicated that they intend to make NEST financially self-sustaining in the long term. NEST will undergo eight demonstrations using the data aggregated by the system, which the FDA hopes will prove that “real-time device safety information means better outcomes for patients who depend on devise to improve their health.”

Sen. Sanders & Rep. Khanna To Introduce Drug Pricing Bill in Next Congress

Progressive lawmakers Sen. Bernie Sanders (I-VT) and Rep. Ro Khanna (D-CA) released a bill last Tuesday aimed at curbing rising drug prices by combining Republican and Democratic proposals. The legislation would expand President Trump’s international reference pricing model to span the entire U.S. drug market, and would give the government power to invalidate branded drug manufacturers exclusivity in retaliation for “excessively high” prices. The members will introduce the bill in the 116^th Congress, as the Democratic-led House is poised to take more action on rising drug prices.

Specifically, the bill will require the Department of Health and Human Services (HHS) to compare U.S. drug prices to the median prices in Canada, the United Kingdom, France, Japan, and Germany to determine whether U.S. prices have grown “excessively.” If a branded company’s prices are deemed excessive in comparison to the identified countries, HHS would have the power to approve generic competitors, regardless of any patents, and allow other companies to create cheaper generic versions of a drug. The Pharmaceutical Research and Manufacturers of America (PhRMA) has announced their opposition to international pricing index models and the Sanders-Khanna bill, stating that the policies will reduce innovation and investment in research and development. Although the bill may find support in the Democratic-led House, it is unlikely to gain traction in the Senate under a GOP majority.