Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Senate Pushes Forward on Health Care Bill, Though Skepticism Remains

Majority Leader Mitch McConnell (R-Ky.) has officially fast-tracked Affordable Care Act (ACA) repeal and replace legislation, allowing it to skip over the committee process. The move will allow him to bring the bill to the floor quickly once Republicans are ready to vote. Aides spent the week-long Memorial Day recess negotiating a draft of the Senate health care legislation, and early proposals possibly contained in the draft began circulating last week. The Majority Leader also presented the blueprint of the legislation to his colleagues during a closed-door GOP meeting last week. According to some sources, McConnell may propose to keep protections in place that would prevent people with pre-existing conditions from being charged higher premiums for health insurance coverage. Sen. Bill Cassidy (R-La.), a moderate whose vote is considered pivotal for passage of the legislation, said that he was encouraged that recent discussions have been geared toward addressing the needs of vulnerable patients.

Senators are still sending mixed messages about when the legislation will be ready for introduction, and are expressing various levels of optimism on whether or not it will successfully pass. Divisions remain about how to phase out Obamacare’s Medicaid expansion, and how to reform the Medicaid program in general. The Senate bill is expected to include a lengthy off-ramp for ending Medicaid expansion. The Senate is also weighing the possibility of keeping some of the ACA’s taxes in place, at least temporarily, in order to stabilize the insurance market in the short term. Several senators have also posed the possibility of a short-term legislative fix to stabilize insurance markets.

White House officials continue to state that the Senate will vote on Obamacare repeal and replacement by the end of July. Republican leadership is pushing for an even earlier vote, hoping to finish health care by the July 4th recess so they can move on to other items on the GOP agenda. In order to meet this deadline, however, the bill would have to be sent to the Congressional Budget Office (CBO) for a score approximately two weeks in advance. The chamber is required to produce $133 billion in savings. If the Senate is able to pass legislation, Republicans would still have to spend time merging the bill with the House-passed Affordable Health Care Act (AHCA). Major differences are expected, with the Senate bill being more modest in repeal of the ACA than its House counterpart.

Energy and Commerce Advances FDARA, Additional Public Health Bills

The House Energy and Commerce Committee advanced the Food and Drug Administration Reauthorization Act (FDARA), along with several other public health bills, during a markup last week. FDARA would reauthorize the agency’s user fee programs, set to expire on September 30. Lawmakers approved five amendments to the bill, including a resolution offered by Rep. Jan Schakowsky (D-Ill.) directing Congress to work to lower prescription drug prices. She also offered an amendment to create a pilot program to gather post-market safety data on medical devices. Reps. Scott Peters (D-Calif.) and Ryan Costello (R-Pa.) offered two amendments. The first would create a regulatory pathway for imaging devices intended for use with contrast agents. The second aims to address concerns about the safety of medical devices serviced by third parties. Rep. Mimi Walters (R-Calif.) offered an amendment that would require medical device accessories to be classified according to the accessories’ own risk rather than the risk of the parent device. The panel also debated several controversial amendments dealing with issues such as off-label communication and drug re-importation, which were ultimately withdrawn by the sponsors. The Committee voted 54-0 to advance FDARA to the House floor for consideration. Many members stressed the importance of passing the bill in a timely and bipartisan fashion during their opening statements. A number of Democratic members of the Committee also used the opportunity to request a hearing on drug pricing. The Senate version of the user fee legislation has already been passed out of committee and awaits action by the full chamber. During the markup, the Energy and Commerce Committee also advanced H.R. 1222, the Congenital Heart Futures Reauthorization Act, H.R. 2410, the Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act, and H.R. 1492, the Medical Controlled Substances Transportation Act, all by voice vote.

HELP Hearing to Examine Rx Prices

The Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on the prescription drug delivery system on Tuesday. According to a statement from the Committee, the hearing will focus on the process of moving prescription drugs from the manufacturer to patients –– and how that system affects what patients pay when picking up their prescriptions.” This hearing will feature testimony from academic experts, while a second hearing yet to be scheduled is expected to hear from industry witnesses. The hearing was requested by Sen. Al Franken (D-Minn.) and nine other bipartisan HELP Committee members last month.

December 31, 1969: | Page 1 Page 2 Page 3



 -  2019

 +  2018