The United States House Committee on Energy and Commerce, Subcommittee on Health held a hearing on Tuesday, May 17, 2016, on the Centers for Medicare & Medicaid Services (CMS) proposed rule for Part B reimbursement rates. The hearing, titled “The Obama Administration’s Medicare Drug Experiment: The Patient and Doctor Perspective,” heard from witnesses including Debra Patt, MD, MPH, MBA; Marcia Boyle, the President and Founder of the Immune Deficiency Foundation; Michael Schweitz, MD, FACP, MACR National Advocacy Chair for the Coalition of State Rheumatology Organizations (CSRO); Heather Block, a patient advocate; and Joe Baker, the President of the Medicare Rights Center.
Issue Background
On March 8, 2016, CMS issued a proposed rule that has the potential to dramatically change the way many Part B administered drugs are reimbursed. Not only would the program affect the statutorily set reimbursement rate from 6% to 2.5% plus $18, but it would also impose untested purchasing arrangements.
It is also important to note that the changes proposed do not take into account the changes that are being proposed under the Medicare Access and CHIP Reauthorization Act (MACRA).
Representative Larry Bucshon, M.D., has also introduced a bill, H.R. 5122, in an attempt “to prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models,” which was also discussed at the hearing.
The hearing showed the true divisiveness of Congress: the Republicans tended to oppose the model (as evidenced by the introduction of Rep. Bucshon’s bill), whereas the Democrats were more likely to support the model.
Opening Statements
In his opening statement, Subcommittee Chairman Joseph Pitts expressed concern about unelected officials making decisions behind closed doors to take healthcare away from seniors, as well as concerns about the lack of stakeholder ability to weigh in on Phase II value-based purchasing proposals because they are too vague.
Subcommittee Ranking Member Gene Green, in his opening statement, stated that the loudest voices are the ones that oppose the proposal and that all issues deserve to be thoroughly evaluated before a decision was made. Full Committee Ranking Member Frank Pallone confessed that he thought the proposal was “imperfect,” but that he had faith in the administration to listen to concerns prior to finalizing the demonstration.
Witness Testimony
Dr. Debra Patt referred to the model as an “experiment,” that it was clinical research without an “opt out” for patients. She believes that this model would prevent patients from having access to treatments with known survival advantages, which would likely lead to higher death rates and lower quality of life for patients suffering severe ailments. She believes that the demonstration would lead physicians to acting in ways contrary to patient’s best interests.
Dr. Michael Schweitz believes that the demonstration was ill-considered and that there is no data to support the idea that add-on payments impact prescribing behavior. His concerns did not stop there, however. He also expressed concerns about the model, including: the lack of consideration for sequestration; hardships that smaller practices currently face; and the vagueness of Phase II.
Marcia Boyle was also not too favorable of the proposal, expressing concern that the proposal tested value initiatives without defining what value means, and how to ensure that the initiation of value-based alternatives does not reduce patient access.
Heather Block shared her personal story and background with cancer and voiced support for the demonstration model while voicing skepticism for a model that rewards prescribing medications that cost more money. She noted that one of the proposed value based purchasing tools actually eliminated beneficiary co-payments and hoped that proposition would be included in the rule.
Joe Baker also supported the model, but also noted the importance of preserving access and allowing prescribers to retain control over which medications they feel are right for patients. He stated that his organization had some concerns about the model, but had voiced practical solutions that could be implemented alongside it.
Panel Discussion
Patient Access
A large portion of the hearing focused on the demonstration’s impact on patient access. A lengthy list of Representatives expressed concern about the ability of patients to receive needed treatments in areas where the model has pricing reforms preventing doctors from being able to afford the drugs. Ms. Block, a patient advocate, however, made known that she and her personal physician got together and read the regulation; neither one of them felt that any specific part of the demonstration would give rise to issues with patient access.
Stakeholder Engagement
Another contentious issue discussed in the hearing is that of stakeholder engagement. Republican representatives bemoaned the lack of engagement and transparency in the development of the model, and used that oversight and lack of participation as reason to repeal the demonstration. Democrats, on the other hand, didn’t find lack of previous engagement as much of a deal breaker, provided going forward, CMS involves stakeholders as it refines the demonstration prior to finalization.
Size/Scope of the Model
Throughout the hearing, Republican lawmakers continued to equate the demonstration to a clinical trial, voicing concerns that for all the similarities, the demonstration did not have adequate beneficiary safeguards the way traditional clinical trials do. Representative Michael Burgess opined that through a national demonstration, seniors would essentially be forced into a mandatory test without their consent. Dr. Pratt also pointed to differences: that the model had no adverse events follow up, no informed consent, and likely would not pass institutional board review.