Health Update (June 24)
Numerous healthcare hearings took place this week on Capitol Hill, including the much-anticipated hearing in the Senate H.E.L.P. Committee on the Lower Health Care Costs Act. Medicaid funding in the U.S. territories was a big topic as well, with the House Energy & Commerce Committee holding a hearing on the matter on Thursday (June 20). Additionally, the Food & Drug Administration (FDA) announced a new framework for dealing with opioids and the Centers for Medicare and Medicaid Services (CMS) announced a new proposition surrounding Medicare Part D.
Senate H.E.L.P. Committee Hearing
The Senate H.E.L.P. Committee held a hearing on Tuesday, June 18, entitled “Lower Health Care Costs Act.” Chairman Lamar Alexander (R-TN), Ranking Member Patty Murray (D-WA), and fellow committee members pointed out the strong bipartisan cooperation in drafting the Lower Health Care Costs Act. Chairman Alexander pointed out that the bill aims at reducing out-of-pocket healthcare costs by ending surprise billing, creating more transparency, and increasing competition in the prescription drug industry. Finding solutions to rural healthcare, telemedicine, and drug-pricing negotiations between third parties were some of the other main topics discussed surrounding the bill. Overall, the committee members and panel seemed to be very satisfied with the Lower Health Care Costs Act and noted their intentions to continue cooperating moving forward.To read a more detailed summary of this hearing, click here.
Senate Special Committee on Aging Hearing
The Senate Special Committee on Aging held a hearing on Wednesday, June 19, entitled “The Complex Web of Prescription Drug Prices, Part III: Examining Agency Efforts to Further Competition and Increase Affordability.” Chairman Susan Collins (R-ME) and Ranking Member Bob Casey (D-PA) both agreed that legislation needs to be passed to lower prescription drug prices. Committee members had many questions surrounding the Administration’s focus and solutions for this growing problem. Democrats questioned the Administration’s commitment to lowering drug costs and questioned how drug pricing has related to the attempted repeal and attacks on the Affordable Care Act. Committee members were concerned about the process that occurs after the FDA approves a medication, where the anti-competitive behaviors have occurred. Many additional questions were presented about PBM’s and their relationship to the rising cost of prescription drugs.To read a more detailed summary of this hearing, click here.
House Oversight Committee Hearing
The House Oversight & Government Reform Committee held a hearing on Wednesday, June 19, entitled “Medical Experts: Inadequate Federal Approach to Opioid Treatment and the Need to Expand Care.” The Comprehensive Addiction Resources Emergency Act (The CARE Act), H.R. 5545, introduced by Chairman Elijah Cummings (D-MD) and Sen. Elizabeth Warren (D-MA), which would provide $100 billion in federal funding to states and local entities to combat the opioid epidemic, was the main focus of Wednesday’s (June 19) hearing as each witness, apart from Dr. Young, expressed their support for the legislation. The witnesses overwhelmingly agreed the substance abuse treatment must be evidence-based, and that medication-assisted treatment (MAT) is the most effective treatment method. There was much discussion that treatment be “holistic” and include psychological health services as well as wrap around services such as transportation and housing support. Witnesses also expressed the importance of Medicaid, and the need to remove barriers to treatment access such as prior authorization. Some members briefly referenced the role of the pharmaceutical companies in the opioid crisis. However, conversation was primarily focused on how to best expand substance abuse treatment access.To read a more detailed summary of this hearing, click here.
Medicaid Funding in Puerto Rico
Lawmakers are negotiating another short-term funding deal for Medicaid in Puerto Rico — just a year after Congress last shored up the health program’s finances. Unlike the entitlement program in the 50 states, federal funding is capped for Puerto Rico’s Medicaid program, which covers nearly half the island’s population. Its funding is much lower than it would be if Puerto Rico was a state, and benefits are skimpier. The House Energy & Commerce Committee’s Subcommittee on Health held a hearing on the Medicaid funding on Thursday, June 20, entitled “Strengthening Health Care in the U.S. Territories for Today and into the Future.” Committee members echoed the remarks of Chairwoman Anna Eshoo (D-CA) and Ranking Member Michael Burgess (R-TX) in saying that the U.S. Territories are facing chaos with the upcoming Medicaid Cliff and that funding is desperately needed in a short amount of time as they are all U.S. citizens and deserve the same health benefits as those in the states. There was a significant amount of conversation about the problems arising in Puerto Rico as of late due to recovery from Hurricane Maria, shortages in doctors and healthcare professionals, and a large population of their people relying on Medicaid coverage. Ms. Angela Avila, the Executive Director of the Puerto Rico Health Insurance Administration, provided thorough answers to the committee and laid out in detail the everyday problems Puerto Ricans face, and the extent of what they could face with the upcoming Medicaid expiration date.To read a more detailed summary of this hearing, click here.
FDA’s New Framework for Opioids
The FDA announced draft guidance this week aimed at assessing the benefits and risks of new opioids within a broader public health context. Under the new framework, the FDA said it will consider a potential new drug’s benefits and risks compared to other opioids and non-opioid pain medicines already on the market. The agency also recommended that companies supply information on any potential safeguards, such as the drug’s ability to mitigate overdose, abuse or risk of addiction. Companies will have to note whether their products have the same or greater risk than others on the market and if there are public health implications or risks of non-patients accessing the drug. While all opioids are approved with a risk management plan known as a REMS program, FDA also recommended that drugmakers propose a new REMS plan if they think that will enhance the benefits of the painkiller being reviewed. 
Grassley and HHS at Odds over Drug Pricing Plan
Senate Finance Chairman Chuck Grassley (R-IA) and the Department of Health and Human Services (HHS) are on opposite sides of the Administration’s drug pricing plan. Grassley announced his opposition on Wednesday (June 20) to an HHS drug pricing proposal tying the cost of certain medicines to their price in foreign countries, in what could be a powerful blow to the Trump administration’s health agenda. “I’m gaining a view that I don’t think that this administration’s approach on international pricing is going to be to the benefit of the adoption of and research for modern drugs,” Grassley told reporters. “I’ve been slow arriving at that conclusion … but I think I’ve studied it long enough now.” The administration’s proposal would tie Medicare Part B payments to a basket of lower European prices, bringing down payments by roughly 30 percent for select drugs. HHS has targeted August for issuing a draft of the new regulation — but Grassley’s opposition could embolden conservative opponents on and off Capitol Hill. Grassley said he will instead press forward in negotiating drug reform legislation with the committee’s ranking member, Sen. Ron Wyden (D-OR). That package, expected in July, includes changes to Medicare Parts B and D as well as Medicaid. The Part B reforms are intended to be an alternative to the international referencing plan, cutting costs but without changing the structure of the program. 
CMS Part D Proposition
CMS announced in a proposed rule earlier this week that Medicare Part D drug plans should use the National Council for Prescription Drug Programs’ SCRIPT standard for prior authorization purposes. The standard is intended to ease the submission of prior authorization requests through web portals, rather than fax or other paper methods, which the agency believes will speed up authorizations and streamline red tape surrounding some drug prescriptions. Plans would be required to use the standard by Jan. 1, 2021 under the proposal. The rule would have a one-time implementation cost of about $100,000 for each plan, the agency estimates. About 20 percent of the 750 plans would need to make the changes to implement the process, for a total cost of $15 million. The changeover would save a net $3.7 million annually in administrative costs, the agency says.
 Cancryn, Adam. “Grassley opposition deals blow to key Trump drug price plan.” Politico Pro. 19 June 2019. https://subscriber.politicopro.com/article/2019/06/grassley-opposition-deals-blow-to-key-trump-drug-price-plan-3456788
 Tahir, Darius. “CMS proposes prior authorization standard for e-prescriptions in Part D.” Politico Pro. 17 June 2019. https://subscriber.politicopro.com/article/2019/06/cms-proposes-prior-authorization-standard-for-e-prescriptions-in-part-d-3432963
 Owermohle, Sarah. “FDA lays out new framework for evaluating opioids in a broader context.” Politico Pro. 20 June 2019. https://subscriber.politicopro.com/article/2019/06/fda-lays-out-new-framework-for-evaluating-opioids-in-a-broader-context-3460453