Health Policy Report

The Week in Review
 
With Congress out, last week was a hugely significant period in the race for the White House as Donald Trump’s resounding win in Indiana’s primary election on Tuesday forced his two remaining competitors for the Republican presidential nomination to suspend their campaigns. Sen. Ted Cruz (R-TX) and Ohio Governor John Kasich both officially dropped their bids for the presidency, making Trump the presumptive Republican nominee for this November’s general election. However, even though the celebrity-turned-politician has effectively sealed the nomination, he has yet to consolidate support within his own party. Last week, former presidents George H.W. Bush and his son George W. Bush, 2012 GOP presidential nominee Mitt Romney, and current Speaker of the House Paul Ryan (R-WI) all disavowed Trump to a varying degree, but it remains to be seen how much that will affect the candidate looking forward to July’s Republican National Convention in Cleveland, Ohio. 

On the Democratic side, Sen. Bernie Sanders (I-VT) remains far behind former Secretary of State Hillary Clinton in the delegate race, despite winning Indiana by a slim margin on Tuesday. Clinton’s overall lead is considered insurmountable by most political analysts, but Sanders has reiterated that he will continue to campaign “until the last vote is counted.” In any case, last week the Clinton camp appeared to shift its attention and resources to the seemingly inevitable general election matchup with Donald Trump. 
 
The Week Ahead
 
The Senate and House are set to return today and tomorrow, respectively. The upper chamber returns to resume consideration of the Energy-Water Development spending measure (H.R. 2028) after it was derailed prior to last week’s recess over a controversial amendment related to White House negotiations with Iran. Senate Majority Leader Mitch McConnell (R-KY) has scheduled a cloture vote for the substitute amendment to the measure for tomorrow evening. Following completion of work on that bill, Senate lawmakers may seek to combine the next two appropriations bills due for floor consideration – the Transportation-HUD and Military Construction-VA spending measures – into an appropriations minibus that also could include emergency funding sought by the White House to combat the Zika virus.
 
Meanwhile, the House returns tomorrow and will likely begin consideration of a pair of opioid measures, notably including the House companion bill (H.R. 5046) to the Senate-passed Comprehensive Addiction and Recovery Act (S. 524). Sen. Rob Portman (R-OH) and others in the Senate have already criticized changes made by the lower chamber in the emerging opioid package, such as the House Judiciary Committee’s move to reduce the number of grant programs targeted for opioid abuse treatment and prevention (H.R. 5052), and the House package’s lack of a provision that would make it harder for patients to seek opioid prescriptions from multiple doctors. While both parties largely agree on the necessity for an opioid bill, differences between the two chambers could complicate the eventual conferencing of a bicameral opioids package.
 
Medical Device Stakeholders, FDA Collide over User Fee Goals
 
Medical device stakeholders and the Food and Drug Administration (FDA) are in disagreement over the agency’s high-priority goals for next year’s user fee laws, which requests $329 million in addition to the Medical Device User Fee Amendments (MDUFA) III baseline. It was released last week that medical device industry members were upset over several proposals laid out by the FDA during their March meeting that were not included in the industry’s own proposed package, as they said the proposals are not industry priorities for user tee talks and believed initiatives could be advanced through other means. Among these proposals included: using real-world evidence in premarket decision-making; improving the review paradigm for innovative digital health products; hiring device coordinators who would ensure consistency in process and feedback for a device's entire regulatory lifespan; increasing the capacity of device center Branch Chiefs to provide greater oversight and ensure consistency of review procedures; and implementing effective recruitment and hiring strategies.
 
While the industry lobby expressed strong opposition to many of these proposals, the bid to use real-world evidence in premarket decision-making received the largest backlash. While the FDA argued that the plan was worth the needed $50 million in investment, industry did not agree and stated that the FDA’s proposal is only relevant to a small segment of the industry, has not yet been proven as an effective concept, and does not fit within the premarket premise of user fees. Furthermore, medical device stakeholders expressed concern over the lack of performance goals for pre-submissions and de novo requests, and the absence of an independent assessment of the premarket review process in the agency's overall March proposal. They noted that their proposal had incorporated some of the FDA's key initiatives, such as quality management, while the FDA's proposal had moved key industry priorities into an area for further discussion.
 
On the other hand, the agency appeared to garner some industry support for its proposal to add a workload adjustment mechanism to the user fee framework. There is currently no mechanism for the agency to receive additional user fees if submission volumes and their associated workload increase, which the FDA has said would put its ability to achieve the performance goals at risk. Stakeholders stated during their meeting that they are willing to consider such a mechanism and indicated that a greater understanding of the proposed inflation adjustment formula and financial baselines would facilitate discussion on the development of a workload mechanism.
 
W&M Chair Drafting Bipartisan Bill To Exempt Some Hospitals From Site-Neutral Pay Cuts
 
On Monday, House Ways and Means Chairman Kevin Brady (R-TX) announced that a bipartisan bill is in the works aimed at exempting some off-campus facilities from site-neutral pay cuts if they were still being built when the cuts took into effect last year. The two-year budget law, which passed in October, was created to direct the Centers for Medicare and Medicaid Services (CMS) to apply physician pay rates to practices that hospitals buy and turn into outpatient facilities. The policy applies to all off-campus outpatient facilities that were not billing Medicare as of November 2, but the pay cuts do not take effect until January 1, 2017. A number of hospitals who had outpatient facilities under development during the law’s passing have stressed that the new law presents a substantial burden on them. Therefore, Chairman Brady has decided to draft a bill to give providers a smooth transition to new pay policies and provide “relief to hospitals there were mid-build.” While it is yet clear how lawmakers will determine which hospitals are exempted from the site-neutral measure, it is likely that Chairman Brady will move the November 2 effective date to March 31. However, it will likely be difficult to pay for the change as the delay is expected to cost more than $500 million dollars.  A congressional aid noted last week noted that the House Energy and Commerce Committee – which has primary jurisdiction over Part B – might also be less inclined to help hospitals on the issue.
 
Meanwhile, Chairman Brady’s potential bill is already receiving bipartisan support as House Ways and Means members Devin Nunes (R-CA) and Joseph Crowley (D-NY) have been collecting signatures for a letter that asks CMS to exempt some hospitals from the site-neutral requirement that was included in the budget deal. Furthermore, Sens. Rob Portman (R-OH) and Chuck Schumer (D-NY) have been circulating a similar “Dear Colleague” letter which suggests that CMS provide some administrative relief to hospitals without legislation.
 
Poll: More Action needed Against Drug Abuse
 
A poll conducted by the Kaiser Family Foundation last month revealed a number of key findings surrounding American sentiments on government, doctor, and user efforts to curb the opioid and heroin abuse epidemic in the country. Notably, the poll discovered that the majority of Americans believe that efforts to curb the epidemic are not robust enough. More than 60 percent of respondents generally faulted federal efforts as too little, despite the fact that lawmakers have been working on legislation to address opioid and heroin abuse and President Barack Obama has proposed to add $1 billion to the federal budget for treatment programs. Furthermore, respondents expressed dissatisfaction with state governments’ actions and those of doctors who prescribe painkillers. The survey found that 58 percent of Americans believe that lack of access to care for those suffering from addition is a major problem and 70 percent of Americans believe drug users themselves are not doing enough. In addition, eight in ten respondents called a number of potential policy actions as only somewhat effective. The five potential policy actions given include: (1) increasing pain management training for medical students and doctors; (2) increasing access to addiction treatment programs; (3) increasing public awareness and education programs; (4) increasing research about pain and pain management; and (5) monitoring the habits of doctors who prescribe prescription painkillers.
 
Meanwhile, the Kaiser survey also examined Americans’ views on issues involving access to mental health services. About one in five people surveyed said that they or someone in their family once needed mental health treatment but did not get it, for reasons that included affordability and insurance not covering it. Furthermore, the poll found that most people are unaware the federal government requires insurance plans to provide mental health benefits and substance abuse treatment under the same rules they apply to other medical services in terms of copays, deductibles and coverage limits. About four in ten people surveyed knew that applied to health plans and three in ten knew that for substance abuse treatments.
 
House Republicans to Announce ACA Alternative Before July
 
Speaker Paul Ryan’s (R-WI) policy task force will likely unveil its Affordable Care Act (ACA) alternative before the Republican National Convention in July, reported House Ways and Means Committee Chairman Kevin Brady (R-TX) last week. Republicans have long been promising to replace the ACA but so far have failed to unite behind one alternative or bring one up for a vote. Speaker Ryan says he wants to put forward a plan, but said earlier last month that the plan is not expected to be put into legislative text, meaning it will remain as an outline of ideas. While it is not yet clear what the task force is developing, Speaker Ryan said last week that he wants to include a provision that would end the ACA’s ban on allowing insurers to discriminate based on pre-existing conditions and instead fund state-based high-risk pools where people with pre-existing conditions could get coverage. Furthermore, Chairman Brady has said that he envisions people having a healthcare “backpack” that includes a health insurance plan, a health savings account, and easy access to their medical records. Meanwhile, an alternative could be revealed earlier than July as House Energy and Commerce Committee Chairman Fred Upton (R-MI), another member of the task force, outlined last week a shorter timeline for mid-April.