Health Policy Report

The Week in Review
 
Both chambers of Congress were in recess last week for the Easter holiday. The Senate will return today, while the House is expected to reconvene next week on Monday, April 11.

The Week Ahead
 
While the House remains out, the Senate returns from its spring break this week to work on a measure designed to help protect trade secrets before moving on to a bill reauthorizing the Federal Aviation Administration (FAA). The bipartisan legislation (S. 1890) addressing the misappropriation of trade secrets was passed on a voice vote by the Senate Judiciary Committee on Jan. 28 and would allow companies to seek civil penalties – including court orders of property seizures – to prevent the spread of proprietary information. A floor vote on that measure could come as early as this evening, paving the way for consideration of a FAA reauthorization bill (S. 2658) that was recently approved by the Senate Commerce, Science, and Transportation Committee – and is viewed as significantly less controversial than its House-led counterpart (H.R. 4441).
 
Off the floor, Senate Republican appropriators will decide this week which of 12 annual spending bills they will mark up first, with the hope of holding their first committee markup on April 14. Typically, the Military Construction-Veterans Affairs (VA) spending bill is the first to be considered, but with the House likely not moving any appropriations bills until at least mid-May, the upper chamber may need to use House-passed fiscal 2016 spending bills as vehicles. With the FY 2016 Military Construction-VA spending bill already used as the “shell” for last year’s omnibus, the remaining options include the Transportation-HUD, Legislative Branch, Commerce-Justice-Science and Energy, and Water Development spending measures.
 
Finally, the Senate Health, Education, Labor, and Pensions (HELP) Committee has scheduled the last of its series of three medical innovation bill markups for Wednesday, with measures addressing antibiotics policy, the National Institutes of Health (NIH) and Food and Drug Administration (FDA) workforce, and the promotion of biomedical research all set to be considered. A full breakdown of the bills and the potential timeline for the entire ‘Innovation’ package to move forward is included in the third entry of our health policy roundup below.
 
Obama Announces New Efforts to Curb Opioid, Heroin Abuse
 
Last week, President Obama introduced a number of policy changes and new grant opportunities to address the growing opioid abuse epidemic. Among the new steps announced, the Administration is launching a new task force on mental health parity aimed at ensuring that 23 million people in Medicaid receive the same access to mental health and drug addiction benefits as people with private health plans. Additionally, President Obama announced $120 million worth of grants, $94 million of which had already been promised to community health centers under the Affordable Care Act (ACA). Most substantially, President Obama unveiled that the Administration is aiming to expand access to medication-assisted treatment (MAT) by releasing a proposed rule that changes restrictions on the amount of patients per practitioner that may be prescribed medications that treat opioid dependence.  Specifically, the proposal would raise the existing limit of 100 patients per practitioner to 200 patients for a subset of practitioners, provided they fulfill several additional requirements. The change would amount to “tens of thousands of people” receiving treatment, the Administration said.
 
Last week’s announcement comes as the Administration has escalated its efforts to combat drug abuse during the President’s final term in office.  In March, the Centers for Disease Control and Prevention (CDC) issued new prescribing guidelines for opioids, which may help doctors and patients better understand the risks associated with prescription painkiller use. Meanwhile, the Food and Drug Administration (FDA) recently announced changes to the safety warnings that are required on the labels of prescription painkillers, stating that labels must now include a boxed warning about risks of misuse, addiction, overdose and death.  The FDA has also revealed new steps to scrutinize applications for opioids.
 
FDA Releases Biosimilar Labeling Guidance  
 
The Food and Drug Administration (FDA) has released a long-awaited guidance that says a biosimilar’s label does not have to be identical to that of its reference product, adding that differences may be appropriate to inform safe and effective use of the product. The guide also says it may be appropriate to include information about reference product uses not approved for the biosimilar for safety reasons, and additionally calls for a “biosimilarity statement” as part of the prescribing information highlights.  The hot-button issue of how interchangeable products should be labeled was not resolved in the draft guide released Thursday (March 31), however. FDA says it is considering the types of data and information that would support a demonstration that a biosimilar is interchangeable with a reference product, and that labeling recommendations will be included in future guidance.
 
FDA explains in the draft guidance that a demonstration of biosimilarity means, among other things, that the agency has determined there are no clinically meaningful differences between the proposed product and reference product in terms of safety, purity and potency.  FDA said generally that biosimilar product labeling should not include clinical study data because it is not likely to be relevant to a health care practitioner’s considerations regarding safe and effective use of the biosimilar product and potentially may cause confusion.
 
HELP Committee Prepares for Final ‘Innovation’ Markup
 
The Senate Health, Education, Labor, and Pensions (HELP) Committee is set to hold the last in a series of three mark ups this week on the so-called Innovation for Healthier Americans Initiative. Last week, the Committee released a bipartisan legislative agenda including five bills for an April 6 session including measures that would improve FDA’s hiring capabilities, establish a program to approve antibiotics for limited populations, and support the President’s Precision Medicine Initiative.  The Committee will also consider two bills that have not been previously introduced: the NIH Strategic Plan and Inclusion in Clinical Research and the Promoting Biomedical Research and Public Health for Patients Act. 
 
Next week’s markup comes as House lawmakers, who hope to “marry” the HELP Committee’s package with the House-passed 21st Century Cures Act, encourage the Senate to pass legislation ahead of the July 4 recess.  The likelihood of the Senate at least considering a package of bills appears to be improving, as a source close to Senate Republican Leadership indicated that Senate Leaders are reserving floor time in April – perhaps as early as next week –  to consider the HELP Committee’s Innovation package. 
 
Despite the apparent bipartisanship in the five bills expected at next week’s markup, funding remains a sticking point for the Senate’s efforts. Last week, Chairman Lamar Alexander (R-TN) announced that he will seek bipartisan agreement on cuts to offset a boost for NIH in the Senate's biomedical innovation package, a step that would address the Democrats' chief demand for the legislation.  The offsets included in the companion, House-passed 21st Century Cures Act “were stolen” in the year-end budget deal, Chairman Alexander said, so "we will work hard together to find a way to have a surge in mandatory funding." While the funding agreement may not obtain unanimous support, it should achieve the 60 votes needed to move forward, he added.
 
Another potential concern for those hoping to advance the package is how legislators plan to tiptoe around the topic of drug pricing – a largely contentious issue that has fueled considerable election-year partisanship.  Chairman Alexander has expressed openness to including a bipartisan proposal from Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO), who have been investigating spikes in drug prices in the Senate Aging Committee.  It’s anticipated that Sen. Collins, who also sits on the HELP Committee, will offer their proposal as an amendment at next week’s markup.  Moreover, Chairman Alexander said he expects other amendments on drug pricing to be offered next week, though it is unclear whether any would pass.
 
OMB Reviews MACRA Implementation Rule  
 
The White House’s Office of Management and Budget (OMB) has begun reviewing the Centers for Medicare and Medicaid Services’ (CMS) major proposed rule on the new Medicare physician pay system.  A proposed rule on implementing the Medicare Access and CHIP Reauthorization Act (MACRA) is expected as early as this week, as stakeholders await details on the proposed payment schemes that encourage physicians to take financial responsibility for the services they charge Medicare.  Providers must begin reporting under the new system on Jan. 1, 2017, and are eager for guidance on how to design alternative payment models or improve their performance under the new Merit-Based Incentive Payment System (MIPS), which will be used to adjust pay in 2019.
 
Under MACRA, providers who get a substantial part of their revenue from alternative payment models (AMPs) will also get a 5 percent bonus from 2019 through 2024, in addition to shared-savings bonuses they might receive for participating in those models. Starting in 2026, pay rates for physician services will increase annually by 0.75 percent for physicians in APMs. Those not in alternative pay models will get only a 0.25 percent pay bump each year, and they will be subject to MIPS.
 
Report: Newly Insured Slightly Less Healthy Than Expected
 
According to a report by the Blue Cross Blue Shield Association, people who gained health coverage from the Affordable Care Act (ACA) are less healthy than those who previously bought coverage on their own, but are only slightly less healthy than those with coverage through their employer. Notably, the report showed that compared to people with employer-provided insurance, individuals who enrolled in health plans through new exchanges starting in 2014 had higher rates of conditions like diabetes, depression, and coronary artery disease.  Furthermore, findings revealed that consumers who bought individual plans before 2014 were much healthier than those newly enrolled – likely because they were healthy enough to obtain and afford individual plans before the health care law made everybody eligible, regardless of preexisting conditions.
 
The report also suggests that one of the key promises of the health care law when it was passed in 2010 may finally be coming to fruition, as patients with pre-existing conditions are obtaining health coverage in significant numbers. However, the findings also suggest that individuals covered by the exchanges may not be taking advantage of the full range of services available to them, including preventive care. The report showed that newly enrolled members and those with employer plans both had a higher rate of emergency room visits than the generally-healthier people who enrolled in individual plans before 2014.
 
Avalere: One-Third of 2016 QHP Enrollees Kept 2015 Plan
 
On Friday, Avalere confirmed that only 33 percent of consumers who enrolled in the Affordable Care Act’s (ACA) federally-managed exchange portal, HealthCare.gov, in 2016 picked the same plan they had the previous year, marking the volatile nature of the exchange market. According to the health research firm, 3.2 million of the 9.6 million people who purchased coverage through the federal market kept their 2015 coverage while 2.4 million people chose a different plan. The remaining consumers were new to the market. Avalere also reported that between people who switch plans and those that weave in and out of the marketplace, the majority of exchange consumers are enrolled in a plan for a year or less.