Health Policy Report

The Week in Review
 
A relatively quiet week in Washington featured the confirmation of a new commissioner for the Food and Drug Administration (FDA) in the Senate and the passage of a slew of homeland security and federal land use bills in the House.

The former issue proved to be less contentious than originally anticipated, as Dr. Robert Califf was approved by the Senate overwhelmingly, despite a vocal group of senators opposed to his nomination. Those senators – including Democrats Sen. Joe Manchin (D-WV), Sen. Ed Markey (D-MA), and presidential candidate Sen. Bernie Sanders (I-VT) – expressed concerns over the pharmaceutical industry’s past support for Califf’s academic research and the FDA’s approach to combatting the opioid epidemic. Califf’s confirmation, approved on a vote of 89-4, marks a rare instance of significant Republican support for a high level Obama-nominee.
 
Meanwhile in the House, lawmakers passed a series of measures related to homeland security, including a bill (H.R. 4402) to require the Department of Homeland Security (DHS) to review known instances of individuals traveling from the U.S. to join or support terrorist organizations in Syria and Iraq, and a measure (H.R. 4408) that would force DHS to produce a national strategy on restricting terrorist travel. Later in the week, the House passed measures addressing federal land use and tort reform. The former measure (H.R. 2406) – passed 242-161 with 12 Democrats voting in favor – would open federal lands to hunting and fishing and allow for sportsmen to use lead ammunition and fishing tackle through an exemption from the Toxic Substances Control Act. Under the latter measure (H.R. 3624) – passed 229-189 with no Democratic lawmakers in support – plaintiffs would have to meet higher requirements in their cases against defendants to keep a lawsuit in state.
 
The Week Ahead
 
This week, the Senate will work on energy legislation and vote on a bill addressing the opioid epidemic, the House will consider measures on Medicaid reform and brick kiln emissions, and voters in eleven states across the country will head to the polls as part of the “Super Tuesday” primary elections.
 
Senate lawmakers may try a second time to pass comprehensive energy legislation (S.2012) after the last effort was derailed earlier this month by Democratic demands for additional federal funding to help Flint, Michigan rebuild its water system. Under a compromise unveiled last week, the Senate would take up legislation intended to address lead-tainted water after completing work on the energy bill. The compromise package may also include a House-passed bill (H.R. 4470) that deals with Flint’s water supply, but Senate leadership has stipulated that any bill would have a 60-vote threshold for passage. Sen. Lisa Murkowski (R-AK), sponsor of the energy legislation, has suggested that the chamber will vote early this week on the energy bill.
 
Senate Majority Leader Mitch McConnell (R-KY) has also scheduled a cloture vote for this evening on a measure (S. 524) to address the opioid abuse epidemic. The bill (S. 524) would authorize $77.9 million a year from fiscal 2016 through 2020 for grants awarded by the Health and Human Services and the Justice departments. 
 
The House will start the week with consideration of a bill that would expand requirements for states to share information when they terminate the participation of healthcare providers in Medicaid and the Children’s Health Insurance Program. The legislation includes the text of a separate measure (H.R. 3821) that would require state Medicaid agencies to establish online databases with information about fee-for-service and other providers. Another bill (H.R. 4557) to be considered this week would block environmental standards governing emissions from brick and clay ceramic tile manufacturers until all related court challenges have been resolved.
 
Senate Confirms Dr. Robert Califf to Lead FDA 
 
The Senate voted overwhelmingly, 89-4, last Wednesday to confirm Dr. Robert Califf as the new commissioner of the Food and Drug Administration (FDA). A few in the Democratic caucus, including presidential candidate Sen. Bernie Sanders (I-VT), and Sens. Richard Blumenthal (D-CT), Ed Markey (D-MA) and Joe Manchin (D-WV), strongly opposed Califf’s nomination over the pharmaceutical industry’s support for his academic research and questions on the FDA’s approach to combatting the opioid epidemic. Sen. Kelly Ayotte (R-NH) was the sole Republican to join the opposition, as she has made combatting the opioid epidemic central to her re-election bid.
 
In part due to Congressional pressure, the FDA recently agreed to a number of changes in its opioid approval process, including convening an advisory panel meeting before approving new painkillers that do not include an abuse-deterrent feature. The FDA’s new commissioner formerly served as the agency’s deputy commissioner for medical products and tobacco, and has previously worked as a medical researcher and cardiologist at Duke University.
 
Burwell to Update Congress On Part B Drug Demo 
 
In a hearing before the House Energy and Commerce Committee on Wednesday, Health and Human Services (HHS) Secretary Sylvia Mathews Burwell reported that the Centers for Medicare and Medicaid Services (CMS) will soon be updating Congress on the Part B drug demonstration plan that the agency mistakenly alerted contractors to earlier this month. The inadvertent notice that CMS inadvertently sent to Medicare Administrative Contractors stated that the agency plans to test whether removing the incentive to pay physicians to administer drugs would change prescribing patterns.  
 
However, the notice failed to explain how the agency plans to design the demonstration. Rep. John Shimkus (R-IL) was quick to criticize the accidental posting, saying, “[What] CMS did by shooting this publicly is … raise a lot of red flags, is there going to be a rule, when there’s going to be a rule, [and] when you're going to notify Congress.”  Secretary Burwell noted that the transmittal to Medicare Administrative Contractors “came out ahead” erroneously, but declined to offer specifics on next steps because of market sensitivity.  
 
Appropriators Wary of Mandatory Funding for Medical Research
 
Last Thursday, a bipartisan group of House appropriators slammed the White House for relying on mandatory spending to deliver funding increases for medical research and substance abuse treatment. President Obama’s fiscal 2017 budget proposes $33.1 billion for the National Institutes of Health (NIH), including new funds for the “moonshot” initiative to cure cancer. The fiscal 2016 omnibus (PL 114-113) increased the agency’s budget by $2 billion, raising it to $32.1 billion. The President’s plan also proposes $1 billion in new mandatory funding over two years to combat prescription drug and heroin abuse through enhanced treatment, prevention and recovery efforts. Members on the Appropriations Subcommittee on Labor-HHS-Education raised concerns that NIH's discretionary funding would decrease if the proposed mandatory programs’ appropriations don't materialize. The President’s budget plan includes $30.3 billion in discretionary funding for NIH, with the remaining $1.83 billion in mandatory spending.
 
At a hearing last Thursday, lawmakers characterized the White House’s plan as a budgetary gimmick. Rep. Charlie Dent (R-PA) called the proposal to use mandatory dollars for NIH priorities “completely unacceptable,” while Committee Chairman Rep. Harold Rogers (R-KY) said it was “simply disingenuous.” Democrats on the panel largely agreed. But Health and Human Services (HHS) Secretary Sylvia Mathews Burwell defended the Administration’s funding decisions, arguing that if the Labor-HHS spending bill had a higher allocation, the Administration’s priorities wouldn’t need to utilize mandatory dollars. Last fall, Congress passed a two-year budget deal last fall to lift discretionary spending caps, and the fiscal 2016 omnibus spending measure subsequently provided nondefense discretionary programs with a 6.9 percent increase overall. Programs in the Labor-HHS title received a modest 3.3 percent increase over 2015 levels.
 
Senate Moving Forward with Opioid Abuse Bill
 
Last Thursday, Senate Majority Leader Mitch McConnell (R-KY) said he plans to bring up the Comprehensive Addiction and Recovery Act (CARA) for a vote this week, despite disagreement from Democrats over how to fund the measure. The bill has bipartisan support and passed the Judiciary Committee on a voice vote. Democratic leaders say that while the bill is a good start, it only authorizes funding and doesn't actually appropriate any funds. They are pushing an amendment from Sen. Jeanne Shaheen (D-NH) to add $600 million in emergency appropriations. While top Democrats have suggested they plan to fight for a vote on the amendment, they've stopped short of suggesting they would reject the overall legislation if it's not included.  Leader McConnell avoided responding to the Democrats’ push, but said he's "hopeful that we can reach an agreement to finish this bill with just a handful of amendments." 
 
CARA authorizes funding for a range of programs to battle prescription drug and heroin abuse, including education and prevention, as well as increasing the availability of naloxone, a drug to treat overdoses.  Some advocacy groups have expressed concern that the bill could be derailed by a funding fight. Earlier this month, the Majority Leader’s office pushed back on Democrats’ argument, saying the regular appropriations process should be used to address funding questions.
 
CMS Releases New Standards for ACA ‘Special Enrollment Periods’
 
In an attempt to quell growing fury among health insurers, the White House issued new standards last week for the thousands of people who sign up for Affordable Care Act (ACA) coverage after the national marketplace deadline. The federal government will now require ACA customers to prove that they are eligible for the law's “special enrollment periods.” Last Wednesday, the Centers for Medicare and Medicaid Services (CMS) said it will start requiring documentation or proof from people who say they need to buy a plan or change coverage outside that window for reasons such as marriage, a permanent move, or the birth of a child. The ACA established that window to prevent people from waiting until they become sick to buy insurance.
 
The health care law also created special enrollment periods in case a life-changing event causes a customer's insurance needs to change outside of open enrollment. Insurers have long argued that without proof of verification, customers can avoid paying premiums until they get sick, and therefore drag down companies' bottom lines with their steep medical costs. Under the new guidelines, verification can come in the form of a birth certificate or a marriage license, and insurers require it for coverage purchased off the ACA's public exchanges. The special enrollment documentation will be required in the 38 states that use the federal HealthCare.gov website for their exchange. CMS said the new requirements will unfold over the next several months.