Health Policy Report

The Week in Review
 
The House and Senate were both in recess for the Presidents’ Day Holiday last week. The Senate aims to reconvene today, with the House set to follow suit tomorrow.
 
Over the weekend, voters in South Carolina and Nevada went to the polls for the Republican primary and Democratic caucus, respectively, with real estate mogul Donald Trump and former Secretary of State Hillary Clinton gaining victories. Former Florida governor Jeb Bush, who was considered an early favorite to gain the Republican nomination, decided to end his campaign for the presidency after finishing fourth in the Palmetto state. 

The Week Ahead
 
Both chambers will return this week, but any substantive work on legislation is likely to be overshadowed by the partisan divide on filling Supreme Court Justice Antonin Scalia’s seat on the Supreme Court. While the White House is likely to name a moderate candidate, Republican leadership has been steadfast in their opposition to confirming any justice prior to this November’s elections. In a Washington Post op-ed published last week, Senate Majority Leader Mitch McConnell and Judiciary Committee Chairman Chuck Grassley (R-IA) reiterated that the vacancy on the nation’s highest court should become an election issue and that the American people should not be “robbed of this unique opportunity” to include Supreme Court considerations in their vote for president.  
 
On the floor in the upper chamber this week, senators will deliberate on the confirmation of Robert Califf to be commissioner for the Food and Drug Administration (FDA) and make another effort to pass comprehensive energy legislation that has become embroiled in the debate over helping Flint, Michigan recover from its tainted water crisis. Leader McConnell has scheduled a cloture vote on the former action for Monday evening after Sen. Lisa Murkowski (R-AK) lifted her hold on the nomination in protest of the agency’s approval of genetically engineered salmon for human consumption. The nomination has drawn further opposition, however, with presidential candidate Sen. Bernie Sanders (I-VT) and Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) opposing Califf due to his ties to the pharmaceutical industry and the FDA’s alleged lack of sufficient action on the opioid epidemic.
 
Sen. Murkowski will hope to be more successful in shepherding energy legislation (S.2012) through the Senate this week after her last effort was derailed by Democratic demands for additional federal funding to help Flint rebuild its water system. She has emphasized her commitment to finding a bipartisan offset for the funding, even if that offset comes from a separate legislative package. Later in the week, the Senate may also take up a bill (S. 524) that would target the emerging epidemic of addiction to opioids such as prescription drugs and heroin. While Congress appropriated $250 million to the issue in last year’s omnibus, the White House and Democrats have sought additional resources for tackling the problem.
 
Meanwhile in the House, Majority Leader Kevin McCarthy (R-CA) has scheduled consideration of a pair of bills, one related to federal land use and another on tort reform. The former measure (H.R. 2406) 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), plaintiffs would have to meet higher requirements in their cases against defendants to keep a lawsuit in state.
 
Finally, Republican and Democratic presidential candidates will switch states in their campaigns for their party’s nomination, with the Republicans caucusing in Nevada on Tuesday and the Democrats voting in South Carolina on Saturday. This week’s elections will mark the final votes cast before “Super Tuesday” on March 1. 
 
CMS, Private Insurers Move to Align Quality Metrics
 
The Centers for Medicare and Medicaid Services (CMS) announced Tuesday, along with America’s Health Insurance Plans (AHIP), the inaugural release of seven sets of core clinical quality measures intended for use in multi-payer settings. The core measures were selected in response to growing concern over the complexity of reporting different measures to different entities and are intended to support multi-payer alignment on core measures primarily for physician quality programs. The seven areas to which the measures will be incorporated include: primary care, cardiology, gastroenterology, HIV and Hepatitis C, medical oncology, obstetrics and gynecology, and orthopedics. The measure sets were selected as part of Core Quality Measures Collaborative, a project between CMS, AHIP, private payers, and other stakeholders to establish “broadly agreed upon core measure sets that could be harmonized across both commercial and government payers.”
 
The new measurements will be adopted by CMS as well as many private insurers, ultimately covering an estimated 70 percent of all health care payers. CMS, which already uses some of the new measurements, is expected to begin implementing the rest of the changes—including eliminating redundant measures—through its rulemaking process later this year. The measure sets will be phased in by private payers over time as contracts between providers and insurers are renewed and renegotiated.  However, the implementation of certain measures is expected to hinge on the providers’ ability to collect and report data through their electronic health record (EHR), and therefore further infrastructure may be required for the adoption of certain measures.
 
House GOP Budget Strategy Remains Out of Reach Amid Divisions
 
A Republican path forward on a fiscal 2017 budget resolution remains unclear as members appeared divided over potential options during a recent House GOP conference meeting. According to lawmakers at the meeting, Speaker Paul Ryan (R-WI) originally argued for “regular order” in the process, but said that “the sky won’t fall” if the conference does not create a budget and appropriations bills. He added that the conference, not him, would make that decision. Republicans, who have the power to stop the fiscal 2017 budget resolution, disagree on how much spending should be cut in the plan. For example, some are open to supporting a budget resolution set at the levels of last year’s budget deal, including the House Freedom Caucus who voted against the agreement last year to raise discretionary spending caps for fiscal year 2016 and 2017 – which passed with the overwhelming support of Democrats.
 
During the private meeting, Speaker Ryan reportedly offered three options, including: (1) passing a budget set at sequester spending levels, with the result that the Senate likely would block all spending bills and a stopgap spending bill which would eventually would be passed; (2) increasing defense spending but with a similar result — a blockage of appropriations bills in the Senate and a continuing resolution or omnibus spending bill which would be eventually passed; and (3) passing a budget that balances and incorporates a GOP vision but also "respects" the budget deal. Still unknown is whether House Budget Committee Chairman Tom Price (R-GA) is committed to sticking with last year’s budget deal amount; however, Price noted that his goal remains to mark up the budget resolution during a House Budget committee meeting later this week.
 
Sandoz Appeals Biosimilar Pathway Case to The Supreme Court
 
Sandoz, the generic unit of pharmaceutical company Novartis, asked the US Supreme Court last week to resolve a contentious dispute with rival Amgen over the biosimilar approval pathway's commercial marketing notification requirements. Specifically, Sandoz wants the court to decide when a drug maker that wants to sell a biosimilar must give notice to the manufacturer of the brand-name version about its launch product. Currently, a generic drug maker is required to provide 180-days commercial marketing notice before selling its drug in order to allow the brand-name company time to determine, what, if any, patent challenges can be pursued. The dispute is centered around when the countdown of the 180-day notice begins, as it could affect how quickly a biosimilar can come to the market. 
 
The appeal comes in response to the Federal Circuit appeals court’s decision not to approve requests made by Amgen and Sandoz for the full court to hear the case. A three-member panel of the court had previously responded with a fractured ruling that stated that the law's patent exchange is optional and that the market notification requirement is only effective after the drug has been licensed. As of now, it is unknown whether the Supreme Court will decide to hear the case.
 
Confirmation of FDA Commissioner Likely This Week
 
After a long and contentious five-month period since Robert Califf was nominated to lead the Food and Drug Administration (FDA), it appears as if the Senate will finally confirm his nomination to become FDA commissioner this week. Califf had previously come under fire for his ties to the pharmaceutical industry and the FDA’s role in opioid painkiller approvals, genetically modified salmon, and drug prices. For these reasons, a number of Senators have vowed to block his nomination, including Sens. Joe Manchin III (D-WV), Ed Markey (D-MA), Bernie Sanders (I-VT), and Kelly Ayotte (R-NH). Nonetheless, Majority Leader Mitch McConnell (R-KY) has scheduled a cloture vote on his nomination today in order to prevent a promised filibuster from Sen. Manchin.
 
Once confirmed, Califf will be able to keep his FDA commissioner title for a minimum of eleven months, and is likely to attempt to make changes in areas that he’s spent his career working on, such as improving how the agency utilizes patient perspectives and real-world evidence in regulatory decision making. Furthermore, Califf’s confirmation will allow him to be better placed in a position to tackle high-profile issues, including FDA policies surrounding prescription painkillers – part of a broader administration effort to address the prescription drug abuse crisis.
 
FLOTUS Calls for National Focus on Ending Mental Health Stigma
 
First Lady Michelle Obama is officially calling for a stronger focus on ending stigma surrounding mental illness, she said in an op-ed published in the Huffington Post last week. In her article, Obama states that attitudes surrounding mental health need to be changed, as stigma has often hindered people from seeking the treatment they need. The first lady, who has become a champion for physical activity and nutrition, is urging people to consider mental health just as important. She calls for the nation to become more aware of the signs of mental health issues and be more willing to have those “tough conversations” with people who might be suffering.
 
Mental health reform has garnered the attention of policy makers in the White House and on Capitol Hill. The Obama administration has long sought to increase access to mental health care as part of the Affordable Care Act (ACA), and earlier this year, First Lady Obama announced that she would be taking on the issue of mental health as part of her “Campaign to Change Direction.” Mental health reform has long divided lawmakers, but recently the issue has been gaining momentum in both chambers. Health officials have partnered with the Senate Health, Education, Labor and Pensions (HELP) Committee for a bipartisan bill that has been in the works since last year, and the bill is expected to be marked up next month. Meanwhile, talks on Rep. Tim Murphy’s (R-PA) mental health bill (H.R. 2646), which had previously been stalled for years, are accelerating in the House, due in part to new discussions with Health and Human Services Secretary Sylvia Mathews Burwell.