Health Policy Report

The Week in Review

The Senate returned from a truncated August recess last Wednesday and continued work on its presidential nominations queue and the appropriations process. Following the completion of its scheduled nominations work — confirming Marvin Quattlebaum, Jr. and Julius Ness Richardson to be judges on the Fourth U.S. Circuit Court — the Senate officially began consideration of the massive Defense-Labor-HHS-Education minibus (H.R. 6157). While leaders on both sides of the aisle are optimistic that they can avoid partisan fights over “poison pill” riders that could derail the process, this latest appropriations minibus could bring about a contentious debate as senators consider controversial amendments related to Affordable Care Act (ACA) funding, abortion, education policy, and child detention centers.

The Trump administration announced its position on the funding bill in a Statement of Administration Policy, which, while not explicitly threatening a veto, scrutinized the minibus for excluding some of its specific spending priorities related to health care research, defense, and education. The White House also said it was "disappointed" that the Senate had ignored a request to consolidate several agencies into the National Institutes of Health (NIH). While it’s unlikely the statement will result in wide-ranging changes to the underlying bill, President Trump has repeatedly threatened to shut down the government if Congress does not adhere to his spending priorities — especially his request for funding a border wall between the U.S. and Mexico. Senate Leadership will likely remain steadfast in their desire to pass as many appropriations bills as they can before the September 30th government funding deadline.

House lawmakers are still out of town for August recess, and will return to Washington on Tuesday, September 4th.

The Week Ahead

The Senate plans to spend the bulk of its work week considering the Defense-Labor-HHS-Education minibus. Prior to adjourning for this past weekend, Majority Leader Mitch McConnell (R-KY) teed up a pair of bipartisan amendment votes for Monday, including: (1) an amendment (#3705) that would dedicate funding toward a firefighter cancer registry, and (2) a measure (#3706) that would allocate an additional $10 million for prisoner of war identification.

Following the consideration of the appropriations minibus, the Senate’s schedule for the rest of the month remains unclear. While some lawmakers have openly speculated whether the upper chamber would actually remain in session the week before Labor Day, officials from Leader McConnell’s office pushed back against the rumor, stating that the Senate will be working through the end of the month. A spokesman for the Majority Leader noted that legislation to combat the opioid epidemic — as well as reauthorization of the Federal Aviation Administration (FAA) (H.R. 4) and Water Resources Development Act (WRDA) (H.R. 8) — is next on the Senate’s agenda.

House Ways and Means Republican Leadership Release Medicare Red Tape Relief Report

House Ways and Means Chairman Kevin Brady (R-TX) and House Ways and Means Subcommittee on Health Chairman Peter Roskam (R-IL) released a report last week highlighting steps lawmakers and the administration can take to cut “excessive red tape and regulatory burden” in the Medicare program. The report, which is the latest development coming out of the committee’s ongoing Medicare Red Tape Relief initiative, called out three cross cutting issues identified by all provider groups: (1) the need for improved flexibility to provide telehealth services; (2) challenges associated with the Stark anti-kickback law; and (3) documentation and reporting burdens. The leaders committed to continued discussion with the Centers for Medicare and Medicaid Services (CMS) over whether specified solutions can be accomplished through regulation or congressional action, with emphasis on how Congress could “untie CMS’s hands” to better achieve burden reduction aimed at enhancing patient care and bending the health care cost curve.

The Medicare Red Tape Relief Project was launched in July 2017 by former Health Subcommittee Chairman Pat Tiberi (R-OH). The initiative is ostensibly intended to deliver relief from the regulations and mandates that impede innovation, drive up costs, and ultimately are found to impede the delivery of better care for Medicare beneficiaries. The committee has solicited input from stakeholders and is continuing to work with doctors, nurses, clinicians, and other health care professionals to identify opportunities to reduce unnecessary legislative and regulatory burdens on Medicare providers. The committee also has convened hearings on issues identified through this process, including the July 2018 hearing to discuss the need to modernize the Stark Law, and is in discussions with the Centers for Medicare and Medicaid Services (CMS) about insights received through the agency’s separate Patients Over Paperwork initiative. 

The committee leaders noted that four letters will be sent to CMS applauding the agency for its work to reduce burdens in hospital, post-acute are, physician and ancillary services, and rural settings, but also asking for additional action to further cut red tape. Additionally, the report highlights work already underway through past congressional action, including policies passed in the Securing Fairness in Regulatory Timing Act of 2015 (H.R. 3831) and provisions included in the Bipartisan Budget Act of 2018. The report authors also stressed the importance of continued stakeholder feedback during open comment periods on proposed regulations, and promised additional congressional action on the issue in the coming year. 

Trump Administration Takes Aim at Opioids

The Justice Department and Drug Enforcement Administration (DEA) proposed a plan last week to decrease manufacturing quotas for six frequently misused opioids by ten percent next year. DEA Administrator Uttam Dhillon noted that the significant drop in prescriptions by doctors and DEA’s production quota adjustment would continue to reduce the amount of drugs available for illicit diversion and abuse while ensuring continued access to proper medication for those who need it. The agency was granted authority to consider a drug’s potential for abuse when setting annual opioid production limits in a final rule released in July, and previously could only consider factors such as past sales and estimated demand. The proposed quotas for 2019 would decrease manufacturing for oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl. The administration will collect stakeholder feedback during a 30-day comment period before the proposed quotas are finalized.

Additionally last week, President Trump asked Attorney General Jeff Sessions during a White House cabinet meeting to file federal lawsuit against drug manufacturers producing opioids rather than just joining state suits. He also asked that the Justice Department explore ways to halt the flow of opioids from China and Mexico. The President noted that the countries are “sending their garbage and killing our people” via opioids, and said “it’s almost a form of warfare.” After the Attorney General reportedly agreed, the President pressed him to be “very, very firm” on the issue. 

CMS Announces Plan to Increase Efficiency in Medicaid Waiver Review

The Centers for Medicare and Medicaid Services (CMS) issued an informational bulletin to states outlining key areas for furthering federal and state collaboration and more effective Medicaid program management. The bulletin follows on CMS’ November 2017 guidance, which announced the agency’s process improvement initiative to streamline state Medicaid approvals. This week’s guidance details CMS’ three updated SPA and 1915 waiver review pathways, new strategies to reduce approval backlogs that stem from formal requests for information CMS issues to states, and policies to increase the efficiency with which home and community based services SPAs and waivers are reviewed.

Increased effectiveness in Medicaid program management had been highlighted as a priority for both the administration and the National Association of Medicaid Directors (NAMD). States use SPAs and 1915 waivers to make certain changes to their Medicaid programs, but these have sometimes been held up in months-long federal review processes. CMS Administrator Seema Verma noted that the faster processing times and earlier communication will give states greater ability to manage their programs in an effective and predictable manner. At the end of 2017, CMS issued a bulletin detailing the plan to revamp these processes, including (1) increased communication lines between states and CMS, (2) additional resources to facilitate complete submissions, (3) a strategy to reduce a significant backlog of state requests, and (4) the expanded use of the web-based system for processing requests – MACpro.

The latest guidance also reported successes from implementing the detailed strategies from the 2017 bulletin. According to CMS the agency was able to achieve a 23 percent decrease in the median approval time for Medicaid SPAs, and 84 percent of Medicaid SPAs were approved within the first 90-day review period in 2018. This is a 20 percent increase over approval times in 2016.

Medicaid Advocates Sue Administration Over Arkansas Work Requirements

Advocates for Medicaid beneficiaries filed a lawsuit against the Trump administration last Tuesday in an attempt to block proposed Medicaid work requirements in Arkansas. The National Health Law Program filed the suit on behalf of three Medicaid beneficiaries in the same federal district court in which advocates recently brought a lawsuit of similar nature against work policies for Kentucky’s Medicaid program. The suit argues that imposing work requirements in Medicaid is not within the Trump administration’s authority without action from Congress, and enacting the measures is “threatening irreparable harm to the health and welfare of the poorest and most vulnerable in our country.” The lawsuit also challenges a related provision in which CMS authorized Arkansas to scale back retroactive coverage for new enrollees from three to one month. The lawsuit seeks a court order blocking the state from enforcing that provision and the work requirement program.

The suit is set to be tried by the same judge who stopped Kentucky’s planned work requirements from taking effect in July. Judge James Boasberg, ruled on June 29 that CMS overstepped its authority when it approved an 1115 waiver for Kentucky to add work requirements and other restrictions to its Medicaid program. Judge Boasberg blocked the waiver from taking effect and sent it back to the agency for further consideration. Typically, new cases are randomly assigned to a district court judge, but if a new case is deemed to be related to another case that is already pending before the court, it can be assigned to the judge who is presiding over the earlier case. The Arkansas case was assigned to Judge Boasberg under these policies, although the Kentucky and Arkansas work-requirement programs contain some differences.