On The Hill

The incoming House Democratic leadership team has released the 2019 legislative work schedule. The House schedule for the first session of the 116th Congress can be viewed here.

Prescription Drug Comments, Rules, and Litigation

The Food and Drug Administration (FDA) is requesting public comment on creating new software applications for drug sponsors to use with prescription drug products. The intent of this request is to “align with ongoing Agency initiatives and foster innovation while ensuring sponsors’ communications are consistent with applicable prescription drug labeling requirements.” Public comments can be submitted through January 19th of next year. The full request can be viewed here.^[1]

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule this week entitled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” The proposed rule would “amend the Medicare Advantage Program and Part D regulations to support health and drug plans’ negotiation for lower drug prices and reduce out-of-pocket costs.” CMS is proposing to allow greater flexibility in coverage for six protected drug categories. The proposed rule also would require all Part D plans to select a real time benefit tool for e-prescribing. Comments on the proposed rule can be submitted until 5 pm on January 25th, 2019. The full rule can be viewed here.^[2]

The Health Resources and Services Administration issued a final rule on 340B Drug Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. This changes the effective date for the final rule that sets the calculation of 340B drug ceiling prices and details the application of civil penalties. The final rule can be viewed here.^[3]

An amicus brief has been filed by 22 state attorneys general in support of the respondents in Merck Sharp & Dohme Corp. v Doris Albrecht, et al. The amicus brief asks the Supreme Court to uphold the ruling of the Third Circuit, which rejected Merck’s impossibility preemption defense regarding manufacturer responsibility for drug warning labels. The interest statement reads, “States have a strong interest in preserving state laws that protect their citizens from unsafe drugs and providing remedies to consumers injured by drugs.” The Supreme Court will hear this case in January.^[4]

Another amicus brief was filed by 32 state Attorneys General in support of Arkansas Attorney General Leslie Rutledge, who is petitioning the Supreme Court for a writ of certiorari to clarify Employee Retirement Income Security (ERISA) preemption law as it relates to drug reimbursement rates. The Supreme Court will have to decide whether the Eighth Circuit ruled correctly that pharmacy benefits manager (PBM) reimbursement rates are preempted by ERISA. State Attorneys General said, “The court of appeals’ expansive interpretation of ERISA preemption in this case threatens to interfere with States’ ability to exercise their long-standing authority to regulate PBM conduct, causing confusion and uncertainty for regulators and market participants, and ultimately harming patients.” The full brief can be read here.^[5]

Medicaid in the News

Maine Governor Paul LePage (R-ME) filed a motion this week to delay the case on Medicaid expansion, which was approved by Maine voters last November. His motion requests a stay of the order to compel the Maine Department of Health and Human Services to begin Medicaid expansion, which will make 70,000 people eligible for health insurance beginning in December. While Governor LePage is refusing to implement Medicaid expansion, incoming Governor-elect Janet Mills (D-ME) said she would implement expansion on day one of her administration. The 2017 referendum was approved 59-41 percent, and the Maine legislature approved $60 million to fund Medicaid expansion (LePage vetoed the funding). While Maine will be responsible for roughly $50 million a year to pay for expansion, the federal government will send Maine over $500 million a year to help pay for new Medicaid beneficiaries.^[6]

CMS Administrator Seema Verma says it’s “too early to draw conclusions” on Arkansas’ work requirements for Medicaid enrollees. She announced this week that the Trump administration is continuing to move ahead with other states who are in the process of creating similar work requirements for Medicaid eligibility. Administrator Verma said “We have a long list of states that want to do (the work requirements). These are demonstration waivers so we think it’s important to put out as many as we can so we can learn from the different states and different approaches that work.”^[7]

Affordable Care Act

Affordable Care Act (ACA) enrollment figures are down again this week, lagging behind last year’s sign-ups by about 350,000. Open enrollment has been going on for four weeks, for a grand total of 2,424,913 sign-ups this year. At the same time last year, there were 2,781,260 signups. Several factors at play may explain this decreased enrollment, namely the absence of the individual mandate penalty, new alternative coverage options, and decreased funding for ACA navigators. Current state-by-state data from CMS can be found here.^[8]

With a newly elected Attorney General, Wisconsin will soon withdraw from the lawsuit against the ACA. Detailing one of his first acts once he takes office, incoming Attorney General Josh Kaul said, “I’m looking forward to working with Governor Evers to withdraw the state of Wisconsin from the lawsuit, which, if it’s successful would eliminate protections for people with a preexisting condition.” The Republican leadership in the state legislature will be at odds with the new administration, but there is a healthy appetite among both parties to support protections for people with preexisting conditions.^[9]

References

^[1] “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.” Food and Drug Administration, 20 Nov 2018. https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-25206.pdf

^[2] “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” Centers for Medicare & Medicaid Services, 30 Nov 2018. https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-25945.pdf

^[3] “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” Health Resources and Services Administration, 30 Nov 2018. https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-26223.pdf?utm_campaign=pi%20subscription%20mailing%20list&utm_source=federalregister.gov&utm_medium=email

^[4] “Brief for Doris Albrecht, et al. as Amici Curiae Supporting Respondents, Merck Sharp & Dohme Corp. v Doris Albrecht, et al.” United States Supreme Court, No. 17-290, 21 Nov 2018. http://www.marylandattorneygeneral.gov/News%20Documents/112118_Merck_v_Albrecht.pdf

^[5] “Brief for Leslie Rutledge as Amici Curiae Supporting Petitioner, Leslie Rutledge v Pharmaceutical Care Management Association.” United States Supreme Court, No. 18-540, 21 Nov 2018. https://oag.ca.gov/system/files/attachments/press-docs/no.18-540-amicus-brief-11-21-18.final.pdf

^[6] Joe Lawlor. “Weeks Before Medicaid Expansion Deadline, Maine Governor Files Motion to Delay.” Governing the States and Localities, 29 Nov 2018. http://www.governing.com/topics/health-human-services/tns-medicaid-maine-paul-lepage-expansion.html

^[7] Tina Reed. “CMS’ Seema Verma says administration forging ahead on work requirements as it examines Arkansas.” FierceHealthcare, 28 Nov 2018. https://www.fiercehealthcare.com/payer/cms-seema-verma-says-administration-forging-ahead-work-requirements-as-it-examines-arkansas

^[8] Shelby Livingston. “ACA sign-ups still trailing in fourth week of open enrollment.” Modern Healthcare, 28 Nov 2018. https://www.modernhealthcare.com/article/20181128/NEWS/181129928

^[9] Brendan Cullerton. “What’s next for Wisconsin healthcare?” CBS 58 WDJT-Milwaukee, 9 Nov 2018. https://www.cbs58.com/news/whats-next-for-wisconsin-healthcare