DCMedical News: Friday, Sept. 7, 2018
DCMedical News
Washington, D.C.
Friday, Sept. 7, 2018
DCMedical News is published every day either the House or the Senate is in regularly scheduled session.
THE BIG STORY TODAY IN HEALTH CARE:
Confirmation Hearings Conclude for Judge Kavanaugh: Today’s hearing will conclude confirmation hearings for D.C. Circuit Court of Appeals Brett Kavanaugh to become a Justice on the Supreme Court. For background on Judge Kavanaugh and health issues see DCMN 7-11-2018 (here). For general background, see Judge Kavanaugh’s ABA profile, here.
Only sparse attention has been given during the first two days of hearings to health issues other than abortion. Community Catalyst’s Dan Frost noted that Judge Kavanaugh’s guide (“lead Sherpa”) for the confirmation process is pharma lobbyist, former Senator and now Senator-designate Jon Kyl who “famously mocked the Affordable Care Act’s requirement that health insurance cover maternal health by saying 'I don’t need maternity care.'”
Just in time for the wrap-up, JAMA has a piece (here) by Georgetown’s Lawrence Gostin and James Hodge on “Substantial Shifts in Supreme Court Health Law Jurisprudence.” On health care access, for example, they write that
“In 2012, the Supreme Court narrowly upheld the Affordable Care Act (ACA) but undercut a key pillar, permitting states to opt out of Medicaid expansion. Judge Kavanaugh had previously argued that the ACA’s individual mandate (another key pillar of the ACA) exceeded congressional powers. That became a reality in the 2017 Tax Act, which negated the individual mandate by removing the tax penalty. Judge Kavanaugh has also cast doubt on the ACA’s tax credits for health exchange consumers. The legal future of the ACA is tenuous. Congress has unsuccessfully sought to repeal the ACA 70 times, but numerous judicial challenges are pending. The Justice Department has refused to defend the constitutionality of portions of the ACA. Health care protections that Americans strongly support are at risk, including essential benefits, health exchange subsidies, and a ban on preexisting conditions. The Centers for Medicare & Medicaid Services (CMS) recently authorized state waivers for Medicaid work requirements. Although a lower court overturned CMS’s approval of Kentucky’s work requirement, the issue is ripe for appellate review. Medicare reimbursement rates are also under litigation. Judge Kavanaugh recently sided with hospitals challenging Medicare reimbursement rates, calling the US Department of Health and Human Services (HHS) reimbursement limits “arbitrary and capricious.”
The authors provide a table (here) summarizing major health law issues facing the Supreme Court.
Judge O’Connor Promises a Quick Decision: Federal District Court Judge Reed O’Connor presided over three hours of oral arguments on Wednesday in Texas v. U.S.(Azar). He promised a decision “as quickly as possible.” Plaintiffs are twenty states attempting to stop enforcement of the Patient Protection and Affordable Care Act (PPACA), joined in that quest by the Department of Justice (specifically focusing on elimination of the individual mandate the guaranteed issue and community rating requirements in the plaintiffs' states). Judge O’Connor’s questioning, however, focused not on constitutional issues, but on the “severability” of various provisions of PPACA. His questioning also focused on whether the intent of Congress in 2010 (when PPACA passed) or the intent of Congress in 2017 (when the penalty tax for failure to have health insurance was reduced to zero) should be seen as the “intent of Congress.” DoJ asked that the effective date of any injunction be after the coming open enrollment period, which will also be after the coming mid-term elections.
First Apple, then Amazon . . . now Medicare, $1 trillion: Members of MedPAC, the Congressional advisory committee for the Medicare program, heard this projection—Medicare expenditures reaching $1 trillion by 2022—at their Washington, D.C. meeting December 6, continuing today. The projection came in the draft of a chapter on “Context” for Medicare policy making; the chapter, in turn, is part of the report which MedPAC makes before and during each session of Congress. The draft chapters, not yet public, are summarized in slides (“Context” slides here), and presented by MedPAC staff to group members, followed by questions and discussion. The projection (by the Trustees and by CBO) of $1 trillion in annual Medicare expenditures by 2022 shows, in addition, doubling of 2018’s projected $700 billion plus Medicare expenditures to $1.4 trillion by 2026.
PHARMA, DEVICES
Ways and Means Pursuit of Drug Price Control: The House Ways and Means Committee is pursuing with HHS Secretary Azar specific elements of the Administration blue print for drug price control (May 11, here). CQ has created a chart (here) which details specifics involved in implementation of the plan, under these headings: (1) “What’s Been Done?” (example, “Discouraging drug companies from using safety protocols to block potential generic competitors from obtaining drug samples needed for approvals”; (2) “Who Needs to Do What?” (example, “The FDA is setting up website to show which drugs generic drug makers have complained about not being able to access the drugs samples. Congress is considering a bill that would provide legal action to discourage this practice.”); and (3) “Who’s Opposed?” (example, “The branded drug industry says this could be bad for patient safety, and several key lawmakers appear to be opposed to the bill in Congress.”)
Energy and Commerce Committee Also Seeking to Act on Drug Price Control: Other elements of the Administration blue print are within the jurisdiction of the House Energy and Commerce Committee. That group will meet today (Friday) to mark up a bill to prevent insurance plans from using “gag clauses” in their contracts with pharmacy benefit managers or pharmacies. Coverage has focused on this phenomenon: a pharmacist could (but for such a “gag clause”) advise a patient that a generic drug paid for with cash would be less expensive to the patient than it would be if covered by their insurance plan with a co-payment.
Ways and Means Steps in to Avoid Local Disqualification for Device Coverage (Payment) by Medicare: The House Ways and Means Committee took action Wednesday on other health bills (here), including the “Local Coverage Determination Clarification Act of 2018.” That bill was offered at the behest of AdvaMed, the trade group for medical device manufactures. The device lobby was concerned that “Local Coverage Determinations” (LCDs) by Medicare Administrative Contracts (MACs) would create a “patchwork” of payment, even if a national coverage determination by Medicare was in place. A variety of new steps are required of MACs, such as requiring MACs to publicly post proposed LCDs online.
EVENTS & MEETINGS
Sept. 10
9:00 a.m., continuing September 11, Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). Information about ACTPCMD and the agenda for this meeting can be found as follows: ACTPCMD Meetings, https://www.hrsa.gov/advisory-committees/primarycare-dentist/meetings.html; ACTPCMD Agenda (September 10-11, 2018), https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/primarycare-dentist/meetings/20180910/agenda-actpcmd-meeting-sept2018.pdf. Federal Register notice here.
Sept. 11
1:00 p.m., “A new Ebola epidemic in the Democratic Republic of the Congo is shaping up to be the most dangerous and difficult test of the world’s ability to contain the disease since the catastrophic West African outbreak in 2014 and 2015.” STAT “Live Chat,” information at www.statnews.com.
Sept. 26
9:00 a.m. to 4:00 p.m., continuing September 27, meeting of the National Advisory Council on
Nurse Education and Practice. Details here.
FOR REFERENCE
Members of the Senate (here) and Members of Senate Committees (here), Senate Calendar (here).
Members of the House with their House Committees (here), House Calendar (here).
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
September publication dates: 12, 13, 14, 17, 18, 20, 21, 24, 25, 26, 27, 28.
October publications dates: 1, 2, 3, 4, 5, 9, 10, 11, 12, 15, 16, 17, 18, 19, 22, 23, 24, 25, 26
November publication dates: 13, 14, 15, 16, 26, 27, 28, 29, 30
December publication dates: 3, 4, 5, 6, 7, 10, 11, 12, 13, 14
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com