5 Things That Happened in Health Policy This Week is produced by a mix of research assistants from the Healthcare Quality & Outcomes (HQO) Initiative at the Harvard T.H. Chan School of Public Health. In each edition we feature a variety of news articles, reports, and studies focused on U.S. health policy and health services research.
Today’s “post-election” edition is a little different. We’ve curated a number of articles (plus a podcast) that offer unique insight into what direction health policy may be moving over the next four years.
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The FDA, in a major decision, has given permission for a large Phase 3 clinical trial of MDMA (better known as ecstasy) for treatment of PTSD. According to Dr. Marmar of NYU’s Langone School of Medicine, current treatments for PTSD fail for between 30 to 40 percent of patients. Prior clinical trials, funded by the Multidisciplinary Association for Psychedelic Studies, treated a total of 130 PTSD patients. The coming Phase 3 trial will include 230 patients. There are some tentative reasons to think the new trial will be successful. One prior study, for instance, found no difference on the Clinician-Administered PTSD Scale (CAPS), but participants did report substantial benefits including improved sleep and better general well-being. The researchers noted that an intent-to-treat analysis suggests that 74% of study participants saw long-term improvement from MDMA treatment. The researchers who conducted the trials have applied for “breakthrough therapy” designation with the FDA, which would speed up the approval process. The proposed use of the drug would be under observation by a trained psychotherapist. Nevertheless, some worry that approval could increase recreational use of the drug.
President-elect Trump has chosen Representative Tom Price to head HHS. Price is a well-known harsh critic of the ACA, and has introduced numerous bills proposing comprehensive, detailed replacement plans since before the ACA passed in 2010. Representative Price is an orthopedic surgeon by training and current serves as the chair of House Budget committee. Mr. Price’s proposed replacement legislation, the Empowering Patients First Act, would repeal the ACA and offer age-adjusted tax credits for individuals and families to purchase insurance plans. Democrats are criticizing Trump’s pick; Price is a fierce opponent of abortion, has sought to defund Planned Parenthood, and many see picking him as the first step toward the Trump administration’s undoing of the current healthcare safety-net.
The House passed a $6.3 billion bill, which will fund biomedical research, by a 392-26 margin. If the legislation passes, as expected to, through the Senate next week, $4.8 billion will go to the National Institutes of Health over the next 10 years, and another $500 million will go to new programs within the FDA. Included in the legislation is a program to promote treatment of mental illness and $1 billion to prevent and treat opioid addiction, two provisions that made the bill liked by both parties. This legislation is especially popular with the drug and medical device industries, who wanted this passed because it would speed up product approvals – others fear what this mean for patient safety. Indeed, some have voiced concerns that provisions of the bill will weaken the FDA’s standard of approval for new drugs. Other concerns have been raised as well. For example, Sen. Dick Durbin (D., Ill.) was totally underwhelmed by the amount of money in this bill” and Sen. Chuck Grassley (R., Iowa) objected to language that would have allow drug and medical-device companies to pay doctors without disclosure.
Judge rejects Obama administration’s request to freeze insurer’s risk-corridor lawsuit (Modern Health Care, 11/30)
Judge Wheeler, a federal judge, denies request to pause from Obama administration in regards to Moda Health’s (Portland, Oregon based insurer) risk-corridor case. In June, under the Affordable Care Act’s risk corridor program, Moda health sued the government for $191 million owed to them for 2014 and 2015. CMS paid Moda Health $11.3 million to them thus far. The Obama administration argued for postponement until similar cases be resolved, claiming resources would be strained. Congress passed laws requiring risk corridors to be budget neutral, only paying what it brings in and thus CMS is paying 13 cents for every dollar. The Obama administration argues that under a budget-neutral system payouts are not guaranteed and the mean-time Republican senators introduced a bill to block the government from using federal funds to pay the settlements.
The most recent Kaiser Health Tracking Poll finds that fewer Republican voters support a full repeal of the Affordable Care Act than before the election, even though there is now a clear political path to do so. The poll shows that the country remains split in its support (49%) or dislike (43%) of the ACA, with the majority of Trump supporters (81%) having negative views and the majority of Clinton supporters (79%) maintaining favorable views of the health law. Amongst Republicans, sentiments towards the health law have shifted since the election: fewer people now want a full repeal, and instead more people want to modify and/or scale back the ACA’s reaches. Republicans and President Elect Trump have been discussing options for repealing and replacing the ACA without causing major disruptions in coverage or a collapse in the insurance markets, but thus far no official plan has been announced.