Mid Week Update

Happy Fourth of July eve.

Today initially was the due date for briefing on the justiciability issue in the Texas v. United States case in which the constitutionality of the Affordable Care Act is being challenged.  In contrast to State courts, which hold general jurisdiction, federal courts are courts of limited jurisdiction and cases submitted to federal courts must meet certain justiciability requirements. The U.S. Court of Appeals for the Fifth Circuit, which is hearing the case, asked for these supplemental briefs principally because the U.S., which was initially the defendant in the case, is now supporting the plaintiff States.  The Court extended the supplemental brief submission deadline to July 5 at the request of the plaintiff States. The plaintiff states had requested a 20 day extension which would have moved the July oral argument date into August. So the case will be argued on Tuesday afternoon In New Orleans.

Healthcare Dive reports on how the various approaches that insurers are taking to coverage of Zolgensma the new genetic therapy drug that is priced at $2.125 million per course of treatment.

So far, 11 of 30 major insurers tracked by Bernstein, an investment firm, have published policies for Zolgensma, with all opting to cover the gene therapy. But some, like Anthem and several Blue Cross Blue Shield affiliates, include limits on maximum age at treatment and whether patients must be symptomatic to receive the drug.

The Centers for Medicare and Medicaid Services has extended Medicare coverage to ambulatory blood pressure monitoring in certain circumstance.  Health Data Management explains that

ABPM, a non-invasive diagnostic test that uses a device to track blood pressure over 24-hour cycles, was only previously covered under specific conditions for those patients with suspected white coat hypertension—having higher blood pressure in a doctor’s office than out-of-office BP.

Now, CMS has also extended its policy to beneficiaries with suspected masked hypertension—the opposite of white coat hypertension, which occurs when blood pressure measurements in a doctor’s office are lower than measurements taken outside of the clinical environment.

“ABPM devices provide a larger number of readings than (office blood pressure monitoring) and a profile of blood pressure in the patient’s usual environment,” states the agency’s decision memo, which notes that CMS received a request from stakeholders to reconsider its national coverage determination. “ABPM is intended to allow identification of white coat and masked hypertension, uncover nocturnal hypertension, and assess blood pressure variability over a 24-hour period as well as the 24-hour efficacy of antihypertensive medication.”

Health Payer Intelligence informs us that

UnitedHealthcare (UHC) is launching a hearing healthcare program to combat hearing loss and improve access to quality, affordable hearing aids. The program, titled UnitedHealthcare Hearing, is available to all consumers, including members enrolled in individual, employer-sponsored, and Medicare Advantage plans, the payer stated in a recent announcement. Eligible members will have access to customized hearing aids at up to 80 percent less than the traditional price.

Stat discusses the status of a 21st Century Cures Act initiative to study the extent to which, if at all, real-world evidence can be used to replicate the results of a specific randomized, controlled clinical trial. A Food and Drug Administration "spokeswoman said  [based on the  results of a recent FDA funded analysis] there is a 'stronger scientific justification' for randomized controlled trials, but that 'recent efforts to use rigorous design and statistical methods' might lead to a greater chance of obtaining valid results with real-world evidence.