About public policy
Court: Tennessee can enforce Down syndrome abortion ban:”A federal appeals court ruled Friday that Tennessee can begin outlawing abortions because of a prenatal diagnosis of Down syndrome, as well as prohibit the procedure if it’s based on the race or gender of the fetus.”
Modernizing and Clarifying the Physician Self-Referral Regulations: In a strictly fe-for-service environment, these self-referral laws are important to avoid financial conflicts of interest. But with increasing value arrangements where risks and rewards are shared among providers, these restrictions need to be loosened to provide proper incentives.
“This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.” Here is a shortened CMS Fact Sheet of the changes,
About hospitals and health systems
Ascension's net income hits $1B in Q1: Hospitals and systems will start to report Q1 results when some elective services opened up. Now that we are into a pandemic relapse, we may see Q2 results look like they did during the first wave of COVID-19.
About pharma
Amazon’s drugs unlikely to prove fatal to pharmacies, say experts: “CVS, Walgreens, Cigna and United — will begin Monday’s trading a combined $40bn lighter” after Amazon announced its expanded pharmacy service last Tuesday. But many experts predict that it will not have a big impact on retail pharmacies and PBMs because of existing contracts and patient relationships. Also, physicians must want to break established patterns and be able to easily prescribe on the Amazon platform. The one segment that makes sense for Amazon to take over is the low, fixed-price 90 day prescription that some pharmacies now offer for common generics. The “free” delivery feature ia also attractive, helping customers stay clear of crowded facilities.
AstraZeneca, Oxford Covid-19 Vaccine Up to 90% Effective in Late-Stage Trials: The vaccine requires two doses and does not have to be kept at the same low temperatures as the Pfizer-BioNTech product. Also, the most efficacious dose was a smaller first one followed by a full dose a month later.
Hey, pharma: When it comes to influencers, forget lifestyle gurus and stick to patient advocates, study says: “Its recent network survey found that only 14% percent of the WeGo users surveyed mostly or completely trust lifestyle influencers, while 51% completely or mostly trust patient influencers. When it comes to branded pharma products, the survey was even more positive for patient influencers: 85% said they would be very or somewhat receptive to an ad from a patient influencer promoting a drug-related to the patient’s condition.”
Frequently Asked Questions Regarding the Department of Health and Human Services’ Announcement on the Unapproved Drugs Initiative: In addition to the executive orders to end drug price rebates and implement foreign country index drug pricing (see Friday’s post), in Friday’s presidential message is an announcement ending the Unapproved Drug Initiative.
Briefly, some drugs were grandfathered into allowed use or came to market without FDA approval. In the former category were very old drugs (like colchicine for gout); the newer ones did not have equivalents practitioners wanted to treat specific conditions. Since 2006, when the Unapproved Drugs Initiative started, some formulations of these unapproved drugs were pulled from the market because of harmful effects. The result was that pharma companies patented and/or obtained monopolies on those pulled drugs by submitting them for approval. From a quality standpoint, it might seem like process was a good idea; however, the approved drugs often raised the prices dramatically- even for the very old generics. For example, a Vizient analysis published today showed that ending the Unapproved Drugs Initiative could save between $7.52 Billion and $26.59 Billion. This case is a perfect example of cost-quality tradeoff. But the fundamental problem is lack of drug price oversight.
About healthcare IT
FDA clears Baxter’s virtually connected, in-home peritoneal dialysis system: “Baxter has received clearance from the FDA for the latest version of its automated peritoneal dialysis system designed for home use, combining it with a digital platform that aims to help patients with kidney disease manage their care remotely.
The Homechoice Claria system was cleared for both adults and children. Its interface is available in 38 languages and features step-by-step, voice-activated instructions through an accompanying app to help guide the user through therapy.”
About the public’s health
Poor Performance of Masks Secured Using Ear Loops: “When comparing a surgical mask with head ties vs a procedure mask with ear loops, there was a large difference in fitted filtration efficiencies (FFEs) (71.5% v 38.1%, respectively).Even more worrying, there was also a similar trend of poor FFE performance for N95 respirators designed with ear loops vs those with head straps…”
About health insurance
CMMI announces participants of Primary Care First Model: “The Primary Care First Model will begin in January 2021 with 916 primary-care practices participating along with 37 payers. The model, first announced in April 2019, is part of the agency's ongoing effort to expand value-based payment options in Medicare toreduce healthcare spending.”
“Primary Care First is oriented around comprehensive primary care functions: (1) access and continuity; (2) care management; (3) comprehensiveness and coordination; (4) patient and caregiver engagement; and (5) planned care and population health...
Eligible practitioners (that each practice applicant must identify by NPI in its application) are those in internal medicine, general medicine, geriatric medicine, family medicine, and/or hospice and palliative medicine.” For more information, check the CMMI summary.