About Covid-19
Moderna to file for EUA of COVID-19 shot for very young kids by April end “Moderna plans to submit an application to the U.S. health regulator for emergency use authorization (EUA) of its COVID-19 vaccine among kids between the ages of six months to five years by end of the month, a company spokesperson said on Wednesday.”
Most People Under 50 Don’t Need 4th Shot Yet, CDC Panel Suggests “Most Americans under 50 should wait for the next generation of booster shots rather than getting a fourth dose now to prevent Covid-19 infections, according to several members of a panel of advisers to the U.S. Centers for Disease Control and Prevention.
The goal of booster shots should be to limit severe outcomes rather than to prevent transmission of the virus, the advisers said in a meeting Wednesday. That means people with high risk of grave illness from an infection should consider an extra shot, but most people should hold out for better vaccines later this year, they said.”
Justice Department Announces Nationwide Coordinated Law Enforcement Action to Combat Health Care Related COVID-19 Fraud “The Department of Justice today announced criminal charges against 21 defendants in nine federal districts across the United States for their alleged participation in various health care related fraud schemes that exploited the COVID-19 pandemic. These cases allegedly resulted in over $149 million in COVID-19-related false billings to federal programs and theft from federally-funded pandemic assistance programs. In connection with the enforcement action, the department seized over $8 million in cash and other fraud proceeds.”
After rejecting COVID rule, Arizona could lose oversight of workplace safety “The U.S. Occupational Safety and Health Administration on Wednesday moved to revoke Arizona's ability to police workplace safety within the state after it refused to adopt a federal rule requiring COVID-19 protections for healthcare workers.”
OSHA has also warned Utah, South Carolina.
COVID-19 tracker: UK study finds strong responses 84 days after booster shot “A U.K.-wide study found prolonged ‘strong immune responses’ 84 days after participants received a booster COVID-19 shot. The study, led by the University Hospital Southampton (UHS) and published in the Journal of Infection, tested immune responses after seven different vaccines used as a boosters 28 days after receiving two doses of AstraZeneca or Pfizer vaccines. While different initial vaccines yielded different results from the booster, “the rate that immune cell responses declined after third doses was similar between all the vaccine combinations and doses,” according to a UHS spokeswoman…”
Novavax touts early data for flu-COVID combo vaccine as FDA decision looms for single shot “Novavax says its combo flu and COVID vaccine elicits a strong immune response similar to standalone flu and COVID jabs, according to initial results of a phase 1/2 trial.
The results, announced Wednesday, came from a phase 1/2 trial in 642 older adults between 50 to 70 conducted in Australia. One hundred percent of the participants had been vaccinated by an initial series of one of the available COVID vaccines. The objective of the trial was to identify an optimal dose of the vaccine using a modelling-based approach.”
About health insurance
CMS Updates Guidance for Independent Dispute Resolution [IDR] Entities “CMS has updated its surprise billing guidance to require independent dispute resolution (IDR) entities to consider more than just the qualifying payment amount (QPA) when determining reimbursement amounts for out-of-network services under the No Surprises Act…
The No Surprises Act states that IDR entities should consider several different factors when determining a reimbursement rate.
The revised guidance from CMS addresses these concerns. It states that IDR entities must consider the QPA—the payer’s median contracted rate for the service—and other information that either party submits or the IDR entity requests.
For non-air ambulance items and services, additional factors include:
the provider’s level of training, experience, quality, and outcomes measurements
the provider’s regional market share
the acuity of the individual who received the item or service, or the complexity of providing the service
the teaching status, case mix, and scope of services that the provider or facility offers
demonstration of good faith efforts, or lack of efforts, from the provider and payer to enter into network agreements…
The guidance also stated that IDR entities may not consider usual and customary charges for the service, the amount that providers would have billed without the No Surprises Act provisions, or the reimbursement rate for the service by public payers.
The CMS guidance noted that it is not the IDR entity’s responsibility to determine whether the QPA is correct, make determinations of medical necessity, or review coverage denials.”
The No Surprises Act has two components: Provider provision of estimated treatment costs and balance billing guidelines.
Here are three additional resources:
Implementing the No Surprises Act From the MGMA
GOOD FAITH ESTIMATES (GFE) FOR UNINSURED (OR SELF-PAY) INDIVIDUALS From CMS
Notice of IDR Initiation Just-opened site from CMS
Louisiana AG sues UnitedHealth, alleging drug overcharges in Medicaid “Louisiana Attorney General Jeff Landry has sued UnitedHealth Group, claiming that the healthcare and insurance giant has inflated drug charges in the state's Medicaid program by billions.
The suit was filed April 13 in state court, Bloomberg reported, and alleges that the company's pharmacy benefit manager Optum Rx took advantage of the secrecy of the pharmacy supply chain to "needlessly" charge Medicaid billions for prescription drug benefits.”
Bankrupt health sharing ministry leaves families with $50M in unpaid bills “About 10,000 families have been left with $50 million in unpaid medical bills after the shuttering of their health sharing ministry…
Sharity Ministries, formerly known as Trinity HealthShare, filed for bankruptcy and started the liquidation process in 2021, according to the report…
The Atlanta-based nonprofit had faced challenges, class-action lawsuits, and cease-and-desist-orders in several states, where regulators said it had been operating as an unauthorized insurance provider, according to the report.”
Association of Medical Financial Hardship and Mortality Among Cancer Survivors in the United States “Among cancer survivors aged 18-64 years and 65-79 years, 29.6% and 11.0%, respectively, reported financial hardship in the past 12 months. Survivors with hardship had higher adjusted mortality risk than their counterparts in both age groups: 18-64 years (hazard ratio [HR] = 1.17, 95% confidence interval [CI] = 1.04 to 1.30) and 65-79 years (HR = 1.14, 95% CI = 1.02 to 1.28). Further adjustment for health insurance reduced the magnitude of association of hardship and mortality among survivors aged 18-64 years (HR = 1.09, 95% CI = 0.97 to 1.24). Adjustment for supplemental Medicare coverage had little effect among survivors aged 65-79 years (HR = 1.15, 95% CI = 1.02 to 1.29).” {Emphases added]
About hospitals and healthcare systems
Changes in Ownership of Hospital and Skilled Nursing Facilities: An Analysis of Newly-Released CMS Data Some Key Points:
—“Analysis of this dataset indicates that 348 hospitals and more than 3,000 skilled nursing facilities experienced a change in ownership between 2016 and 2021, with wide variation in hospital rates across states.
—Ownership changes were more common in medium and larger hospitals (compared to small hospitals), hospitals with negative profit margins, and long-term care hospitals.
—Future research can link this new dataset to other sources of information to support policymaking and research on consolidation, health care quality, and health care costs.”
Tenet Healthcare reports $139M profit, above-expectations EBITDA for Q1 2022 “As a whole, the company logged net operating revenues and operating income of more than $4.7 billion and $648 million, respectively, during the first quarter of the year. This is down slightly from 2021’s nearly $4.8 billion net operating revenues but up from its $520 million operating income.”
About pharma
EMA Reports Record Numbers of Adverse Drug Reactions in 2021 “The European Medicines Agency (EMA) said its EudraVigilance system for tracking suspected adverse reactions to medicines last year logged the highest number of cases ever, driven by COVID-19 vaccine reporting.
The agency said that more than 3.5 million individual case safety reports were recorded. The EudraVigilance database currently holds more than 22.3 million individual case safety reports relating to 12.9 million suspected adverse drug reactions. Adverse reactions can lead to several individual case safety reports, including the initial report and follow-ups.
More than 25 percent of the adverse event reports in 2021 discussed by the agency’s Pharmacovigilance Risk Assessment Committee were related to COVID-19 vaccines, the agency said.”
About the public’s health
White House unveils national drug control strategy amid rising overdoses “The Biden administration on Thursday is sending its National Drug Control Strategy to Congress, amid a record level of drug overdoses…
he White House plan is centered on increasing treatment for addiction while also fighting trafficking for drugs. It calls for greater access to naloxone, a drug to fight overdoses that first responders can carry.
It also includes measures aimed at boosting treatment for people at highest risk for overdoses, ‘which includes people experiencing homelessness [and] those who are incarcerated or re-entering society,’ the White House said.”
CMS releases health equity strategy centering on outreach, data collection “CMS’ equity action plan, released Wednesday, calls for increased efforts to expand outreach efforts to enroll people in coverage and standardize the use of data on social risk factors and other demographics. The agency has sought comments over the past year from stakeholders on how to incorporate equity into regulations…
Some of the actions CMS seeks to take on equity are:
Building on outreach effort to get more people into coverage via Medicare, Medicaid, Children’s Health Insurance Program and the Affordable Care Act’s exchanges.
Evaluating policies to ensure they help safety net providers that often care for underserved communities.
Promoting services in the culture and language of patients’ preferred languages and health literacy.
Incorporating screening on social needs and promoting broader access.”
MITIGATING AND PREVENTING MEDICAL DEVICE SHORTAGES AND PRIORITIZING PUBLIC HEALTH From the FDA’s Center for Devices and Radiological Health (CDRH): “The CARES Act, enacted in March 2020, gave the FDA device shortages authority for the first time. It required certain medical device manufacturers to provide information to the FDA on product availability, and on potential meaningful supply chain disruptions, during or in advance of a PHE [Public Health Emergency]. Thanks to that authority, CDRH has been able to better understand and monitor the complex web of supply chains that feed the medical device industry, and to be more proactive in solving problems before they occur…
To better protect public health, the statutory authority should be revised to require notifications from manufacturers to CDRH any time there is the potential for a device shortage (similar to the FDA’s broader authority for drugs)—and not just during or in anticipation of a PHE. Without more comprehensive authority, our device supply chain and U.S public health remain at risk.”
About healthcare finance
Wallaby hops to €500M acquisition of fellow stroke devicemaker Phenox “Both companies have developed lines of neurovascular devices meant for use in interventional stroke treatments. Wallaby’s include a neuro-embolic coil system to treat aneurysms and a handful of stroke-focused catheters—while Phenox has put out ranges of flow diverters and stent retrievers, plus coating technologies for those implants. Phenox also owns its subsidiary Femtos, which uses femtosecond laser technology to churn out stents and other neurovascular implants.
Wallaby and Phenox have been partners since 2019 when the latter began serving as the exclusive distributor for several of Wallaby’s offerings in the U.S. and Europe.”
FTC Gives OK to Hikma’s Acquisition of Custopharm “The Federal Trade Commission (FTC) has granted approval to UK-based Hikma Pharmaceuticals to acquire generic drugmaker Custopharm from Water Street Healthcare Partners.
The approval is contingent on Custopharm, which is headquartered in Carlsbad, Calif., divesting its corticosteroid drug triamcinolone acetonide (TCA) to another Water Street subsidiary, Long Grove Pharmaceuticals.
Hikma sells several injectable generic medicines in the U.S. market. Without the divestment, the FTC believes Hikma would stop developing its own injectable TCA drug, which would limit competition in the market.”
Regeneron to Acquire Checkmate Pharmaceuticals for $250 Million “Regeneron has inked a deal to acquire Cambridge, Mass.-based Checkmate Pharmaceuticals for $250 million.
The purchase gives Regeneron access to Checkmate’s vitudolimod, an investigational toll-like receptor 9 (TLR 9) agonist that has shown promising antitumor activity.”
Humana to sell 60% stake in Kindred at Home to private equity firm “Humana is selling a 60 percent stake in its Kindred at Home hospice and personal care business to the private equity firm Clayton, Dubilier & Rice.
The deal is worth $2.8 billion, according to an April 21 news release. The transaction is expected to close in the third quarter of 2022.”