About Covid-19
Supreme Court hears challenges to Biden’s vaccine rules for workers: The Court heard two cases today. The first concerned whether OSHA has regulatory authority to impose COVID regulations in the workplace. Given the questioning, it seems likely the Court will reject this authority.
The second case centered on CMS’s ability to require COVID precautions as a condition of participation in federal health programs (Medicare and Medicaid). The argument was that the federal government has the right (and responsibility) to assure safety of beneficiaries for whom it is paying. The justices seems to be inclined to accept CMS’s right to require precautions; however, the basis for such a decision may narrowly focus on the standing of the states that brought the suit (as occurred with the last decision to uphold the ACA).
Throughout the proceedings, the conservative justices raised questions about why COVID was different from past infectious diseases (like the flu) that made the above measures necessary. No one brought up the healthcare state of emergency that the HHS Secretary has renewed during the pandemic.
WHO: Record weekly jump in COVID-19 cases but fewer deaths: “The World Health Organization said Thursday that a record 9.5 million COVID-19 cases were tallied over the last week as the omicron variant of the coronavirus swept the planet, a 71% increase from the previous 7-day period… However, the number of weekly recorded deaths declined.”
False-Positive Results in Rapid Antigen Tests for SARS-CoV-2: “There were 903 408 rapid antigen tests conducted over 537 workplaces, with 1322 positive results (0.15%), of which 1103 had PCR information. Approximately two-thirds of screens were trackable with a lot number. The number of false-positive results was 462 (0.05% of screens and 42% of positive test results with PCR information). Of these, 278 false-positive results (60%) occurred in 2 workplaces 675 km apart run by different companies between September 25 and October 8, 2021. All of the false-positive test results from these 2 workplaces were drawn from a single batch of Abbott’s Panbio COVID-19 Ag Rapid Test Device.”
COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting: A few highlights:
—”Hospitals are responsible for reporting the information to the Federal government. Facilities should report at the individual hospital level, even if hospitals share a Centers for Medicare & Medicaid Services (CMS) Certification Number (CCN).
We recognize that some health care systems choose to report for all facilities in their network from a central corporate location.We also recognize that many states currently collect this information from the hospitals. Therefore, hospitals may be relieved from reporting directly to the Federal government if they receive a written release from the state indicating that the state is certified and will collect the data from the hospitals and take over the hospital’s Federal reporting responsibilities…
—Hospitals, with the exception of psychiatric and rehabilitation hospitals are required to report seven days a week but, where possible and pending further direction from their state or jurisdiction, are encouraged to report weekend data on the following Monday with the data backdated to the appropriate date. Psychiatric hospitals and rehabilitation hospitals report once weekly on Wednesday.”
—The document provides the several accepted methods for reporting the data.
FDA must hit the gas on FOIA request tied to Pfizer's COVID-19 vaccine, judge orders: “Rather than 75 years, it will now take about eight months for the FDA to make public the information it used to license Pfizer and BioNTech’s COVID-19 vaccine—provided the regulator can keep up with the new schedule.
U.S. district judge Mark Pittman on Thursday ordered the FDA to produce all remaining data on the vaccine at a rate of 55,000 pages per month, much faster than the 500-page-per month quota the FDA proposed in November.”
West Virginia seeks permission to offer 4th vaccine dose: “West Virginia is seeking permission from the federal government to offer a fourth COVID-19 vaccine dose to at-risk people, making it the first state to do so. West Virginia Gov. Jim Justice sent a letter to the Biden administration requesting the FDA and CDC authorize the state to offer a second booster to people 50 and older and essential workers at least three months after receiving their first booster, according to Jan. 6 news release.“
Responding to Omicron: Aggressively Increasing Booster Vaccinations Now Could Prevent Many Hospitalizations and Deaths: From the Commonwealth Fund:
”According to the model, at the current pace of booster vaccination, during the next four months COVID-19 will cause an additional 210,000 deaths, nearly 1.7 million hospitalizations, and almost 110 million additional infections. Immediately doubling the December pace of boosters to 1.5 million per day could prevent approximately 41,000 deaths and more than 400,000 hospitalizations by the end of April and avert more than 14 million infections. Tripling the daily rate to 2.3 million per day could prevent more than 63,000 deaths and nearly 600,000 hospitalizations, while preventing more than 21 million infections.”
Insurers, Employers Urge Price Caps on ‘Free’ Home Covid Tests: “Federal health officials are expected to release guidance this month outlining how private health plans must reimburse their beneficiaries for the cost of at-home Covid tests. The policy is key to the administration’s effort to tamp down the spread of the virus, now occurring at historic levels…
The concern for consumer advocates is that some retailers or even diagnostic companies will raise the cost of the tests once they know insurers are footing the bill.
‘If insurers have to reimburse for at-home tests from anywhere at any price, they will be at the mercy of price gouging by unscrupulous sellers,’ Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, said. ‘If insurers are left holding the bag, consumers will be shielded in part from price gouging, but they still face risks.’”
Risk Factors for Severe COVID-19 Outcomes Among Persons Aged ≥18 Years Who Completed a Primary COVID-19 Vaccination Series — 465 Health Care Facilities, United States, December 2020–October 2021:
From the CDC:
”Among 1,228,664 persons who completed primary vaccination during December 2020–October 2021, severe COVID-19–associated outcomes (0.015%) or death (0.0033%) were rare. Risk factors for severe outcomes included age ≥65 years, immunosuppressed, and six other underlying conditions. All persons with severe outcomes had at least one risk factor; 78% of persons who died had at least four.”
About hospitals and health systems
Hospitals lose 5,100 jobs in December: “Hospitals lost jobs in December for the second straight month, according to the latest jobs report from the U.S. Bureau of Labor Statistics.
Hospitals lost 5,100 jobs in December, compared with 3,900 lost in November. Hospitals gained 1,100 jobs in October and lost 8,100 jobs in September.”
And in a related article: More than 19% of US hospitals are critically understaffed: Numbers by state: “Just over 19 percent — or 1,167 of 6,051 — of all hospitals in the U.S. are experiencing critical staffing shortages, according to HHS data posted Jan. 6.
A critical staffing shortage is based on a facility's needs and internal policies for staffing ratios, according to HHS. Hospitals using temporary staff to meet staffing ratios are not counted among those experiencing a shortage.”
Rates range from 53% in Vermont to 0% in DC.
About pharma
States Oppose Purdue's 2nd Circ. Appeal Try In Ch. 11 Case: “Numerous states filed briefs Thursday in New York federal court opposing the request by bankrupt drugmaker Purdue Pharma to appeal the unraveling of its Chapter 11 plan to the Second Circuit, arguing that the appeal would further delay resolution of the case.”
Walgreens Posts Higher Sales and Profit From Covid-19 Demand: “Walgreens Boots Alliance Inc. rode the latest Covid-19 surge to its highest retail sales increase in 20 years, but Americans’ scramble for vaccines and tests has overwhelmed workers and dented growth in prescriptions…
Covid-19-related demand took a toll on other parts of the business, Walgreens said. Prescription sales, not including vaccines, grew 1.8%, as staffing shortages prompted some stores to close early and prevented pharmacists from calling patients to ensure they are keeping up on their medications.”
Merck leans into AI with $610M in biobucks for Absci drug discovery pact: “Merck is taking a deep dive into complex proteins with the help of artificial-intelligence-powered drug discovery company Absci. The two companies have signed a research collaboration for up to three targets in a deal worth up to $610 million in upfront fees and milestone payments.
Merck will use Absci’s Integrated Drug Creation platform, which uses AI and synthetic biology to find new drug targets and match them up with potential medicines. The company also generates cell lines to manufacture the therapeutic candidates, all in one process.”
Merck KGaA to acquire Exelead for $780 million: “Merck KGaA said Thursday that it is acquiring biopharmaceutical contract development and manufacturing organisation (CDMO) Exelead for about $780 million in cash. The German drugmaker noted that Exelead specialises in complex injectable formulations, including lipid nanoparticle (LNP)-based drug delivery that is a key component in mRNA therapeutics.”
Note: Merck KGaA is a different company from Merck mentioned above.
About health insurance
CY 2023 Medicare Advantage and Part D Proposed Rule (CMS-4192-P): “This proposed rule would revise the MA and Part D regulations related to marketing and communications, the criteria used to review applications for new or expanded MA and Part D plans, quality ratings for MA and Part D plans, provider network adequacy requirements, medical loss ratio reporting, special requirements during disasters or public emergencies, and the use of pharmacy price concessions to reduce beneficiary out of pocket costs for prescription drugs under Part D. This proposed rule would also revise regulations for D-SNPs, and in some cases other special needs plans, related to enrollee advisory committees, health risk assessments, and ways to improve integration of Medicare and Medicaid. Many proposals are based on lessons learned from the Medicare-Medicaid Financial Alignment Initiative.”
A few highlights:
—”CMS is proposing a policy that would require Part D plans to apply all price concessions they receive from network pharmacies to the point of sale, so that the beneficiary can also share in the savings. Specifically, CMS is proposing to redefine the negotiated price as the baseline, or lowest possible, payment to a pharmacy, effective January 1, 2023. This policy would reduce beneficiary out-of-pocket costs and improve price transparency and market competition in the Part D program…
—Current regulations have special requirements for MA plans during disasters or emergencies, including requirements for plans to cover services provided by non-contracted providers and to waive gatekeeper referral requirements. The proposal would require a MA plan to comply with the special requirements when there is a declaration of disaster or emergency (including a public health emergency) and disruption in access to health care…
CMS is proposing to require thatplan applicants demonstrate they have a sufficient network of contracted providers to care for beneficiaries before CMS will approve an application for a new or expanded MA plan.
—Our proposal would require MA organizations and Part D sponsors to report the underlying cost and revenue information needed to calculate and verify the MLR [Medial Loss Ratio] percentage and remittance amount, if any. In addition, we propose to require that MA organizations report the amounts they spend on various types of supplemental benefits not available under original Medicare (e.g., dental, vision, hearing, transportation).”
Use of Preventive Care Services and Hospitalization Among Medicare Beneficiaries in Accountable Care Organizations That Exited the Shared Savings Program: “How is the exit of an accountable care organization (ACO) from the Medicare Shared Savings Program (SSP) associated with clinical quality delivered to beneficiaries, and does the association change over time after exit?…
In this cohort study of more than 1.7 million Medicare beneficiaries, SSP exit was associated with considerably lower rates of preventive service use, though not associated with rates of hospital utilization. These associations differed depending on how far removed an ACO was from SSP participation, where the reductions in clinical quality were most prominent in the first 2 years after exit…
Observations of declines in clinical quality after ACO exit from the SSP are important given recent changes to the SSP that could accelerate program exit.”