About Covid-19
Covid deal hampered by GOP opposition to Biden immigration policy “Just a day after Republican Sen. Mitt Romney and Majority Leader Chuck Schumer announced a deal on billions for therapeutics, vaccines and testing, GOP senators threw in a wrench that could mean Congress will break with nothing. Senate Republicans say they want a vote on an amendment that would keep in place the Title 42 border restrictions, which allows limits on immigration due to the pandemic. Without one, they say the bill can’t proceed.”
HRSA says it will reopen pandemic relief reporting to providers with 'specific extenuating circumstances' “Following industry outcry, the Health Resources and Services Administration is now planning to give another chance to providers who were unable to report on COVID-19 pandemic assistance “as a result of specific extenuating circumstances,” according to a notice recently added to the Provider Relief Funding Reporting Requirements and Auditing page of the agency’s website.
HRSA’s notice did not detail which circumstances will qualify providers for the new reporting window…
The update came shortly after a report from Bloomberg Law that the administration planned to claw back up to $100 million in Provider Relief Fund assistance from those who didn’t meet reporting requirements.”
FDA updates Sotrovimab emergency use authorization “Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant.”
FDA says Covid vaccines may need to be updated to ensure high level of effectiveness against virus ”The currently approved Covid-19 vaccines may need an update to ensure a high level of protection as the virus continues to evolve, according to the Food and Drug Administration.
The FDA, in a briefing document published ahead of an advisory committee meeting this week, said scientists still don’t entirely understand Covid variants and the effectiveness of the vaccines. For example, mutations to the spike protein, which is used by the virus to invade human cells, have reduced effectiveness of current vaccines. That’s because today’s Covid shots were developed to target the spike protein in the original strain of the virus that emerged in Wuhan, China in late 2019.”
Heart issues more common after Covid infection than vaccination, CDC reports “Compared to vaccination, Covid-19 itself is far more likely to lead to heart problems in teenage boys and young men, the Centers for Disease Control and Prevention reported…”
Protection by a Fourth Dose of BNT162b2 against Omicron in Israel “Rates of confirmed SARS-CoV-2 infection and severe Covid-19 were lower after a fourth dose of BNT162b2 vaccine than after only three doses. Protection against confirmed infection appeared short-lived, whereas protection against severe illness did not wane during the study period.”
About health insurance
Optum continues buying spree and scoops up Houston-based Kelsey-Seybold Clinic: report “With more than 500 physicians, Kelsey-Seybold Clinic operates multi-specialty care centers, a cancer center, a women’s health center, two ambulatory surgery center locations, and a specialized sleep center with more than 30 locations in the Greater Houston area. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans…
In early 2020, TPG Capital, the private equity platform of global alternative asset firm TPG, made a minority investment in Kelsey-Seybold. At the time of the investment, the medical group's valuation was estimated to be $1.3 billion…”
Comment: Since Optum is a division of UnitedHealth Group, it remains to be seen what other insurers will do about their Clinic contracts.
Association of Maryland Global Budget Revenue With Spending and Outcomes Related to Surgical Care for Medicare Beneficiaries With Cancer “Question Is the Maryland global budget revenue (GBR) model associated with meaningful changes in 30-day episode spending and clinical outcomes among Medicare beneficiaries who undergo cancer-directed surgery?
Findings In this difference-in-differences analysis, comparison of Maryland Medicare beneficiaries with a matched control group found that GBR was associated with a statistically significant decrease in 30-day readmissions. However, we found no consistent changes in 30-day episode spending, emergency department visits, or all-cause mortality.”
About hospitals and healthcare systems
Payer mix in the nation's top 20 hospitals FYI: “The 2019 data released April 5 is from the coverage, cost and value team at the National Academy for State Health Policy in collaboration with Houston-based Rice University's Baker Institute for Public Policy.”
About pharma
Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019 “…the accelerated approval (AA) program permits the FDA to approve novel drugs for serious or life-threatening diseases on the basis of changes to surrogate measures that only are reasonably likely to predict clinical benefit. Surrogate measures are laboratory values that can be observed faster than clinical end points but may not accurately estimate how a patient feels, functions, or survives. The analogous approval pathway in the European Union (EU) is the conditional marketing authorization (CMA). Special designations in the US and Europe are also available for drugs addressing rare diseases and promote regulatory flexibility when evaluating the evidence….
we found that less than one-third of novel drugs approved by the FDA and EMA in recent years had high added therapeutic value. These results are consistent with a previous study focusing on drugs approved until 2017. None of the AA or CMA drugs had high added therapeutic benefits. Because we examined only drugs approved in 2018 to 2019, our results may not be generalizable to drugs approved in earlier years. The fact that so few of the expedited drugs or those for rare diseases had a high added therapeutic value supports the need for more scrutiny about which drugs qualify for these programs.”
FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments “The first guidance, “Inclusion of Older Adults in Cancer Clinical Trials,” provides recommendations to sponsors and institutional review boards for including older adult patients, aged 65 years and older, in the clinical trials of drugs for the treatment of cancer…
The second guidance for industry “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics,” provides advice on designing and conducting trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of first-in human cancer drugs…
Finally, the “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics” guidance addresses master protocol design including information on what sponsors should submit to the FDA as part of these trial design approaches. It also directs how sponsors should interact with the FDA to facilitate efficient review and mitigate risks to patients.”
About the public’s health
Health and Health Care for Women of Reproductive Age From the Commonwealth Fund:
”Highlights:
Among women of reproductive age in high-income countries, rates of death from avoidable causes, including pregnancy-related complications, are highest in the United States.
U.S. women of reproductive age are significantly more likely to have problems paying their medical bills or to skip or delay needed care because of costs.
U.S. women of reproductive age have among the highest rates of multiple chronic conditions and the highest rate of mental health needs.
Sweden, the U.S., Canada, and Australia are the countries where women of reproductive age are the least likely to report having a regular doctor or place to go for care.”
Comment: It is interesting to note that having a regular doctor is not solely a function of the national insurance scheme.
Medical bills for US shooting survivors top $2.5B in 1st year after injury, study says “In the first year after a firearm injury, gunshot survivors spent on average $2,495 more in healthcare per month than those who did not suffer gunshot wounds. When extended to all gunshot survivors in the U.S., direct healthcare spending amounts to $2.5 billion in the first year. Cost-sharing, including copays and deductibles, is $102 more per person per month for gunshot survivors.
The largest healthcare spending increases were found during the first month after injury, reaching on average $25,554 per person in spending and $1,112 per person in cost-sharing.
Each year, gun violence kills nearly 40,000 people in the U.S. and costs the nation $280 billion, including medical, criminal justice and quality-of-life expenses.”
EPA moves to ban the most common type of cancer-causing asbestos “The Environmental Protection Agency on Tuesday proposed to ban chrysotile asbestos, the most common form of the toxic mineral still used in the United States.
Also known as ‘white asbestos,’ it has remained on the market despite decades of research showing that it is a deadly carcinogen, linked to about 40,000 U.S. deaths each year. Chlorine manufacturers and companies that make vehicle braking systems and sheet gaskets still import chrysotile asbestos and use it to manufacture new products.
The proposed rule would ban all manufacturing, processing, importation and commercial distribution of six categories of products containing chrysotile asbestos, which agency officials said would cover all of its current uses in the United States.”
FDA Gains Power to Regulate Synthetic Nicotine in e-Cigarettes “Closing a loophole in the federal government’s oversight of e-cigarette products, new legislation gives the US Food and Drug Administration (FDA) the authority to regulate synthetic nicotine, used by some e-cigarette makers to evade a ban on flavored e-cigarettes, favored by teen vapers.
The new law will become effective on April 14. Closing the synthetic nicotine loophole is intended to help advance the public health goal of reducing nicotine addiction that US teens acquire through use of flavored e-cigarettes.”
About healthcare finance
Fitness company Tivity Health to be bought by Stone Point Capital for $2 bln “Fitness company Tivity Health said on Tuesday it had agreed to be bought and taken private by investment firm Stone Point Capital for $2 billion in cash…
The company owns SilverSneakers, a fitness program offered in-person and virtually for people eligible for Medicare - the U.S. government's medical insurance program for people age 65 and older and the disabled.”
Healthcare not as ‘recession-proof’ as expected, analysts say “Healthcare corporations are at increased danger of defaulting on their loans than many different industries, a brand new report signifies.
The healthcare {industry} had the very best chance to default over the subsequent yr at a 4.4% median, first-quarter S&P Global Market Intelligence data evaluating U.S. sectors present. That likelihood was up from 3.3% as of the top of final yr, in response to S&P’s evaluation, which is predicated on the volatility of share costs for public corporations and country- and industry-related dangers.
‘There was a perception before the pandemic that healthcare was “recession-proof.” But this is a fundamentally different environment,’ mentioned Matt Wolf, director and senior healthcare analyst with RSM. ‘Providers have had to shut down non-emergent procedures, either due to lockdowns or not having the staff to perform them. They’ve paid the staff they do have more while reimbursement levels are not going up. They are not going to hire their way out of this.’”