About Covid-19
FDA authorizes third vaccine dose for immunocompromised people: “The Food and Drug Administration (FDA) on Thursday authorized a third dose of COVID-19 for certain people with compromised immune systems, a narrow move into the realm of booster doses amid a growing debate over their use.
The move will allow a third dose of both the Pfizer-BioNTech and Moderna vaccines, and applies to certain immunocompromised people, including those with organ transplants and those ‘diagnosed with conditions that are considered to have an equivalent level of immunocompromise,’ the FDA said.
The agency emphasized that the general public does not need a third dose at the moment.”
Change in Saliva RT-PCR Sensitivity Over the Course of SARS-CoV-2 Infection: “Saliva was sensitive for detecting SARS-CoV-2 in symptomatic individuals during initial weeks of infection, but sensitivity in asymptomatic SARS-CoV-2 carriers was less than 60% at all time points. As COVID-19 testing strategies in workplaces, schools, and other shared spaces are optimized, low saliva sensitivity in asymptomatic infections must be considered. This study suggests saliva-based RT-PCR should not be used for asymptomatic COVID-19 screening.[Emphasis added]”
Gov. Abbott argues San Antonio’s mask mandate will ‘shatter’ Texas’ ability to respond to pandemic: “Texas Gov. Greg Abbott and Attorney General Ken Paxton filed an appeal Thursday seeking to reverse a Bexar County judge’s temporary restraining order that allowed the county to mandate masks in school…
The temporary restraining order against Abbott’s executive order is only in effect until Monday, when a local district judge will determine whether the local governments can continue mandating masks…
Lawyers for the statewide officials argued that the restraining order ‘will have shattered’ the state’s ability to ‘carry out an orderly, cohesive, and uniform response to the COVID-19 pandemic.’”
As far as I can tell, the only response the ruling has “shattered” is the ability to implement a science-based initiative.
Herd immunity is 'mythical' with the Covid delta variant, experts say: “Achieving herd immunity with COVID-19 vaccines when the delta variant is spreading is "not a possibility," said Andrew Pollard, head of the Oxford Vaccine Group..
Pollard said that while COVID-19 vaccines may slow the spread of the virus — because in studies fully vaccinated but infected people appeared to shed less virus, giving the virus less opportunity to spread — new variants were likely to emerge that would also spread.”
Speaks to the need to both vaccinate and wear masks.
WHO Broadens COVID-19 Study to Feature Three Licensed Drugs: “Expanding its existing Solidarity trial, the World Health Organization (WHO) will test three additional anti-inflammatory drugs as potential treatments for COVID-19.
Solidarity PLUS will determine whether artesunate, imatinib and infliximab — all of which are already approved for other indications — might reduce the risk of death or hospitalization in patients with the disease, WHO reported. An independent expert panel selected the candidate medications, which will be donated by the manufacturers.”
Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents: “The mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19.”
Despite obstacles, Native Americans have the nation’s highest COVID-19 vaccination rate: Despite poverty and remote living conditions, “data — collected by the U.S. Centers for Disease Control and Prevention — suggest that Native Americans are 24% more likely than whites to be fully vaccinated, 31% more likely than Latinos, 64% more likely than African Americans and 11% more likely than Asian Americans.”
The reason is the strong efforts by tribal leaders to promote the vaccine in the face of many deaths early in the pandemic.
About pharma
AHIP Letter Concerning National Coverage Determination Analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease: While the entire letter is a good summary of the issue, the insurance trade organization hedges its opposition with the following statement:
”While we do not believe CMS can conclude that aducanumab meets the Medicare coverage standard based on the risk of serious beneficiary harm and the lack of clinical benefit, we recognize that even if CMS agrees, CMS may still consider other statutory approaches that permit some degree of coverage under the Medicare program. In that context, an available approach under the Medicare statute would be for CMS to approve coverage only in connection with a CED [Coverage with Evidence Development]. As CMS has previously noted, an NCD involving CED is appropriate when CMS decides after a formal review of the medical literature that it will cover an item or service only in the context of an approved clinical study or when additional clinical data are collected to assess the appropriateness of an item or service for use with a particular beneficiary.”
Despite pharma's pandemic push, consumer trust in the industry still comes down to costs: study: “A new study from Accenture shows a boomerang back to a familiar topic—drug costs…
The top two answers specifically pointed to reduced medication costs (41%) and more transparency in pricing (39%) as measures that would make the respondents trust pharma companies more. Accenture surveyed 1,800 people in May and June about their healthcare experiences.”
About health insurance
Innovation At The Centers For Medicare And Medicaid Services: A Vision For The Next 10 Years: Chiquita Brooks-LaSure (Administrator, Centers for Medicare and Medicaid Services) is the lead author of this Health Affairs article. The beginning is a good review of recent CMMI initiatives and a call for simplification of its programs. It continues by offering areas for improvement for the future. Notably missing are implementation of evidence-based guidelines and reforms that would allow cost-benefit analyses to be used in care decisions.
Physician assistants will benefit with direct pay under CMS proposed rule: “In its proposed rule for the 2022 Physician Fee Schedule, CMS includes a section on billing for physician assistant services. It has people talking, but few know what it does – and does not – mean.
If approved as a final rule, physician assistants (PAs) may choose to bill Medicare and be paid directly for their services, reassign their payment and incorporate as a solo or group practice comprised solely of PAs…
Section 403 of the Consolidated Appropriations Act of 2021 amends section 1842(b)(6)(C)(i) of the Social Security Act and removes the requirement that payment for services performed by PAs be made to their employer.”
The final rule is pending and awaits comment period closing on September 13.
If this provision is retained it could be one of the biggest changes in professional practice since physician licensure laws.
Oscar Health, Inc. Announces 2022 Market Expansion Plans, Culturally Competent Care Focus: “During the upcoming Open Enrollment period, the company plans to offer health insurance to individuals and families in 3 new states and 146 new counties.1 With this expansion, Oscar will have a footprint in a total of 22 states and 607 counties across its Individual & Family, Medicare Advantage, and Small Group (including Cigna+Oscar) plans.”
UnitedHealthcare loses Medicare overpayment appeal: 5 things to know: “In a 49-page opinion, the U.S. Court of Appeals for the District of Columbia Circuit reversed a 2018 decision that vacated Medicare's overpayment rule, which requires insurers to refund payment to CMS within 60 days if it learns a diagnosis lacks medical record support.
UnitedHealthcare had argued the overpayment rule was subject to "actuarial equivalence." However, the court ruled actuarial equivalence doesn't apply to the overpayment rule, and there's no legal basis for UnitedHealthcare's claim.”
UnitedHealth, Change Healthcare strike timing agreement with DOJ: 5 things to know: “UnitedHealth Group and Change Healthcare entered an agreement with the Department of Justice that dictates when the organizations can consummate their $13 billion proposed deal…
UnitedHealth and Change agreed to wait at least 120 days after certifying compliance with the request for information to consummate the deal, according to an Aug. 7 filing with the Securities and Exchange Commission. Both organizations agreed to not certify compliance with the request before Sept. 15.
The organizations could complete the acquisition before the 120-day period ends if they get a written notice saying the DOJ has closed its investigation into their deal.”
UnitedHealthcare to pay $15.6M in mental health parity settlement: “UnitedHealthcare will pay $15.6 million to settle federal and state investigations into mental health parity, the Department of Labor announced Thursday.
The settlement includes $13.6 million in payments to members for wrongfully denied claims as well as just over $2 million in penalties and lawyers fees, DOL said.
An investigation by DOL's Employee Benefits Security Administration found that UnitedHealth would reduce reimbursement rates for out-of-network behavioral health services and would flag members who were undergoing mental health treatment for utilization reviews.
UnitedHealthcare also failed to sufficiently disclose information about its practices to plan sponsors and members, according to DOL.”
Anthem partners with CareMax to open 50 medical centers: “Miami-based CareMax, a senior healthcare provider with an emphasis on value-based care, penned a partnership with Anthem that will lead to the duo opening 50 medical centers around the country.
The medical centers will primarily be created in areas where Anthem is focusing value-based care efforts, according to the Aug. 13 announcement. Some of the identified states include Indiana, Texas, Kentucky, Wisconsin, Georgia, Connecticut and Virginia.”
How Would Drug Price Negotiation Affect Medicare Part D Premiums?: “Under drug price negotiation, premium savings for Medicare beneficiaries are projected to increase from an estimated 9% of the Part D base beneficiary premium in 2023 to 15% in 2029. Medicare’s actuaries have estimated that the Part D base beneficiary premium, which covers the cost of basic Part D coverage, will increase from around $440 per year in 2023 to around $560 in 2029. The $14 billion in aggregate Part D premium savings from drug price negotiation over a decade translates into estimated per capita savings for Part D enrollees who pay premiums of $39 annually in 2023, increasing to $85 annually in 2029. This translates to savings of 9% of the base beneficiary premium in 2023 and 15% in 2029.”
See Figure 1 for a quick view of the impact.
About healthcare IT
Amwell expects fewer telehealth visits in fall, winter as delta variant creates uncertainty: “The company is projecting an $8 million impact on its 2021 revenue as a result of the drop in projected virtual care visits. Amwell adjusted its 2021 revenue guidance to between $252 million and $262 million from the previous range of $260 million to $270 million, executives said during the company's second-quarter 2021 earnings call Wednesday.
’The recent emergence of the delta variant has introduced some uncertainty to our second half visits outlook,’ said Ido Schoenberg, M.D., chairman and CEO of Amwell, during the call.”
Another big company hit by a ransomware attack: You know you are in trouble when your IT consultant is a ransomware victim: “Accenture, the global consulting firm, has been hit by the LockBit ransomware gang, according to the cybercriminal group's website. Accenture's encrypted files will be published by the group on the dark web on Wednesday unless the company pays the ransom, LockBit claimed, according to screenshots of the website reviewed by CNN Business and Emsisoft, a cybersecurity firm.”
About hospitals and health systems
Mississippi braces for ‘failure’ of hospital system due to covid-19 surge and lack of ICU beds: “A surge in coronavirus patients and a shortage of health-care workers and intensive care unit beds have pushed Mississippi’s hospital system to the brink of “failure,” state health officials warned Wednesday, saying drastic federal intervention was needed to help the state grapple with the thousands of new daily infections that have overwhelmed doctors and nurses.
Mississippi is averaging nearly 2,700 new covid-19 infections a day in the past week — a 54 percent spike in the past seven days…”
Former Broward Health director gets more than 3 years in prison for taking kickbacks: “In his role as procurement director, Mr. Bravo was responsible for deciding which vendors would provide Broward Health with products and services, including healthcare products, linens, compression sleeves and printer repair.
According to prosecutors, Mr. Bravo used his role to orchestrate a bribery and kickback scheme between 2008 and 2015 that involved four vendors.”
FTC’s Merger Review Process Change Muddies Deal-Closing Outlook: This article is in this section because most of the FTC’s scrutiny in healthcare has centered on hospital/health system mergers. “A shift in the Federal Trade Commission’s merger review process will add more risk management work for companies hoping to quickly wrap up mergers.
The FTC said this month it will tell some companies that it lacks resources to complete an initial review of their mergers and acquisitions within 30 days, as generally laid out in the Hart-Scott-Rodino (HSR) Act.
The FTC will now send a letter to companies doing deals that can’t be fully reviewed within 30 days that its investigation remains open and their deal may be subsequently declared unlawful.”