About Covid-19
Moderna aims to launch a single-dose COVID-19 vaccine next year in India: report: “Moderna aims to launch a single-dose version of its mRNA COVID-19 vaccine in India next year and is in discussion with Mumbai-based pharmaceutical firm Cipla among others to supply it, according to the India news agency PTI.”
Inhalable Nanobody (PiN-21) prevents and treats SARS-CoV-2 infections in Syrian hamsters at ultra-low doses: “Intranasal delivery of PiN-21 [ Pittsburgh inhalable Nanobody 21] 0.6 mg/kg protects infected animals from weight loss and substantially reduces viral burdens in both lower and upper airways compared to control. Aerosol delivery of PiN-21 facilitates deposition throughout the respiratory tract and dose minimization to 0.2 mg/kg. Inhalation treatment quickly reverses animals’ weight loss after infection, decreases lung viral titers by 6 logs leading to drastically mitigated lung pathology, and prevents viral pneumonia. Combined with the marked stability and low production cost, this innovative therapy may provide a convenient and cost-effective option to mitigate the ongoing pandemic.”
Sinopharm's two COVID-19 shots effective, study says: “Two COVID-19 vaccines from China’s Sinopharm showed more than 70% efficacy against symptomatic cases, but it remains unclear how much protection they provide against severe or asymptomatic cases, according to the first detailed result of a large late-stage study published to the public.”
HHS and DOD will spend $27M to replenish medical supplies:”HHS and the U.S. Department of Defense announced this week that they will spend an additional $27.7 million to increase production of low dead-space syringes and needles, which are in short supply due to the pandemic.
LDS syringes and needles allow providers to extract every dose of vaccine vial upon injection.
This can help providers stretch out current vaccine supply by 20%.”
Resistance to vaccine mandates is building. A powerful network is helping: “Attorneys from Siri & Glimstad — a New York firm that has done millions of dollars of legal work for one of the nation’s foremost anti-vaccination groups — are co-counsel in a case against the Durham County Sheriff’s Office. They’ve sent warning letters to officials in Rock County, Wis., as well as to the president of Rutgers University and other schools.”
These lawyers should be ashamed of themselves.
DOJ Announces Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19: “The Department of Justice today announced criminal charges against 14 defendants, including 11 newly-charged defendants and three who were charged in superseding indictments, in seven federal districts across the United States for their alleged participation in various health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings…
The defendants in the cases announced today are alleged to have engaged in various health care fraud schemes designed to exploit the COVID-19 pandemic. For example, multiple defendants offered COVID-19 tests to Medicare beneficiaries at senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or blood sample. The defendants are alleged to have then misused the information and samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive laboratory tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests. In some cases, and as alleged, the COVID-19 test results were not provided to the beneficiaries in a timely fashion or were not reliable, risking the further spread of the disease, and the genetic, allergy, and respiratory pathogen testing was medically unnecessary, and, in many cases, the results were not provided to the patients or their actual primary care doctors. The proceeds of the fraudulent schemes were allegedly laundered through shell corporations and used to purchase exotic automobiles and luxury real estate.”
U.S. FDA gives emergency use approval for GSK-Vir COVID-19 antibody drug: “The antibody drug, Sotrovimab, is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy, the health regulator said on Wednesday.”
U.S. FDA may not review new COVID-19 vaccine EUA requests during pandemic:The headline is the message. Better to focus on permanent approval of current vaccines and ramp up production and delivery.
Eli Lilly's COVID-19 antibody halted in 6 more states as Regeneron's competing option sails along: “Within hours of granting emergency use approval to a COVID-19 antibody drug by GlaxoSmithKline and Vir, the United States has restricted the use of another COVID antibody treatment, this one from Eli Lilly.
The FDA has halted the distribution of Lilly’s combination of bamlanivimab and etesevimab in Arizona, California, Florida, Indiana, Oregon and Washington––all states where coronavirus variants from Brazil and South Africa account for more than 10% of those with the disease. The antibody combo had previously been paused in Illinois and Massachusetts.
Providers in those states should use Regeneron’s antibody treatment of casirivimab and imdevimab, the FDA says. Lab studies have shown that option is more effective against the Brazilian (P.1) and South African (B.1.351) strains…”
In a related story: Eli Lilly hit with DOJ subpoena over New Jersey factory making COVID-19 drug: “Thursday, Lilly revealed the DOJ has issued a subpoena demanding documents relating to the site in Branchburg, New Jersey. The site produces doses of Lilly's COVID-19 antibody treatment, which has recently faced setbacks for its susceptibility to certain variants…
The findings included details about the production of bamlanivimab, which has been widely deployed in the U.S. to treat adult and certain pediatric COVID-19 patients with mild to moderate disease…”
Scientists claim to have solved Covid vaccine blood-clot puzzle: “Rolf Marschalek, a professor at Goethe university in Frankfurt who has been leading studies into the rare condition since March, said his research showed the problem sat with the adenovirus vectors that both vaccines use to deliver the genetic instructions for the spike protein of the Sars-Cov-2 virus into the body. The delivery mechanism means the vaccines send the DNA gene sequences of the spike protein into the cell nucleus rather than the cytosol fluid found inside the cell where the virus normally produces proteins, Marschalek and other scientists said in a preprint paper released on Wednesday.”
Another study linked the clots to an additive in the vaccines.
WHO reboots IP sharing scheme for Covid shots, drugs and tests: “The World Health Organization is moving to reboot its intellectual property sharing scheme as vaccine shortages threaten poorer nations’ attempts to emerge from the pandemic and as the debate over patents intensifies. In a letter published on Thursday, WHO director-general Tedros Adhanom Ghebreyesus and Costa Rican president Carlos Alvarado Quesada called on member states to engage with vaccine manufacturers to encourage IP sharing and tech transfer through the scheme.”
About the public’s health
A new tool tracks health disparities in the U.S. — and highlights major data gaps: “On Wednesday, a coalition of researchers and advocates launched a tool they hope will fill some of those gaps: the Health Equity Tracker, a portal that collects, analyzes, and makes visible data on some of the inequities entrenched in U.S. medicine…
Today, the tracker includes the 26 million lines from that restricted CDC database, each of which represents a single Covid-19 patient — including their state and county, race and ethnicity, sex, age, whether they were hospitalized, and whether they died. It combines that information with state-level health insurance and poverty data from the American Community Survey, and details on diabetes and COPD prevalence from America’s Health Rankings.”
2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association: Ten recommendations, many not new, e.g., lifestyle modifications.
Tobacco Cos. To Pay $200M To End Texas' Settlement Fight “Texas notified a federal court Wednesday that R. J. Reynolds Tobacco Co. and fellow tobacco company ITG Brands LLC have agreed to pay a total of more than $200 million to end the state's suit to enforce a 1998 tobacco settlement agreement. Reynolds agreed to pay Texas roughly $173 million in funds owed to the state under the 1998 tobacco master settlement for the years 2015 through 2020, plus $2. 5 million in attorney fees. ITG agreed to pay Texas about $19 million for payments owed to the state in 2020…”
I wonder what Texas will do with the money.
The effect of morning vs evening exercise training on glycaemic control and serum metabolites in overweight/obese men: a randomised trial: “Improvements in cardiorespiratory fitness were similar regardless of the time of day of exercise training. However, improvements in glycaemic control and partial reversal of HFD [High Fat Diet]-induced changes in metabolic profiles were only observed when participants exercise trained in the evening.”
About pharma
Truepill launches virtual primary care, diagnostics services to flesh out its white label digital pharmacy platform: “San Mateo, California-based digital pharmacy startup Truepill is building upon last year’s funding momentum with the formal launch of two new business lines: one focused on virtual primary care and another offering in-home and in-person diagnostic testing…
Designed for payer and employer customers, the Virtual Primary Care offering provides access to a network of primary care physicians able to take video calls or asynchronous text-based messages around the clock and across all 50 states.
Members or employees using the service can select an individual physician to become their primary care provider for all scheduled visits down the line and can receive referrals or other support from the company’s care coordination teams.”
CMS delays controversial best price requirement for drugmakers: “The Biden administration delayed part of a Trump-era rule requiring them to include the discounts they offer to patients when calculating the “best price” for drugs under Medicaid’s drug rebate program, according to a proposed rule on Wednesday.
Drugmakers were supposed to start reporting multiple best prices beginning Jan. 1, but CMS delayed the requirements until July 1, 2022. The agency said the additional time would allow the healthcare industry to address concerns over patient access and quality of care before the new requirements take effect.”
Teva Pharmaceutical to Settle Intuniv Lawsuit for $1.1 Million: “The 2016 lawsuit alleged that Actavis, which Teva acquired that year, had a pay-for-delay deal with Shire that delayed the launch of a generic of Shire’s attention deficit hyperactivity disorder (ADHD) drug Intuniv (guanfacine).”
Companies are still trying to use this method to retain market exclusivity. Although legal actions may curtail some of these activities, the penalties will have to be much larger to be truly effective.
Judge Clears Purdue Pharma’s Restructuring Plan for Vote by Thousands of Claimants: “A federal bankruptcy judge in New York indicated Wednesday that he would permit Purdue Pharma’s proposal to remake itself as a nonprofit company to be put to a vote by thousands of plaintiffs, who have sued to compel the maker of OxyContin to help pay for the terrible costs of the opioid epidemic.”
About health insurance
Health Insurance Trends May 2021: “This report, eHealth’s inaugural edition of its new biannual signature research series, presents an analysis of survey responses and first-hand interviews collected from more than 4,700 consumers and more than two dozen insurer representatives across three megatrends that dominate the health care market today: COVID-19, Technology and Innovation, and Public Policy Reforms.”
Look at page 4 for a summary of the findings. Some opinions are conditional. For example, “60% favor expanding access to Medicare in some form, whether that means making Medicare available to all Americans (28%), lowering the eligibility age to 60 (18%), or allowing adults age 50+ to buy in early (14%).”
But if you ask respondents if they are willing to pay for that option, you will probably get a different answer.
Premium Assistance for COBRA Benefits: From the IRS: This notice provides guidance on the application of… the American Rescue Plan Act of 2021… relating to temporary premium assistance for Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) continuation coverage.
Section 9501 of the ARP provides for a temporary 100 percent reduction in the premium otherwise payable by certain individuals and their families who elect COBRA continuation coverage through the Internal Revenue Code (Code), the Employee Retirement Income Security Act of 1974 (ERISA), or the Public Health Service Act (PHS Act) due to a loss of coverage as the result of a reduction in hours or an involuntary termination of employment.2 The temporary premium assistance is also available to individuals enrolled in continuation health coverage under State programs that provide for coverage comparable to COBRA continuation coverage, often referred to as ‘mini- COBRA.’”
Nurse Practitioner Sentenced to 20 Years, Ordered to Pay More Than $52 Million in Restitution: ”Mr. Reddy and co-conspirators created false patient bills using the provider numbers of six doctors as the treating physicians on the claims. All the claims were false and at no time did the six doctors provide billable services to any of Mr. Reddy’s medical clinics.”
[Nevada] Senate passes ‘public option’ health insurance plan: “SB420 aims to create health insurance policies for individuals that are at least as good as Medicare but provide the coverage at lower costs than Medicare.
The bill was passed on a party line vote with Democrats for it and Republicans unanimously opposed.
The legislation, which now goes to the Assembly, directs the head of Health and Human Services, the executive director of the Silver State Health Insurance Exchange and the Insurance Commissioner to apply to the U.S. Secretary of Health and Human Services for a waiver to obtain federal pass-through funding to pay for the program as well as other waivers to get funding to support the plan including potentially the Social Security Act.”
This legislation is an example of states acting on their own until/if Congress passes a federal public option.
In a related story: Leading Dems seek input on ‘public option’ health care plan: “The wide-ranging request from Sen. Patty Murray of Washington and Rep. Frank Pallone of New Jersey asks basic questions such as who should be eligible to enroll in a new federal health plan, how the benefits would be designed and what payments should look like for hospitals, doctors, drug companies and other medical providers.”
Cost Measures: Traditional MIPS Requirements: From CMS, the latest Merit-based Incentive Payment System payment activity category weights. Go to the bottom of the page and select the pdf.
Physician Compensation Flattens due to the Pandemic’s Impact on Medical Groups: “Primary care physician compensation saw modest growth during 2020. With support for medical practices from the government, most notably the Paycheck Protection Program and the Provider Relief Fund, as well as a rebound in patient volumes in the latter part of the year, physician compensation stabilized as practices covered their overhead with federal assistance. Total compensation for primary care physicians increased by 2.6% between 2019 and 2020 compared to the three- and five-year cumulative increases of 5.27% and 10.15% respectively. Advanced practice providers (APPs) also experienced a slight increase in compensation during the same one-year timeframe…
Compensation changes for most specialties were very modest or essentially flat, and the decreases in compensation seen for certain specialties were not as large as expected. Surgical physicians, for example, whose patient volumes were significantly limited because of regional lockdowns and overwhelmed hospitals, experienced a compensation decrease of 0.89% in 2020. Nonsurgical specialists also reported a decrease of 1.29% despite the significant challenges faced by those specialists last year.”
About healthcare professionals
Best & Worst places to practice: From Medscape: best state to practice is Minnesota; worst is West Virginia.