Expected immediate actions after today’s inauguration:
President Biden will
Stop the US withdrawal from the WHO.
And in a related action: Biden will join WHO-backed vaccine initiativeRequire masks on federal property.
Restore the global health security and biodefense team.
Rejoin the Paris climate accord.
About health insurance
CMS and Its Contractors Did Not Use Comprehensive Error Rate Testing Program Data To Identify and Focus on Error-Prone Providers: From the HHS OIG: “CMS and its contractors did not use CERT [Comprehensive Error Rate Testing] to identify and focus on error-prone providers for review and corrective action. Using CERT data, we identified 100 error-prone providers from 2014 through 2017. Of the $5.8 million reviewed by CERT, $3.5 million was incorrect, which is an improper payment rate of 60.7 percent. We determined that during the same period, Medicare made $19.1 billion in FFS payments to these 100 error-prone providers…
We recommend that CMS: (1) review the list of 100 error-prone providers identified in this audit and take specific action as appropriate, such as prior authorization, prepayment reviews, and postpayment reviews, and (2) use annual CERT data to identify individual providers that have an increased risk of receiving improper payments and apply additional program integrity tools to these providers.”
Compounding Pharmacy Mogul Sentenced for Multimillion-Dollar Health Care Fraud Scheme: ”A Mississippi businessman was sentenced… for his role in a multimillion-dollar scheme to defraud TRICARE, the health care benefit program serving U.S. military, veterans, and their respective family members, as well as private health care benefit programs.
Wade Ashley Walters, 54, of Hattiesburg, a co-owner of numerous compounding pharmacies and pharmaceutical distributors, was sentenced… on his guilty plea to one count of conspiracy to commit health care fraud and one count of conspiracy to commit money laundering. U.S. District Judge Keith Starrett of the Southern District of Mississippi ordered Walters to serve a total of 18 years in prison and to pay $287,659,569 in restitution. Walters was remanded into custody following the sentencing hearing. Walters was further ordered to forfeit $56,565,963, representing the proceeds he personally derived from the fraud scheme…
Between 2012 and 2016, Walters orchestrated a scheme to defraud TRICARE and other health care benefit programs by distributing compounded medications that were not medically necessary.”
Trump grants clemency to 143 people in late-night pardon blast: Among the actions was commutation of “the sentence of Salomon Melgen, a West Palm Beach, Fla., eye doctor who was sentenced in 2018 to 17 years in prison, accused of stealing $73 million from Medicare by persuading elderly patients to undergo unnecessary procedures.
Separately, Melgen had been accused of bribing Sen. Robert Menendez (D-N.J.) to intercede on his behalf in the Medicare investigation.”
AMA announces update to COVID-19 vaccine CPT codes: The new codes will be used to bill and track administration of J&J’s vaccine when it is available.
UnitedHealth Group Reports Fourth Quarter and Full Year 2020 Financial Results: ”The full year and fourth quarter results reflect continued strong performance, impacted by COVID-19 care costs, continued voluntary consumer and customer assistance initiatives and other pandemic-related factors. As expected, fourth quarter net earnings of $2.30 per share and adjusted earnings of $2.52 per share declined as care patterns normalized, while COVID-19 costs rose, and further rebate effects were recognized. The 2020 results were consistent with the outlook provided by the Company at its December 1st, 2020 Investor Conference.
The Company affirmed its recently issued full year earnings outlook for 2021, including net earnings of $16.90 to $17.40 per share and adjusted net earnings of $17.75 to $18.25 per share. As previously discussed, this outlook includes approximately $1.80 per share in potential net unfavorable impact to accommodate continuing COVID-19 effects, such as: testing and treatment costs; the residual impact of people deferring care in 2020; and unemployment and other economy-driven factors.”
Feds Near Win In Mass. ACA Birth Control Coverage Suit: “A Massachusetts federal judge has ruled that the state can't block a pair of Trump administration rules expanding the religious exemption to the Affordable Care Act's contraceptive mandate, finding that the exemptions don't run afoul of the U. S. Constitution or federal statutes in light of the high court's recent Little Sisters ruling. In a 29-page, Jan. 15 opinion, U. S. District Judge Nathaniel M. Gorton said the state has not established that the final rules are statutorily or constitutionally invalid, and therefore he was denying its bid for summary judgment…”
About COVID-19
Elderly begin to drop out of Novavax vaccine trial to get Pfizer and Moderna shots: Seniors want to know if they were in the placebo group for Novavax’s vaccine. If so, they want to drop out and get a vaccine that is already approved.
Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community-Based Testing Sites — Pima County, Arizona, November 3–17, 2020: Published yesterday from the CDC. “Sensitivity of the BinaxNOW [from Abbott] antigen test, compared with polymerase chain reaction testing, was lower when used to test specimens from asymptomatic (35.8%) than from symptomatic (64.2%) persons, but specificity was high. Sensitivity was higher for culture-positive specimens (92.6% and 78.6% for those from symptomatic and asymptomatic persons, respectively); however, some antigen test-negative specimens had culturable virus.”
Lab-Developed Virus Tests Get Authorization Without FDA Input: “The HHS on Tuesday authorized three lab-developed Covid-19 tests in an unusual move that skirts the FDA’s traditional role to review products.
The tests from the Ponce Medical School in Puerto Rico, the University of Louisville Infectious Diseases Laboratory in Kentucky, and the Hospital of the University of Pennsylvania are already on the market, Health and Human Services testing leader Brett Giroir said in an interview Tuesday. The authorizations give them liability protections and insurance coverage through federal laws passed earlier in the pandemic.”
Cheap antiparasitic could cut chance of Covid-19 deaths by up to 75%: “The University of Liverpool’s Andrew Hill and others carried out a meta-analytical breakdown of 18 studies that found that ivermectin was associated with reduced inflammation and a faster elimination of Sars-Cov-2, the virus that causes Covid-19. In six of these trials, the risk of death was reduced by 75 per cent in a subset of patients with moderate to severe Covid-19.”
More data needs to be accumulated. Recall we have had many drugs touted as helping prevent/treat COVID-19. Remember hydroxychloroquine?
US scientists develop blood test for high-risk Covid-19 patients: “Scientists at Washington University School of Medicine in St Louis, US, have developed a new simple and rapid test that can measure mitochondrial DNA in the blood of a Covid-19 patient and identify those who are at highest risk of severe disease or death.”
Moderna to Start New Trial Adding Third Shot of COVID-19 Vaccine: “Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot” starting in July.
“The study will enroll adults who previously took part in the initial phase 1 study led by the National Institutes of Health [and] aims to assess the safety of an extra shot given a year after the second dose and the additional immune response it elicits.”
Association of Intensive Care Unit Patient Load and Demand With Mortality Rates in US Department of Veterans Affairs Hospitals During the COVID-19 Pandemic: Volume/quality relationships do not always apply.
”In this cohort study of patients with COVID-19 in US VA hospitals, receiving treatment during peak COVID-19 ICU demand, with demand describing the caseload of patients with COVID-19 in the ICU when the patient was treated compared with peak COVID-19 ICU caseload, was consistently and independently associated with COVID-19 ICU mortality. In the extreme case, the adjusted hazard of death was 1.94 for patients with COVID-19 treated in the ICU during periods with greater than 75% to 100% of the peak COVID-19 ICU caseload. The finding that COVID-19 ICU demand was associated with increased mortality for patients with critical COVID-19 early in the pandemic (ie, March-May) and later in the pandemic (ie, June-August) supports the overall study results that suggested that strains on critical care capacity were associated with increased COVID-19 ICU mortality.”
A number of “Limitations” at the end of the article should make the reader interpret these results cautiously.
About pharma
Merck & Co. loses Supreme Court bid to restore $2.5-billion award in Gilead patent dispute: “The US Supreme Court on Tuesday declined to hear arguments by Merck & Co. in its attempt to appeal a lower court ruling that had overturned a $2.5-billion award it won against Gilead Sciences in 2016. The patent infringement case involved the latter's hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir).”
Mylan Can't Escape EpiPen Distributors' Antitrust Claims: “A Minnesota federal judge has refused to throw out a proposed class action that accuses drugmaker Mylan Inc. of paying bribes and kickbacks to a group of pharmacy benefit managers and conspiring to engage in anti-competitive practices that jacked up the price of its anti-allergy injection EpiPen. Mylan and the so-called PBM defendants — Express Scripts, Optum and CVS Caremark — each argued in separate but identical motions to dismiss that they did nothing unlawful outside their normal commercial business practices.”
About healthcare IT
OCR lifts HIPAA penalties for COVID-19 vaccine scheduling apps: 5 details: “HHS' Office for Civil Rights will not impose penalties for potential HIPAA violations of healthcare providers and their business associates who use online or web-based scheduling applications to coordinate COVID-19 vaccine appointments.”
Philips to buy medical device integrator Capsule Technologies for $635M: “Philips has moved to acquire Capsule Technologies—a provider of data platforms that aim to connect all of the medical devices and record systems within a hospital—to help build out its integrated care and vital sign monitoring solutions.
The $635 million cash deal is expected to be completed by the end of March, with Capsule’s 300 employees slated to join Philips’ connected care division. Capsule’s software-as-a-service offerings are currently used by over 2,800 healthcare organizations globally, with development teams based in the U.S. and France, while its platform can connect to over 940 unique devices.”
About healthcare quality
Predicted Cost Savings Achieved by the Radiology Support, Communication and Alignment Network from Reducing Medical Imaging Overutilization in the Medicare Population: “The Radiology Support, Communication and Alignment Network (R-SCAN) is a quality improvement program through which patients, referring clinicians, and radiologists collaborate to improve imaging appropriateness based on Choosing Wisely recommendations and ACR Appropriateness Criteria. R-SCAN was shown previously to increase the odds of obtaining an appropriate, higher patient or diagnostic value, imaging study. In the current study, we aimed to estimate the potential imaging cost savings associated with R-SCAN use for the Medicare population…
We observed a substantial reduction in the costs associated with lesser value imaging in the R-SCAN cohort, totaling $260,000 over 3.5 months. When extrapolated to the Medicare population, the potential cost reductions associated with the decrease in lesser value imaging totaled $433 million yearly.”
About healthcare systems
Community Health Taps Into Junk-Bond Frenzy to Tame Debt: “Community Health Systems Inc., the debt-laden hospital chain that’s been staging a comeback, has more than doubled the size of a bond offering as it takes advantage of some of the lowest yields ever for speculative-grade issuers.
After strong recent earnings results, the company is using the momentum to refinance a high coupon and push out maturities.
Community is selling a $1.8 billion high-yield bond maturing in 2029 and announced a related tender offer Tuesday…
Community Health was once known as one of the most distressed companies in the healthcare sector. But the firm has been selling hospitals to raise cash and refinancing debt to improve its balance sheet. In recent months, the bonds have risen after it posted better-than-expected earnings in the second and third quarters.
The company is rated in the riskiest tier of junk debt, CCC+ by S&P Global Ratings and CCC by Fitch Ratings. Moody’s Investors Service upgraded the company by one notch to Caa2 on Tuesday and viewed the new transaction as a credit positive event.”