About healthcare devices
Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”: “This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. This rule also implements regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.
DATES: This final rule is effective on March 15, 2021.”
About healthcare systems
Tenet aims to acquire 25 to 40 surgical centers in 2021 as pivot away from urgent care continues: “Tenet Healthcare plans to spend $150 million to acquire between 25 to 40 ambulatory surgery centers in 2021 as the hospital system continues its pivot to more higher acuity facilities and away from urgent care.”
Very interesting move, considering elective surgery volumes have been down the past year due to COVID-19 concerns. Does this action also signal health systems’ cooling to physician practice acquisition?
Aspirus Health to buy Ascension hospitals, clinics in Wisconsin – Modern Healthcare: ”Ascension will divest seven hospitals, 21 doctor clinics and a medical transport firm in northern and central Wisconsin. Ascension owns 24 hospital campuses and greater than 100 healthcare services throughout the state.
Wausau, Wis.-based Aspirus employs 8,700 staff at 10 hospitals in Michigan’s Higher Peninsula and Wisconsin.”
8 health systems opening hospitals: The article details which systems are opening hospitals. What is interesting is that they have gone ahead with those openings in the face of declining use due to COVID-19.
Cleveland Clinic CEO and President Tom Mihaljevic, M.D., Announces New Mission Statement in State of the Clinic Address: “‘Our mission has served the community for generations, yet our role has evolved with the passage of time,’ Dr. Mihaljevic said in a virtual address to Cleveland Clinic caregivers worldwide. ‘As stewards of this organization, we carry out the will of our founders to reach for higher and nobler ends. So today, I am privileged to unveil our new mission statement for the next 100 years. “Caring for life, researching for health and educating those who serve.[emphasis added]” It stays true to our past, encompasses the present and outlines the future.’”
The announcement highlights the fact that a mission statement is a “living” document that needs to be periodically reevaluated.
About the public’s health
US has suffered its worst day ever for Covid-19 deaths: “The US reported its highest daily number of Covid-19 deaths on Tuesday with more than 4,320 fatalities attributed to the virus.
It marked the second time -- both this month and since the pandemic's start -- that the US reported more than 4,000 Covid-19 deaths in a single day.
Over the past week, the US has averaged more than 3,300 deaths every day, a jump of more than 217% from mid-November.” Despite these numbers: As pandemic worsens, most US states resist restrictions: “As the U.S. goes through the most lethal phase of the coronavirus outbreak yet, governors and local officials in hard-hit parts of the country are showing little willingness to impose any new restrictions on businesses to stop the spread.” The article gives examples of restriction avoidance.
The 10 most under-reported humanitarian crises of 2020: It is important to remember other public health problems in the age of the COVID-19 pandemic. These problems will remain after widespread vaccinations.
Justices say women must obtain abortion pill in person: “The Supreme Court ordered Tuesday that women must visit a doctor’s office, hospital or clinic in person to obtain an abortion pill during the COVID-19 pandemic, though similar rules for other drugs have been suspended during the public health emergency.” The vote was as expected. No opinion was written but the Chief Justice deferred to FDA “experts” on this issue. However, these “expert” opinions may be politically motivated. The Biden administration can reverse the requirement (and probably will).
Cancer Statistics, 2021: This annual report (from the American Cancer Society) is the best information on cancer statistics. Among the overall findings: “After increasing for most of the 20th century, the cancer death rate has fallen continuously from its peak in 1991 through 2018, for a total decline of 31%, because of reductions in smoking and improvements in early detection and treatment. This translates to 3.2 million fewer cancer deaths than would have occurred if peak rates had persisted. Long‐term declines in mortality for the 4 leading cancers have halted for prostate cancer and slowed for breast and colorectal cancers, but accelerated for lung cancer, which accounted for almost one‐half of the total mortality decline from 2014 to 2018.”
Accelerometer measured physical activity [PA] and the incidence of cardiovascular disease: Evidence from the UK Biobank cohort study: “In this study, we found no evidence of a threshold for the inverse association between objectively measured moderate, vigorous, and total PA with CVD. Our findings suggest that PA is not only associated with lower risk for of CVD, but the greatest benefit is seen for those who are active at the highest level.[emphasis added]”
Innovative biopharmaceutical industry comment on COVID-19 vaccines dosing strategies and recommend following the science: Acknowledging the uncontrolled pandemic and relative vaccine shortage, a number of industry organizations are warning that spacing of vaccine administration should follow the scientific data.
Youth Vaping Triples Odds for Adult Smoking: “A new study finds that teens who start vaping are three times more likely to smoke cigarettes in adulthood than those who never started with electronic cigarettes.
Although the number of teens who start smoking cigarettes in high school has declined, vaping has soared. From 2016 to 2019, the number of cigarette smokers among U.S. high school seniors dropped from 28% to 22%, but e-cigarette use increased from 39% to 46%, the researchers found.”
Scientists develop breakthrough COVID-19 antibody test: “Scientists at the University of Denver's (DU) Knoebel Institute for Healthy Aging, in collaboration with two other research entities, have developed and tested a new and highly sensitive antibody test for COVID-19 that is so accurate, it can predict if a patient will experience ‘mild’ COVID symptoms verses more ‘severe’ symptoms.
The test has received an Emergency Use Authorization from the U.S. Food & Drug Administration (FDA).”
A COVID-19 treatment candidate that fuses tiny antibodies from llamas and alpacas shows promise: “By fusing two nanobodies selected from a llama and an alpaca that were immunized with SARS-CoV-2—the novel coronavirus behind COVID-19—the researchers were able to synthesize nanobodies that can simultaneously attack multiple sites of the virus’s spike protein, according to a new study published in Science. The tiny antibodies also fought mutated variants of the virus, the team showed in lab dishes.
A company called Dioscure Therapeutics has spun off from the University of Bonn with plans to bring its lead COVID-19 candidates, DIOS-202 and DIOS-203, into clinical trials this year.”
Hospitals to Report Covid-19 Vaccination Data: “The Health and Human Services Department will start collecting hospital data on how many health-care personnel and patients have gotten Covid-19 vaccines amid a faltering national push to widely and quickly immunize the public.
The agency on Tuesday unveiled the change that asks hospitals to report once a week on progress immunizing health-care personnel and patients. Data won’t initially be made public for individual hospitals, according to senior HHS officials. HHS expects to make the data public after verifying its quality, they said.”
US to require negative Covid-19 test for international air travellers: “The Centers for Disease Control and Prevention will require the test result from January 26. After landing, the CDC recommends travellers take a test three to five days later and remain at home for seven days. Airlines will have to deny boarding to visitors who do not have a negative test result from the previous three days — or documentation that proves they have recovered from the disease.”
Two articles about the efficacy of vaccines:
Chinese vaccine efficacy lower than originally thought in Brazil trials: “Brazilian health officials say a Chinese coronavirus vaccine has demonstrated an overall efficacy rate of 50 per cent, far lower than originally indicated in a blow to one of the Latin American nation’s hopes for defeating the pandemic.”
Australian scientists cast doubt on Oxford/AstraZeneca vaccine: “A group of Australian scientists has called on the government to review its Covid-19 immunisation strategy over concerns that the Oxford/AstraZeneca vaccine was not effective enough to generate herd immunity.”
Johnson & Johnson Expects Vaccine Results Soon but Lags in Production: “Johnson & Johnson expects to release critical results from its Covid-19 vaccine trial in as little as two weeks — a potential boon in the effort to protect Americans from the coronavirus — but most likely won’t be able to provide as many doses this spring as it promised the federal government because of unanticipated manufacturing delays…
Unlike those products, which require two doses, Johnson & Johnson’s could need just one, greatly simplifying logistics for local health departments and clinics struggling to get shots in arms. What’s more, its vaccine can stay stable in a refrigerator for months, whereas the others have to be frozen.”
Operation Warp Speed chief resigns at Biden team’s request, will stay through transition, sources say: “Operation Warp Speed chief advisor Dr. Moncef Slaoui has submitted his resignation at the request of the incoming Biden team under a plan that would see him stay in the role for a month to help with the transition, according to two people familiar with the situation.”
In 'nasty parting shot,' HHS finalizes rule axing LGBTQ nondiscrimination protections:”With little more than a week left to the Trump administration, the Department of Health and Human Services has finalized a rule permitting social-service providers that receive government funds to discriminate based on sexual orientation and gender identity.”
Another policy that a Biden administration will reverse.
Moderna, Uber partner to support uptake of COVID-19 vaccines:”The two companies will work together initially to provide accessible, credible information on vaccine safety through Uber’s in-app messaging, the organizations announced Tuesday.
The two companies will also work with public health and other organizations to identify additional opportunities to support ongoing efforts to broaden access to COVID-19 vaccines.
Uber and Moderna said they are evaluating other options, including incorporating ride scheduling directly into the immunization appointment process, and possibly integrating with vaccine providers’ systems to text reminders and enable patients to book rides in advance of their first or second immunization appointments.”
Immunological characteristics govern the transition of COVID-19 to endemicity: “We are currently faced with the question of how the CoV-2 severity may change in the years ahead. Our analysis of immunological and epidemiological data on endemic human coronaviruses (HCoVs) shows that infection-blocking immunity wanes rapidly, but disease-reducing immunity is long-lived. Our model, incorporating these components of immunity, recapitulates both the current severity of CoV-2 and the benign nature of HCoVs, suggesting that once the endemic phase is reached and primary exposure is in childhood, CoV-2 may be no more virulent than the common cold. We predict a different outcome for an emergent coronavirus that causes severe disease in children. These results reinforce the importance of behavioral containment during pandemic vaccine rollout, while prompting us to evaluate scenarios for continuing vaccination in the endemic phase.”
About pharma
PCMA sues Trump administration over rebate rule:”The Pharmaceutical Care Management Association has filed suit against the Trump administration in an effort to block the recently finalized rebate rule…
In the complaint (PDF), PCMA warns that the rule would lead to higher premiums in Medicare Part D and reflects an ‘erratic and highly irregular administrative process’ in which the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) did not effectively coordinate.”
Health Canada approves Lundbeck's (Pr)VYEPTI (eptinezumab)--the first and only intravenous preventive treatment for migraine: This article is a reminder of the different time frames for drug approvals among countries; the FDA approved this drug last February.
GSK Strikes $224 Million Pact with Eligo for Acne Gene Therapy: “Eligo said its Eligobiotics technology can ‘precisely modify the composition of the skin’s microbiome to treat or reduce the risk of developing moderate-to-severe acne.’” This treatment is a new way to treat acne and should be watched.
New Bayer drugs will not bridge revenue gap, says pharma head: “Potential new blockbuster drugs from German pharma giant Bayer will not be enough to offset a fall in revenues when its two best-sellers go off patent, the group’s head of pharma has told the Financial Times.
Stefan Oelrich, who joined the company in 2018 from rival Sanofi, said Bayer would soon launch up to three new drugs with annual sales potential of €1bn. However, he acknowledged this would not compensate for the effects of the forthcoming patent expiry on both the blood thinner Xarelto and the eye treatment Eylea, which will start this year in stages globally, saying that this was ‘mathematically impossible.’”
About healthcare IT
Biogen teams up with Apple to see whether iPhones can spot cognitive decline: “The study will enroll adults young and old, using the devices to track subtle changes in a person’s movements and interactions that, over time, may add up and correlate with the earliest signs of cognitive impairment.”
Teladoc to pilot CGMs in Type 2 diabetes as Dexcom eyes new growth market: ”Teladoc Health will launch a pilot demonstration of Dexcom’s wearable, continuous glucose monitoring systems in patients with Type 2 diabetes—picking up the torch from the devicemaker’s partnership with Livongo following its $18.5 billion acquisition last year.
The project will start by supplying the blood sugar sensors at no cost to certain members of Teladoc and Livongo’s diabetes program before expanding the pilot’s reach throughout the course of the year.
The goal is to improve outcomes and healthy glucose levels among people with Type 2 diabetes, by providing them with the same real-time recommendations for lifestyle decisions, visual data and personal trends offered to people with Type 1 diabetes.”
Evaluation of Internet-Based Crowdsourced Fundraising to Cover Health Care Costs in the United States: “From May 2010 through December 2018, more than $10 billion was sought through online medical fundraisers in the US, with more than $3 billion raised. Cancer represented the most common medical condition for which funding was sought, followed by trauma/injury.”
AdventHealth meets CMS quality metrics, saves money with digital health platform: “Through the app, enrolled patients received regular reminders to complete their medication check-ins, submitted photos of themselves taking their medications and received personalized bonus incentives in the form of messages of encouragement from family and friends.”
The “pilot saw a 57% reduction in readmissions for high-risk patients, taking their readmissions from 19% to 8%, ultimately saving the health system $183,000 in care costs.”
Cerner wants to build a $1B data business as it expands reach into pharma market: “Building on its acquisition of clinical research company Kantar Health, health IT giant Cerner is setting its sights on building a $1 billion data business for the healthcare and life sciences industries.
Cerner announced plans in December to acquire the health division of Kantar Group, which provides data, analytics and research to the life sciences industry, for $375 million.
The company is looking to create a leading data insights and clinical research platform and wants to harness data to improve the safety, efficiency, and efficacy of clinical research across life sciences, pharmaceuticals, and health care at large.”
Trump administration to invest $8M in broadband for rural telehealth access: “The Health Resources and Services Administration (HRSA), part of the Department of Health and Human Services, awarded the funding to the Telehealth Broadband Pilot (TBP) program. That program will assess the broadband capacity available to rural health care providers and patient communities to improve their access to telehealth services.”
athenahealth and Humana Collaborate to Improve Healthcare Outcomes for its Members: “The collaboration utilizes intelligence from Humana to empower providers to proactively address patient needs within the native EHR workflows – facilitating care management discussions between providers and patients, making it easier for providers to transition to value-based care programs, and supporting quality program performance goals such as Medicare Advantage Star Ratings…
By marrying patients’ medical records with insights from their health plan data, athenahealth and Humana will integrate supplemental and clinical data in real time to give providers the necessary insights to spot potential time-sensitive gaps in patient care. For instance, patients with diabetes can become overwhelmed with numerous annual appointments including blood pressure screenings, blood sugar control tests, eye exams, and medication reviews. Automatic appointment alerts generated by Humana’s data can help providers stay on top of diabetes management – thereby improving diabetic patients’ healthcare experiences and closing care gaps.”
About health regulation
New rule makes it harder for HHS to penalize guidance violations: “HHS officials bolstered President Donald Trump's deregulation agenda on Tuesday, signing off on a rule that makes it more difficult for regulators to go after individuals and organizations for not following standards laid out in guidance documents. The rule effectively bans the department from penalizing individuals and organizations for noncompliance with a standard or practice if HHS only announced it in a guidance document. It also lays out a substantial process HHS must follow to carry out civil enforcement actions for potential violations. HHS said the rule is necessary to ensure fairness.”