About the public’s health
Pfizer and BioNTech will seek regulatory clearance of their coronavirus vaccine: Filing is expected today with vaccine availability in mid to late December.
SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis:”Mean duration of SARS-CoV-2 RNA shedding was 17·0 days… in upper respiratory tract, 14·6 days… in lower respiratory tract, 17·2 days… in stool, and 16·6 days… in serum samples. Maximum shedding duration was 83 days in the upper respiratory tract, 59 days in the lower respiratory tract, 126 days in stools, and 60 days in serum. Pooled mean SARS-CoV-2 shedding duration was positively associated with age... No study detected live virus beyond day 9 of illness, despite persistently high viral loads [emphasis added], which were inferred from cycle threshold values. SARS-CoV-2 viral load in the upper respiratory tract appeared to peak in the first week of illness, whereas that of SARS-CoV peaked at days 10–14 and that of MERS-CoV peaked at days 7–10.”
Nearly half of patients say they'd feel safest getting COVID-19 vaccine at doctor's office: survey: “When asked in the second annual ‘State of Patient Access and Engagement’ 2020 survey where consumers would feel safest receiving the COVID-19 vaccine, nearly half chose the doctor's office. The survey, conducted OnePoll and commissioned by DocASAP, a patient access platform, polled 1,000 U.S. adults who had visited a doctor in the last 12 months. It also found one in three respondents said they'd feel safest getting a vaccine at a hospital and 29% said they'd feel safest at a pharmacy.”
Tobacco Product Use Among Adults — United States, 2019: From the CDC: ”In 2019, approximately 20.8% of U.S. adults (50.6 million) currently used any tobacco product. Cigarettes were the most commonly used tobacco product among adults, and e-cigarettes were the most commonly used noncigarette tobacco product (4.5%). The highest prevalence of e-cigarette use was among smokers aged 18–24 years (9.3%), with over half (56.0%) of these young adults reporting that they had never smoked cigarettes…
18.6% reported using two or more tobacco products.”
The evidence doesn't support closing schools to stop the coronavirus: A good overview of this contentious issue. “The nation's top infectious disease expert, Anthony S. Fauci, said last night he too was a proponent of keeping schools open if at all feasible. ‘One of the things we need to do...is try to keep the kids in school,’ Fauci, director of the National Institute for Allergy and Infectious Diseases, told CNN yesterday. ‘My feeling is the default condition is to keep the schools open if you possibly can.’”
Primary Care & COVID-19: Week 22 Survey: Among the results from this survey:
“Patients’ overall health continues to suffer due to the pandemic. Over 85% of respondents report that the mental health of their patients has decreased during the pandemic, with 31% seeing a rise in patients suffering with addiction. Over a third (37%) say their patients with chronic conditions are in “noticeably worse health resulting from the pandemic.” This is due, in part, to visits that are not happening: 56% of surveyed clinicians have seen an increase in negative health burdens due to delayed or inaccessible care.”
AMA urges multifaceted approach to address social determinants of health: “At the Special Meeting of the American Medical Association (AMA) House of Delegates, physicians adopted policies…to address social determinants of health as part of health insurance coverage. The disproportionate impacts of the COVID-19 pandemic have highlighted the need to address nonmedical, yet critical, health needs and the underlying determinants of health — economic stability, neighborhoods, transportation, education and life opportunities, access to food, quality and safe housing, community/social support, and access to health care.”
About healthcare IT
The Sequoia Project Publish Person Matching Case Study with 99.5% Accuracy: “The Sequoia Project, a non-profit and trusted advocate for nationwide health information exchange, patient identity management experts collaborated with the Blue Cross Blue Shield Association to apply A Framework for Cross-Organizational Patient Identity Management for the payer community and develop person matching strategies. Today, The Sequoia Project published Person Matching for Greater Interoperability: A Case Study for Payers which demonstrates high matching accuracy rates, and provides actionable insights for improving person identity matching across the payer community, a critical component of successful health information exchange and interoperability.”
Comment: Identity confusion is a not uncommon error in healthcare. While great strides are being made to flawlessly identify patients, the standards do not come close to even acceptable manufacturing errors. At an error rate of 0.5%, assuming everyone in the US is subject to misidentification, the affected number would be about 16.4 million. The fundamental problem is we still do not have a universal patient identifier, a feature which was removed from the original HIPAA legislation.
About health insurance
CMS says 800K more have signed up for coverage on HealthCare.gov in 2nd week: “More than 800,000 additional people signed up for coverage on HealthCare.gov in the second week of open enrollment, according to new data from the Trump administration.
The Centers for Medicare & Medicaid Services (CMS) said Thursday that 803,741 enrolled in plans through HealthCare.gov between Nov. 8-14. Through two weeks, 1.6 million have enrolled in coverage.
That includes 170,284 new customers and 633,457 people renewing coverage in week two, CMS said.”
About pharma
Trump Administration Finalizes Proposal to Lower Drug Costs by Targeting Backdoor Rebates and Encouraging Direct Discounts to Patients: This final rule affects rebates from drug companies to Medicare Part D and PBMs. (See the article for an explanation for why the rule was put in place.) HHS allowed these rebates because there was a “safe-harbor” protection. This final rule eliminates the protection. Medicaid Managed Care Organizations will still have a “safe-harbor” protection on rebates.
Trump Administration Announces Prescription Drug Payment Model to Put American Patients First: From the HHS Fact sheet: “The Centers for Medicare & Medicaid Services (CMS) is announcing a new payment model, the Most Favored Nation (MFN) Model (or the ‘MFN Model’), and issuing a corresponding Interim Final Rule with Comment Period (IFC). The MFN Model will lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals (hereinafter called ‘drugs’) than the lowest price that drug manufacturers receive in other similar countries. The MFN Model will also pay providers a flat add-on amount for each dose of an MFN drug, instead of a percentage of each drug’s cost, removing the tie between drug cost and the add-on amount. Beneficiaries will pay lower coinsurance for these high-cost Part B drugs and will not pay coinsurance on the add-on payment. The MFN Model will require participation of Medicare providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs, with certain exceptions, and begin nationally January 1, 2021…
The MFN Model will test paying Part B drugs at comparable amounts to the lowest adjusted price paid by any country in the Organisation for Economic Co-operation and Development (OECD) that has a Gross Domestic Product (GDP) per capita that is at least 60 percent of the U.S. GDP per capita…
The mandatory MFN Model will operate for seven years, from January 1, 2021 to December 31, 2027.”
Comments: Go to this website to see the large number of countries that will be in the 60% bracket (start on the right and go to the left until you get to Estonia). Also, note this announcement is an Interim Final Rule open for comment.
Surprise Federal Drug Rule Directs Insurers to Reveal What They Pay for Prescription Drugs: “Health insurance companies will have to give their customers estimated out-of-pocket costs for prescription drugs and disclose to the public the negotiated prices they pay for drugs, under an unexpected new Trump administration rule.
The administration said those requirements, part of a broader rule issued Oct. 29 forcing health plans to disclose costs and payments for most health care services, will promote competition and empower consumers to make better medical decisions.
The new rule does not, however, apply to Medicare or Medicaid.
The drug price provisions, which would not begin until 2022, were a surprise because they were not included in the original proposed rule issued in 2019.”
A living WHO guideline on drugs for covid-19: These updates from the WHO are ongoing and published by BMJ. The update includes remdesivir (not recommended, weak evidence) and corticosteroids (recommended only for severe or critically ill patients). The evidence for these recommendations is included in tabs below the introductory graphic. In a related article: Eli Lilly arthritis drug gets FDA nod for emergency use with remdesivir to treat COVID-19:”The U.S. Food and Drug Administration on Thursday approved the emergency use of Eli Lilly and Co’s arthritis drug, baricitinib, in combination with Gilead Sciences Inc’s remdesivir, to treat COVID-19 patients. Baricitinib, sold under the brand name of Olumiant, is an FDA-approved oral medication to treat moderately-to-severely active rheumatoid arthritis.”
Are patients more adherent to newer drugs?: “This study has investigated the relationship between drug quality that we captured by a drug’s vintage as measure of productivity of treatment and medication adherence in the US working population. We demonstrate that patients tend to be more adherent to newer drugs. The medicine possession ratio increases by 2.5 percentage points when the mean vintage of a drug increases by ten years. This effect may appear small, but our estimates indicate that a 10-year increase in drug vintage has the same effect on medication adherence as a 0.35 USD reduction in copayment per day of therapy. Also, our estimates of vintage reflect averaged effects across all drugs of the same vintage, some of which may be more effective in terms of effectiveness than others.”
Comment: This article is likely to be used by the pharma industry to support its case for innovation expenses; but the results should be cautiously interpreted. After reading the article I could not find an answer to a concern I had about the methodology: Patients whose drugs do not work for their illness or who develop side effects will stop them and be classified as non-compliant. For these patients, newer drugs are likely to be used and, if they work, will appear as a higher level of compliance than the discontinued ones. The research is couched in economic theory with little medical input.