DCMedical News: Tuesday, November 16, 2021
DCMedical News is published every day both the House and the Senate are scheduled to be in session.
THE BIG STORY Tuesday, November 16, 2021
Cancer Rates Down, But Not Uniformly, And At High Cost, in the 50-Year ‘War on Cancer’
A report in JAMA Oncology (here) recounts the half century since the ‘War on Cancer’ was declared in the National Cancer Act of 1971. Since passage of the Act, “The National Cancer Institute’s annual budget increased 25-fold, from $227 million in 1971 to $1 billion in 1980 and $6.01 billion in 2019, a total of $137.8 billion.”
Comparing cancer mortality in 2019 to that in 1971, the study found “The cancer mortality rate has reduced considerably since 1971 overall and for most cancer sites because of improvements in prevention, early detection, and treatment. Specifically, the decline in lung, oral cavity, and bladder cancers (table here) largely reflects reduction in smoking because of enhanced public awareness of health consequences, implementation of increased cigarette excise taxes, and comprehensive smoke-free laws. Adult smoking prevalence in the US has decreased from 42% in 1965 to 14% in 2018.” A news release from the American Cancer Society claims, “Mortality rates for all cancers combined dropped by 27 percent since 1971 and by 32 percent since 1991,” and “Mortality rates have dropped since 1971 for 12 of 15 investigated cancer sites, including by as much as 70 percent for cervical and stomach cancer.”
The report notes, however, that some rates increased after 1971, before subsequently declining. “For example, lung cancer mortality in 2019 was 44% lower than the peak rate in 1993, vs 13% lower than in 1971. Conversely, mortality was higher in 2019 than in 1971 for pancreas, esophagus, and brain cancers, despite a considerable decline from the peak rate for the latter 2 cancers. Overall cancer mortality was higher for 845 of 2930 (29%) counties, mostly in the South (map here).”
Drug Prices in the Spotlight
Especially the cost to the Medicare program, and the impact of anticipate drug costs (for Aduhelm) on the recently announced Part B Medicare premium for 2022 (see DCMN 11-15-2021, here). STAT+ reports (here) that “The high cost of the Alzheimer’s drug from Biogen is a key reason that standard monthly premiums for Medicare Part B beneficiaries will increase $21.60 in 2022, the largest annual rate hike — in dollar terms — ever for the Part B program. And the higher premium works out to a 14.5% annual boost, which is the third-largest increase in percentage terms.” In other action, CMS (memo here) has lowered the price for drugs found by the HHS Office of the Inspector General (report here) to have had average sales prices (ASPs) 5% greater than the average manufacturer prices (AMPs); CMS then sets the price it will pay for those drugs at the lesser of either the widely available market price or 103 percent of the AMP. CMS began making such substitutes in April of 2013. “OIG found that in the second quarter of 2021, 7 drug codes met CMS’s price-substitution criteria by exceeding the 5-percent threshold for 2 consecutive quarters or 3 of the previous 4 quarters, based on complete AMP data.”
A study in JAMA Internal Medicine (here) examines drug price reimbursement at “top performing” hospitals, revealing large variability in the charges by those hospitals to commercial insurers. Background: “Nearly one-third of pharmaceutical spending in the US is for clinician-administered drugs (e.g., infusions). Medicare Part B reimbursement for these drugs is set at the average sales price (ASP)—the average price charged by manufacturers to wholesalers net of any rebates or discounts—plus a 6% markup (or 4.3% during budget sequestration). By contrast, hospitals and physician offices charge commercial insurers whatever price they negotiate, and they retain any difference between the negotiated price and cost of acquisition.”
“While these negotiated prices have long been confidential, a transparency rule that took effect on January 1, 2021 requires hospitals to post payer-specific negotiated prices for all items and services, including clinician-administered drugs. We analyzed a set of top-performing hospitals to quantify drug pricing variation across insurers.” Results: “Prices varied between and within hospitals. Median negotiated prices for the 10 drugs in the study sample ranged from 169% of the Medicare payment limit at Rush University Medical Center to 344% at the Mayo Clinic Hospital–Arizona, and median self-pay cash prices ranged from 149% of the Medicare payment limit at Rush to 306% at Brigham and Women’s Hospital and Massachusetts General Hospital. There was also substantial variation by drug, with the lowest median negotiated prices relative to the Medicare payment limit observed for abatacept and the highest median negotiated prices observed for infliximab.” Of incidental interest, 82% of the hospitals examined were 340B participants, a program begun in 1992 to provide a subsidy (buy low from the manufacturer, sell high to the third party) to “safety net” hospitals.
Vaccine Design Issue Continues for Merck
Bloomberg Health Law reports (here) that Merck’s Zostavax shingles vaccine (made with a live but attenuated virus) is facing 2,200 cases in a federal multidistrict proceeding in which the plaintiffs allege that “Merck & Co.'s Zostavax shingles vaccine caused the disease rather than prevented it.” Judge Harvey Bartle III has ruled that the cases “may proceed with claims that the company should have sought approval for a safer design . . . The plaintiffs say Merck should have originally submitted a safer vaccine for approval—one without a live virus, such as GlaxoSmithKline’s Shingrix vaccine, which was approved in 2017.”
The Bloomberg report notes that “Federal drug law preempts state-law claims if it would be impossible for the drugmaker to fulfill both state and federal obligations. A defendant must show by clear evidence that the FDA would have rejected the plaintiff’s proposed design to prevail on a preemption defense. Here, the plaintiffs allege that Merck could have designed Zostavax in compliance with state-law duties before FDA approval. They didn’t raise claims based on Merck’s actions after FDA approval.”
HOSPITALS AND OTHER HEALTH CARE FACILITIES
MedPAC Resumes Consideration of “Flattening” Site of Service Differentials
MedPage Today reports (here) that the November MedPAC meeting included consideration of minimizing the difference between payment rates by Medicare for the same service in different locations, especially comparing physician office rates to hospital outpatient department (HOPD) rates. Physicians have largely favored such actions, believing that CMS will increase their reimbursement to match that of rates paid to HOPDs. However, the staff presentation and exercise for MedPAC members shows that the likely change is in the other direction, that is, lowering HOPD rates to match those paid to physicians. Senior analyst for MedPAC Daniel Zabinski explained, “Because hospital outpatient departments often get paid at higher rates for the same service compared to physician offices, hospitals will buy up physician practices and then make money by receiving those higher rates. Possibly as a result, the share of office visits, cardiac imaging, echocardiology, and chemotherapy administration performed in HOPDs has greatly increased, while the proportion performed in physician offices has decreased . . . For example, 13.1%of physician office visits were in HOPDs in 2019, compared with 9.6% in 2012; for chemotherapy administration, 50.9% of Medicare visits for that service were in HOPDs in 2019, compared with 35.2% in 2012.”
READINGS & REFERENCES
Select Coronavirus Public Health Resources and References may be found here.
2021 CQ Congressional Calendar here.
Leading Causes of Death in the U.S. in 2020
JAMA report here, table here.
Annual U.S. Preventive Services Task Force Report to Congress
Report, here. Introduction, history and purpose here: “The U.S. Preventive Services Task Force is an independent, volunteer group of national experts in prevention, primary care, and evidence-based medicine. Since its inception in 1984, the Task Force has made evidence-based recommendations about clinical preventive services to improve the health of people nationwide (e.g., by improving quality of life and prolonging life). These recommendations include screening tests, behavioral counseling, and preventive medications. The purpose of this report is to update the U.S. Congress and the research community about high-priority evidence gaps in clinical preventive services identified by the Task Force from fiscal year 2021 (October 1, 2020, to September 30, 2021).”
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
November 17, 18, 30
December 1, 2, 3, 6, 7, 8, 9, 10
Notes to Fred Hyde, MD, JD, MBA, news@dcmedicalnews.org