DCMedical News: Thursday, June 27, 2019
DCMedical News-DCMN
Washington, D.C.
Thursday, June 27, 2019
DCMedical News is published every day both the House and the Senate are in session. Congress is in recess beginning tomorrow, returning July 9, when DCMN will also return. Subscription information below.
THE BIG STORY IN HEALTH CARE
Democratic Candidates Debate
Health and health insurance were subjects for lively debate at the first of two televised, live debates among Democratic candidates for President Wednesday night. Of the ten candidates present, only Mayor de Blasio and Senator Warren raised their hands to signify that they would support elimination of private health insurance and support Medicare-for-All. All of the candidates appear to support universal access, some specifically mentioning public options to supplement private health insurance. Former Maryland Congressman John Delaney noted that America’s hospitals (as currently run) would go broke with only Medicare-level payment for services. Other aspects of health and health insurance were mentioned—Senator Klobuchar noting that President Trump’s promise of “head spinning” reductions in the price of drugs was “all foam, no beer.”
DOCTORS, NURSES AND OTHER HEALTH PROFESSIONALS
One Quarter of U.S. Diabetics Ration Insulin
STAT+ reports (here) “18% of people who have diabetes around the world rationed their insulin at least once last year, but this occurred among nearly 26% of people with diabetes in the U.S. . . By contrast, rationing was reported among just 6.5% of people with diabetes in other high-income countries and almost 11% of those living in low or middle-income countries.”
The report adds that “More than 29 million Americans, or 9.3 percent of the U.S. population, have some form of diabetes, according to the Centers for Disease Control and Prevention. Meanwhile, the average list price for insulin nearly tripled between 2002 and 2013, according to the American Diabetes Association. Fifteen years ago, for instance, a patient with diabetes might have paid $175.57 for a 20-milliliter vial of the long-acting insulin Humulin R U-500. Today, that medicine would cost $1,487.”
HOSPITALS, NURSING HOMES AND OTHER HEALTH CARE FACILITIES
Hospital Profits Denounced by Center for American Progress (CAP)
CAP issued a report (here) which noted that “Hospital profitability has risen to its highest levels in decades, boosted by the nation’s rebound from the Great Recession and the Affordable Care Act’s expansion of health coverage. A common measure of hospital profitability is the total margin, which is the difference between revenues and expenses relative to revenues, considering all the hospital’s business activity. As of 2016, the total margin across the hospital industry was 7.8 percent. The industry’s operating margin—which measures the expenses and revenues that are directly associated with patient care—was 6.7 percent.” By way of comparison, CAP found that “Hospitals rank well above health insurers, pharmacies, and pharmacy benefit managers, though hospital margins are still below profit estimates for the medical device and drug manufacturing industry,” the latter at 12%, and of course pharmaceutical manufacturers, at 26%.
Results of Readmissions Reduction Questioned, Again
A study published this week (here) finds that “Random chance or luck rather than improvement in quality of care appears to be the primary driver of improvements in readmissions experienced at hospitals initially classified as below-mean performers under the HRRP” [Hospital Readmissions Reduction Program]. But David Cutler, in the same edition of JAMA Internal Medicine, finds that “Taken together, the best evidence seems to suggest that the HRRP likely had a small, favorable effect on readmission rates.”
DRUGS AND DEVICES
Bad News Will Find You
The Food and Drug Administration this week (here) unveiled two decades’ worth of reports detailing adverse events involving medical devices. Some six million such reports dating from 1997 had been sequestered in the “Alternative Summary Reporting (ASR) Program,” not included in the publicly available database known as the Manufacturer and User Facility Device Experience (MAUDE). “By law, manufacturers may request exemptions, variances or alternatives to reporting requirements under 21 CFR 803.19. Under this provision, the FDA has allowed alternative summary reports (ASRs) for specific well-known and well-characterized events associated with specific devices.” Also not previously included in MAUDE were reports received through CDRH's legacy Device Experience Network (DEN) reporting system from 1984 – 1996. Now the reports are provided on this page, at https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files.
The Minneapolis StarTribune reported (here) that “The Star Tribune first wrote about the program in 2016 (http://www.startribune.com/infuse) after Medtronic, which is run from offices in Fridley, disclosed that it had filed more than 1,000 reports of patient harm associated with the use of its Infuse bone-growth product as summaries instead of individual reports.”
The Regulatory Affairs Professionals Society noted (here) that the FDA cautioned data in ASR reports cannot be used to determine “rates of adverse events due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.”
READINGS AND REFERENCES
Medical Cost Trends for 2020, by PwC, here.
U.S. House of Representatives:
Members at https://www.house.gov/representatives.
Committees and Members at https://www.house.gov/committees.
U. S. Senate:
Members at https://www.senate.gov/general/contact_information/senators_cfm.cfm.
Committees and Members at https://www.senate.gov/committees/membership_assignments.htm.
House and Senate 2019 Calendar of Regularly Scheduled Sessions, here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
July publication dates: 9, 10, 11, 12, 15, 16, 17, 18, 23, 24, 25, 26
August publications dates: None
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com.