DCMedical News: Thursday, May 13, 2021
DCMedical News-DCMN
Washington, D.C.
Thursday, May 13, 2021
DCMedical News is published every day both the House and the Senate are scheduled to be in session. Subscription information and archives from 2018 to the present at dcmedicalnews.org, here.
THE BIG STORY IN HEALTH CARE
Drug Target: Prices or Affordability?
Democratic legislators in a letter (here) to Speaker Pelosi argue that affordability, not price control, should be the aim of bipartisan drug legislation. Separately, some of the same lawmakers have argued that QALYs (quality of life years) is the wrong metric, ignoring the disabled and those older patients without many years left. They wrote, “Health legislation that Congress pursues should make patient affordability the number one goal, whether it’s the cost of premiums and co-pays, price of medicines, or expense of care.”
DOCTORS, NURSES AND OTHER HEALTH PROFESSIONALS
Primary Care Still a Stepchild in Federal Policy
Commentary on a new report on primary care from the National Academies of Sciences, Engineering and Medicine (in JAMA, here) notes that “Twenty-seven years ago, the Institute of Medicine launched a primary care consensus study that, at the time, seemed highly aligned with the country’s appetite for health reform and managed care. Primary Care: America’s Health in a New Era produced a primary care definition still used around the world; however, the report’s recommendations received no traction in the US. Similarly, a 2012 Institute of Medicine report on the integration of primary care and public health largely went unheeded. While primary care is uniquely positioned to support COVID-19 testing, tracing, and vaccination and to help address pervasive health and social inequities, primary care was not considered in congressional relief packages in 2020 and many practices may be closed when they are needed most.
A new consensus report by the National Academies of Sciences, Engineering, and Medicine emphasizes that while primary care in the US provides more than one-third of all health care visits and more than half of all outpatient visits, it receives a relatively small proportion of resources, has no federal coordinating capacity, has no dedicated research support, has a declining workforce pipeline, and remains inaccessible to large portions of the population.”
HOSPITALS, NURSING HOMES AND OTHER HEALTH CARE FACILITIES
June 30 Deadline for Pandemic Provider Relief Fund Distribution May be Extended
$33 billion remains unspent in the fund, which, if not spent by June 30, will be returned to the federal government. HHS Secretary Becerra told the Energy & Commerce Committee “We'll be driven by facts in this case to make sure providers who have a need get those needs addressed."
The Emergency Department in HCUP Studies
The Hospital Cost and Utilization Project has reported (here) on the cost of and payment for ED visits in 2017. The results: “Emergency department (ED) visits have grown in the United States, with the rate of increase from 1996 to 2013 exceeding that for hospital inpatient care. In 2017, 13.3 percent of the U.S. population incurred at least one expense for an ED visit. Furthermore, more than 50 percent of hospital inpatient stays in 2017 included evidence of ED services prior to admission. There were 144.8 million total emergency department (ED) visits in 2017 with aggregate ED costs totaling $76.3 billion. Aggregate ED costs were higher for females ($42.6B, 56 percent) than males ($33.7B, 44 percent); 55 percent of total ED visits were for females. Average cost per ED visit increased with age, from $290 for patients aged 17 years and younger to $690 for patients aged 65 years and older. As community-level income increased, shares of aggregate ED costs decreased and average cost per visit increased. In rural areas, one half of ED visit costs were for patients from the lowest income communities. The expected payer with the largest share of aggregate costs was private insurance in large metropolitan areas (31.4 percent of $39.5B) and Medicare in micropolitan (34.0 percent of $7.6B) and rural (37.3 percent of $5.5B) areas. Patients aged 18–44 years represented the largest share of aggregate ED costs in large metropolitan, small metropolitan, and micropolitan areas (36.4, 34.2, 32.5 percent, respectively). Patients aged 65 years and older represented the largest share of aggregate ED costs in rural areas (32.5 percent).” Cost were determined by applying respective cost to charge ratios to charges.
Earlier HCUP studies of the ED focused on ED visits from influenza (here); the impact of hurricanes on ED visits (here); ED visits due to injuries (here); ED visits due to suicide ideation or attempt (up) 2008-2017 (here); ED visits for opioid use disorder by county (here); opioid inpatient stays and ED visits among older patients (here); opioid inpatient stays and ED visits 2010 and 2015 by state (here); and ED visits by age and payer 2006-2015 (here).
Thirty-two hospitals in nine “red” states (not expanding Medicaid) have sued HHS to obtain more DHS (Disproportionate Hospital Share) payments, on grounds that patients who “would be eligible” for Medicaid in those states (had the states expanded Medicaid) should be counted, increasing DSH to the hospitals.
MEDICARE, MEDICAID AND COMMERCIAL HEALTH INSURANCE
Commercial Health Insurers Forecast Higher Profits, and Higher Utilization
Healthcare Dive reported (here) that “Almost all major payers hiked their full-year guidance following a strong first quarter . . . signaling widespread optimism despite ongoing uncertainty due to the COVID-19 pandemic. Payer executives said patient demand for care was generally back to normal levels or almost nearly there in the first quarter . . . UnitedHealth, parent company of the biggest private payer in the country, reported the largest profit in the quarter with $4.9 billion, up almost 44% year over year . . . Centene boasted the biggest year-over-year profit jump. The St. Louis-based insurer brought in net income of $699 million, more than 15 times its earnings compared with the same time last year. Centene . . . benefited from acute growth in Medicare and Medicaid membership and in the Affordable Care Act exchanges, as the COVID-19 recession caused some millions to lose job-based insurance last year.”
The Healthcare Dive also found (here) that “Healthcare lost about 4,000 jobs overall in April, an unwelcome sign as the economy continues recovering from the COVID-19 pandemic, according to new data from the Bureau of Labor Statistics. Nursing home losses (-19,000) were offset by notable gains (+21,000) in ambulatory service jobs. In March, healthcare employment changed little. The industry is still down 542,000 jobs since February 2020.”
DRUGS & DEVICES
510(k) FDA Clearance for Medical Devices and the Transvaginal Mesh Mess
A commentary (here) in JAMA Surgery puts focus on the 510(k) FDA medical device approval process and the tens of thousands of tort claims by women who have experienced vaginal bleeding, pelvic pain and infection, already resulting in billions of dollars in settlements. “501(k)” refers to a process through which the majority of FDA-reviewed medical devices enter the market; the 1976 Medical Device Amendment’s 510(k) pathway does not require new safety or effectiveness data. “The higher cost of a premarket approval review (estimated at $870 000 compared with $18 200 per 510(k) review in 2005) largely explains why the 510(k) has become the primary premarket review pathway used by manufacturers to secure FDA clearance. The 510(k) pathway’s lower costs are achieved by using a predicate-based review system as a proxy for directly evaluating safety and effectiveness. Manufacturers must demonstrate that a new device is equivalent both technologically and in intended use to a previously cleared device, known as the predicate. Iterative clearances since 1976 have resulted in complex networks of predicate ancestries that serve as the foundation for modern devices.”
The authors add, “Boston Scientific recalled ProteGen in 1999 owing to high rates of complications, but manufacturers continued using ProteGen as the predicate to gain clearance for multiple other devices. The FDA has cleared more than 100 meshes that either used ProteGen as a direct predicate or are the descendants of other devices that did.” Another famous 510(k) approval is robotically assisted surgical tools.
READINGS & REFERENCES
Select Coronavirus Public Health Resources and References (alphabetical) may be found here.
2021 CQ Congressional Calendar here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
May 14, 17, 18, 19, 20
June 14, 15, 16, 17, 22, 23, 24, 25
July 19, 20, 21, 22, 26, 27, 28, 29, 30
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com.