DCMedical News: Tuesday, December 7, 2021
DCMedical News is published every day both the House and the Senate are scheduled to be in session.
THE BIG STORY Tuesday, December 7, 2021
Cleaning Up by Christmas, But the Debt Ceiling Comes First
Senate Majority Leader Schumer has put forward a schedule (“Dear Colleague” letter, here) calling for “clean up” of House-passed bills, pending resolutions and undone 2021 business, especially the social and climate infrastructure bill, by Christmas.
Physicians, hospitals and health industry manufacturers continue to appeal through favorably-disposed Members of Congress (e.g., here) for “fixes” to Medicare cutbacks coming January 1. Eighteen Members most recently decried “The expiration of a 3.75% payment adjustment to the Medicare Physician Fee Schedule Conversion Factor, a 2% cut to providers as a result of sequestration, and a 4% cut due to Statutory Pay-As-You-Go (PAYGO) being triggered. Additionally, we need to reverse looming cuts to radiation oncologists set to take effect under the Radiation Oncology Alternative Payment Model.”
The Hill reports (here) that Schumer didn't specify in his letter when he would bring the spending bill to the floor, but reiterated that it is Democrats’ goal to pass the spending bill by Christmas . . .House Majority Leader Steny Hoyer (D-Md.) argued Monday that Congress must raise the debt ceiling by mid-month or risk an economy-gutting government default.”
DOCTORS, NURSES AND OTHER HEALTH PROFESSIONALS
“Less is More”: Is It Better Over Time?
A study (here) and editorial (here) in this week’s JAMA Internal Medicine examines the long term outcome of advising patients against “low value” care. (“Low-value care is broadly defined as services that are of limited to no benefit to patients, may cause patients harm, and lead to waste of health care resources.”) Some 626 “Choosing Wisely” recommendations from physician specialty societies were examined. Early criticism of the campaign focused on the extent to which physicians avoided recommending against high revenue services in their own specialty. In the study here, imaging and laboratory studies represent half of the group of 626. “Most of the identified low-value services were revenue neutral for the recommending society and the plurality were low cost . . . 44.7% of recommendations identified services with high direct harm potential, and 388 (62.0%) identified those with high potential for cascades (i.e., triggering downstream services).”
The editorial on low value care discusses tactics for implementation. “A randomized clinical trial of changes to the electronic health record system to withdraw low-value tests from the quick shortcut ordering menu and adding US Preventive Services Task Force grading recommendations for testing at the point of care showed substantial reduction in unnecessary ordering practices.” Less successful were education, clinical decision support, audits and feedback.
Low value care was found to be surprisingly common, with wide variation not easily explained. “The provision of low-value care is common among all physicians. In one study of more than 3 million patients cared for by more than 41,000 physicians, low-value services were provided to 33% of patients annually. There was wide variation in the rates of low-value care provided by different physicians, even within the same health system. This variation was not explained by easily measurable characteristics, such as age, sex, years of experience, academic degree, or panel size. Many factors contribute to the provision of low-value care, including time constraints, patient requests, fear of malpractice, and cultural and professional norms. There is also evidence that most physicians tend to underestimate harms and overestimate the benefits of care.”
HOSPITALS AND OTHER HEALTH CARE FACILITIES
ICUs Fill Up Across the Nation
Newsweek (here) reports that “Only five states have less than 70 percent of ICU beds in use, as of Monday morning. These states include, Connecticut, Hawaii, New Jersey, South Dakota and Wyoming. A map tracking ICU bed utilization across the U.S. shows that the rest of the U.S., except for those five states, have 70 percent or more ICU beds currently in use . . . Rhode Island and New Mexico currently have the highest percentage of ICU beds in use, with 92 percent and 90 percent, respectively. In addition to Rhode Island and New Mexico, at least six states have 85 percent or more ICU beds in use. These states include Kentucky (89 percent), Michigan (86 percent), Nebraska (89 percent), New Hampshire (86 percent), Texas (86 percent) and Vermont (85 percent) . . . at least nine states have 30 percent or more ICU beds in use for COVID-19 patients. New Mexico currently has the highest percentage with 45 percent, followed by New Hampshire with 42 percent.”
As of December 3, the U.S. was averaging around 106,132 new daily cases per week. In comparison, CDC data shows that in mid-October, the U.S. was averaging around 65,000 to 70,000 new daily cases per week.
DRUGS & DEVICES
Draft Guidance From the FDA Points to Societal and Public Health Context of Drug Use as Factors in Regulatory Approvals
Peter Lurie and Joshua Sharfstein write in JAMA (here) that “FDA [has] proposed a draft guidance on benefit-risk assessment in the review of new drug and biological products. According to the draft guidance, ‘In certain circumstances, such as in the review of drugs to diagnose and treat communicable diseases or drugs identified as controlled substances, FDA’s benefit-risk assessment incorporates broader public health considerations for both the target patient population and others, such as risks related to misuse, accidental exposure, or disease transmission.’ This indicates that FDA intends to embrace the broader view of its authority in certain circumstances, a promising alignment of the tools of regulation with the agency’s mission to protect public health.”
The agency is responding in part, according to these authors, to the opioid epidemic: “By 2017, FDA leaders embraced the view that regulatory decisions had to reflect “not only the outcomes of prescription opioids when used as prescribed, but also the public health effects of inappropriate use.” That same year, FDA removed the opioid analgesic oxymorphone hydrochloride (Opana ER) from the market in part because of a shift in misuse of the product from intranasal administration to injection. The agency described its action as “the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.” The impact of the new guidance, however, would be felt far beyond opioids, and would include evaluation of antibiotics, vaccines, and in fact any FDA decisions which would incorporate public health into drug product marketing considerations.
Limits on Accelerated Approval May Not Be Financially Significant
“Policymakers looking to rein in Medicare spending should look beyond the lens of the accelerated approval pathway, as drugs that exclusively fall under this indication make up a small percentage of overall Medicare spending . . . Medicare is spending more and more each year on drugs approved through the accelerated approval pathway, up to $9.1 billion by 2019. However, most of that spending (87% over the study period) is on drugs that have other indications approved via the traditional approval pathway.” This according to Benjamin N. Rome, of the Program On Regulation, Therapeutics, And Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital, and colleagues in an interview (story here) with Regulatory Focus. [Italics added here and below.]
In a research letter, published in JAMA Health Forum on 3 December, “Rome and colleagues looked at 66 drugs (74% oncologic drugs) between 2015 and 2019 with an accelerated approval indication as well as Medicare Part B and Part D spending during the same timeframe . . . Between 2015 and 2019, Medicare Part D annual spending increased from $2.1 billion to $3.2 billion for accelerated approval drugs, while Part B annual spending during that time increased from $2.7 billion to $5.9 billion. However, drugs exclusive to the accelerated approval pathway saw decreased Part D annual spending from $0.7 billion to $0.4 billion between 2015 and 2019, and Part B spending decreased from $0.9 billion to $0.1 billion.”
READINGS & REFERENCES
Select Coronavirus Public Health Resources and References may be found here.
2021 CQ Congressional Calendar here.
2022 CQ House of Representatives Calendar here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
December 8, 9, 10
January 10, 11, 12, 13, 18, 19, 20, 21
February 1, 2, 3, 4, 7, 8, 9, 28
Notes to Fred Hyde, MD, JD, MBA, news@dcmedicalnews.org