DCMedical News: Friday, March 9, 2018
DCMedical News
Washington, D.C.
Friday, March 9, 2018
THE BIG STORY TODAY IN HEALTH CARE
The Omnibus Budget bill:
Objections to the use of federal funds for family planning appear difficult to overcome as the House continues to assemble its version of the FY2018-2019 $1.3 trillion Budget Omnibus bill, scheduled for consideration by the full House next Thursday. The current Continuing Resolution which funds federal government operations expires in 10 Congressional work days, March 23. The Labor-HHS-Education appropriations bill has $286 million for family planning in the Senate version, which also protects funding for Planned Parenthood; the House version zeroes this funding out and has a prohibition on any funding going to Planned Parenthood.
The new Budget study committee is considering changing the federal fiscal year to coincide with the calendar year, to avoid the succession of “Continuing Resolutions” in future budget years. (The federal fiscal year was last changed in 1974, from July 1 to October 1, for roughly the same reason: difficulty and delay in obtaining consensus on federal expenditures. The same change created OMB.)
DOCTORS, NURSES, HEALTH PROFESSIONALS
Questioning authority:
Healthcare Dive reports that among 43,500 professionals swarming Las Vegas to swap ideas on health IT strategy “An undercurrent throughout was the need for buy-in. Without it, from physicians or executives, the promises these tech tools offer are for naught.” CMS Administrator Verma (who attended with White House adviser Jared Kushner and a large group of CMS staff) reported that, for hospitals, “The days of finding creative ways to trap patients in your system must end.” Reporting on her effort to obtain her husband’s medical records during a medical episode “After the federal government has spent more than $30 billion on EHRs, I left with paper and a CD-ROM.”
Questioning authority, continued:
For a walk on the other side of medical orthodoxy, see the “Rebel.MD” attack on “Choosing Wisely” (here), the Skeptical Scalpel, ZDOGG, the National Board of Physicians and Surgeons, and the many blogs carried through physician-only sites Doximity and Sermo. Guidelines, best practices, clinical pathways and the payment policies which enforce them are often the target of this alternative universe of medical practice. In that universe--generally unknown to policy makers--the emphasis is on clinical practice, candor and opposition to rampant commercialism in health care, especially in academia.
HOSPITALS AND HEALTH CARE FACILITIES
Harvard’s Neel Shah writes in JAMA (here) on the emerging calamity facing women’s health services (childbirth) in rural areas. “Although it is difficult to imagine a health care service that is more valuable to society than childbirth, US hospitals often lose money when they provide local childbirth services for healthy mothers. This discrepancy is a major flaw in the design of the maternal health system that may be the basis for lagging birth outcomes in the United States compared with other high-income nations.”
HRSA’s Office of Rural Health Policy supported a study (here) of 5 million births in rural counties which found “loss of hospital-based obstetric services, compared with counties with continual services, was associated with increases in out-of-hospital and preterm births and births in hospitals without obstetric units in the following year.”
HEALTH INSURANCE, MEDICARE, MEDICAID, COMMERCIAL
CMS’ Verma found time to tell Idaho Governor Butch Otter that, no, he could not offer skinny health insurance plans, at least until federal law is changed, letter here. Maybe, she wrote, there will be something in a §1115 or §1332 waiver for Idaho. Letter is followed by a helpful chart, comparing the Idaho plan to PPACA requirements.
PHARMA
More questioning authority:
Researchers from Oregon H&SU and Memorial Sloan Kettering publish a study in the British Medical Journal (here) which examines National Comprehensive Cancer Network (NCCN) guidelines for anticancer drugs, compared to the “on-label” use of those drugs in accord with FDA approvals. The conclusion: the NCCN frequently makes recommendations which go beyond FDA approved indications, and the evidence for those NCCN recommendations is weak. “Our findings raise concern that the NCCN justifies the coverage of costly, toxic cancer drugs based on weak evidence.” This off-label use is $4.5 billion per year.
How did we get here? The authors explain:
“In 1993, as part of the Omnibus Budget Reconciliation Act, Congress mandated that CMS use three expert compendiums to determine coverage decisions for off-label drugs used in cancer care. In other words, CMS would reimburse for off-label use if the compendiums sanctioned that use. Over time, the number of compendiums has grown. As of 2016, there are now five: Wolters Kluwer Clinical Drug Information Lexi-Drugs, the American Hospital Formulary Service, Clinical Pharmacology, Micromedex DrugDex, and the National Comprehensive Cancer Network Drugs and Biologics accepted by the CMS. These compendiums are often used by commercial insurance providers for coverage decisions.”
The researchers note that systematic reviews of the quality of evidence used by NCCN was low, with 6% of the recommendations meeting the standards of, for example, the best peer-reviewed publications.
Is PBM a real business? Cigna thinks so, paying $96.03 a share for Express Scripts, a 30% premium, a total of $67 billion including assumed debt. Diversification and leverage, an unbeatable combination (today). Bad blood: Anthem, unable to buy Cigna (FTC), broke ties with Express Scripts last year, accusing the PBM of overcharging.
Opioids heading for litigation: judge handling 355 lawsuits issues an order (here) setting up conditions for trials, in the absence of a settlement.
And did The Joint Commission foment the opioid epidemic? KevinMD.com, a popular blog, reprints (here) from the Skeptical Scalpel : “In December 2001, the Joint Commission and the National Pharmaceutical Council (founded in 1953 and supported by the nation’s major research-based biopharmaceutical companies) combined to issue a 101-page monograph entitled ‘Pain: Current understanding of assessment, management, and treatments.’” Pain as a “fifth vital sign” is not stated specifically, says the author. “It also stresses that the patient, not clinician, is the authority on the pain and that his or her self-report is the most reliable indicator of pain.” Of course, HCAHPS didn’t help, surveys of patients to see how happy they were with their doctor. The Joint Commission’s defense is found here and here.
TECHNOLOGY
Jennifer Tharp of Squire Patton Boggs reports through the American Health Lawyers Association that the FDA has approved (news release here) the first clinical decision support software to analyze CT scans and notify physicians of a potential stroke in their patients. The decision may show acceptance of clinical decision support software using AI, at least for triage. Also of import: the approval pathway: “The FDA approved the platform through the de novo premarket review pathway. This risk-based process is intended for novel devices that have not yet been classified by the FDA and for which there is no legally marketed predicate device. If the FDA classifies the device as Class I or Class II, then it may be used as a predicate device for other 510(k) submissions.”
More: “The program attaches to a CT scanner, and when it finds a suspected large vessel occlusion (LVO) stroke, the program sends a notification to a specialist’s mobile device (though the image must still be viewed on a clinical workstation). To gain FDA approval, Viz.AI submitted results from a performance study with 300 patients. The study compared the system’s ability to analyze CT images for suspected LVO strokes against two trained neuro-radiologists. The platform demonstrated a 90% sensitivity rate at identifying suspected LVOs and had a median time between the scan and notification of a provider of six minutes. Within the study, such automatic notifications saved 52 minutes on average in the majority of cases.”
Allscripts and Lyft announced (at HIMSS) a joint venture which will enable a physician to dispatch transportation for a patient, even if the patient has no smartphone.
EVENTS & MEETINGS
Your March Calendar:
March 13
1:00 p.m., The Alliance of Community Health Plans (ACHP) holds a briefing on "The Value of
Medicare Advantage, rsvp to achpcommunications@achp.org, 2203 Rayburn Bldg.
March 14
2:00 p.m., Open Payments “National Provider Call.” Provider (physician and teaching hospitals especially) chances to review the “sunshine law payment” methodology, to be followed (April 1-May 15) by the dispute period. Publication of payments for 2017 takes place in June.
Info at openpayments@cms.hhs.gov or call 1-855-326-8366
March 15
10:00 a.m., Senate Health, Education, Labor and Pensions Committee (HELP), hearing on the
340B drug discount program, 430 Dirksen S.O.B.
March 16
11:00 a.m., AHRQ, National Advisory Council for Healthcare Research and Quality, by WebEx, information at https://www.ahrq.gov/news/events/nac/.
March 26
PTAC, Physician-Focused Payment Model Technical Advisory Committee, continuing March 27, information at www.regonline.com/PTACMeetingsRegistration or livestream at www.hhs.gov/live.
FOR REFERENCE
Members of the Senate (here) and Members of Senate Committees (here), Senate Calendar (here).
Members of the House with their House Committees (here), House Calendar (here).
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
DCMedical News is published every day that either the House of Representatives or the Senate is in session. Past issues can be accessed by clicking on “View this email in your browser.” Subscription information is found at the bottom of these pages. Trial subscriptions may end without notice.
March publication dates remaining: 12, 13, 14, 15, 16, 19, 20, 21, 22, 23.
April publication dates: 9, 10, 11, 12, 13, 16, 17, 18, 19, 20, 23, 24, 25, 26, 27
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com