DCMedical News: Tuesday, September 21, 2021
DCMedical News-DCMN
Washington, D.C.
Tuesday, September 21, 2021
DCMedical News is published every day both the House and the Senate are scheduled to be in session.
THE BIG STORY
Traffic Jam in Congress
InsideHealthPolicy reports (here) that:
“Congressional Democrats and the White House are now expected to continue hammering out the details of the major health reforms and a drug-pricing payfor to be included in their partisan reconciliation package well into October, after leaders acknowledged . . . the potential $3.5 trillion reconciliation package won’t be ready in time for a Sept. 27 vote on the bipartisan infrastructure bill”;
“Congress also must vote on a short-term continuing resolution by Oct. 1 to prevent a government shutdown -- a bill Democrats on Monday (Sept. 20) said would be packaged with legislation to lift the debt ceiling limit”;
“After three centrist Democrats on House Energy & Commerce last week blocked Pelosi’s Medicare drug negotiation plan, House leaders’ other health priorities that were to be paid for by that policy are now hanging in the balance”;
House Ways & Means and Energy & Commerce passed their sections of the Democrats’ Build Back Better reconciliation package out of committee last week -- though the drug-pricing piece was voted down by E&C. Still, the other health reforms, including adding new Medicare benefits and closing the so-called Medicaid gap coverage [see below], moved further in the process.”
DOCTORS, NURSES AND OTHER HEALTH CARE PROFESSIONALS
Physician Practices as (Poor) Bill Collectors
David Cutler and colleagues writing in JAMA examine (here) “The Increasing Role of Physician Practices as Bill Collectors, Destined for Failure,” finding that “The result is a system with substantial administrative burden, frustrated patients struggling with confusing bills, and physicians receiving less compensation.”
PET Imaging to Expand Beyond Oncology
Radiology Business reports (here) that “The Centers for Medicare & Medicaid Services is dropping certain coverage restrictions around PET imaging outside of oncology . . . The noncoverage determination dates to 2000, when CMS enacted broad, national restrictions for using positron emission tomography scans outside of cancer care. This forced providers to seek coverage determinations for each individual indication beyond oncology. Under the recently released 2022 Medicare Physician Fee Schedule, however, CMS is proposing to lift this ‘outdated’ restriction. This would leave coverage decisions tied to non-oncologic PET scans up to each Medicare Administrative Contractor. . . The Society of Nuclear Medicine & Molecular Imaging on Monday called the news ‘significant’ for the profession.”
HOSPITALS AND OTHER HEALTH CARE FACILITIES
The Pandemic Has Killed Some Hospitals, Too
CNN examines (here) the fate of rural hospitals in the pandemic. “They also couldn't make up for the significant loss of revenue from canceled appointments from early in the pandemic. A February report from The Chartis Center for Rural Health found 82% of the rural hospitals surveyed said suspension of outpatient services resulted in a loss of at least $5 million per month. More than 180 rural hospitals have closed since 2005. Closures were already occurring at an accelerated rate over the last decade, and now 21 have shut down since the start of the pandemic.”
MEDICARE, MEDICAID AND COMMERCIAL HEALTH INSURANCE
Commercial Health Insurers May Benefit Under Proposals to “Fill the Medicaid Gap” in Non-Expansion States
The House Energy & Commerce Committee has proposed a “hybrid policy” for coverage of the 2 million people who, with expansion of Medicaid in 12 additional states, would have been covered.
InsideHealthPolicy reports that “The Medicaid gap plan passed by House Energy & Commerce this week would temporarily extend [2022-2024] the ACA tax credits to residents earning below 100% of the poverty level and direct HHS to craft a permanent, federally funded program by 2025 . . . At issue is 12 states’ refusal to expand Medicaid as allowed under the ACA, which has left millions of people without access to coverage. Congress included an incentive to the non-expansion states in the American Rescue Plan enacted in March, but it failed to move the needle, leading stakeholders – and lawmakers – to conclude that a federal solution is needed to get coverage to the gap population.”
ModernHealthcare (here) reports (“Large insurers prepare to profit from Democratic proposal to expand Medicaid”) that the program would be geared to coverage through commercial health insurers’ managed Medicaid programs. The hybrid proposal “would create a new federal Medicaid look-alike program in non-expansion states, with its administration to be outsourced to managed care organizations and other third parties by the Health and Human Services Department through a bidding process. Managed-care organizations, which deliver Medicaid benefits on the behalf of states, already cover 54 million people, nearly 70% of Medicaid beneficiaries, according to the Kaiser Family Foundation.”
DRUGS & DEVICES
FDA “Close Call Decisions” Are Bespoke; New Intended Use Regulations In Effect
A study in the Annals of Internal Medicine (here) examined close decisions by the FDA (“multiple review cycles because the evidence for clinical efficacy was initially deemed insufficient”), 2013-2018, and found “The FDA has no mechanism to find or tradition to cite similar cases when weighing evidence for approvals, resulting in standalone, bespoke decisions. These decisions show highly variable criteria for ‘substantial evidence’ when flexible evidential criteria are used, highlighted by the recent approval of aducanumab.”
Also, under proposed rules from 2020 (Federal Register, here) the “FDA proposes to amend its intended use regulations for medical products (§§ 201.128 and 801.4) to better reflect the Agency’s current practices in evaluating whether a product is intended for use as a drug or device, including whether an approved or cleared medical product is intended for a new use.” A report in InsideHealthPolicy (here) notes that the rules, effective September 1, are essentially unchanged from the 2020 proposal. According to the FDA’s comments, “The intended use regulations describe evidence that might be relevant to establishing intended use, but they do not in themselves directly regulate speech . . intended use helps determine the marketing status for products that are potentially subject to those laws -- products that Congress has directed FDA to regulate in the interest of the public health. Excluding all truthful speech from regulatory review would undermine FDA's ability to promote and protect the public health through premarket review of medical products, including review of proposed labeling, and post-market regulatory surveillance and actions.”
READINGS & REFERENCES
While You Were Away, Final Rules from CMS, Part 1
MLN Connects (the Medicare Learning Network) reports that “On July 29, CMS issued a final rule updating Medicare payment policies and rates for Skilled Nursing Facilities (SNFs) under the SNF Prospective Payment System (PPS) for Fiscal Year (FY) 2022. In addition, the final rule includes several policies that update the SNF Quality Reporting Program and the SNF Value-Based Program (VBP) for FY 2022.” Fact Sheet here, final rule here. Among the rule’s provisions, CMS will increase payments to skilled nursing facilities by 1.2 percent in fiscal 2022, with total Medicare Part A payments increasing by $410 million; blood clotting factors will be excluded from the Part A payment system and will be paid instead through Medicare Part B, and CMS will require skilled nursing facilities to report the COVID-19 vaccination status of their employees.
Select Coronavirus Public Health Resources and References may be found here.
2021 CQ Congressional Calendar here.
PUBLICATION SCHEDULE FOR DCMEDICAL NEWS
September 22, 23, 24, 27, 28, 29, 30
October 1, 19, 20, 21, 22, 25, 26, 27, 28
November 1, 2, 3, 4, 5, 15, 16, 17, 18, 30
Notes to: Fred Hyde, MD, JD, MBA; fredhyde@aol.com.