Issue Request for Public Input as Part of Inquiry into Impacts of Corporate Ownership Trend in Health Care “The Justice Department’s Antitrust Division, Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care.
Private equity firms and other corporate owners are increasingly involved in health care system transactions and, at times, those transactions may lead to a maximizing of profits at the expense of quality care. The cross-government inquiry seeks to understand how certain health care market transactions may increase consolidation and generate profits for firms while threatening patients’ health, workers’ safety, quality of care and affordable health care for patients and taxpayers.
The agencies issued a Request for Information (RFI) requesting public comment on deals conducted by health systems, private payers, private equity funds and other alternative asset managers that involve health care providers, facilities or ancillary products or services. The RFI also requests information on transactions that would not be reported to the Justice Department or FTC for antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act.”
About Covid-19
A reminder:
USPS will stop accepting orders for free COVID tests on March 8 “Two government-run efforts to distribute free COVID-19 tests and to offer free courses of Pfizer's Paxlovid antiviral are set to end Friday, as trends of the virus have largely slowed.
The Administration for Strategic Preparedness and Response, or ASPR, will stop accepting orders to ship COVID-19 tests to all households through the U.S. Postal Service, an agency spokesperson confirmed, marking an end to this season's round of shipments.”
Updated COVID shot expected this fall, says CDC director “Researchers are working on selecting a strain for the upcoming version, and will probably wait until May to pick one to target with vaccines, Centers for Disease Control and Prevention Director Mandy Cohen said in an interview at Bloomberg’s offices in Washington.”
About health insurance/insurers
HHS Statement Regarding the Cyberattack on Change Healthcare “Today, HHS is announcing immediate steps that the Centers for Medicare & Medicaid Services (CMS) is taking to assist providers to continue to serve patients. CMS will continue to communicate with the health care community and assist, as appropriate. Providers should continue to work with all their payers for the latest updates on how to receive timely payments.
Affected parties should be aware of the following flexibilities in place:
Medicare providers needing to change clearinghouses that they use for claims processing during these outages should contact their Medicare Administrative Contractor (MAC) to request a new electronic data interchange (EDI) enrollment for the switch. The MAC will provide instructions based on the specific request to expedite the new EDI enrollment. CMS has instructed the MACs to expedite this process and move all provider and facility requests into production and ready to bill claims quickly. CMS is strongly encouraging other payers, including state Medicaid and Children’s Health Insurance Program (CHIP) agencies and Medicaid and CHIP managed care plans, to waive or expedite solutions for this requirement.
CMS will issue guidance to Medicare Advantage (MA) organizations and Part D sponsors encouraging them to remove or relax prior authorization, other utilization management, and timely filing requirements during these system outages. CMS is also encouraging MA plans to offer advance funding to providers most affected by this cyberattack.
CMS strongly encourages Medicaid and CHIP managed care plans to adopt the same strategies of removing or relaxing prior authorization and utilization management requirements, and consider offering advance funding to providers, on behalf of Medicaid and CHIP managed care enrollees to the extent permitted by the State.
If Medicare providers are having trouble filing claims or other necessary notices or other submissions, they should contact their MAC for details on exceptions, waivers, or extensions, or contact CMS regarding quality reporting programs.
CMS has contacted all of the MACs to make sure they are prepared to accept paper claims from providers who need to file them. While we recognize that electronic billing is preferable for everyone, the MACs must accept paper submissions if a provider needs to file claims in that method.”
Comment: Strongly encouraging and issuing guidance does not help providers get paid.
The Medicare Advantage Quality Bonus Program New Ideas and New Conversations Really good summary from The Urban Institute.
“Based on a review of the literature and interviews with six prominent experts in quality measurement and Medicare performance, we suggest a revised structure for ensuring adequate administrative performance and quality in MA. We recommend the following policies be implemented to replace the QBP:
1. Implement enhanced, more stringent Centers for Medicare & Medicaid Services oversight of MA plans to ensure adherence to their contractual obligations on various administrative responsibilities, concentrating on areas of demonstrated substandard performance, like prior authorization and claims denials.
2. Use a limited number of validated quality measures to identify exceptional and poor MA plan performance in areas of interest. These measures would be focused on prevention activities and, where possible, patient-reported outcomes and patient experiences with their health plan. Measurement would be limited to identifying exceptionally strong and poor performance, not broadly rating or ranking MA plans, and need not be made public.
3. Replace the current regime of external performance measurement that provides overly generous rewards without penalties with a program that encourages or requires MA plans to implement quality improvement projects or adopt continuous quality improvement methods.”
The state canceling $2B in medical debt “Up to 1 million residents in Arizona may have their medical debt forgiven through a new program the state's governor announced March 4.
Arizona Gov. Katie Hobbs said the state has partnered with RIP Medical Debt, a nonprofit that buys and eliminates debt, to cancel approximately $2 billion in residents' medical debt. Through the partnership, Arizona will make up to $30 million in COVID-19 relief funds available for the nonprofit to use for debt purchasing.”
About pharma
Gilead tries new triple-target T-cell engagers in $1.5B-plus Merus collab “Gilead and Merus have inked a partnership worth more than $1.5 billion to discover trispecific T-cell engagers, the companies announced Wednesday. In exchange for $56 million in upfront cash plus a $25 million equity investment from Gilead, Merus will lead early-stage research on two programs, with the potential for a third.”
About the public’s health
FDA advisory panel recommends a streamlined flu vaccine for next fall “Experts who advise the Food and Drug Administration on vaccine-related issues voted unanimously on Tuesday to recommend that the FDA approve trivalent flu vaccines for the 2024-2025 season, instead of the quadrivalent, or four-in-one, shots that have been the industry standard for the past decade or so.
The Vaccines and Related Biological Products Advisory Committee — VRBPAC, as it’s known — has been pushing for the removal of one of the influenza B components in flu vaccines, the portion that targeted B/Yamagata viruses, for some time now. B/Yamagata viruses haven’t been detected anywhere in the world since late March 2020, when Covid pandemic lockdowns and social distancing appeared to have halted circulation of this family of lineage of flu B.”
PrEP Discontinuation In A US National Cohort Of Sexual And Gender Minority Populations, 2017–22 “We found a high annual rate of discontinuation (35–40 percent) after PrEP initiation. Multivariable analysis with 6,410 person-years identified housing instability and prior history of PrEP discontinuation as predictors of discontinuation. Conversely, older age, clinical indication for PrEP, and having health insurance were associated with ongoing PrEP use. To promote sustained PrEP use, strategies should focus on supporting those at high risk for discontinuation, such as younger people, those without stable housing or health insurance, and prior PrEP discontinuers.”
About healthcare IT
GE HealthCare, Vanderbilt AI models predict immunotherapy responses among cancer patients “GE HealthCare said its artificial intelligence programs were able to help predict cancer patients’ responses to immunotherapies by finding patterns within routinely collected clinical data.
Developed through a yearslong collaboration with Vanderbilt University Medical Center (VUMC), the models were able to parse electronic medical records and digest real-world information such as diagnosis codes and certain medication regimens; additional, manually entered inputs included the patient’s smoking history and the number of previous immune checkpoint inhibitor drugs they had taken.
According to the company, the algorithms were able to deliver 70% to 80% accuracy in forecasting efficacy outcomes and the likelihood of unwanted side effects—across a range of different cancer types, including melanoma and lung or genitourinary cancers—by analyzing deidentified demographic, genomic, tumor, cellular, proteomic and imaging data collected from more than 2,200 VUMC patients.”
About health technology
FDA Clears First Over-the-Counter Continuous Glucose Monitor “U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition.”
About healthcare finance
Healthcare M&A: 10-point status update A good update on this activity.
Morningstar Indexes Selected by IMX Health for First Healthcare Futures Exchange Product Offering “ Morningstar, Inc…. announced that the Intelligent Medicine Exchange (“IMX”), the first futures and options exchange focused on the healthcare economy, has aligned with Morningstar Indexes to offer its first futures product. The IMX exchange was designated by the Commodity Futures Trading Commission in January of this year.
Healthcare represents nearly 20% of U.S. GDP but until IMX there was no dedicated derivatives market specifically focused on managing healthcare risk.
The new futures product from IMX Health will be based on the Morningstar US Healthcare Index, which measures the performance of approximately 170 U.S. public healthcare companies representing biotechnology, pharmaceuticals, research services, home healthcare, hospitals, long-term care facilities and medical equipment and supplies. This market capitalization-weighted index is designed for optimal tradability and liquidity. Among the largest current holdings in the index are household names like UnitedHealth, Eli Lilly, and Johnson & Johnson.”