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We’ve been talking about telehealth and mental health this week. Here’s both combined in one interesting and highly valued announcement today, followed by several tests – well, 3 million COVID tests a week to be exact, and, speaking of Exact Sciences, developments in the early detection tests for the other major disease that is most feared, cancer.…
Sitting in the dark before 6 am in my Los Angeles house with my face lit up by yet another Zoom screen, wearing a stylish combination of sweatpants, dress shirt and last year’s JPM conference badge dangling around my neck for old times’ sake, I wonder at the fact that it’s J.P. Morgan Annual Healthcare Conference week again and we are where we are. Quite a year for all of us – the pandemic, the healthcare system’s response to the public health emergency, the ongoing fight for racial justice, the elections, the storming of the Capital – and the subject…
On April 1, 2021, the California Department of Health Care Services (“DHCS”) will be transitioning all Medi-Cal pharmacy benefits from managed care to fee-for-service (“FFS”).  This new system to administer FFS pharmacy benefits is being called “Medi-Cal Rx” and was developed by DHCS in response California Governor Gavin Newsom’s January 7, 2019 executive order (the “Order”), which instructed DHCS to transition all Medi-Cal pharmacy benefits to FFS by January 1, 2021.  The rationale behind the Order is to combat rising prices for prescription drugs by increasing the State’s bargaining power in negotiating prescription drug prices with pharmaceutical companies.  The date…
On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs.[1]
On December 28, 2020, the Consolidated Appropriations Act, 2021 (“Appropriations Act”) was passed into law. The Appropriations Act included the No Surprises Act (“Act”), which seeks to protect patients from surprise medical bills in situations where patients have little or no control over who provides their care, including nonemergency services provided by out-of-network providers at in-network facilities, emergency services provided by out-of-network providers and facilities, and air ambulance services. The Act, a rare piece of bipartisan, bicameral legislation, has been a long time in the making, and has undergone multiple iterations. Particularly during the public health emergency, the issue of…
In our December 7, 2020 Blog Post, “Permanent Expansion of Medicare Telehealth Services,” we discussed the 2021 Medicare Physician Fee Schedule Final Rule (the “Final Rule”) and the regulatory changes made therein by the Centers for Medicare and Medicaid Services (“CMS”) to expand Medicare telehealth coverage within the confines of existing Medicare statutory law.  The Final Rule was first posted on December 2, 2020 and was formally published in the Federal Register on December 28, 2020.…
On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment models – one model for prescription drugs covered by Part B of the Medicare program (in general terms, Medicare Part B covers drugs that are administered by infusion or injection in physician offices and hospital outpatient departments, as well as certain drugs furnished by suppliers), and a second model for prescription drugs covered by Part D of the Medicare program (Medicare Part D covers most medications that are dispensed by…
In our November 25, 2000 Healthcare Law Blog article, “Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays,”  we discussed the advanced publication of two significant final rules intended to “modernize” and “clarify” regulations regarding the Physician Self-Referral Law (“Stark Law Final Rule”) and the Anti-Kickback Statute (“AKS Final Rule”) – both formally published on December 2, 2020 by the Centers for Medicare and Medicaid Services (“CMS”) and the Department of Health and Human Services, Office of Inspector…
On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) finalized policies that “aim to increase choice, lower patients’ out-of-pocket costs, empower patients, and protect taxpayer dollars” with changes to the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and the Ambulatory Surgical Center (“ASC”) Payment System in the Medicare OPPS and ASC Final Rule (“Final Rule”). These changes include: elimination of the “Inpatient Only List” and additions and revisions to the “ASC Covered Procedures List” – two key areas of “site neutrality”. Site neutrality is a move to diminish or eliminate the reimbursement differences between different sites of service.…
As mentioned in our November 25, 2000 Healthcare Law Blog article, “Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays,” the Centers for Medicare & Medicaid Services (CMS) published a final rule (“Final Rule”) on December 2, 2020 making significant changes to the regulatory framework implementing the federal physician self-referral prohibition (the “Stark Law”), 42 C.F.R. 411.351 et seq.…
N.B.  Concurrent with the posting of this article, the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (“FDA”) has decided to recommend to the FDA that the FDA approve the emergency use authorization applications submitted by Pfizer and BioNTech.  It is being reported that the FDA may formally approve the applications as soon as tomorrow, Friday, December 11, 2020.  More detail regarding the recommendation and the FDA’s decision will be discussed in a follow-up article. On Monday, December 7, 2020, California Governor Gavin Newsom announced that, “Hope is on the horizon with the [COVID-19] vaccination.…
As part of the “CY 2021 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule” (the “Final Rule”) published on December 2, 2020, the Centers for Medicare and Medicaid Services (“CMS”) finalized policies designed to overhaul the methodology used to calculate the Overall Hospital Quality Star Rating effective 2021.…
On December 3, 2020, Centers for Medicare & Medicaid Services (“CMS”) announced key details concerning a new value-based reimbursement and patient care model – the Geographic Direct Contracting Model (the “Model” or “Geo”). Geo is a geographic-based approach to value-based Medicare reimbursement and patient care that focuses on improving health outcomes and decreasing the cost of care across an entire geographic region. Direct contracting entities (“DCEs”) participating in the Model will be taking responsibility for the total cost of care of Medicare fee-for-service beneficiaries in their region.  Accountable care organizations (ACOs), health systems, health care provider groups, health plans, and other…
On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019 Executive Order #13890 on “Protecting and Improving Medicare for Our Nation’s Seniors” (the “EO”) by expanding the use of proven alternatives like telehealth services to Medicare beneficiaries even after the conclusion of the COVID-19 Public Health Emergency (the “Pandemic”).…
On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute (“AKS”) safe harbor regulations as such regulations relate to the cost of prescription drugs as covered by the Medicare and Medicaid programs.  More specifically, the Final Rule amends the AKS discount safe harbor (“Discount Safe Harbor”) at 42 C.F.R. §1001.952(h) to eliminate safe harbor protection for drug discounts and rebates offered by pharmaceutical manufacturers to pharmacy benefit managers (“PBMs”) and  Medicare Part D prescription…