K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
On November 16, the Centers for Medicare & Medicaid Services (CMS) published its Medicare Physician Fee Schedule (PFS) final rule for calendar year 2024 (PFS Final Rule). According to the CMS press release, the PFS Final Rule...more
In the buffet of regs (and eggs) released a couple of weeks ago, the fried egg served up by the Centers for Medicare & Medicaid Services (CMS) was the 340B Remedy Final Reg. Unlike the other final regs that will affect...more
Hungry for some Regs & Eggs? Well, you are in luck, because this week, the Regs & Eggs buffet is open, with your choice of eggs made any style. Enough regs were released this week to feed an entire family—and the...more
Last week, the Centers for Medicare & Medicaid Services (CMS) released the two major regulations we all were waiting for: the Calendar Year (CY) 2024 Physician Fee Schedule (PFS) proposed reg and the CY 2024 Outpatient...more
On July 13, 2023, CMS published a proposed rule to update the payment policies, payment rates, and other provisions for services furnished under the Medicare Outpatient Prospective Payment System (OPPS) and the Ambulatory...more
On July 15, the Centers for Medicare & Medicaid Services (CMS) published the Calendar Year 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) Payment System proposed rule...more
Earlier this month, the Centers for Medicare and Medicaid Services (CMS) released its final rules for the 2022 Medicare Physician Fee Schedule (PFS Final Rule) and 2022 Medicare Hospital Outpatient Prospective Payment System...more
Report on Medicare Compliance 30, no. 32 (September 13, 2021) - Saint Francis Medical Center in Missouri agreed to pay $1.625 million in a civil settlement of allegations it violated the Controlled Substances Act, the...more
CMS made impactful changes to the Federal physician self-referral law’s (i.e., Stark Law’s) regulations in its Final Rule that were effective January 19, 2021 (with the exception of the changes to 42 C.F.R. § 411.352(i) that...more
Non-surgical extended duration therapeutic services (NSEDTS) are services which have a significant monitoring component that can: extend for a lengthy period of time, are not surgical, and typically have a low risk of...more
Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more
With the COVID-19 pandemic response and civil discourse on race and health disparities raising new questions about the future of U.S. health care policy, the winners of the 2020 federal elections will face a multitude of...more
In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more
On December 12, 2019, the Centers for Medicare and Medicaid Services (CMS) announced that it will automatically reprocess claims which had been reimbursed at a reduced rate in 2019 under the site-neutral payment policy and...more
Report on Medicare Compliance 28, no. 40 (November 11, 2019) - CMS has given the green light to prior authorization for five types of procedures in an attempt to control “unnecessary increases” in these procedures as part...more
KEY POINTS - - A new CMS Medicare Rule for Calendar Year 2020 reduces the default level of supervision required for hospital outpatient therapeutic services in all hospitals, from "direct" to "general" supervision. -...more
Key Points - ·On September 17, 2019, the District Court for the District of Columbia rejected the Centers for Medicare and Medicaid Services’ (CMS) latest attempt to limit Medicare reimbursement at off-campus outpatient...more
Hospitals can breathe (at least temporarily) a sigh of relief as the U.S. District Court for the District of Columbia determined that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory authority when it...more
In recent years, changes to Centers for Medicare and Medicaid Services’ (CMS) reimbursement policies for outpatient interventional procedures has both expanded the scope of surgical services that may safely be performed in...more
On September 17, 2019, the U.S. District Court for the District of Columbia ruled against the Centers for Medicare and Medicaid Services (“CMS”), vacating CMS’ 2018 Final OPPS Rule, which cut Medicare reimbursement rates for...more
In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more
The Centers for Medicare and Medicaid Services (CMS), recently announced that it plans to activate systematic validation edits for Outpatient Prospective Payment System (OPPS) providers with multiple service locations that...more
Among the many provisions in the FY 2020 Outpatient Prospective Payment System (OPPS) proposed rule is one that would alter the supervision standards applicable to hospital outpatient therapeutic services. See 84 Fed. Reg....more
As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more
On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule (Rule), which includes modifications to Medicare payment policies and rates....more