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 January 19, 2021, CMS announced the results of its audit of off-campus outpatient departments claiming the “mid-build” exception following enactment of the 21st Century Cures Act (the Cures Act). Of the 334 providers that...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
CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted. The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more
Providers seeking to classify certain off-campus departments as “mid-build” for purposes of eligibility for Hospital Outpatient Prospective Payment System (OPPS) reimbursement must file a provider-based attestation with their...more
A new section of the 21st Century Cures Act provides much-needed relief for hospitals with an off-campus provider-based department (off-campus PBD) that was mid-build or under development as of November 2, 2015 (the Mid-Build...more
Off-campus provider-based departments (PBDs) of hospitals face changes in reimbursement beginning Jan. 1, 2017, the effective date of the Centers for Medicare & Medicaid Services (CMS) outpatient prospective payment system...more
CMS has issued guidance documents addressing how hospitals can (1) qualify an off-campus provider-based department (PBD) for the “mid-build” exception set forth in the 21st Century Cures Act and (2) request from their CMS...more
Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more