Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance. FDA justified its reversal on including the...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
On October 13, 2022, CMS announced it will extend the Bundled Payments for Care Improvement Advanced Model (BPCI Advanced) for two years, with the opportunity for new entities to join the model beginning in 2024. CMS also...more
In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft...more
FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” ...more
With just days remaining until the “Deemed to Be a License” transition takes effect, the FDA issued an unexpected sweeping change to compounding practice. ...more
The Centers for Medicare & Medicaid Services (CMS) has issued an amendment to the Bundled Payments for Care Improvement (BPCI) Advanced Participation Agreement (Amendment). Changes imposed by the 18-page Amendment were...more
CMS intends to release its second enrollment period for the Bundled Payment for Care Improvement (BPCI) Advanced payment model sometime in April 2019, allowing for eligible providers to participate beginning January 1, 2020...more
The past decade has seen a tremendous amount of private equity investment in physician practice recapitalizations, primarily in hospital-based practices such as anesthesiology and radiology as well as “retail medicine...more
While the Biologics Price Competition and Innovation Act (BPCI) was originally enacted under the Obama Administration as part of the Affordable Care Act, it appears that the Trump Administration will continue to take steps to...more
Despite some initial difficulty in gaining momentum, the use of value-based payment methodologies will likely increase across all provider niches. This change is partly a function of cost savings driven by margin compression...more
On January 11, 2018, CMS announced a new voluntary episode payment model (bundled payments for care improvement advanced–BPCI Advanced) that will test a new iteration of bundled payment for the following thirty-two (32)...more
On January 9, 2018, The Centers for Medicare & Medicaid Services (CMS) announced a new voluntary bundled payment model program – Bundled Payment for Care Improvement Advanced (BPCI Advanced). The episode payment model, which...more
This week, the Centers for Medicare & Medicaid Services (CMS) released details on the much-anticipated new version of the Bundled Payments for Care Improvement (BPCI) payment model, which will be known as BPCI Advanced. Like...more
On January 9, the Centers for Medicare and Medicaid Services (CMS) announced a new voluntary bundled-payment demonstration program, also known as Bundled Payments for Care Improvement (BPCI) Advanced. The new model will test...more
The Centers for Medicare & Medicaid Services (CMS) recently published a final rule that cancels the Episode Payment Models (EPMs) and the Cardiac Rehabilitation (CR) incentive payment model, each of which were slated to begin...more
The Centers for Medicare & Medicaid Services (CMS) recently published a proposed rule that furthers the U.S. Department of Health and Human Services’ goal to promote cooperative, value-based care and tie at least 50 percent...more
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on July 25, 2016, entitled, Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and...more
Summary - McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and...more
The Centers for Medicare & Medicaid Services (CMS) has traditionally paid health care providers separately for each of the individual services they furnish to beneficiaries for a single illness or course of treatment. This...more
Recent action by the Centers for Medicare and Medicaid Services (CMS) announces significant change in reimbursement methodology for high volume orthopedic surgical procedures in many markets nationwide. Affected stakeholders...more
On August 13, 2015, the Centers for Medicare & Medicaid Services (CMS) announced that 2,115 providers are participating in Phase 2 of the Medicare Bundled Payment for Care Improvement initiative (BPCI). These providers...more
On July 14, 2015, CMS released a proposed rule regarding a new, alternative payment model: the Comprehensive Care for Joint Replacement (CCJR) program. Modeled in large part on the Bundled Payments for Care Improvement (BPCI)...more
The federal physician self-referral ban or Stark law has been a part of the legal landscape for almost 25 years. The breadth of the law’s prohibitions, its strict liability formulation and draconian remedies have made it the...more
On July 14th, 2015, the Centers for Medicare and Medicaid’s (CMS) latest proposed rule (Rule) introduced a new alternative payment model. The Rule proposes CMS’ latest alternative payment model known as the Comprehensive Care...more