On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would establish a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (“MCIT”), for medical devices that are designated by the Food and
proposed rule
HHS Issues Proposed Rule on Good Guidance Practices


On August 20, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would impose requirements regarding the issuance and reliance on HHS guidance documents. This proposed rule results from the 2019 U.S. Supreme Court…
President Trump unveils executive orders on lowering drug prices
On Friday, July 24, 2020, President Trump issued three executive orders, and announced a potential fourth executive order, with the stated intention of lowering the cost of prescription drugs in the United States. The general consensus among legal commentators is…
CMS Proposed Rule Includes Significant Changes to Medicare GME Funding

On May 11, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its Fiscal Year (FY) 2021 hospital inpatient prospective payment system (IPPS) and long term care hospital (LTCH) prospective payment system (PPS) proposed rule. We previously reported on…
CMS Issues FY 2021 Hospital IPPS and LTCH PPS Proposed Rule
On May 11, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its Fiscal Year (FY) 2021 hospital inpatient prospective payment system (IPPS) and long term care hospital (LTCH) prospective payment system (PPS) proposed rule. Under the proposed rule…
CMS releases proposed rule on extension and changes to the Comprehensive Care for Joint Replacement Model

On Thursday, February 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (February 24 Federal Register publication) to extend the Comprehensive Care for Joint Replacement (CJR) Model for an additional three years in order to…
CMS Publishes Notice of Benefit and Payment Parameters for 2021 Proposed Rule

On January 31, 2020, CMS issued the Notice of Benefit and Payment Parameters for 2021 proposed rule (“Payment Notice”). The proposed rule introduces updates to the “regulatory and financial standards applied to issuers and Exchanges” and also proposes parameters for…
ONC Releases Draft 2020-2025 Federal Health IT Strategic Plan for Public Comment

On January 15, 2020 the U.S. Department of Health and Human Services (HHS) released the draft 2020-2025 Federal Health IT Strategic Plan (“strategic plan”) for public comments. Developed by the HHS Office for the National Coordinator for Health Information Technology…
AHA Requests 60-Day Extension to Comment Period for CMS’s proposed rule Medicaid Fiscal Accountability Regulation
On December 16, 2019, the American Hospital Association requested a 60-day extension to the comment period for the Centers for Medicare & Medicaid Services’ proposed rule Medicaid Fiscal Accountability Regulation. The proposed rule was published in the November 18 Federal…
CMS Proposes Major Changes in Medicaid Fiscal Accountability Rule

On November 12, 2019, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule for public inspection entitled Medicaid Fiscal Accountability Regulation. CMS states that the intent of the proposed rule is to ensure that state supplemental…