Tag archives: proposed rule

CMS Publishes Proposed Rule on Medicare Coverage for Innovative Technologies

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on September 4, 2020 Posted in General, Regulatory

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 Drug Administration (“FDA”) as breakthrough devices. Under the proposed MCIT pathway, CMS would provide national … Continue reading

HHS Issues Proposed Rule on Good Guidance Practices

By Jeff Wurzburg (US), Thomas Dowdell (US) and Hayley White (US) on August 25, 2020 Posted in Coronavirus, General, Regulatory

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 decision in Azar v. Allina Health Services (139 S. Ct. 1804). In this case the … Continue reading

President Trump unveils executive orders on lowering drug prices

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on July 30, 2020 Posted in Coronavirus, Enforcement, General, News from DC

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 that the executive orders are not self-executing and implementation of the policies therein will, therefore, … Continue reading

CMS Proposed Rule Includes Significant Changes to Medicare GME Funding

By Andrew Roth (US) and Thomas Dowdell (US) on May 20, 2020 Posted in General, News from DC, Regulatory

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 the hospital IPPS and LTCH PPS proposed changes. See link here . In this rulemaking, … Continue reading

CMS Issues FY 2021 Hospital IPPS and LTCH PPS Proposed Rule

By Thomas Dowdell (US) on May 13, 2020 Posted in Coronavirus, General, Regulatory

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 Medicare IPPS payment rates would increase an estimated net 3.1 percent for hospitals that successfully … Continue reading

CMS releases proposed rule on extension and changes to the Comprehensive Care for Joint Replacement Model

By Jeff Wurzburg (US) on February 25, 2020 Posted in General, News from DC, Regulatory

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 better evaluate the program. CMS states in the proposed rule that participating hospitals in the … Continue reading

CMS Publishes Notice of Benefit and Payment Parameters for 2021 Proposed Rule

By Rachel Park (US) and Jeff Wurzburg (US) on February 4, 2020 Posted in General, Regulatory

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 the risk adjustment program. The proposed payment rule is available here. CMS also issued the … Continue reading

ONC Releases Draft 2020-2025 Federal Health IT Strategic Plan for Public Comment

By Rachel Park (US) and Jeff Wurzburg (US) on January 29, 2020 Posted in General, News from DC

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 (ONC) in collaboration with more than 25 federal organizations, the strategic plan outlines health IT … Continue reading

AHA Requests 60-Day Extension to Comment Period for CMS’s proposed rule Medicaid Fiscal Accountability Regulation

By Thomas Dowdell (US) on December 17, 2019 Posted in General, News from DC

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 Register and the comment period closes January 17, 2020. The AHA requested an extension in … Continue reading

CMS Proposes Major Changes in Medicaid Fiscal Accountability Rule

By Jeff Wurzburg (US) and Thomas Dowdell (US) on November 20, 2019 Posted in General, News from DC, Regulatory

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 payments and financing arrangements under the Medicaid program are consistent with federal statutory requirements. In a … Continue reading

CMS and OIG release sweeping proposals to modernize Stark Law and AKS regulations

By Joseph Keillor (US) on October 16, 2019 Posted in General, News from DC, Regulatory

On Thursday, October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) will publish in the Federal Register two proposals to implement major changes to Stark Law and Anti-Kickback Statute (AKS) regulations. We have summarized a portion of those proposed … Continue reading

CMS Publishes CY 2020 Proposed Rules for Hospital OPPS and ASC, MPFS, and ESRD and DMEPOS Policies and Payments

By Thomas Dowdell (US) on July 30, 2019 Posted in Regulatory

On July 29, the Centers for Medicare & Medicaid Services (CMS) published three proposed rules for Calendar Year (CY) 2020: Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule; Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule (MPFS); and End State Renal Disease … Continue reading

CMS proposes to remove a ban on pre-dispute arbitration agreements at long-term care facilities

By Yvonne Puig (US) and Mark Faccenda (US) on June 7, 2017 Posted in Regulatory

On June 5, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to revise requirements established by the Reform of Requirements for Long-Term Care Facilities final rule (2016 Final Rule). Specifically, the proposed rule would remove regulations prohibiting long-term care facilities from entering into pre-dispute arbitration agreements with residents or their … Continue reading

CMS proposes rule to stabilize health insurance market

By Mark Faccenda (US) on February 16, 2017 Posted in Regulatory

On February 15, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to stabilize the individual and small group health insurance market by increasing incentives for individuals to maintain enrollment in health plans, decreasing incentives to enroll in coverage only after healthcare services are needed, and reducing the regulatory burdens for … Continue reading

CMS proposes program integrity enhancements to provider enrollment

By Mark Faccenda (US) on February 25, 2016 Posted in Regulatory

The Centers for Medicare and Medicaid Services (CMS) has issued a proposed rule implementing additional provisions of the Affordable Care Act designed to ensure that questionable providers and suppliers are kept out of or removed from the Medicare program. If finalized, these regulations would enable CMS to remove or prevent the enrollment of entities and … Continue reading