News & Analysis as of

21st Century Cures Act Comment Period

Holland & Knight LLP

CMS Previews Changes to Medicare Advantage Capitation Rates, Parts C and D Payment Policies

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released its Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies on Jan....more

McDermott+

Stakeholders Request Changes to Proposed Information Blocking Disincentives for Healthcare Providers

McDermott+ on

The public comments are in! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) are now reviewing the 136 comments they received on a proposed...more

BakerHostetler

ONC's Proposed Rule Updates to the 21st Century Cures Act Regulations

BakerHostetler on

On April 18, the Office of the National Coordinator for Health Information Technology (ONC) formally published its proposed rule titled Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm...more

McDermott Will & Emery

ONC Extends Compliance Date for Information Blocking Rule

McDermott Will & Emery on

On November 4, 2020, the US Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published an interim final rule with comment period in the Federal Register that...more

Sheppard Mullin Richter & Hampton LLP

Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule

In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on...more

Polsinelli

HHS Extends 21st Century Cures Act Final Rule Compliance Dates for Information Blocking and Health IT Certification Requirements

Polsinelli on

On October 29, 2020, the Office of the National Coordinator for Health Information Technology (ONC) announced it was delaying the compliance deadlines for information blocking and other health IT provisions initially...more

Sheppard Mullin Richter & Hampton LLP

Top 10 Provisions of CMS Proposed Rule: Medicare Advantage and Part D Programs for CY2021 and CY2022

As promised, here is a summary of some key provisions in CMS’ proposed rule relating to the Medicare Advantage and Part D programs for contract years 2021 and 2022. CMS is soliciting comments on a number of issues and we urge...more

ArentFox Schiff

CMS Moves to Expand Medicare Advantage Program Access to Individuals with End-Stage Renal Disease

ArentFox Schiff on

On February 5, 2020, the Centers for Medicare and Medicaid Services (CMS) proposed removing long-standing prohibitions and eligibility restrictions that had barred many individuals with End-Stage Renal Disease (ESRD) from...more

McDermott Will & Emery

HHS Releases Draft Federal Health IT Strategic Plan for 2020-2025

The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more

Foley Hoag LLP - Medicaid and the Law

CMS Is Seeking Guidance on Medicaid Coverage for Children Provided Across State Lines

The Medicaid program generally has more generous coverage rules for children than for adults. For example, under the Early and Periodic Screening, Diagnostic and Testing (EPSDT) provisions of the Medicaid statute, if a...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...more

McDermott Will & Emery

Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents

McDermott Will & Emery on

The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more

Mintz - Health Care Viewpoints

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more

Akin Gump Strauss Hauer & Feld LLP

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Series of Guidance Documents Aimed at Medical Software Regulation

The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more

K&L Gates LLP

K&L Gates Triage: Digital Health Update: ONC Information Blocking Proposal Aims to Remove Barriers to Data Sharing

K&L Gates LLP on

The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule aimed at promoting the interoperability of health information technology and enabling access to electronic...more

King & Spalding

CMS Requests Comments on Proposal to Require Providers to Disclose Price Information

King & Spalding on

On March 4, 2019, HHS published a proposed rule, which includes a request for public comment on the implications of requiring providers to make public disclosures of price information for the services they perform. The 21st...more

King & Spalding

CMS Proposes Rule Regarding the Exchange of Electronic Health Information Which Impacts Hospitals, Clinicians and Government...

King & Spalding on

On February 11, 2019, CMS issued a proposed rule, to improve access to electronic health information (the Proposed Rule). The Proposed Rule results from the 21st Century Cures Act (the Cures Act), in which CMS and the Office...more

Hogan Lovells

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

Hogan Lovells on

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more

Kelley Drye & Warren LLP

FDA Releases 2018 Roadmap: Focus On Digital Health Continues

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities,...more

Epstein Becker & Green

FDA Guidance on Decision Support Software: Implications for Industry

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”). According to FDA Commissioner Scott Gottlieb, M.D., the CDS...more

Holland & Knight LLP

Digital Health: FDA Issues Long-Awaited Draft Guidance on Clinical Decision Support Technology

Holland & Knight LLP on

On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more

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