News & Analysis as of

EHR Safe Harbors

Jones Day

OIG and CMS Modify AKS Safe Harbor and Stark Law Exception for EHR Donations

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The Situation: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid...more

McGuireWoods LLP

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

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As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more

Davis Wright Tremaine LLP

New Sprint Regulations Encourage Investment in EHR and Cybersecurity Technology

On December 2, 2020, under the Trump Administration's "Regulatory Sprint to Coordinated Care" initiative, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final...more

Tucker Arensberg, P.C.

Cybersecurity AKS Safe Harbor and Stark Exception

Tucker Arensberg, P.C. on

EHR Safe Harbor Permanent - The existing electronic health records items and services Safe Harbor in 42 CFR Section 1001.952(y) was amended by deleting the sunset provision, thereby making the protection permanent....more

Manatt, Phelps & Phillips, LLP

[Webinar] Re-Mapping the Fraud and Abuse Landscape: Understanding Proposed Reforms - February 13th, 1:00 pm ET

What larger healthcare goals are fueling the proposed revisions to AKS and Stark? What safe harbors and exceptions are introduced in the proposed rules? And what would the potentially transformational changes mean for...more

McDermott Will & Emery

Stark Law and Anti-Kickback Statute Proposed Rules Would Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on

On October 17, 2019, the Department of Health & Human Services (HHS) published proposed rules in the Federal Register that would amend existing and create new exceptions to the physician self-referral law (Stark Law) and safe...more

Baker Donelson

Regulatory Sprint: HHS Proposes Expansion of Protections for EHR and Cybersecurity Donations

Baker Donelson on

In furtherance of its goals of expanding the adoption of electronic health records (EHR) and improving security through the use of cybersecurity technology, the Department of Health and Human Services (HHS) has proposed...more

Tucker Arensberg, P.C.

Anti-Kickback EHR and Cybersecurity Safe Harbor

Tucker Arensberg, P.C. on

As another part of the Regulatory Sprint to Coordinated Care, OIG proposed revisions to the existing EHR Anti-Kickback Safe Harbor and added a cybersecurity component. The initial EHR Safe Harbor was developed in response...more

Bricker Graydon LLP

CMS and OIG propose changes to existing rules for donations of electronic health records and new rules for donations of...

Bricker Graydon LLP on

On October 9, 2019, the Office of Inspector General (OIG) released proposed changes to the regulations interpreting the federal Anti-Kickback Statute (AKS). On the same day, the Centers for Medicare and Medicaid Services...more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

Epstein Becker & Green on

This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...more

Bass, Berry & Sims PLC

CMS and the OIG Issue Far-Reaching Proposed Rules to the Federal Stark and Anti-Kickback Laws

Bass, Berry & Sims PLC on

In a coordinated effort, CMS and the Office of Inspector General (OIG) published proposed rules to modernize regulations implementing the federal physician-self referral law, commonly referred to as the “Stark Law” (Stark),...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

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 2: OIG Issues Long-Awaited Proposed Rules

Epstein Becker & Green on

This Client Alert serves as the second in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) as part of its...more

Katten Muchin Rosenman LLP

OIG Proposes to Add and Expand AKS Safe Harbors

Key Points - On October 17, 2019, the OIG proposed rules to add safe harbor protections for coordinated care and associated value-based arrangements. - The OIG proposed several new safe harbors: value-based...more

Akin Gump Strauss Hauer & Feld LLP

CMS Proposes Changes to Physician Self-Referral Regulations to Promote Value-Based Health Care

• The Centers for Medicare and Medicaid Services (CMS) have issued a long-awaited proposal to reform the Physician Self-Referral Law’s (Stark Law’s) regulatory exceptions and to provide updated guidance for physicians and...more

Akin Gump Strauss Hauer & Feld LLP

HHS Office of Inspector General Proposes Modifications to Anti-Kickback Statute Safe Harbors to Promote Value-Based Care

• On Oct. 9, 2019, the U.S. Department of Health and Human (HHS) Services Office of Inspector General (OIG) has issued its proposed rule to reform the Anti-Kickback Statute’s (AKS) regulatory safe harbors to address...more

Wilson Sonsini Goodrich & Rosati

HHS Announces Overhaul of Kickback and Stark Rules

On October 9, 2019, the U.S. Department of Health and Human Services' (HHS') Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) announced plans for sweeping changes to rules policing health...more

Faegre Drinker Biddle & Reath LLP

New Proposed Cybersecurity and EHR Donation Rules

On October 9, 2019, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) simultaneously released a set of proposed rules (the “Proposed Rules”) that, among other...more

Bass, Berry & Sims PLC

Sprinting to Coordinated Care: Healthcare Industry Urges Stark Law Relief as OIG Solicits Feedback on Changes to the Anti-Kickback...

August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more

Akerman LLP - Health Law Rx

The AHA’s Letter to Santa Claus

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more

Tucker Arensberg, P.C.

Office Of Inspector General Issues Policy Reminder On Information Blocking And The Federal Anti-Kickback Statue

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The federal anti-kickback statute (42 USC § 1320a-7b(b), the “Statute”) prohibits individuals and entities from receiving or soliciting any remuneration for the referral of services reimbursable under any federal health care...more

King & Spalding

OIG Warns Information Blocking May Affect Safe Harbor Protection

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In an alert published October 6, 2015, the OIG reminded the public that “information blocking”—generally described as individuals or entities knowingly and unreasonably interfering with the exchange or use of electronic...more

McDermott Will & Emery

U.S. Privacy and Data Protection: 2013 Year in Review and a Look Ahead to 2014

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In Boston, we celebrated Data Privacy Day (January 28) by presenting “U.S. Privacy and Data Protection: 2013 Year In Review and a Prediction of What’s to Come in 2014” for participants in an IAPP KnowledgeNet. Our panel of...more

Foley & Lardner LLP

CMS and OIG Issue Final Regulations to Extend the Stark Exception and Anti-Kickback Statute Safe Harbor for EHR Donations

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On December 27, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of Inspector General (OIG) finalized amendments to the Physician Self-Referral Law (Stark) and...more

King & Spalding

CMS and OIG Issue Final Rules Extending EHR Stark Law Exception and AKS Safeharbor to December 31, 2021

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On December 27, 2013, CMS published a final rule in the Federal Register revising the previously enacted exception to the Stark law that permits certain arrangements involving the donation of electronic health records (EHR)...more

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