The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
On September 28, 2022, the Centers for Medicare & Medicaid Services (CMS) issued approval letters for Section 1115 Medicaid demonstration applications previously submitted by Oregon and Massachusetts. Section 1115 waivers...more
Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor. ...In its mission to reward value over volume, the Centers for Medicare & Medicaid Services’ (CMS)...more
According to an April 13, 2020 Press Release issued by the National Association of ACOs (“NAACOS”), a recent NAACOS survey shows that 56% of the survey-participating at-risk accountable care organizations (“ACOs”) – i.e.,...more
Last week CMS issued a new round of regulatory waivers and rule changes in response to the COVID-19 public health emergency, including its Interim Final Rule with comment period, CMS-5531-IFC. The key changes relax certain...more
The Centers for Medicare & Medicaid Services (“CMS”) recently proposed a major redesign of its Medicare Shared Savings Program (“MSSP”) under a new plan it calls “Pathways to Success.” In this Part II of the two-part series...more
On December 29, 2016, CMS and OIG issued a Notice of Amended Waivers of Certain Fraud and Abuse Laws in Connection with the Next Generation ACO Model (the 2016 Notice). The 2016 Notice does not change or limit arrangements...more
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 care delivery...more
Vermont moves closer to launching the country’s first all-payer ACO; CMS approves Arizona’s 1115 waiver extension but rejects the State’s proposed work requirement and premiums for those earning below the FPL; and CMS issues...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
Massachusetts releases $1.8 billion DSRIP program waiver for public comment; CMS awards $32 million in grants to enroll uninsured children in Medicaid/CHIP; and Wisconsin withdraws proposed changes to Medicaid long-term care....more
Nearly four years after introducing waivers to certain fraud and abuse laws for Accountable Care Organizations (“ACOs”) and other entities participating in the Medicare Shared Savings Program (“MSSP”), the Centers for...more
On October 29, 2015, the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) published a final rule regarding the waiver of several federal health care fraud and abuse laws with respect...more
On October 29, 2015, CMS issued its Final Rule setting forth waivers of the application of the physician self-referral law (the Stark law), the Federal anti-kickback statute (AKS), and the civil monetary penalties (CMP) law...more
On October 29th, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued its final rule (“Final Rule”) for waivers of fraud and abuse laws in the context of the Medicare Shared Savings Program (“Shared Savings...more
Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more
Accountable Care Organizations (ACOs) can share costs of telehealth and remote patient monitoring services among their hospitals, providers/suppliers, and other ACO participants, according to federal regulations under the...more
The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services just issued a final rule setting forth waivers of specified fraud and abuse laws...more
The most recent Shared Savings Program final rule, published in the Federal Register on June 9, 2015, finalizes a number of the revisions to the original November 2011 final rule that CMS proposed on December 8, 2014. In...more
On October 17, 2014 the Centers for Medicare and Medicaid (CMS) and Office of Inspector General (OIG) within the Department of Health and Human Services published a continuation notice in the Federal Register extending the...more
Fridays are for fraud and abuse news-related releases, yet again. Last Friday, the HHS Office of the Inspector General (OIG) released a notice (Notice) informing the public that it has delayed the release of a final rule...more
On October 17, 2014, CMS and OIG jointly published a notice extending the effectiveness of a November 2011 interim final rule establishing waivers that protect qualifying accountable care organizations (ACOs) from liability...more
The Centers for Medicare & Medicaid Services (“CMS”) announced a new initiative, the ACO Investment Model, on October 15, 2014. Under the model, ACOs which are made up of “providers [who] lack adequate access to … capital”...more