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Troy Barsky is a partner in Crowell & Moring's Washington, D.C. office, and serves as a member of the firm’s Health Care Group Steering Committee where he focuses on health care fraud and abuse, and Medicare and Medicaid law and policy. Troy counsels all types of health care entities, including hospitals, group practices, and health plans on the physician self-referral law (Stark Law) and the Anti-Kickback Statute, innovative healthcare delivery models, such as Accountable Care Organizations (ACOs), and Medicare & Medicaid payment and coverage policy. He also defends clients seeking resolution of government health care program overpayment issues or fraud and abuse matters through self-disclosures and negotiated settlements with the U.S. Department of Justice, U.S. Health & Human Services Office of the Inspector General and the Centers for Medicare & Medicaid Services (CMS).

President Biden signs Executive Order directing HHS to “consider additional actions to further drive down prescription drug costs”

On October 14, 2022, President Biden signed an Executive Order (EO) directing the Secretary of the Department of Health and Human Services (HHS) to consider new healthcare payment and delivery models the Center for Medicare & Medicaid Innovation (CMMI), part of the Centers for Medicare & Medicaid Services (CMS) and created by the Affordable Care Act, can test to lower drug costs and promote access to innovative drug therapies for Medicare and Medicaid beneficiaries. The EO specifies the HHS Secretary should include models that may lead to lower cost-sharing for commonly used drugs and support value-based payment initiatives that promote high-quality care. The Secretary must submit its report, describing any models selected, within 90 days of the EO’s issuance.  

Continue Reading White House looks to CMMI to test new ways to lower drug prices

Crowell & Moring and Crowell Health Solutions hosted a HealthTech roundtable with discussions focused on value-based care, health equity, data privacy, artificial intelligence, and other trends in health care technology in the Washington, D.C. office on October 27. The sessions featured numerous experts from health technology companies, advocacy organizations, and trade associations, all of whom

CMS Administrator Chiquita Brooks-LaSure and CMS Innovation Center Director Elizabeth Fowler continue to forge ahead with the Biden-Harris Administration’s plans to evaluate and streamline the alternative payment models being tested at the Innovation Center. The most recent example, announced late last month, includes the redesign and renaming of the controversial Global and Professional Direct Contracting (GPDC) model that aims to introduce value-based payment arrangements in traditional Medicare. The newly announced model, renamed the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model, aligns with CMS’s restated goals for the Innovation Center—as outlined in its October 2021 “strategic refresh” white paper—to drive accountable care, advance health equity, support care innovations, improve access by addressing affordability, and partner to achieve system transformation.
Continue Reading CMS Innovation Center Redesigns Direct Contracting Entity Model, Launches ACO REACH

Today, CMS released its strategy for the CMS Innovation Center (the “Strategy”) in a White Paper, Innovation Center Strategy Refresh. This Strategy and the connection to broader CMS priorities was outlined by CMS Administrator Brooks-LaSure and CMS Innovation Center Director, Liz Fowler, in a webinar and is intended as a blueprint for the next 10 years.  While the Innovation Center’s overarching goal continues to be expansion of successful models that reduce program costs and improve quality and outcomes for Medicare and Medicaid beneficiaries, CMS highlights five strategic objectives: Drive Accountable Care, Advance Health Equity, Support Innovation, Address Affordability, and Partner to Achieve System Transformation and created a new vision: “A health system that achieves equitable outcomes through high-quality, affordable, and person-centered care.”

Continue Reading CMS Innovation Center Announces New Strategic Direction Under the Biden Administration

Earlier this month, OIG issued a Special Fraud Alert on Speaker Programs warning drug and device companies and health care providers that it has significant concerns about payments for “speaker programs.” Based on recent investigations and enforcement activity, the OIG has found that a number of speaker programs sponsored by drug and device manufacturers violate the federal Anti-Kickback Statute (AKS). OIG is skeptical about the educational value of speaker programs provided under circumstances that are not conducive to learning and to audience members who have no legitimate reason to attend. Additionally, OIG questions the value of such events given that health care providers can access the same or similar information online, on the product’s package insert, third-party educational conferences, medical journals, and more. Because all of this material is already available, OIG warns “that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals” in violation of the federal Anti-Kickback Statute (AKS).

OIG defined speaker programs as drug or device “company-sponsored events at which a [outside] physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other [outside] HCPs about a drug or device product or a disease state on behalf of the company” using a presentation developed and approved by the company. HCPs are paid an honorarium and attendees are paid generally through free meals and drinks, for example.

Based on its investigations to date, OIG provided an illustrative list of speaker program characteristics that result in higher level of scrutiny with respect to AKS violations:

Continue Reading OIG Sends a Special Fraud Alert on Speaker Programs

As of October 3, 2019, the Office of Management and Budget completed its review of the proposed rules for “modernizing and clarifying” the Physician Self-Referral Regulations and revising the safe harbors under the Anti-Kickback Statute and rules regarding the Beneficiary Inducement Civil Monetary Penalties Law.

These regulations were the subject of two Requests for Information

In the latest episode of Payers, Providers, and Patients – Oh My!, Troy Barsky and Alice Hall-Partyka talk with Joe Records and Payal Nanavati about how recent litigation challenging the constitutionality of the Affordable Care Act may impact providers and payers. The discussion focuses on the authority for innovative health care models and

On November 1, 2018, the Centers for Medicare & Medicaid Services (“CMS”) filed the pre-publication version of the CY 2019 Physician Fee Schedule Final Rule (“2019 PFS Final Rule”). Within this massive publication, CMS finalized two regulatory changes affecting the exceptions at 42 CFR § 411.357 to the Physician Self-Referral Law (also known as the “Stark Law”) for compensation arrangements. The 2019 PFS Final Rule reconciles the regulations with the statutory changes made to the Stark Law enacted by the Bipartisan Budget Act of 2018 (“2018 BBA”) with respect to (1) how arrangements may fulfill the “writing” requirement under the compensation exception and (2) how arrangements that initially proceed without a signed agreement may still meet the signature requirement of an applicable exception. Parties to financial arrangements in effect on or after February 9, 2018 that implicate the Stark Law may rely upon these new modifications.

The Stark Law generally prohibits a physician from making a referral of designated health services (“DHS”) to an entity with which he or she (or an immediate family member) has a financial relationship. Section 411.357 details several excepted compensation arrangements carved out from the “financial relationship” definition for the purposes of the Stark Law. These exceptions include arrangements for the rental of office space and equipment, bona fide employment relationships, group practice arrangements with hospitals, certain fair-market-value compensation arrangements, among others.
Continue Reading 2019 Physician Fee Schedule Rule Modifies Stark Regulations to Reflect Statutory Changes

On November 28, 2016, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued an unfavorable advisory opinion (No. 16-12) that addresses the permissibility, under the federal Anti-Kickback Statute (AKS), of a laboratory’s proposal to label test tubes and collect specimen containers at no cost to, and for