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Matthew S. Mora

Associate

[email protected]

+1.202.434.7411

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Matt advises health care clients on regulatory and transactional matters, including fraud and abuse, HIPAA privacy and security, and general contracting.

Prior to joining Mintz, Matt worked as in-house counsel at an independent hospital and outpatient facility, where he provided guidance on a range of fraud and abuse issues, including compliance with the Stark Law, the Anti-Kickback Statute, and the False Claims Act. He also counseled on HIPAA privacy and security as well as other regulatory matters. Matt handled the structuring and negotiation of physician and referral source arrangements, negotiated vendor contracts, and assisted in the formation of a Medicare Shared Savings Program Accountable Care Organization. In addition, Matt conducted due diligence and drafted, negotiated, and finalized complex transactions for the facility. He also regularly provided guidance on corporate governance issues and prepared regulatory and corporate filings.

Matt received the Health Law Certificate at the University of Maryland ‘s Francis King Carey School of Law and was a law clerk in the Office of the General Counsel at the Johns Hopkins Health System and at the Maryland Department of Health and Mental Hygiene.

Education

  • University of Maryland (JD)
  • University of Maryland (BA, cum laude)

Involvement

  • Member, American Health Lawyers Association

Viewpoints

HHS and Medicare Default Image

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 1: Value-Based Arrangements

October 15, 2019 | Blog | By Theresa Carnegie, Matt Mora, Michelle Caton

As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if finalized, would implement sweeping changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). The proposed rules seek to reduce barriers to value-based contracting in several ways, including: (1) creating new safe harbors to the AKS; (2) adding new exceptions to the Stark Law; and (3) retooling existing AKS safe harbors, along with the Civil Monetary Penalties rules regarding beneficiary inducements. Below are key takeaways from both the OIG’s and the CMS’s proposed rules as they relate to the new value-based arrangements safe harbors and Stark Law exceptions.
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Senate Finance Committee Passes Drug Pricing Bill

July 30, 2019 | Blog | By Theresa Carnegie, Ellyn Sternfield, Matt Mora, Michelle Caton, Eli Greenspan

Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the Senators introduced their much-anticipated proposal to lower drug prices: a chairman’s mark called the Prescription Drug Pricing Reduction Act (PDPRA) of 2019.

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Another Chance for HIPAA and Part 2 Harmony?

July 22, 2019 | Blog | By Dianne Bourque, Matt Mora

There are reports that HHS plans to issue a proposed rule next month, which would again amend 42 CFR Part 2 (“Part 2”) and modify how the medical records of patients with substance abuse disorders are currently shared between providers. Part 2 amendments, especially amendments to align Part 2 with the Health Insurance Portability and Accountability Act (“HIPAA”), would be welcome news to the many stakeholders in the industry who have repeatedly voiced their concerns regarding the regulatory hurdles that surround the disclosure of drug and alcohol treatment records.
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Trump Administration Withdraws Proposed Rebate Rule

July 11, 2019 | Blog | By Susan Berson, Theresa Carnegie, Matt Mora

In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate protections for certain drug rebates paid by pharmaceutical manufacturers. “Based on careful analysis and thorough consideration, the president has decided to withdraw the rebate rule. The Trump administration is encouraged by continuing bipartisan conversations about legislation to reduce outrageous drug costs imposed on the American people, and President Trump will consider using any and all tools to ensure that prescription drug costs will continue to decline," White House Deputy Press Secretary Judd Deere said in a statement.
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OIG Issues Fraud Alert Regarding Fraudulent Genetic Testing Schemes

June 5, 2019 | Blog | By Karen Lovitch, Matt Mora

Earlier this week the OIG took the somewhat unusual step of issuing a fraud alert directed to Medicare beneficiaries (rather than to Medicare providers) regarding “fraud schemes” that involve genetic testing. According to the OIG, beneficiaries are being offered genetic tests in order to obtain their Medicare information, which is then used to commit identity theft or to submit fraudulent claims to Medicare. Beneficiaries are being targeted through telemarketing calls, booths at public events, health fairs, and door-to-door visits.
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OIG Approves Free Post-Discharge Care Program

March 18, 2019 | Blog | By Ellen Janos, Matt Mora

Earlier this month, the Department of Health and Human Services Office of the Inspector General (OIG) issued an advisory opinion (Advisory Opinion No. 19-03) (Opinion) concluding that a program consisting of free, in-home follow-up care to patients at a higher risk of admission or readmission (the Arrangement) was “low risk” under the civil monetary penalties prohibition on beneficiary inducement (the Beneficiary Inducement CMP). This comes as good news to hospitals and other providers who are focused on care coordination and value-based programs.
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Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a limited-use smartphone to financially needy patients taking the digital version of an antipsychotic drug. The OIG concluded that the arrangement would not constitute grounds for the imposition of civil monetary penalties (CMPs) under the prohibition on beneficiary inducement (the “Beneficiary Inducement CMP”) or administrative sanctions under the Anti-Kickback Statute (AKS).
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HHS Proposes to Remove Drug Rebate Protections

February 1, 2019 | Blog | By Susan Berson, Theresa Carnegie, Tara E. Dwyer, Matt Mora

On January 31, 2019, the U.S. Department of Health & Human Services (HHS) issued a proposed rule that would amend the discount safe harbor under the Anti-Kickback Statute (AKS) to eliminate protection for certain drug discounts paid by manufacturers to plan sponsors or their pharmacy benefit managers (PBMs) under Medicare Part D, and Medicaid managed care organizations (MCOs). Additionally, the proposed rule would create two new safe harbors to protect: (i) certain point-of-sale discounts on prescription pharmaceutical products; and (ii) certain fixed fee service arrangements between manufacturers and PBMs.
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OIG Opinion Illustrates the Need for New AKS Safe Harbors

October 17, 2018 | Blog | By Matt Mora

The Department of Health and Human Services Office of the Inspector General (“OIG”) has issued an Advisory Opinion regarding a surgical device and wound care product manufacturer’s proposal to offer its hospital customers who purchase a suite of three joint replacement products a warranty program covering the Product Suite.
As a continuation of the recent drug pricing developments tied the Trump Administration’s American Patients First Blueprint, beginning January 1, 2019, Medicare Advantage plans will be able to apply step therapy for physician-administered and other Part B drugs in an effort that CMS hopes will lower drug costs and improve the quality of care for Medicare beneficiaries.