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Supreme Court Considers Circuit Split On The “Implied Certification” Theory Under the False Claims Act

On April 19, 2016, the United States Supreme Court heard oral argument on the viability and breadth of the “implied certification” theory of the False Claims Act (“FCA”). The implied certification theory supports FCA...more

OIG Updates Permissive Exclusion Criteria – Suggests Compliance Programs Are Expected

On April 18th, the Office of Inspector General (OIG) issued updated guidance describing the factors it will consider in determining whether to exercise its permissive authority to exclude individuals and entities from federal...more

Differences in Medical Opinions: Not Enough to Prove FCA Liability

In a $200 million False Claims Act (FCA) litigation with certain twists and turns, the U.S. District Court for the Northern District of Alabama recently found that the federal government failed to show that claims submitted...more

Site-Neutral Billing Exemptions

The Balanced Budget Bill Act of 2015 has a site-neutral billing provision relating to off-campus hospital outpatient departments (HOPDs). Those are facilities away from the hospital campus but certified as part of the...more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

HUD Proposes Expanding Indebtedness Eligible for Refinancing with FHA-Insured Loans

The U.S. Department of Housing and Urban Development (HUD) recently published proposed revisions to its Handbook covering its Healthcare Insurance Mortgage Program under Section 232 of the National Housing Act (the Section...more

Final Blacklisting and Contractor Paid Sick Leave Rules Slated for Late Summer Publication, According to Spring Regulatory Agenda

Although this election season may feel endless, there are only six more months until voters decide the next president and members of Congress. Within this window, federal agencies are scrambling to finalize rules before the...more

Manatt on Health Reform: Weekly Highlights - May 2016 #3

Maryland becomes the first State to mandate over-the-counter contraceptive coverage; Missouri plans to increase Medicaid asset limitations by 500% by 2021; and HHS' final rule extends protections against sex discrimination to...more

Manatt on Medicaid: Observations from New York's DSRIP Implementation

Editor's note: Medicaid is the largest healthcare payer in virtually every state. States are increasingly leveraging that position to drive payment and delivery system reform efforts. One powerful tool to enable...more

Guest Post - Implied Certification: An Eradicated Pest or Here to Stay?

Today’s guest post is courtesy of Reed Smith’s Lindsey Harteis. She’s been following the big-deal UHS v. Escobar False Claims Act that the Supreme Court could decide any day now (or could wait until the end of June), which...more

CMS Unveils Revised Voluntary Self-Referral Disclosure Protocol

On May 6, 2016, the Centers for Medicare and Medicaid Services (CMS) released proposed revisions to its Voluntary Self-Referral Disclosure Protocol (SRDP), through which providers may disclose actual or potential violations...more

Civil Penalties for False Claims May Nearly Double, Raising the Stakes for Qui Tam Suits

Federal agencies are now promulgating regulations nearly doubling the per claim civil penalty for False Claims Act violations. The Bipartisan Budget Act of 2015 requires federal agencies to implement a “catch up adjustment”...more

Qui Tam Defendant’s Confidentiality-Breach Counterclaim Fails

What if a whistleblower discloses the protected health information (PHI) of privately insured patients in making the claim that his employer submitted false Medicare claims? And what if that violates a confidentiality...more

ACO Insider: MACRA – Don’t Let Indecision Be Your Biggest Decision

By now, most of us have heard of accountable care organizations and bundled payment. But for many of you, the shift to value-based population health management or compensation based on performance hasn’t affected your...more

Former Medicaid Auditor for D.C. Government Permitted to Proceed with FCA Retaliation Claim

The Federal District Court for the District of Columbia recently ruled that a former director of Medicaid audits in Washington D.C. can proceed with retaliation claims alleging he was fired for trying to stop his former...more

Medicare Rolls Out Proposed Rule Altering Physician Payment Model

Currently, Medicare measures the value and quality of care provided by doctors and other clinicians through a patchwork of programs. Some clinicians are part of Alternative Payment Models such as the Accountable Care...more

Massachusetts Long-Term Services and Supports: Achieving a New Vision for MassHealth

Long-term services and supports (LTSS) enable hundreds of thousands of people of all ages in Massachusetts to live with independence and dignity, participate in their communities and increase their overall quality of life....more

Manatt on Medicaid: CMS Finalizes Overhaul of Medicaid and CHIP Managed Care Rules

Overview - On April 25, 2016, the Centers for Medicare and Medicaid Services (CMS) released its highly anticipated final rule to overhaul the regulatory framework governing Medicaid managed care and make conforming...more

House v. Burwell: Insurer Cost-Sharing Subsidies Unauthorized

A U.S. District Judge has ruled that HHS unlawfully has spent billions of dollars to reimburse insurers for cost-sharing reductions granted to individuals who bought health insurance through an ACA Exchange such as...more

Health Law Insights Newsletter - Issue 9 - May 2016

NATIONAL - Medicare Proposes New Part B Payment System - The Center for Medicare and Medicaid Services (CMS) on April 27 proposed a new rule that would transform Medicare Part B reimbursement to practitioners into...more

New Exclusion Guidance Includes Presumption of Compliance Plan

Section 1128 of the Social Security Act (42 U.S.C. 1320a–7) (available here) established mandatory and permissive authority for exclusion of health care providers from Federal health care programs based on provider conduct. ...more

CMS’s Final Medicaid Rule Creates a Medicaid MLR Framework but Leaves Room for State Variation

In Depth - The final Medicaid managed care rule issued by the Centers for Medicare & Medicaid Services (CMS) on April 25, 2016, (the Final Rule) establishes a new federal medical loss ratio (MLR) standard for Medicaid...more

On May 4, 2016 changes to the procedure for applying the “third one is out” rule in state procurement of medical devices entered...

RF Government Resolution No. 102 of February 5, 2015 approved a list of certain types of foreign-manufactured medical devices (the “List” and “Devices,” respectively) in the procurement of which state and municipal customers...more

OIG Issues New Criteria for Implementing its Section 1128(b)(7) Exclusion Authority

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued new, non-binding “Criteria for Implementing Section 1128(b)(7) Exclusion Authority” updating the factors OIG will consider in...more

First Agency Publishes Significant Increase in FCA Penalties; Others Expected to Follow

On May 2, 2016, the Railroad Retirement Board (Board) published an interim final rule in the Federal Register amending its regulations to increase the minimum and maximum civil monetary penalty amounts under the Board’s...more

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