News & Analysis as of

CMS and OIG Issue Notice of Amended Waivers for Next Generation ACO Model

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

HHS OIG Issues Report on Medicare’s 2-Midnight Rule

On December 19, 2016, the HHS OIG issued a report on Medicare’s 2-midnight rule titled “Vulnerabilities Remain Under Medicare 2-Midnight Hospital Policy.” The report reviews data from 2013 and 2014 and reaches several...more

New Initiatives for the New Year: Highlights of the OIG’s 2017 Work Plan

On November 10, 2016, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued its 2017 Work Plan. The 2017 Work Plan outlines the areas of special concern to the OIG and...more

HHS OIG Issues Report on CMS’s Management of the Quality Payment Program

On December 21, 2016, the HHS OIG posted a report summarizing its early review of CMS’s management of the implementation of the Quality Payment Program (QPP) and related findings (“Report”). The Report concludes that, while...more

Health Care Institutions

Originally published in Haig, Business and Commercial Litigation in Federal Courts, Fourth Edition §§ 87:1 et seq. © 2016 American Bar Association. This chapter discusses federal court litigation relating to health care...more

OIG Issues Report on Medicare’s ‘2-Midnight Hospital Rule’

On December 19, 2016, the US Department of Health and Human Services Office of Inspector General (OIG) posted a report examining the Centers for Medicare & Medicaid Services’ (CMS’s) “2-Midnight Rule.” The OIG concluded that...more

OIG Report Offers Glimpse into CMS Progress Towards MACRA Implementation

Last week, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a report analyzing CMS’ readiness to implement major parts of the Medicare Access and CHIP Reauthorization Act of...more

OIG Finalizes CMP Regulations, Largely as Proposed

On December 7, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) finalized [PDF] its proposal to update the civil monetary penalty (CMP) regulations – namely, incorporate new CMP authorities...more

CMS Issues Final Mandatory Episode Payment Models for Cardiac and Orthopedic Cases, Plus New Cardiac Rehabilitation Incentive...

In the waning days of the Obama Administration, the Centers for Medicare & Medicaid Services (CMS) has unveiled a lengthy and complex final rule to establish mandatory Medicare bundled payment programs for acute myocardial...more

HHS-OIG reports on impact and vulnerabilities of Medicare's Two-Midnight Rule

On December 19, 2016, the US Department of Health and Human Services, Office of Inspector General (HHS-OIG) issued a report, "Vulnerabilities Remain Under Medicare 2-Midnight Hospital Policy" (OEI-02-15-00020). The report is...more

OIG Still Rejects Lab's Free Labeling Services for Dialysis Facilities in Advisory Opinion No. 16-12

8 Years and New Reimbursement Methodology Later - On November 28, 2016, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued an unfavorable advisory opinion, No. 16-12, regarding a...more

Senate Finance Committee Releases Report on Concurrent and Overlapping Surgeries

On December 6, 2016, Senate Finance Committee Chairman Orrin Hatch (R-Utah) and Ranking Member Ron Wyden (D-Ore.) issued a Committee staff report detailing concurrent and overlapping surgery practices. The report also offers...more

OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more

2016 Health Care Year in Review

Since I began writing this year-end review in 2013, there have been some common themes – a shift to pay for quality and away from fee-for service, much of which has been brought about by the Affordable Care Act (ACA): efforts...more

Practical Considerations for Medical Practices Considering Converting Their Vascular Access Centers Into Medicare-Certified...

On November 2, 2016 the Centers for Medicare & Medicaid Services (CMS) released the 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Although the impact of the Final Rule on nephrology reimbursement is projected to be...more

Manatt on Health Reform: Weekly Highlights - November 2016 #5

The incoming Trump Administration selects HHS and CMS leadership; Alaska moves forward with its proposed 1332 waiver for its ACA reinsurance program; and a new Manatt Health report considers the role of Medicaid supplemental...more

OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) is charged with ensuring the integrity of more than 100 programs administered by DHHS, including...more

OIG Issues 2017 Work Plan

On November 10, 2016, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) posted its work plan (the “Work Plan”) for fiscal year 2017. The OIG publishes its Work Plan on an annual basis. The...more

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

In a special “Manatt on Health Reform” feature, we track Governors’ and state healthcare officials’ reactions to the Presidential election; HHS plans investigations into rising drug costs; and Colorado voters reject a...more

Proposed Rule to Strengthen State Medicaid Fraud Control Units

A recently published proposed rule expands the functions and responsibilities of state Medicaid Fraud Control Units (MFCUs). The rule was issued by the Centers for Medicare and Medicaid Services (CMS) and the Office of...more

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

HealthCare.gov consumers begin previewing 2017 coverage options as HHS projects a 9% enrollment increase over last year and an average 22% benchmark premium increase; Oregon study finds increased primary care spending in...more

Ten Things to Know About the CMS Long-Term Care Requirements Final Rule

Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more

New OIG Studies Reveal Clinical Lab Test Payment Trends and CMS’ Progress in Implementing PAMA

Last week, the OIG released two new studies analyzing what and how Medicare pays for clinical laboratory tests (“lab tests”). The first study, Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of...more

Five Things to Know About the Mylan EpiPen “Settlement” – What It Is and What It Isn’t

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate...more

OIG Raises Concerns Regarding Accuracy of New Clinical Laboratory Payment System

On October 3, 2016, OIG released a report monitoring CMS’s progress on preparing for the implementation of the new payment system for clinical laboratory tests. The new payment system was mandated by the Protecting Access to...more

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