News & Analysis as of

Remuneration Centers for Medicare & Medicaid Services

CMS Completes Final Medicare Part D Reconciliation for 2016

CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017....more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

CMS Releases the Final Medicare Part D DIR Reporting Requirements for 2016

On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of...more

CMS Releases the Proposed Part D DIR Reporting Requirements for 2016

Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline....more

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

by Baker Ober Health Law on

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

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

by McDermott Will & Emery on

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

Senate Bill Targets Part D DIR Fees

Just last month the “Improving Transparency and Accuracy in Medicare Part D Spending Act” was introduced in the Senate to amend the Social Security Act. The bill seeks to prohibit Part D plans (and their contracted pharmacy...more

Important Changes for Physicians from the 2016 Medicare Physician Fee Schedule: Part I (Stark Changes)

by Polsinelli on

On November 16, 2015 the Centers for Medicare and Medicaid Services (CMS) published the final Medicare Physician Fee Schedule (Final MPFS). The Final MPFS addresses changes to the physician fee schedule and related policies,...more

Proposed Changes to Stark Rule Would Create New Hospital Exceptions and Lessen Burden of Self-Disclosures

by Poyner Spruill LLP on

In a development that is limited in scope but still welcomed by hospitals, the proposed 2016 Physician Fee Schedule proposes a number of new exceptions to the physician self-referral or Stark law and other refinements that...more

Stark Regulations: Proposed Physician Recruitment Provisions

by Baker Ober Health Law on

Assistance to Employ a Non-Physician Practitioner (NPP) - Currently under the Stark law, the physician recruitment exception (42 C.F.R. § 411.357(e)) permits hospitals, Federally Qualified Health Centers (FQHCs) and...more

Stark Regulations: Technical Revisions

by Baker Ober Health Law on

The proposed Physician Fee Schedule for CY 2016 includes multiple technical revisions to the regulations implementing the Stark law. These revisions appear to be designed to provide greater clarity and flexibility with...more

OIG Provides Direction and CMS Seeks Direction Relating to Electronic Activities in the Health Care Delivery System

The OIG recently posted an Advisory Opinion which concluded that a hospital's proposal to provide free access to an electronic interface between the hospital and area physicians for laboratory and diagnostic services was not...more

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