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HHS Finalizes Sweeping Changes to Stark Law, Anti-Kickback Statute Regulations

On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and...more

OIG Finalizes Revisions to Safe Harbor Protection for Drug Rebates and Establishes New Safe Harbors for Point-of-Sale Price...

On November 20, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule as part of ongoing administration drug pricing reform efforts and in conjunction with the...more

Special Fraud Alert: OIG Raises Concerns with Speaker Programs

In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more

But Wait, There’s More! CMS Provides Additional Regulatory Relief Through Expanded Blanket Waivers

The Centers for Medicare and Medicaid Services (CMS) issued blanket waivers under Section 1135 of the Social Security Act (Section 1135 waivers) on April 30, 2020. Fast on the heels of a more modest waiver announcement on...more

CMS Announces Immediate COVID-19 Reporting Requirements Applicable to Long Term Care Facilities

As previously reported, President Trump’s Opening Up America plans introduce measures to slowly ease business and social restrictions and require enhanced testing and reporting of Coronavirus (COVID-19) incidences in long...more

CMS Issues Explanatory Guidance on Nationwide Blanket Stark Law Waivers

On April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued explanatory guidance on the scope and application of a series of nationwide Section 1135 waivers of the physician self-referral law (Stark Law)...more

CMS Enhances COVID-19 Reporting and Surveillance Obligations for Long Term Care Facilities

On April 19, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Quality, Safety and Oversight Group (QSO) memorandum (QSO-20-26-NH) informing long term care facilities, including nursing homes, about certain...more

Medicare Resources and Information for Home Health and Hospice Agencies During the COVID-19 Pandemic

The Centers for Medicare and Medicaid Services (CMS) recently provided Section 1135 waivers and guidance granting flexibilities to home health agencies (HHAs) and hospices during the Coronavirus (COVID-19) pandemic national...more

CMS Issues Nationwide Blanket Waivers of Stark Law and OIG issues an AKS Policy Statement

This On the Subject was updated on April 7, 2020, to address the Department of Health and Human Services Office of Inspector General’s (OIG’s) April 3, 2020, Policy Statement and its potential impact as well. The Centers...more

CMS Provides Guidance to Ambulatory Surgical Centers Temporarily Enrolling in Medicare as Hospitals During the COVID-19 Pandemic

On April 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued Quality, Safety & Oversight memorandum QSO-20-24-ASC (the QSO Memo), addressed to state survey agencies to provide guidance on processing attestation...more

CMS Issues Broad Package of Blanket Waivers Under Section 1135

The updated waivers build upon the more limited set of Section 1135 waivers issued on March 13, 2020, and address common concerns among Medicare providers and suppliers as they deal with the Coronavirus (COVID-19) pandemic....more

CMS Expands Accelerated and Advance Payment Program to All Medicare Providers, Suppliers

Accelerated or advance Medicare payments can provide some cash flow as providers and suppliers combat the effects of the Coronavirus (COVID-19) pandemic. This program requires a one-page application and funds may be available...more

HHS OIG Establishes Portal and Process to Provide Guidance on Anti-Kickback and Beneficiary Inducement Statutes During COVID-19...

The US Department of Health and Human Services, Office of Inspector General has created an information portal and established a process to provide guidance on the application of the Anti-Kickback Statute and Beneficiary...more

CMS Dramatically Modifies and Expedites the Medicare Enrollment Process to Combat COVID-19

The Centers for Medicare and Medicaid Services is expediting Medicare enrollment applications and allowing certain categories of practitioners to temporarily enroll in Medicare Part B to increase the number of healthcare...more

CMS Releases Fact Sheets on COVID-19 Medicare Coverage, Billing Guidelines

The Centers for Medicare and Medicaid Services (CMS) released several fact sheets on COVID-19 coverage and benefits, and announced a second Healthcare Common Procedure Coding System (HCPCS) code, U0002, for billing COVID-19...more

New Guidance on Medicare Payment Rule Enforcement

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more

[Webinar] Regulatory Sprint To Coordinate Care - November 19th, 21st, and December 5th, 12:30 pm ET

To help accelerate the transformation of the US healthcare system from a fee-for-service to a value-based system, the US Department of Health & Human Services (HHS) launched its “Regulatory Sprint to Coordinated Care”...more

Stark Law Proposed Change Affects Group Practice Special Rules for Productivity Bonuses, Profit Shares

On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to...more

HHS Proposes Substantial Changes to Stark Law and Anti-Kickback Statute Regulations

The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more

CMS Final Rule Strengthens Integrity of Medicare Provider Enrollment Process

On September 10, 2019, the US Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) expanding Medicare, Medicaid and Children’s Health Insurance Program...more

CMS Publishes Proposed Amendments to Stark Law Advisory Opinion Regulations

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) published the CY 2020 Medicare Physician Fee Schedule Proposed Rule, which included substantial changes to the physician self-referral law (Stark Law)...more

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