Medicare Medicaid

News & Analysis as of

CMS Limits the Scope of Review for Certain Redeterminations and Reconsiderations

For providers who have received inconsistent or varying reasons for denial while navigating through the Medicare appeals process, the Centers for Medicare & Medicaid Services (CMS) has provided much-needed relief in the form...more

HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA...more

CMS Proposes Exceptions, Revisions and Requests Comments to Ease Stark Law Compliance

The Centers for Medicare & Medicaid Services (CMS) recently proposed regulatory changes to the Stark Law that may ease certain compliance challenges. The Physician Self-Referral Law, located at 42 U.S.C. § 1395nn, and its...more

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

Telehealth Commercial Coverage and Parity Laws: Trends, Challenges and Opportunities

There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

Comprehensive Care for Joint Replacement: CMS adopts mandatory approach to payment reform

On July 9, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that seeks to implement a mandatory episode-based payment model for lower extremity joint replacement (and reattachment) care in...more

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

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

The ERISA Litigation Newsletter - August 2015

Editor's Overview - As the summer draws to a close, this month's Newsletter previews three cases that the U.S. Supreme Court already has agreed to hear that ought to be of particular interest to ERISA plan sponsors and...more

Added Compliance Burdens: New York Nonprofits Have to Implement Workplace Violence Programs

In 2010, New York State enacted its New York Prudent Management of Institutional Funds Act (NYPMIFA); in 2012 Governor Cuomo promulgated Executive Order 38 capping excess compensation at nonprofits receiving government...more

OIG Reviews Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors (PODs) of Spinal Devices

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a report on “Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors.” The OIG reviewed 12 hospitals that...more

CMS Publishes Corrections to Comprehensive Care for Joint Replacement Model Proposed Rule

On August 25, 2015, the Centers for Medicare & Medicaid Services (CMS) published technical and typographical corrections to its July 14, 2015 proposed rule to establish a Comprehensive Care for Joint Replacement Model. As...more

Hospital Compliance Program Overview

?In the constantly evolving climate of health care enforcement, maintaining a comprehensive and effective internal compliance program has taken on added significance, especially in the past few years. While detailed coverage...more

Proposed 2016 Medicare Physician Fee Schedule Includes Changes to Stark Regulations

The Centers for Medicare & Medicaid Services ("CMS") recently released the proposed 2016 Medicare Physician Fee Schedule (the "Proposed Rule"), which includes a number of proposed revisions to the regulations under the...more

The 60 Day Rule — Identification and Knowing Avoidance

On August 3, 2015, the United States District Court for the Southern District of New York issued an opinion and order in Kane v. Healthfirst, Inc., et al.[1] that provides the first judicial interpretation of the requirement...more

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

Two-Midnight Rule Update

The Centers for Medicare and Medicaid Services (CMS) announced a further delay, through December 31, 2015, of the Recovery Auditors’ (RA) audits of the “Two-Midnight” Rule. Congress previously passed a law delaying...more

Federal Court Rejects Health System's Efforts to Dismiss 60-Day Rule Suit

On August 3, 2015, the United States District Court in the Southern District of New York issued a long-awaited opinion and order rejecting a motion to dismiss filed by the defendants in U.S. ex rel. Kane v. Continuum Health...more

Compliance: Reporting Overpayments and the 60-day Clock

On August 3, 2015, a federal judge in New York issued an important opinion regarding the False Claims Act and what it means to “identify” an overpayment for purposes of starting the 60-day clock in which Medicare and Medicaid...more

Another Delay for the Two-Midnight Rule

The Centers for Medicare and Medicaid Services (CMS) announced, on August 12, 2015, that it has extended the enforcement delay of the controversial two-midnight rule governing short hospital stays until the end of the year....more

Court Imposes Potentially Unworkable Burden on Providers Under ACA's Report and Return Rule

In Kane ex rel. U.S. v. Healthfirst, Inc., the federal district court for the Southern District of New York (District Court or Court) provided on August 3 the first and long-awaited interpretation as to when a health care...more

Health Law Pulse - August 2015

The Office of the Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a nonprofit health system (System) and a nonprofit psychiatric hospital (Center) regarding a proposal whereby the...more

CMS Continues Its Focus on Quality Initiatives with the FY 2016 IPPS Final Rule

On July 31, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a final rule (Final Rule) updating fiscal year (FY) 2016 Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS)...more

When an Overpayment Becomes a False Claims Act Issue: Explaining the First Judicial Interpretation of the 60-Day Rule

On August 3, 2015, Judge Edgardo Ramos of the United States District Court for the Southern District of New York issued the first judicial opinion addressing when a health care provider has “identified” a Medicare or Medicaid...more

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