News & Analysis as of

Antitrust Considerations Surrounding Health Care Consolidation Among Hospitals and Physicians

The Affordable Care Act (“ACA”) has resuscitated the demand for hospital and health care provider mergers. The law explicitly encourages collaborative care—through, for example, financial incentives surrounding the creation...more

The Reformed Health Care Industry: Creative Structures and Alliances Can Yield Great Benefits, but Also Great Risks

Since the Affordable Care Act (the “ACA”) was enacted in 2010, the health care industry has been on the edge of its proverbial seat waiting to see which care delivery models are best suited to sustain all the changes: to...more

FDA Issues Updated Draft Guidance on Reporting Drug Samples

The guidance calls for 2014 reporting by April 1, 2015. When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment Sunshine Act,...more

Shorts on Long Term Care - Summer 2014

In this issue: - Nursing Facility Survey Trends: Directed Plans of Correction, Privacy Violations and FTag 520 Quality Assurance Committee Citations - COBRA Meets ACA – Time to Update COBRA Notices -...more

Take 5 Newsletter: Five Labor and Employment Issues Faced by Health Care Employers

As the Affordable Care Act and the challenges of reimbursement and funding for health care services drive changes in the health care delivery system and employment in the industry, new issues in labor and employment law are...more

Software Glitch Sparks FCA Suit Against Hospitals for Late Repayment of Medicaid Reimbursements

On June 27, the New York Attorney General’s Office and the U. S. Attorney’s Office for the Southern District of New York intervened in a qui tam suit against Continuum Health Partners, Inc., Beth Israel Medical Center and St....more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

The Dark Side of Health Care Reform: The First “60-Day Rule” False Claims Act Case

The U.S. Department of Justice and New York State Attorney General’s Office recently intervened in a federal False Claims Act case in federal District Court based on allegations that a provider failed to report and refund an...more

The Government Intervenes In False Claims Act Case Alleging Failure To Return Overpayments Within 60 Days

On June 27, 2014, the United States intervened in a qui tam action under the False Claims Act alleging that certain New York hospitals failed to refund Medicaid overpayments within 60 days of identifying them, as required by...more

Health Care Update - June 2014 #2

In This Issue: - Confusion Persists in Anticipation of 340B “Mega-Rule” - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

Healthcare Providers Face Increasing Financial Pressure and Bankruptcy Risk

The health of the healthcare industry can be summarized as follows: as go federal reimbursement rates, so goes the financial viability of healthcare providers, whether hospitals, nursing homes or medical practices. These...more

OIG's Proposed Rule to Expand Civil Monetary Penalties

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) on May 12, 2014 published a proposed rule (Proposed Rule) that would implement the OIG’s expanded authority under the Affordable Care...more

Medicaid Enrollment Continues to Grow

The U.S. Department of Health and Human Services (HHS) has reported that at the close of April, an additional 6 million Americans have enrolled in Medicaid and related health programs for the poor since the launch of coverage...more

Changes Proposed to PRRB Dissatisfaction Requirement

On May 15, 2014, CMS published in the Federal Register its FY 2015 IPPS Proposed Rule [PDF], which included changes and updates to its Medicare IPPS policies. 79 Fed. Reg. 27978-28384. One change that CMS proposes is to amend...more

Health Update - June 2014

In This Issue: - Judge Rules Against 340B Drug Authority - FDA Approves Skin Infection Drug - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

Health Care in 2014: A Brave New World

With the completion of the enrollment phase of the Affordable Care Act (ACA), health care in the United States has entered a new era that will be characterized by extensive changes and challenges for both providers and...more

Federal Court Vacates 340B Rule Regarding Orphan Drugs

On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al. At...more

Health Care Reform Implementation Update - May 2014

Congress held several hearings last week ranging from Sylvia Burwell’s nomination for Secretary of the Department of Health and Human Services (HHS), to Medicare payment oversight, to post-acute care in Medicare. The Centers...more

Proposed 2015 IPPS Rule Contains Many Changes to GME and IME Rules

Each year when CMS publishes its proposed changes to the IPPS Rule, it suggests a number of graduate medical education (GME) and indirect medical education (IME) reforms. This year has been no different. As part of the IPPS...more

Oh Baby: Medicare Wants to Focus on Early Elective Deliveries

Deep within the proposed FY 2015 Inpatient Prospective Payment System (IPPS) rule released a few weeks back is an interesting proposed new measure to the Medicare hospital Value-Based Purchasing (VBP) program – elective...more

HHS OIG Proposes Rule to Expand Exclusion Authorities

On May 9, 2014, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published a proposed rule that would significantly expand the exclusion regulations applicable to persons or entities...more

The push for greater transparency in healthcare continues

Recently, CMS released the proposed fiscal year 2015 Inpatient Prospective Payment System (IPPS) rule for inpatient stays in long-term and general acute care hospitals. Included among the regular updates to Medicare payment...more

Health Headlines: Also in the News - May 2014

OIG Reports Jurisdiction H Contractors Made $3.3 Million in Overpayments for Outpatient Drugs – According to a recent OIG report, the Medicare Contractors for Jurisdiction H overpaid providers approximately $3.3...more

CMS Requests Comments on the Dispute Resolution Process Associated with the Physician Payment Sunshine Act

On May 5, 2014, the Centers for Medicare & Medicaid Services ("CMS") announced an opportunity to submit comments on the dispute resolution and correction procedures proposed in the final rule on the Open Payments reporting...more

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