News & Analysis as of

OCR HIPAA Phase 2 Audits Coming Soon. Be Prepared.

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced that the agency expects to begin Phase 2 Audits in early 2016. OCR intends to conduct desk audits and on-site audits of covered...more

CMS and OIG Issue Final Fraud and Abuse Waivers for ACOs

On October 29, 2015, the Centers for Medicare & Medicaid Services and the Office of Inspector General of the Department of Health & Human Services (jointly, the “Agencies”) issued a final rule (Final Rule) regarding waivers...more

FDA data underscores why patients need to ask tough questions about care

The epidemic of overtreatment is hardly new, and it often stems from physicians’ tendency to order excessive tests. But now Uncle Sam is getting ready to step in even more, prompted in part by disturbing data that detailed...more

CMS Proposes Restrictions on Arbitration Provisions in Nursing Home Resident Agreements

The use of a binding arbitration provision in the pre-admission agreement between a senior living facility and its resident has become quite common. If properly drafted and presented to the resident or his or her...more

Medicare to Implement CJR: Mandatory Bundled Payment Program for Joint Replacement Surgeries

On Nov. 24, the Centers for Medicare & Medicaid Services will publish in the Federal Register the final rule for the Comprehensive Care Joint Replacement (CJR) Program. The CJR Program is a new payment model that requires...more

CMS Finalizes Revisions to Stark to Ease Burden on Providers, Refines “Incident to” Requirements

In its calendar year 2016 Physician Fee Schedule Final Rule published in the Federal Register on November 16, 2015 (Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized amendments to the federal...more

Increased risk of ‘Medjacking’ calls for better security measures on medical devices

Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant...more

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

CMS Gives Providers Some Leverage in RAC Record Collection Requirements: Five Things to Know about ADRs

The Centers for Medicare & Medicaid Services (“CMS”) announced that it has reduced the maximum percentage of records that providers must submit to Recovery Audit Contractors (“RAC”) through the payment auditing process...more

Areas of Unique Legal Concerns and Solutions in Device M&A

With medical device related acquisitions at all-time highs, and regulatory interest from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of Inspector...more

New Medicaid RCOs Raise Antitrust Issues for All Participating Health Care Providers

Physicians and other health care providers who were practicing in the 1990s were involved in numerous attempts to organize themselves in order to be able to participate in and even financially survive the onslaught of managed...more

OIG Issues HHS Fiscal Year 2016 Work Plan

The Work Plan describes more than 100 initiatives, including 43 new initiatives for the upcoming year. On November 2, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued its...more

Methods of treating a subset of patients are likely nonobvious if the subset exhibits unexpected results

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., a recent decision involving methods of treating a specific subset of patients, the Court of Appeals for the Federal Circuit (“Federal Circuit”) ruled that,...more

Abbott Secures Preliminary Injunction in Gray Market Case

On November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle...more

New York State Health Care—DSRIP, PPSs, COPAs and Antitrust “Immunity”

New York has received permission to use over $8 billion in Medicare and Medicaid funds to revamp how healthcare is provided throughout the State. As part of this process, the New York State Department of Health (DOH) is...more

DOJ Antitrust Head Remains Focused on Health Care in Era of Consolidation

Speaking at an industry conference on November 13, U.S. Assistant Attorney General Bill Baer reiterated the government’s focus on competition concerns in the health care industry. According to Baer, head of the Department of...more

Ignorance is Not Bliss: Get to Know the OIG FY 2016 Work Plan

The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently released its FY 2016 Work Plan, in which it identified key areas of focus for the upcoming year. Consistent with its mandate to detect...more

OCR Expected to Strengthen HIPAA Enforcement in 2016

Two recent reports issued by the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) recommended that HHS’s Office for Civil Rights (“OCR”) should fully implement a permanent audit...more

Washington Healthcare Update

This Week: Repealing Obamacare becomes problematic in the Senate... More focus on drug prices and reimbursement... FDA asks, should we regulate “natural” and if so, how? ...more

Blog: White House Publishes Precision Medicine Initiative Privacy Guidelines

On Monday, the White House released its Privacy and Trust Principles (the “Principles”) for the Precision Medicine Initiative (“PMI”). PMI is a federal initiative announced in the 2015 State of the Union to support research,...more

Health Alert (Australia) - November 16, 2015

In This Issue: -Judgments; Legislation; and Reports. - Excerpt from Judgments: Commonwealth. Federal Court 11 November 2015 - Ramsay Health Care Australia Pty Ltd v Compton [2015] FCA 1207 The Federal...more

A New Headache for Home Care Agencies: The New York Domestic Workers’ Bill of Rights

Home care agencies in New York are acutely aware that the U.S. Department of Labor’s recent Final Rule eliminated the companionship exemption for home care agencies. But agencies may not be aware of another important—albeit...more

Washington, D.C. Update – November 2015

In the final week of October, congressional leaders and the White House reached an agreement on a wide variety of measures to "clean the barn" for Speaker John Boehner's (R-OH) successor. The Bipartisan Budget Act of 2015...more

CT AG slams Hartford Hospital and EMC for loss of laptop

True to his word, the Connecticut AG has aggressively entered the data privacy and security enforcement arena with a $90,000 settlement with Hartford Hospital and EMC. The AG has agreed to a payment of $90,000 from...more

Tennessee Supreme Court Modifies Summary Judgment Standard

On October 26, 2015, the Tennessee Supreme Court returned to a summary judgment standard consistent with the Federal Rules of Civil Procedure in a Memphis health care liability case. In Rye v. Women's Care Center of Memphis,...more

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