Health Care Counsel Blog
816 total results. Page 27 of 33.
Douglas A. Grimm, Thomas E. Jeffry, Jr., Stephanie Trunk
The change to the definition provides for exceptions to the prohibition of the offer or transfer of certain Medicare beneficiary inducements tied to their choice of provider for covered health care items or services.
Stephanie Trunk, Emily M. Leongini
The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the com
Hillary M. Stemple
The Department of Health and Human Services Office of Inspector General recently published its 2017 Work Plan, which furnishes key guidance to providers and suppliers and others doing business in the health care industry on the agency’s enforcement priorities for the upcoming year.
Stephanie Trunk, Emily M. Leongini
Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.
Lowell C. Brown, Alexandra M. Romero
The standard, which was sponsored by several labor unions, will require covered healthcare providers to develop workplace violence prevention plans, training programs, and recordkeeping procedures to track certain incidents of workplace violence.
Stephanie Trunk, Emily M. Leongini
On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.
Randall A. Brater, Thomas E. Jeffry, Jr., D. Jacques Smith, Michael F. Dearington
On November 1, 2016, the Supreme Court heard argument in a False Claims Act case in which the defendant sought dismissal of a qui tam action after the whistleblower violated the FCA’s seal requirement and publicly disclosed the complaint.
Stephanie Trunk
Recently, the Health Resources and Services Administration released a new addendum to amend the existing Pharmaceutical Pricing Agreements that drug manufacturers participating in the 340B Drug Pricing Program must have in place with the Secretary of Health and Human Services.
Annie Chang Lee
In addition to federal regulations affecting healthcare providers, many states, including California, have laws prohibiting the abuse of elderly individuals, as well as dependent adults.
Stephanie Trunk, Emily M. Leongini
Mylan recently announced a $465 million settlement with the US Department of Justice and other government agencies regarding the company’s covered outpatient drug (COD) classification of its EpiPen (and EpiPen, Jr.), an epinephrine auto-injector, under the Medicaid Drug Rebate Program (MDRP).
Douglas A. Grimm, Thomas E. Jeffry, Jr.
Kindred Healthcare, Inc., the country’s largest provider of post-acute care, recently paid over $3 million for violating its Corporate Integrity Agreement, the largest issued for a violation of a CIA to date.
Douglas A. Grimm, Stephanie Trunk
In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment.
Stephanie Trunk
Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.
Randall A. Brater, David S. Greenberg, D. Jacques Smith
Life science companies, health care providers, and government contractors will be at risk for significantly larger penalties due to substantial increases to False Claims Act (FCA) penalties and civil monetary penalties (CMPs).
This survey focuses on the data breach notification statutes of the states and territories within the US, and should be a useful tool and guide for data security planning and response purposes.
Sarah G. Benator
Earlier this month, the California Board of Registered Nursing (BRN) proposed significant changes to regulations affecting nurse practitioners (NP) practicing in the state.
Stephanie Trunk
On August 12, 2016, the Health Resources and Services Administration published a proposed rule setting forth the requirements and procedures of the administrative dispute resolution process applicable to all covered entities and drug manufacturers participating in the 340B Drug Pricing Program.
Everyone working in the health care industry today knows how often overpayments can occur; nevertheless, it is clear under the Affordable Care Act that any provider who receives an identified overpayment is under a direct legal mandate to return it.
Thomas E. Jeffry, Jr.
Today, the US Department of Health & Human Services’ Office for Civil Rights (OCR) announced that Advocate Health Care Network (Illinois’ largest healthcare system) will pay a record $5.5 million settlement for violating HIPAA.
Thomas E. Jeffry, Jr.
On June 24, 2016, the non-profit Catholic Health Care Services of the Archdiocese of Philadelphia (CHCS) agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule with the U.S. Department of Health and Human Services (HHS).
Lowell C. Brown, Douglas A. Grimm, Thomas E. Jeffry, Jr., Stephanie Trunk
On Monday, July 11, 2016, the Office for Civil Rights (OCR) released a fact sheet with guidance for covered entities and business associates on HIPAA and ransomware.
Thomas E. Jeffry, Jr., Dan H. Renberg
On July 6th, CMS released a proposed rule (expected to appear in the Federal Register on July 15th) that, if it takes effect, could be devastating to hospital off-campus outpatient department reimbursement – an effect not intended by Congress, and certainly unwelcome to the healthcare industry.
Jon S. Bouker, Douglas A. Grimm, Thomas E. Jeffry, Jr.
In a surprising and promising development, the Senate Finance Committee released a Majority Staff Report on June 30, 2016 that gives the health care industry some hope that Congress may finally address some of the serious concerns with the implementation and enforcement of the Stark law.