Insights on Health Care

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. 

Health Care partner Linda Baumann was quoted in the article “Medicare to Closely Review Nursing Home, Psychiatric Payments” in Bloomberg BNA’s Health Care Daily Report.

From large corporations to small nonprofits, from urban centers to rural communities, the 2016 elections will have an impact across all sectors of the economy and globally as well.

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.

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.

Twenty Arent Fox LLP practices have been recognized in the 2016 “Best Law Firms” rankings that are published annually by U.S. News & World Report and Best Lawyers.

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.

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).

In Compliance Today, Arent Fox Health Care partner and leader of the DC practice Linda Baumann and Health Care associates Samuel Cohen and Hillary Stemple discuss the updated criteria that the US Department of Health and Human Services Office of Inspector General (OIG).

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.

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.

Republicans from the Senate Finance Committee and House Energy and Commerce Commitee issued two letters this month to the Health and Human Services Office of Inspector General (HHS OIG) to review EpiPen’s status within the Medicaid drug rebate program.

A recent ruling could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability.

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.

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).

Arent Fox, serving as class counsel along with co-counsel from the AARP Foundation Litigation and University Legal Services, will be arguing on behalf of thousands of DC-area nursing home residents in a case covered by The Washington Post.

The Department of Health and Human Services (HHS) released  final regulations on the new federal civil monetary penalties (CMPs) that have been adjusted/increased to reflect inflation.

Earlier this month, the California Board of Registered Nursing (BRN) proposed significant changes to regulations affecting nurse practitioners (NP) practicing in the state.

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.

Forty-two Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2017.

In the Law360 article “Ensuring Compliance with CMS 60-Day Overpayment Rule,” Arent Fox Health Care partner and leader of the Health Care group in the DC office Linda Baumann, and Health Care associate Hillary Stemple, discuss the critical importance of the 60-day overpayment rule for health care pr

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.

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).