Legal & Regulatory Issues

Several bills to extend the user-fee programs for prescription drugs and medical devices and to establish user-fees for generic drugs and biosimilars are making rounds in the Senate and House this week. But the version in the House comes with…

Six U.S. senators and two representatives introduced companion bills on Wednesday to address a concern that patients who experience complications from generic-drugs are barred from suing the manufacturing company who produced the drug.

The Office of Inspector General conducted an audit on the Medicare-Medicaid Data Match Program, finding the initiative to collaboratively fight fraud resulted in limited returns.

Two New York hospitals have agreed to a settlement of more than $2.3 million after an Attorney General investigation found the facilities allegedly overbilled Medicaid for physician-administered drugs.

The Massachusetts Hospital Association has addressed regulations that would require surgery centers to obtain a "determination of need" before expanding, according to a Fierce Healthcare report.

The Massachusetts Medical Society and six healthcare organizations announced the start of a major initiative to improve the medical liability system in the state of Massachusetts.

A 2009 lawsuit filed by Oceanside, Calif.-based Tri-City Healthcare District — alleging San Diego-based Scripps Health redirected patients from Tri-City's market to Scripps facilities — is headed to trial, according to a Coast News report.

Since Ohio passed and enacted a tort-reform law in 2003, medical malpractice claims have dropped more than 40 percent and payments declined roughly at the same rate, according to a Columbus Dispatch report.

The U.S. Government Accountability Office has issued a report on stakeholders' perspectives on the adequacy of guidance on antitrust issues for healthcare providers. Six antitrust law experts and four healthcare industry groups provided feedback on guidance offered by the Antitrust…

For the second consecutive year, Massachusetts residents enrolled in the state healthcare program are paying less for health insurance premiums — 5 percent less than last year — and more than 98 percent of residents in the state have health…