Policy & Medicine

CMS Should Improve Wage Index Adjustment for Rural Hospitals

Thomas Sullivan Mar 3, 2021 0

On December 30, 2020, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released a report that recommended that the Centers for Medicare and Medicaid Services (CMS) improve its wage index adjustment for hospitals that are in areas with low wages. The report, which follows a federal audit, found that…

When Money and Doritos Don’t Suffice – The…

Thomas Sullivan Oct 12, 2019 0

The Chaos Over Drug Compounding Continues As Judge Throws…

Thomas Sullivan Sep 17, 2019 0

CMS Should Improve Wage Index Adjustment for Rural Hospitals

On December 30, 2020, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released a report that recommended that the Centers for Medicare and Medicaid…

CMS Prior Authorization Proposed Rule Faces Backlash, Support

In mid-December 2020, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule to address prior authorizations and attempt to reduce the burden on patients and providers. The…

FDA Issues Guidance on STeP

Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance for devices and combination products, Safer Technologies Program (STeP) for Medical Devices. The new guidance…

COVID Vaccine Survey of over 600 Health Care Providers: Shows…

Rockpointe, a continuing education company in Columbia, MD, collaborated with multiple state medical societies to develop and distribute an online survey to healthcare providers to gain insights into…

FTC to Examine Impact of Hospital Acquisitions of Physician…

Earlier this year, the United States Federal Trade Commission (FTC) sent orders to six health insurance companies, seeking data on patient-level claims for inpatient, outpatient, and physician…

Review of 2020 FDA Enforcement Activities

Recently, the attorneys at Ropes & Gray wrote an article reviewing the United States Food and Drug Administration’s (FDA) 2020 enforcement priorities, including protecting patients from those who…

FDA Releases Draft Guidance on IND Submissions for…

Earlier this year, the United States Food and Drug Administration (FDA) issued draft guidance surrounding investigational new drug (IND) submissions for individualized antisense oligonucleotide (ASO)…

Industry Seeks Clarity on Interchangeability for BsUFA III

Towards the end of last year, the United States Food and Drug Administration (FDA) opened a public docket to solicit comments on the reauthorization of the Biosimilar User Fee Act for fiscal years…

FDA Releases Final Guidance Under GDUFA II

In mid-December 2020, the United States Food and Drug Administration finalized updated guidance to generic drug manufacturers. The final guidance updates a 2017 draft, Controlled Correspondence…

Online Platform Launched to Make Telemedicine More Accessible

With COVID-19 and the rise of telemedicine, the Federation of State Medical Boards (FSMB) recently launched an online platform that aims to provide extra clinical help through telehealth. The…

Coalition Calls for Further Extension of Medicare Sequester…

On February 2, 2021, America’s Physician Groups (APG) joined the coalition of groups calling for the United States Congress to fully extend the Medicare sequester moratorium through the end of the…

McKinsey Settles Claims Over Its Role in the Opioid Crisis

In early February 2021, McKinsey & Company agreed to pay $573 million in a multistate settlement for its role in consulting for drug companies that “fueled the opioid crisis.” The agreement, in…