Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Billions of dollars have flown from medical device makers to specialists performing back, spine, knee, and hip surgeries, with unsavory cash and practices also accompanying that fiscal tide. Industry officials and...more
Pharmaceutical and medical device manufacturers should be advised that the government is using its enforcement authority under the Open Payments Program (otherwise known as the Sunshine Act) in conjunction with the...more
There has been a longstanding and regrettable practice in the healthcare industry of pharmaceutical and medical device companies giving physicians gifts as illegal inducements. Concerned about this continued trend, the U.S....more
The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
The Open Payments program established by the Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of covered drugs, medical devices, biologicals, and medical supplies (applicable manufacturers) to report...more
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more
The Centers for Medicare and Medicaid Services (CMS) recently released the CY 2020 Proposed Physician Fee Schedule....more
• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more
The Health and Human Services Office of Inspector General (OIG) recently released a report on its review of the Open Payments program, titled “OPEN PAYMENTS DATA: REVIEW OF ACCURACY, PRECISION, AND CONSISTENCY IN REPORTING.”...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued today its 2017 Work Plan. This annual publication summarizes new and ongoing reviews and activities by the OIG related to various...more
CMS published the 2015 Open Payment Data on June 30, 2015. CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. ...more
On September 10-11, 2015, MedPAC held a meeting to discuss several issues related to the Medicare program, including (1) improving the Open Payments program, which makes public the payments from drug and device manufacturers...more
Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and...more
Policy and Medicine published today an interesting infographic prepared by Open Payments Analytics regarding the 2014 Open Payments data, which contains 11.41 million payments and other transfers of value totaling $6.49...more
The Centers for Medicare & Medicaid Services (CMS) released last week the 2014 Open Payments data, the first release of data reported by applicable manufacturers and group purchasing organizations (GPO) for a full calendar...more
On June 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published detailed information regarding payments made by pharmaceutical and medical device manufacturers to physicians and teaching hospitals during 2014...more
The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more
On Monday, December 15, 2014, CMS published guidance regarding pharmaceutical and medical device manufacturers’ obligations under the Open Payments requirements to report payments they provide indirectly to U.S. physicians in...more
As follow-up to our recent post on the issues that the Centers for Medicare & Medicaid Services (CMS) is experiencing with its Open Payments database, there is new information that additional data also may be excluded when...more
On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more
The Centers for Medicare & Medicaid Services (CMS) released today information regarding registration in the Open Payments system for physicians and teaching hospitals interested in reviewing and verifying data reported by...more