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CMS Guidance Addresses Impact of Value-Based Purchasing on Medicaid Drug Rebates

CMS has received questions from manufacturers regarding whether price concessions and services offered to payers within Value-Based Purchasing (VBP) arrangements in the pharmaceutical marketplace could impact their drug’s...more

Check Your Desk: HIPAA Audits for Covered Entities Have Arrived

The Office of Civil Rights (OCR) of the Department of Health and Human Services has moved forward with Phase 2 of its Health Insurance Portability and Accountability Act of 1996 (HIPAA) audit program. On Monday, July 11,...more

Entity Fined $650,000 in First HIPAA Settlement with a Business Associate

The possibility of business associates potentially being audited, investigated, and ultimately fined is now a reality. On June 24, 2016, the United States Department of Health and Human Services’ Office of Civil Rights...more

FCPA Compliance and Ethics Report-Episode 266, Ben Locwin on people v. systems approach to compliance programs [Video]

In this episode, I visit with Ben Locwin on the different approaches in compliance around people v. systems. ...more

The State of Telehealth - Policy and Reimbursement Q&A

Foley Partner Nathaniel Lacktman, head of the firm’s telemedicine and virtual care practice, participated in a comprehensive Q&A discussing the challenges and opportunities facing the telehealth market with Healthcare...more

Third Party Administrator Update: TPA Regulatory and Legislative Developments

Polsinelli is pleased to share the June 2016 Third Party Administrator Newsletter. This newsletter covers topics throughout the year that impact TPAs. Information specific to Polsinelli's TPA practice is also included....more

Senate Finance Committee Chairman Releases White Paper Examining Potential Reforms to the Stark Law

On June 30, 2016, Senate Finance Committee Chairman Orrin Hatch released a white paper examining potential reforms to the Federal Stark law. The white paper, entitled “Why Stark, Why Now? Suggestions to Improve the Stark...more

Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty

The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached...more

CMS Posts Open Payment Data – $7.52 Billion in 2015

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

Business Associate Settles HIPAA Investigation for $650,000

The U.S. Office for Civil Rights (OCR), the agency responsible for enforcing the HIPAA Privacy and Security rules, has just sent a strong message that business associates are not immune from scrutiny. On June 24, 2016, in a...more

Fourth Circuit Affirms CGL Coverage of Cyber Incident

In a recent, unpublished opinion, the Fourth Circuit held that an insurer had a duty to defend its insured under a CGL policy for a cyber incident. A class action complaint was filed against Portal Healthcare Solutions...more

HIPAA Compliance: Navigating a Health Care Minefield

In the two decades since its original passage, complying with the federal Health Insurance Portability and Accountability Act (HIPAA) hasn’t gotten any easier. Enacted with the primary goal of protecting the confidentiality,...more

[Webinar] Cloud licensing and health care data: Know the risks, learn the solutions - July 13th, 12:00pm CT

As identity theft and malicious attacks against clinical providers increase, more and more health care data is stored in the digital cloud. The health care industry is required to take special precautions when licensing...more

Compliance Reminder — DOJ Announces Largest Healthcare Fraud Takedown

On Wednesday, June 22, 2016, the DOJ announced the largest nationwide heath care fraud takedown in history, which resulted in criminal and civil charges against 301 individuals for alleged participation in health care fraud...more

DOJ Suffers Criminal Trial Setbacks: Warner Chillcott President Acquitted

Last week was a tough week for the Justice Department’s criminal prosecutors. Before everyone gets out their Yates Memorandum trending claims, it is important to recognize that DOJ’s loss in several high profile cases does...more

Preparing for an Exit: Selling Your Robotics Company

Robots are everywhere. Healthcare, logistics, manufacturing and other critical areas of the economy are being redefined by the robotics and artificial intelligence advances of today’s technology entrepreneurs. With this...more

Cybersecurity News & Notes – June 2016 #3

In Case You Missed It: Illinois strengthened its data privacy and security law, with the amendments going into effect in January 2017. The amendments include expanding the definition of “personal information” to include a...more

Health Care E-Note - June 2016

In an effort to review and examine compliance with the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations ("HIPAA"), the Department of Health and Human Services Office for Civil...more

Connecticut Health Law Legislative Update

Current law permits a hospital, health system, or medical school to organize and become a member of a medical foundation, which can practice medicine through its employees or agents who are physicians, chiropractors,...more

Colombian Organizations Send Letter to CEWG Regarding Imatinib Compulsory License

In letter from three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) (posted on the...more

Burr Alert: Phase 2 HIPAA Audits

In an effort to review and examine compliance with the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations ("HIPAA"), the Department of Health and Human Services Office for Civil...more

China Competition Authority Initiates Drug Pricing Investigation

On May 22, 2015, the National Development and Reform Commission (the NDRC) of China promulgated a notice (the Pricing Investigation Notice) announcing that it would carry out a nationwide drug pricing investigation on...more

Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights...more

What's New with HIPAA?

A number of new developments have taken place related to Health Insurance Portability and Accountability Act (HIPAA) privacy and security compliance, and enforcement is increasing. Healthcare providers, health plans and other...more

FTC Enters into Consent Agreement Regarding Company's Use of Exclusive Contracts

The Federal Trade Commission (FTC) recently announced that Invibio, which sells high-performance polymer for medical implants, has settled charges that the company monopolized sales to medical device makers through unlawful...more

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