Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Showing posts with label FierceHealthCare. Show all posts
Showing posts with label FierceHealthCare. Show all posts

Friday, April 14, 2017

Doctors: Ignorance of the Law Harms Patients (& Destroys Your Future, Too)



by Joanne Finnegan | Apr 13, 2017 12:37pm  FiDA highlight


A doctor convicted of accepting a bribe now warns future physicians to never accept anything from drug and device manufacturer reps.

A New York doctor, who is now a convicted felon, is warning other doctors about the dangers of accepting bribes from drug and device representatives.
Michele Martinho, who faces the possibility of jail time and the loss of her medical license when she is sentenced, pleaded guilty in 2014 to one count of accepting a bribe. This week she spoke to a small audience at the Georgetown University School of Medicine, telling her story as a warning to future doctors, according to The Washington Post.
While she learned about medicine, Martinho said her training did not prepare her for the business of medicine.
Martinho was one of more than two dozen doctors who have pleaded guilty in a $200 million health fraud scheme operated by the now-defunct blood-testing company Biodiagnostic Laboratory Services in New Jersey. She accepted monthly payments of $5,000 to refer patients to the lab for blood tests and other screenings, the newspaper said.
She told students her life has been “destroyed,” and she advised them to never accept anything from drug, device and other representatives who parade through doctors’ offices and to consult an attorney who specializes in medical practice with any questions.
Martinho accepted $155,000, always in monthly envelopes full of cash, and acknowledged she knew she was evading tax laws when she took the money, the newspaper said. However, she says she did not understand that the referral itself was considered a kickback.

Now she speaks at healthcare and ethics institutions, but doesn’t know if her efforts at "restorative justice" will help at sentencing.

Wednesday, June 20, 2012

AHLA announced guidelines for apology, compensation of AE victims.


How to apologize for adverse events
American Health Lawyers Association released guidelines on honest disclosure
June 15, 2012 | By Karen M. Cheung  FierceHealthCare
American Health Lawyers Association (AHLA) this week released guidelines for providers on disclosing serious clinical adverse events.
"In analyzing disclosures of information in connection with SCAEs, there are regulatory and legal considerations regardless of the type of incident," Elisabeth Belmont of MaineHealth, AHLA public interest committee task force chair, said in an announcement Wednesday.

AHLA noted that the process is multi-faceted and requires careful planning and coordination of administration and clinicians with the organization. Regardless if the adverse event came from system failures or human errors, hospitals should offer timely and honest communication with empathy to the patient and the family, AHLA noted.

In Massachusetts, Beth Israel Deaconess Medical Center, Massachusetts General Hospital and Baystate Health are testing liability reform with a "disclosure, apology and offer" program, in which legal action is a last resort. The process promotes transparency, in which the hospital investigates and explains why an adverse event occurred and establishes systems to improve patient safety and reporting. When appropriate, the hospital apologizes and offers fair financial compensation without the patient having to resort to legal action.

The honest, transparent approach to adverse events is exemplified in a very public, still-discussed apology. President and CEO Sandra Coletta of Rhode Island's Kent Hospital was hailed for doing the right thing by apologizing for the death of actor James Woods's brother, Michael. In 2006, Michael Woods died of a heart attack, waiting in the emergency room. The hospital attributed the death to both human errors and poorly designed space.
"Quite honestly, I did nothing other than what my mother taught me," Coletta previously said about the apology process. "I think all too often in healthcare, we evaluate, and we are counseled, and we read books upon books. But, sometimes, you just have to go back to your core value.