New conflicts of interest disclosures will broaden physicians’ reporting obligations.
Medical doctors face conflict of interest rules when they recommend dietary supplements to patients and profit from in-office sales of nutritional products. (When Integrative Medicine Physicians Sell Dietary Supplements: Legal Issues).
But conflict of interest rules also apply to payments made to doctors for research, as well as for travel, consulting and speaking, and in other contexts. New rules are likely to increase physicians’ disclosure obligations.
According to recent reports,
Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.
Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures.
… Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.
Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.
Calls for increased transparency are part of health care reform:
The “Physician Payment Sunshine” provisions of the Affordable Care Act (ACA), require that drug, medical device, biologic, and medical equipment manufacturers that produce any products covered by Medicare or Medicaid or the Children’s Health Insurance Program must report all payments made to doctors and hospitals.
The government will post the financial relationship information on a public website where patients and anyone else can check what ties to the medical industry a given doctor has….
The law requires disclosure of payments for food, entertainment, gifts, consulting fees, honoraria, research funding or grants, education or conference funding, royalties or licenses, and charitable contributions.
Medical companies, as well as group purchasing organizations (GPOs), will also have to report stock ownership and investments held by doctors.
There are already existing legal obligations governing physician referrals to medical entities in which they have a financial interest. The new rules add to these established self-referral and anti-kickback rules and also operate whether or not a referral is involved.
***
Michael H. Cohen is a thought leader in health care law, pioneering legal strategies and solutions for business law clients in traditional and emerging healthcare. wellness, and lifestyle markets. As a corporate and regulatory attorney who has also handled litigation matters, Michael H. Cohen represents conscious business leaders in a transformational era. Clients seek Michael H. Cohen’s legal expertise on business structure and entity formation (corporations, partnerships, LLCs); health care licensing matters; employment contracts and independent contractor agreements; dispute resolution; e-commerce; intellectual property issues; informed consent and malpractice liability issues; HIPAA and confidentiality and privacy issues; Stark, self-referral, anti-kickback, patient brokering, and fee-splitting questions; dietary supplement labeling; medical device and FDA matters; insurance reimbursement and Medicare issues; website disclaimers; concierge medicine legal advice; telemedicine; and other business law and health care regulatory compliance arenas. Whether advising start-ups or established companies, he brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges. Attorney Michael H. Cohen is admitted to practice law in California, Massachusetts New York, and Washington, D.C. Contact our attorneys firm today.