Healthcare Law

The Sunshine Rule of the Affordable Care Act requires that drug and medical device manufacturers disclose to CMS any payments they made for the benefit of physicians regarding the drugs or devices.

Health and Human Service’s healthcare compliance guide for new physicians includes the billing requirements for submitting claims to federal programs and commercial insurers.

An interactive questionnaire for mobile health app and medical device developers that covers compliance issues for HIPAA, the FDA&C Act, and the FTC Act

Medical practices and developers need to understand the federal regulations that govern the development and use of digital health products including medical device data systems, mobile medial [...]

The FDA does have authority to regulate medical devices – including digital health technologies that qualify as medical devices. Digital health includes SaMD, AI, ML, medical mobile apps, and [...]

There are numerous types of drugs, cosmetics, and other products used to treat skin disorders. FDA does regulate these products to ensure the products are safe for patients.

Immunotherapy drugs are showing promise for treating cancer. Manufacturers of these therapies and doctors must understand the FDA, HIPAA, and other compliance requirements.

Physicians and other healthcare providers must comply with the Good Faith Estimate Requirement. Disputes between the estimate and final bill will be resolved through a PPDR process.

Doctors and other healthcare providers need to comply with the Good Faith Estimate Requirement which ensures that non-insured and self-paying clients can anticipate their costs.

Physicians and medical practices should review their MSO and referral arrangements to help comply with the new Stark Law and AKS changes.