Tag Archives: health care providers

Obscure FDA Device Reporting Exemptions Draw Patient and Provider Concern

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.

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FDA Announces November Public Hearing on Off-Label Communications: An Important Step Forward or a Signal that FDA is Headed Back to the Drawing Board?

On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.

In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics on which FDA is seeking feedback are broad, but generally include:

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Alternative Provider Reimbursement Models – How Are They Treated Under MLR Rules?

by Joseph J. Kempf, Jr., and Jackie Selby

Evolving reimbursement models for health care providers (away from “fee for service” and toward “pay for performance” and risk sharing) raise interesting questions as to how such payments will be treated under the new medical loss ratio rules under the Patient Protection and Affordable Care Act. Some of the payments will not qualify as “medical expense” or “quality improvement activities” and will be treated as “administrative expense,” so providers and insurers and health plans may want to take these rules into account when structuring alternative reimbursement methodologies.

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