Christopher R. Smith, Jennifer E. Michael, and Alan J. Arville, attorneys in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in Chain Drug Review, titled “A Chance for Pharmacies to Showcase Health Care Services.”
Following is an excerpt:
On October 17, 2019, the Department of Health and Human Services Office of Inspector General (OIG), published a Proposed Rule providing for new safe harbors under the Anti-Kickback Statute and civil monetary penalty (CMP) law for certain value-based arrangements between various health care stakeholders. The comment period closed on December 31, 2019, and OIG received 332 comments. Although the Proposed Rule would protect the participation of many types of providers, payors and other health care industry stakeholders in value-based arrangements, OIG proposed to exclude certain types of entities from such protection, including manufacturers, distributors, and suppliers of durable medical equipment, prosthetics, orthotics or supplies (DMEPOS); drug manufacturers; and laboratories. In addition, OIG questioned whether pharmacies, pharmacy benefit managers, and drug wholesalers/distributors also should be excluded from protection under the new value-based safe harbors. Stakeholders who did not submit comments on the Proposed Rule or in response to OIG’s Solicitation of New Safe Harbors and Special Fraud Alerts may wish to look for alternative ways to engage with OIG, and to educate OIG about the services they provide and the contributions they can make in connection with value-based arrangements.
