April 29, 2014 

• Contract pharmacies and filling prescriptions from community physicians who are not on Covered Entity's medical staff - Err on the side of designing your contract pharmacy program to exclude prescriptions from 340B consideration if the prescriptions are written by physicians who are not on your medical staff.  In order to meet the 340B patient definition, a 340B-priced drug can only be provided to a patient who receives health care services from a health care professional who is either employed by the Covered Entity or under contractual or other arrangements (e.g. referral for consultation) such that the responsibility for the care provided remains with the Covered Entity.  Unless the patient's hospital medical record includes a very precise and explicit referral to the non-staff physician for follow-up care, and the prescription relates back to the care originally provided in the hospital, OPA will find (in most cases) that the dispensation of 340B drugs runs afoul of the 340B patient definition.  This could result in a corrective action plan where OPA requests that the Covered Entity investigates and discloses all such dispensations and issues repayments to drug manufacturers.

• Contract pharmacies and filling prescriptions from non-provider-based clinics or private physician offices - Similar to the above scenario, err on the side of treating such prescriptions as non-340B.  Remember, a patient must receive outpatient hospital services and care must remain under the responsibility of the Covered Entity in order to fill a prescription using 340B-priced drugs.  Since non-provider-based clinics (according to Medicare regulations and OPA) are not considered part of the Covered Entity, prescriptions from the sites should generally be treated as non-340B.  A Covered Entity may only consider the "referral for consultation" exception described above if the Covered Entity has a documented referral for consultation in the outpatient hospital medical record that specifically includes the location/physician to whom the referral is made.  Based on our experience with OPA audits, this is an extremely limited exception that should not be relied on until OPA issues further guidance.   We often see 340B vendors attempting to use this exception to explain why software solutions allowed a 340B dispensation, but OPA often disagrees.

• Contract pharmacy vendors and program design - Please be mindful of the fact that Covered Entities carry the burden of complying with all 340B regulations.  That said, we recommend working very closely with your vendors to ensure that they design your 340B contract pharmacy adjudication process to be consistent with items 1 and 2 above.  We continue to see a pattern of vendors utilizing hospital-provided physician lists to determine if a drug should be filled using 340B.  This methodology, when utilized as a primary versus a multi-element approach, can lead to 340B dispensations to patients who received a prescription from a physician in his/her private office.  Even if a patient received some degree of hospital care within the last 12 months, OPA consistently finds that this care does not establish eligibility unless a documented referral is present.

• Medical Staff Education - Often overlooked, the medical staff does play a vital role in the success of your 340B program. Likewise, the medical staff has a significant compliance role, particularly when Covered Entities have multiple contract pharmacies. Therefore, engagement of the medical staff members is vital. Murer works with its Covered Entity clients to develop medical staff communication strategies and participates in medical staff meetings to provide 340B education to the full staff.  We find that this not only helps with compliance, but it motivates physicians to help achieve additional savings under the 340B program.  For example, physicians may be more engaged in the discharge planning process and better manage discharge medications.

Also, as many of you know, we are expecting the release of the much anticipated proposed 340B Mega-Reg this summer.  We will provide consultation and timely webinars once the rule is released.  Please be on the lookout for upcoming Murer events related to the Mega-Reg.

As always, if you have questions regarding OPA's policies and practices, or you are interested in obtaining a 340B compliance assessment, please feel free to call us.