Representation of Dispensing Physician Practices and Dispensing Physicians
As a national healthcare and life sciences boutique law firm, Frier Levitt represents Dispensing Physician Practices and Dispensing Physicians throughout the country and has an in-depth understanding of the complexities and nuances Dispensing Physician Practices and Dispensing Physicians face. These Practices and Physicians are confronted with numerous legal complexities based on their unique position and role within the healthcare delivery system, including, but not limited to, dual regulation by the state Boards of Pharmacy and Medicine. Frier Levitt has developed extensive knowledge and understanding of these unique issues, but more importantly, has consistently achieved successful results for Dispensing Physician Practices and Dispensing Physicians in addressing these issues and challenges, whether they arise from the process of ensuring dispensing physicians and practices are compliant in establishing their dispensing processes and procedures, or from disputes with third parties, including pharmacy benefit managers (PBMs).
Understanding the Complexities and Challenges of Physician Dispensing
Dispensing Physician Practices and the physicians working within those practices are referred to by many names or phrases including “in-office dispensing,” “medically integrated dispensaries” “point-of-care dispensing” and “physician dispensing.” This practice is especially pronounced in the oncology setting. Oncologists, specifically those in independent oncology practices (as opposed to hospitals), dispense cancer drugs directly to patients under one of two primary practice models based on applicable state board of pharmacy regulations and practices.
- One type of practice, commonly referred to as a “Medically Integrated Dispensary,” is a physician practice that dispenses medications to patients pursuant to the physician’s plenary medical license as permitted by state and federal law. These types of practices do not hold a pharmacy license. Occasionally, dispensing physicians must register as such with state boards of medicine or pharmacy prior to engaging in this activity, while others do not require any additional criteria for physician licensees in good standing.
- The second practice is operationalized through physician-owned pharmacies, whereby a practice dispenses drugs through a licensed retail pharmacy owned by the practice. In this instance, and where permitted by applicable law, the licensed retail pharmacy may be the same entity as the medical practice. This model differs from the a dispensing physician practice, as the entity holds a pharmacy license subject to all board of pharmacy rules and regulations regarding the operation of a pharmacy.
These two practices are distinct from traditional pharmacy practice wherein a physician writes a prescription in the office, gives it to the patient, and the patient takes the prescription to the pharmacy to obtain the prescribed medication.
Overall, the practice of physician dispensing comes with numerous benefits for both the patient and the physician and can help improve patient outcomes. For example, many of the medications that are dispensed directly to patients in a physician’s office are among the most complex , new, and innovative medications in the country including oncology medications, HIV medications, and other rare diseases medications. In addition to being complex, these medications are often expensive, have serious (and in some cases potentially life-threatening) side effects, and have specialized handling and administration requirements. The ability of a patient to work directly with their physician in taking their prescribed medication is directly tied to increases in positive outcomes because it ensures proper administration of and adherence to these drugs and protocols to ensure optimal results. Further, in this setting, physicians can respond much faster when medications are not effective and engage in more proactive patient monitoring. Despite the potential benefits of this model, the legal framework that permits this practice to take place is exceedingly complex and requires advanced legal expertise to accurately and effectively navigate.
Dispensing Physician Practices Face Increased Challenges from PBMs
In addition to the practical challenges of navigating the complex legal framework governing Dispensing Physician Practices and Dispensing Physicians, Dispensing Physician Practices also face challenges in dealing with third-party payers including insurance companies, PBMs, and the Centers for Medicare & Medicaid Services (CMS). More recently, PBMs have presented significant challenges for Dispensing Physician Practices. PBMs have created many obstacles to physicians gaining access to PBM created pharmacy networks. In some instances, PBMs do not grant Dispensing Physician Practices access to their pharmacy networks based on arbitrary distinctions in how the practices operate. In other instances, PBMs attempt to improperly terminate Dispensing Physician Practices from their networks. Improper denial of access to PBMs’ pharmacy networks, as well as improper terminations, directly interfere with patient care and patient outcomes. In addition to Frier Levitt’s comprehensive understanding of the legal framework governing these practices, Frier Levitt has an in-depth knowledge of the laws governing PBMs vis-à-vis Dispensing Physician Practices as well as the various PBM contracts between PBMs and the providers participating in pharmacy networks. Frier Levitt offers legal advice to Dispensing Physician Practices and Dispensing Physicians regarding these various legal issues.
How Frier Levitt Helps Dispensing Physician Practices and Dispensing Physicians
Frier Levitt’s legal services related to Dispensing Physician Practices and Dispensing Physicians include:
- Establishing physician dispensing through medically integrated dispensaries and physician owned pharmacies
- Advising on board of medicine and board of pharmacy laws related to physician dispensing licensing, permissibility and limitations
- Counseling on regulatory fraud, waste and abuse compliance related to physician dispensing, including anti-kickback and self-referral (Stark) compliance
- Assisting with change of ownership matters related to physician owned pharmacies
- Transactional assistance, including mergers and acquisitions
- Representation in state board of pharmacy matters, including disciplinary matters
- Network access, including review and negotiation of pharmacy benefit manager (PBM) contracts, provider agreements and manuals
- Review of pharmacy services administrative organization (PSAO) contracts
- PBM network audits and terminations
- PBM Reimbursement issues
- Direct and Indirect Remuneration fees aka DIR fees
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.