Pharmacy Law & PBM Issues
Pharmacy Law
The Firm provides extensive resources for retail pharmacy owners and operators; from pharmacy benefit manager (PBM) audits and disputes to regulatory compliance and transactional support. We work closely with independent pharmacies to protect their rights and optimize operations and profitability.
The Firm provides extensive resources for retail pharmacy owners and operators; from pharmacy benefit manager (PBM) audits and disputes to regulatory compliance and transactional support. We work closely with independent pharmacies to protect their rights and optimize operations and profitability.
Since the implementation of the ZPIC and RAC programs, healthcare providers and suppliers have experienced increased scrutiny in the pursuit of overpayments and fraud. Medicare’s most vital tool in its progressive search is the use of statistical sampling. In theory, statistical sampling offers a reliable and low cost approach to addressing large volumes of claims. However, this process gives the government a huge advantage as it places a heavy assumption of a large number of claims without actual review of the claims. Thus, it is important for providers and suppliers to understand the process and know how to challenge such studies in order to minimize potential repayment obligations and retain revenue.
Dispensing Controlled Substances
Intended to address the growing nationwide opioid epidemic that has also greatly affected Floridians, Governor Scott signed HB21 into law effective July 1, 2018 that pertains to prescribing and dispensing controlled substances. Those that do not adhere to these new regulations risk facing disciplinary actions that range anywhere from warnings and penalties, to
Telemarketing
Take a moment to reflect – are you engaged in telephonic marketing or sales? Be it a healthcare businesses’ own internal based sales team or a third party providing such services, many individuals and entities are telemarketing and don’t even realize. If conducting telephonic sales either out of a Florida based location, or if calling into Florida, then pay attention! There is a Florida law that requires all such marketers to register for a telemarketing license or file for an exemption therefrom. While it’s not a new regulation, it’s one that is often overlooked and one that carries serious consequences for non-compliance.
Compounding Pharmacies
Compounding pharmacies are subject to a multitude of federal and state laws and regulations, and with huge individual and corporate liability general knowledge of the laws is simply not enough. The Florida Healthcare Law Firm team has deep experience with laws regarding prompt pay, insurance regulations, controlled substances, ERISA, Anti-Kickback Statute, Stark Law, False Claims Act, Tricare rules and regulations, DEA rules and regulations and much more. If you are compounding and submitting claims for reimbursement to Tricare, there is even more to consider. You will also want to have your relationships with any referral sources / marketers reviewed to make sure those are in compliance.
DME
Attention to detail through the entire process of offering Durable Medical Equipment Prosthetics & Orthotics Supplies (“DMEPOS”) to Medicare beneficiaries is of the utmost importance. Incorrectly filling out the state licensure application or Medicare Part B Enrollment Application can result in delays in processing your application, and could ultimately result in the denial of your application. Intentionally providing false or misleading information any enrollment application can subject the applicant to a variety of civil and/or criminal penalties. Additionally, depending on the specifics pertaining to your practice setting and services being offered, there may be a variety of other Federal and State regulations that may have to be considered (Stark, Anti-Kickback, etc.).
PBM Audit
Attention to detail through the entire process of offering Durable Medical Equipment Prosthetics & Orthotics Supplies (“DMEPOS”) to Medicare beneficiaries is of the utmost importance. Incorrectly filling out the state licensure application or Medicare Part B Enrollment Application can result in delays in processing your application, and could ultimately result in the denial of your application. Intentionally providing false or misleading information any enrollment application can subject the applicant to a variety of civil and/or criminal penalties. Additionally, depending on the specifics pertaining to your practice setting and services being offered, there may be a variety of other Federal and State regulations that may have to be considered (Stark, Anti-Kickback, etc.).
Attention to detail through the entire process of offering Durable Medical Equipment Prosthetics & Orthotics Supplies (“DMEPOS”) to Medicare beneficiaries is of the utmost importance. Incorrectly filling out the state licensure application or Medicare Part B Enrollment Application can result in delays in processing your application, and could ultimately result in the denial of your application. Intentionally providing false or misleading information any enrollment application can subject the applicant to a variety of civil and/or criminal penalties. Additionally, depending on the specifics pertaining to your practice setting and services being offered, there may be a variety of other Federal and State regulations that may have to be considered (Stark, Anti-Kickback, etc.).
Wholesalers
The team at Florida Healthcare Law Firm has the diverse experience to provide legal counsel to pharmaceutical wholesalers and distributors across the United States. The objective of our representation is to act a guide and resource to get our clients through Federal and State laws and regulations while striving for the utmost in compliance.
The team at Florida Healthcare Law Firm has the diverse experience to provide legal counsel to pharmaceutical wholesalers and distributors across the United States. The objective of our representation is to act a guide and resource to get our clients through Federal and State laws and regulations while striving for the utmost in compliance.
Transactions
The team at Florida Healthcare Law Firm has the diverse experience to provide legal counsel to pharmaceutical wholesalers and distributors across the United States. The objective of our representation is to act a guide and resource to get our clients through Federal and State laws and regulations while striving for the utmost in compliance.
Telehealth
Providing telehealth services can be a worthy compliment to your practice; however, caution should be exercised before entering into a contractual relationship with a telehealth company. Keep in mind, when a telehealth company touts itself as “HIPAA compliant,” this is only one area where it must maintain compliance. It, along with the telehealth contract, must also be complaint with federal and/or state laws for furnishing telehealth services.
The Florida Healthcare Law Firm has created and reviewed a wide array of diverse business arrangements involving telehealth or telemedicine. If you are considering a telehealth model we can assist you with all components, from vetting a contractual opportunity or advise regarding the laws and landscape.
How We Help
Whether its navigating the increasingly complex PBM contracts to become an in-network provider, assisting with audits and appeals, or fighting payment suspensions and contract terminations, The Florida Healthcare Law Firm is uniquely positioned to help your pharmacy with all of its pharmacy law and PBM needs.
PBM Services
Over the years there has been tremendous consolidation in the healthcare industry; PBMs have been merging with PBMs, and insurance companies has been merging with PBMs. The result is that an increasing number of patient lives are in the hands of fewer administrators. Pharmacies are finding that it is becoming more difficult to gain access to these PBM networks, and once admitted it is becoming increasingly difficult for the pharmacy to adhere to their arduous requirements and to remain in network. Many PBMs even have their own pharmacies, seemingly creating further conflicts of interest. With fewer pharmacies in the PBMs’ network, the market share of pharmacies owned by the PBM increases. Even more money goes to the PBM in such cases. Now more than ever you need to fight to protect your practice and patients from being squeezed out of these PBM networks.
