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IL pharmacy lawyerPharmacies provide a variety of products and services to patients, and they will need to maintain the proper licensing and accreditation to ensure that they can continue operating. Some pharmacies offer products that fall under the category of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS), and to receive payments through Medicare for these products, they will be required to maintain accreditation. Pharmacy owners will need to be sure to understand the requirements that they will need to meet to receive DMEPOS accreditation.

Eligibility Requirements

Pharmacies will be required to complete the DMEPOS accreditation process through the National Association of Boards of Pharmacy (NABP). To qualify for accreditation, a pharmacy will need to meet the following basic eligibility requirements:

  • A pharmacy must have the proper licenses and be in good standing in all areas where it conducts business.
  • A pharmacy must be in a commercial location rather than a personal residence, and it must have been in operation for at least 30 days while complying with all applicable state laws and regulations.
  • A pharmacy must have a licensed pharmacist-in-charge who manages pharmacy operations and staff members.
  • A pharmacy must predominantly serve human customers (as opposed to prescriptions for veterinary medicine), and it must fill prescriptions for at least 10 human patients.

Quality Standards

The Centers for Medicare & Medicaid Services (CMS) also maintains standards for quality that pharmacies will be required to meet to obtain accreditation as a supplier of DMEPOS. These standards address:

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Il license defense lawyerMedical providers that prescribe, dispense, or handle controlled substances are required to follow all applicable laws and regulations related to these drugs. The Drug Enforcement Administration (DEA) monitors providers to ensure that controlled substances are being used correctly, and it may take action to address any potential violations of the law. As part of its ongoing efforts, the DEA often conducts audits and inspections, and providers who have received a Notice of Inspection from the DEA will want to understand their rights and how they can protect themselves from consequences that could affect their DEA registration or their professional license.

Understanding DEA Inspections

The DEA performs regular, routine audits of medical providers that have a controlled substance registration. Inspections may also be performed as part of a larger investigation related to possible drug diversion, including in cases involving reports or claims of unlawful prescribing, unlawful dispensing, or conspiracy to possess or distribute controlled substances.

While the DEA may obtain a search warrant before performing an inspection, in most cases, a provider will receive a Notice of Inspection. This notice will follow a standard form (DEA Form 82), and it will include the name and address of the premises being inspected, the name and title of the owner or operator in charge of the premises, the date and time when the inspection will be performed, and the signature of the person performing the inspection. Typically, a registrant must provide informed consent before an inspection can be performed, and they have the constitutional right to refuse an inspection. Informed consent is given by signing a written statement in which a provider will verify that they understand that the results of an inspection could be used as evidence if the DEA or other law enforcement officials decide to pursue criminal drug charges.

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IL license defense lawyerIn the healthcare industry, there are many safeguards put in place to protect patients. When it comes to medication and pharmacies, it is no different. PBM pharmacy audits are conducted both for the sake of the pharmacy benefit manager (PMB) and for you, the pharmacy owner. A PBM audit can be a stressful experience for a pharmacy, especially a small, independent one, but many pharmacies cannot operate at desired capacity without also working with a PBM. If you have an upcoming PBM pharmacy audit, proper preparation is key to success.

Documentation is Extremely Important

For many pharmacies, but especially independent pharmacies, documentation is often an area that needs attention. When your PBM auditor comes to your pharmacy, they may request to see certain documentation that could be from months or even years ago. This documentation could be anything to do with things such as supply changes, such as going from a 30-day supply to a 60-day supply, or early refills. Having your documentation completed, thorough, and organized will save you much stress during the audit.

Consistency Is Expected

Part of the job of a PBM auditor is to make sure that each patient receives the same standard of care when they use your pharmacy. This is accomplished by making sure that all employees are following the same rules and policies while they perform their job. When your PBM auditor is at your pharmacy, they will be looking for any errors made by your staff, such as checking the amount of medication dispensed or ensuring all of the proper forms and documentation are filled out. It is a good idea to have an official standard operating procedure (SOP) written out and distributed to all of your employees so that they understand what is expected of them every time they fill a prescription.

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Il pharmacist defense attorneyTo become a pharmacist, a person has to go through many years of schooling, pass dozens of tests and complete thousands of hours of an internship. Becoming a pharmacist is a huge accomplishment; to have that all taken away from you can be devastating. There are many reasons why your pharmacist license might have been taken away. Perhaps you got into trouble for illegally distributing controlled substances. Or maybe you made an error in a prescription that you filled for a patient. Whatever the reason, having your ability to practice taken away can be disheartening. However, there are steps you can take to have your license reinstated.

Reinstating Your Pharmacist License

In most cases, it is possible to have your pharmacist license reinstated if it has lapsed into the inactive status. The process of reinstatement will look different depending on the length of time that has passed since the license was inactive status. Depending on the time that has passed, your requirements for reinstatement will be slightly different.

If Your License Has Been Inactive for Less Than Five Years

According to the Pharmacy Practice Act, a pharmacist whose license has been inactive for less than five years can restore their license if they do one of the following:

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IL License Defense LawyerFor many people, the American dream is owning your own business. For some pharmacists, that dream involved starting, owning and growing their own independent pharmacies. According to statistics from the National Community Pharmacists Association (NCPA), there were more than 22,000 independent pharmacies operating in the U.S. in 2015. Of those, an estimated 1,000 pharmacies will change ownership each year.

Buying and selling a pharmacy is a different and more complicated process than buying and selling most other businesses. With a pharmacy, you must pay attention to certain things when transferring ownership, such as informing and coordinating with drug suppliers and vendors, ensuring the pharmacy is enrolled as a provider for Medicaid, Medicare, and supplemental plans and various other things. If you are looking to sell your pharmacy, here are a few things you should keep in mind:

  • Have a legitimate exit strategy and timeline in place. Too many times pharmacy owners do not have a plan when it comes to the sale of their pharmacy and things do not turn out for the best. If you are thinking of selling your pharmacy, set a date of when you would like to have the sale completed. Then you will have a rough idea of when certain tasks should be completed by. In general, it can take several months or even years to complete a sale.
  • You should have your finances in order before you start looking for potential buyers. Whoever is interested in buying your pharmacy will want to look at at least the past three or four years of business record, including audited financial statements, profit and loss statements, balance sheets, corporate tax returns, and prescription sales logs. This allows your prospective buyer to determine whether or not the business is a good investment for themselves.
  • Make your pharmacy as attractive as possible to potential buyers. This includes the physical appearance of your pharmacy. Think of home sales; a person selling their home is not going to host an open house until their home looks as good as it possibly can look. Even just a new coat of paint or new flooring can transform a business and make it look more appealing to a buyer.
  • Make sure all your contracts and licenses are up to date. You should be sure that your reimbursement contracts with third-party payers are available and up to date so that potential buyers can review them. This includes any local business license, state pharmacy licenses or building permits.

Contact an Illinois Pharmacy Sale Attorney Today

When it comes to selling a pharmacy, there are many things you should keep in mind before and during the process. There are many considerations to remember during a pharmacy sale, especially that selling your pharmacy is not as simple as signing over ownership to another person. At the Law Offices of Joseph J. Bogdan, LLC, we have been helping clients successfully buy and sell pharmacy businesses for more than 16 years. One of our skilled Illinois pharmacy sale lawyers is a licensed pharmacist and has extensive knowledge of both the medical and legal fields. Call our office today at 630-310-1267 to schedule a consultation.

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