Federal Healthcare, DEA and FDA Cases
Office of Inspector General (OIG) Medicare Exclusion List Appeals
The United States Department of Health & Human Services Office of the Inspector General regulates Medicare and Medicaid Providers throughout the United States. Medicare and Medicaid providers include Physicians, Nurses, Pharmacists, Social Workers, Medical Billers and Administrators. The Office of the Inspector General (OIG) can institute an Exclusion Action for providers who receive a criminal conviction, receive state professional license discipline, or violate Medicare or Medicaid rules. The OIG initiates an Exclusion process by sending out a Notice of Intent to Exclude. A Respondent to a Notice of Intent to Exclude has the right to file a written Appeal within 30 days. In certain cases, the Appeal must be filed within 20 days. If the Exclusion is granted by the OIG, the Respondent may appeal to an Administrative Law Judge employed by the Department of Health & Human Services. The next level of Appeal is to the HHS Departmental Appeals Board, or DAB.
Drug Enforcement Agency (DEA) Registration Order to Show Cause Hearing Cases
The Drug Enforcement Administration or DEA may move to deny, regulates DEA Registrations held by a healthcare provider. The DEA Enforcement Action begins with an Order to Show Cause. In more serious cases, the DEA issues an Immediate Suspension Order. In some instances, a DEA Agent or Attorney will contact the DEA Registrant and attempt to persuade the Registrant to surrender their DEA Registration Permit.
Upon receipt of an Order to Show Cause or an Immediate Suspension Order, the DEA Registration holder must file a formal request for hearing within 30 days, even if a Hearing date has already been provided on the initial notice document. If the DEA Registrant takes no action after receipt of the Order to Show Cause or the Immediate Suspension Order, the right to a hearing may be waived. DEA Administrative Law Hearings are heard in accordance with the Federal Administrative Procedures Act and are presided over by an Administrative Law Judge.
Food and Drug Administration (FDA) Section 305 Notice Proceedings
Food and Drug Administration (FDA) utilizes Section 305 proceedings to notify companies and individuals of FDA Violations and to provide an opportunity for corrective action before presentation of a criminal case to the United States Attorney’s Office. The FDA Director designates a Compliance Officer to hold a Section 305 Notice meeting. The 305 Notice Hearing is an opportunity to present mitigating circumstances and inform the FDA of corrective actions taken in order to avoid criminal prosecution. Counsel for the Respondent needs to protect the recipient of the 305 Notice from making damaging statements that could aggravate future criminal proceedings. The objective of the 305 Notice meeting is to persuade the FDA to drop the prosecution entirely or at least hold the matter in abeyance until an informal resolution can be reached.
Food and Drug Administration (FDA) Administrative Detention of Foods and Devices
The Food and Drug Administration (FDA) may issue an order detaining food or devices intended for human use. If an Administrative Detention Order is issued, a claimant may Appeal the Detention in writing to the District Director where the items are detained. The FDA may provide an Informal Hearing or Formal Hearing if requested by the Respondent in writing. The FDA Director designates a Presiding Officer for the Hearing. Hearings for perishable food may occur within as little as two days. Hearings for non-perishable foods and device detentions involve longer periods of time.
Food and Drug Administration (FDA) License Revocation or Suspension Cases
The Food and Drug Administration (FDA) issues licenses for the manufacture of biological products including vaccines, cellular and tissue products, and other items. The FDA may move to revoke or suspend these manufacturing licenses. The FDA typically issues a Warning Letter or offer to meet with the FDA for an Informal Conference. If the matter is not resolved, the FDA will issue Notice of Intent to Revoke the License. The FDA may issue a Notice of Intent to Revoke the License if the matter is considered serious. The FDA License Revocation may be resolved through settlement negotiations or via an Administrative Law Hearing.
Food and Drug Administration (FDA) Civil Money Penalties for Foods, Drugs, Devices and Tobacco
The Food and Drug Administration (FDA) assesses Civil Money Penalties for violations of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act for Unsafe Foods, Illegal Sales of Drug, Falsification of Drug Information and misrepresentations in the drug trial and approval process. FDA Civil Money Penalties are also assessed for regarding Devices, Mammography Facilities, Tobacco and Tobacco Retail Sales. Civil money penalties are subject to a formal hearing process under Title 21, United States Code of Federal Regulations, Part 17.
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