Compliance for medical professionals (general)

Summary and actionable guidance for ‘Compliance for medical professionals (general)’ targeted to US business owners/LLC founders running medical practices. The answer below consolidates federal and state compliance priorities, practical steps, and authoritative resources you should consult and register with.

Key takeaways (concise): - Build a written, scaled compliance program based on OIG’s GCPG Seven Elements: governance, policies, training, monitoring, reporting, corrective action, and risk-based auditing.

Appoint a compliance officer and document procedures. (See OIG guidance.) - Privacy & security: Complete a formal HIPAA Security Risk Analysis, maintain Privacy & Security policies, sign Business Associate Agreements, and implement technical safeguards (encryption, access controls).

Prepare a breach-notification plan that meets HIPAA and applicable state breach laws. (See HHS OCR/HIPAA resources.) - Controlled substances & DEA: Obtain/maintain a DEA registration for controlled substances; follow DEA rules on prescribing (including telemedicine flexibilities and any temporary/extended waivers), use PDMP checks where required, and maintain secure e-prescribing controls. (See DEA Diversion Control site.) - Provider enrollment and reimbursement: Enroll with Medicare (PECOS) and with state Medicaid programs as required.

Follow CMS certification/quality and billing standards; implement documentation/billing controls to avoid Stark/AKS/FCA exposure. (See CMS resources.) - Telehealth & state rules: Verify state licensure and telehealth rules for each state where patients are located (NCSL summaries are a practical starting point).

Use interstate licensure compacts or state telehealth registrations where applicable. Review private payer/Medicaid telehealth coverage and payment parity rules by state. (See NCSL telehealth summaries.) - Licensure, credentialing & scope of practice: Maintain active licenses in states where you treat patients, keep credentials and privileging current, and monitor national exclusion lists (OIG LEIE, SAM) before hiring/credentialing. - Clinical labs & diagnostics: Obtain CLIA certification for any laboratory testing offered onsite and comply with CLIA quality standards. - Workplace safety & employment law: Comply with OSHA healthcare workplace standards (bloodborne pathogens, hazard communication, workplace safety) and federal/state employment laws (wage/hour, sick leave, harassment training). - Fraud, waste & abuse: Implement policies and training to prevent False Claims Act, Anti-Kickback Statute, and Stark Law violations; regularly audit coding, billing, and referral/financial relationships; self-report overpayments and cooperate with audits. - Cybersecurity & incident response: Maintain written cybersecurity controls, vendor risk management, logging and backups, periodic penetration/security testing, and an incident response plan with notification timing aligned to HIPAA and state laws.

Practical checklist (first 90 days for an LLC owner starting or running a medical practice):

Key takeaways (concise):

- Cybersecurity & incident response: Maintain written cybersecurity controls, vendor risk management, logging and backups, periodic penetration/security testing, and an incident response plan with notification timing aligned to HIPAA and state laws.

Practical checklist (first 90 days for an LLC owner starting or running a medical practice):

Build a written, scaled compliance program based on OIG’s GCPG Seven Elements: governance, policies, training, monitoring, reporting, corrective action, and risk-based auditing. Appoint a compliance officer and document procedures. (See OIG guidance.)
Privacy & security: Complete a formal HIPAA Security Risk Analysis, maintain Privacy & Security policies, sign Business Associate Agreements, and implement technical safeguards (encryption, access controls). Prepare a breach-notification plan that meets HIPAA and applicable state breach laws. (See HHS OCR/HIPAA resources.)
Controlled substances & DEA: Obtain/maintain a DEA registration for controlled substances; follow DEA rules on prescribing (including telemedicine flexibilities and any temporary/extended waivers), use PDMP checks where required, and maintain secure e-prescribing controls. (See DEA Diversion Control site.)
Provider enrollment and reimbursement: Enroll with Medicare (PECOS) and with state Medicaid programs as required. Follow CMS certification/quality and billing standards; implement documentation/billing controls to avoid Stark/AKS/FCA exposure. (See CMS resources.)
Telehealth & state rules: Verify state licensure and telehealth rules for each state where patients are located (NCSL summaries are a practical starting point). Use interstate licensure compacts or state telehealth registrations where applicable. Review private payer/Medicaid telehealth coverage and payment parity rules by state. (See NCSL telehealth summaries.)
Licensure, credentialing & scope of practice: Maintain active licenses in states where you treat patients, keep credentials and privileging current, and monitor national exclusion lists (OIG LEIE, SAM) before hiring/credentialing.
Clinical labs & diagnostics: Obtain CLIA certification for any laboratory testing offered onsite and comply with CLIA quality standards.
Workplace safety & employment law: Comply with OSHA healthcare workplace standards (bloodborne pathogens, hazard communication, workplace safety) and federal/state employment laws (wage/hour, sick leave, harassment training).
Fraud, waste & abuse: Implement policies and training to prevent False Claims Act, Anti-Kickback Statute, and Stark Law violations; regularly audit coding, billing, and referral/financial relationships; self-report overpayments and cooperate with audits.

Appoint a Compliance Officer and set meeting cadence. Draft a one-page compliance charter. (OIG guidance)

Conduct a HIPAA Security Risk Analysis and document remediation plan; execute BAAs with vendors. (HHS/HIPAA)

Register for DEA controlled-substances registration (if prescribing controlled meds) and set e-prescribing controls. Verify telemedicine prescribing rules and temporary flexibilities. (DEA)

Enroll in Medicare via PECOS and confirm state Medicaid enrollment requirements; check CMS guidance on provider enrollment and certification. (CMS)

Verify state licensure requirements for each state where patients will be treated (telehealth or in-person); check compacts and state telehealth registries. (NCSL)

Put in place billing & documentation policies, train staff on coding and documentation accuracy, and establish an internal audit schedule. (OIG/CMS best practices)

Implement OSHA-required safety plans and trainings (bloodborne pathogens, PPE, hazard communication).

Subscribe to OCR, OIG, DEA and CMS email updates or listservs for timely regulatory changes.

Create an incident/breach response playbook with timelines for notification under HIPAA and state law.

Establish an external counsel/compliance consultant relationship for Stark/AKS/FCA risk reviews and for complex arrangements. Where to register and quick links (start here)

- OIG General Compliance Program Guidance (reference for building compliance programs): https://oig.hhs.gov/compliance/general-compliance-program-guidance/ - HHS OCR HIPAA for Professionals (Privacy, Security, Breach Notification rules and resources): https://www.hhs.gov/hipaa/for-professionals/index.html - DEA Diversion Control (DEA registration, controlled substances schedules, telemedicine flexibilities, forms): https://www.deadiversion.usdoj.gov/ - CMS — Provider certification, enrollment & quality/certification standards (Medicare/Medicaid provider enrollment guidance and program integrity resources): https://www.cms.gov/medicare/health-safety-standards/certification-compliance - NCSL — State telehealth policies and licensure/compact summaries (state-by-state variation): https://www.ncsl.org/health/state-telehealth-policies