Experiencing other healthcare problems? Know your rights and learn how to file complaints and seek compensation.
Beyond the well-known categories of medical malpractice and insurance denials, there exists a broad spectrum of healthcare issues that can affect patients' rights, safety, and financial well-being. These issues range from patient abandonment and emergency care violations to surprise medical bills, pharmacy errors, and hospital-acquired infections.
Understanding your rights in these situations is crucial. Whether you've experienced billing fraud, discrimination in healthcare access, privacy violations, or substandard care in a healthcare facility, legal protections exist to help you seek recourse and compensation.
This comprehensive guide covers 15+ categories of healthcare issues, your fundamental patient rights under federal and state law, types of compensation available, major legal precedents, and step-by-step guidance on how to file complaints and pursue claims.
Click each category to learn more about the issue, legal standards, potential damages, and how to address it.
When a physician terminates the doctor-patient relationship improperly without proper notice or transfer of care, leaving the patient without necessary medical supervision.
Under the Emergency Medical Treatment and Labor Act (42 U.S.C. 1395dd), hospitals with emergency departments must provide medical screening and stabilizing treatment regardless of ability to pay.
Unexpected out-of-network charges for emergency care, care at in-network facilities by out-of-network providers, or air ambulance services.
Problems accessing, correcting, or protecting medical records including loss, breach, denial of access, or incorrect information.
Mistakes in dispensing prescription medications including wrong drug, wrong dosage, wrong patient, or failure to check for dangerous drug interactions.
Fraudulent billing practices including upcoding (billing for more expensive services), unbundling (separately billing bundled services), billing for services not rendered, or duplicate billing.
Discrimination based on race, color, national origin, sex, age, or disability in access to healthcare services, quality of care, or insurance coverage.
Insurance companies imposing stricter limits on mental health and substance use disorder benefits compared to medical/surgical benefits, violating parity laws.
Adverse reactions to vaccines covered by the National Vaccine Injury Compensation Program (VICP) including severe allergic reactions, neurological complications, or death.
Infections acquired during hospital stay due to inadequate infection control practices including MRSA, C. difficile, surgical site infections, catheter-associated UTIs, and ventilator-associated pneumonia.
Preventable surgical errors that should never occur including wrong-site surgery, wrong-procedure surgery, wrong-patient surgery, or retained surgical instruments/sponges.
Defective or recalled medical devices causing patient harm including hip implants, pacemakers, IVC filters, hernia mesh, transvaginal mesh, and insulin pumps.
Negligent handling of eggs, sperm, or embryos including storage failures, labeling errors, unauthorized use or destruction of genetic material.
Abuse, neglect, or substandard care in nursing homes and assisted living facilities including bedsores, malnutrition, medication errors, falls, physical abuse, and abandonment.
Hospice providers enrolling ineligible patients (not terminally ill), providing inadequate care, or billing for services not provided to maximize Medicare reimbursements.
As a patient in the United States, you have extensive legal rights protected by federal and state laws. Understanding these rights empowers you to advocate for yourself and take action when they are violated.
Under the Emergency Medical Treatment and Labor Act (42 U.S.C. 1395dd), every person has the right to a medical screening examination and stabilizing treatment at any Medicare-participating hospital emergency department, regardless of ability to pay or insurance status.
HIPAA Privacy Rule (45 CFR 164.524) grants individuals the right to inspect and obtain copies of their protected health information (PHI) in designated record sets maintained by covered entities.
HIPAA Privacy Rule (45 CFR Part 160 and Part 164) protects the privacy of individually identifiable health information. Covered entities must have patient authorization to disclose PHI except for treatment, payment, or operations.
Patients have the right to receive sufficient information about proposed treatments, procedures, and risks to make voluntary and informed decisions about their care. Physicians must disclose material risks.
Competent adult patients have the fundamental right to refuse any medical treatment, even life-sustaining treatment, based on personal, religious, or other beliefs.
Patients have the right to seek second medical opinions before major procedures, cancer treatment, or for serious diagnoses. Many insurance plans cover second opinions.
Patients with limited English proficiency (LEP) have the right to language assistance services including qualified interpreters and translated documents at no cost.
Americans with Disabilities Act (ADA) Title III requires healthcare providers to make reasonable modifications to policies, practices, and procedures to ensure equal access for people with disabilities.
Patients have the right to file grievances about quality of care and appeal denials of insurance coverage for medically necessary services.
Patients have the right to designate a healthcare agent/proxy to make medical decisions if they become incapacitated and unable to make decisions themselves.
CMS Hospital Price Transparency Rule (45 CFR 180, effective Jan 1, 2021) requires hospitals to provide clear, accessible pricing information online including standard charges for all items and services.
Mental Health Parity and Addiction Equity Act (MHPAEA, 2008) requires health insurance plans to cover mental health and substance use disorder benefits equally with medical/surgical benefits.
No Surprises Act (effective Jan 1, 2022) protects patients from surprise medical bills for emergency services, non-emergency services at in-network facilities by out-of-network providers, and air ambulance services.
Once a physician-patient relationship is established, physician has duty to continue care until: patient no longer needs treatment, patient terminates relationship, or physician terminates with proper notice and transfer assistance.
Statute of Limitations: Most healthcare claims have strict time limits ranging from 1-6 years depending on the type of claim and state law. File promptly to preserve your rights.
Medical Malpractice: Typically requires certificate of merit from medical expert to proceed. Consult attorney early to avoid missing deadlines.
Regulatory Complaints: Can be filed anonymously with some agencies, but named complaints receive more thorough investigation.
Whistleblower Protection: Federal and state laws protect healthcare workers from retaliation for reporting fraud, safety violations, or patient rights violations.
Depending on the nature of your healthcare issue, you may be entitled to various forms of compensation. Understanding what's available helps you pursue appropriate remedies.
Compensation for all medical costs incurred and reasonably expected in the future as a result of the healthcare issue, injury, or negligence.
Past: hospital bills, surgery costs, medications, physical therapy, medical equipment, home health care, transportation to medical appointments. Future: anticipated surgeries, ongoing treatment, medications, assistive devices, life care planning costs.
Past expenses documented with bills and receipts. Future expenses calculated using life care plan prepared by medical experts, factoring in life expectancy, inflation, and probability of needing treatments.
Minor injuries: $10,000-$50,000. Moderate injuries requiring surgery: $100,000-$500,000. Catastrophic injuries (paralysis, brain injury): $1M-$10M+ lifetime medical costs.
Some states cap medical damages. Medicare/Medicaid liens must be repaid from settlements. Collateral source rule varies by state (whether health insurance payments deducted from damages).
Compensation for income lost due to inability to work during recovery and reduced earning capacity if permanently disabled or impaired.
Past lost wages: salary/wages not earned during recovery, sick leave exhausted, lost bonuses, lost benefits. Future lost earning capacity: reduced income due to disability, inability to work same job, need for vocational retraining.
Past wages: actual income lost documented by employer, tax returns, pay stubs. Future capacity: vocational expert analysis of pre-injury vs. post-injury earning capacity over work life expectancy.
Temporary disability (weeks to months): $5,000-$50,000. Permanent partial disability: $50,000-$500,000. Total permanent disability for high earner: $1M-$5M+.
Must prove causal connection between injury and lost income. Duty to mitigate damages by seeking employment within restrictions. Some states cap economic damages in medical malpractice cases.
Non-economic damages for physical pain, emotional distress, mental anguish, loss of enjoyment of life, and diminished quality of life caused by injury or negligence.
Physical pain from injury and treatment, emotional distress (anxiety, depression, PTSD), loss of enjoyment of life activities, disfigurement and scarring, permanent disability and impairment, humiliation and embarrassment.
No formula. Jury determines based on severity of injury, permanence of impairment, age of victim, impact on daily activities. Methods: multiplier of medical expenses (1.5-5x), per diem (dollar amount per day of suffering).
Minor injuries: $5,000-$25,000. Moderate injuries: $50,000-$250,000. Severe permanent injuries: $500,000-$5M+. Catastrophic injuries (quadriplegia, brain injury): $1M-$10M+.
Many states cap non-economic damages in medical malpractice cases, typically $250,000-$750,000. Some caps struck down as unconstitutional. No caps for intentional torts or gross negligence in most states.
Damages awarded to spouses and family members for loss of companionship, affection, sexual relations, household services, and parental guidance due to injury to loved one.
Spouse: loss of companionship, affection, sexual relations, household services, society and comfort. Children: loss of parental guidance, care, companionship. Parents: loss of services and companionship of injured child.
Derivative of injured person's claim. Factors: closeness of relationship, severity of injury, impact on family dynamics, duration of impairment. Testimony from family members about changes.
Moderate injuries: $10,000-$100,000 to spouse. Severe permanent injuries: $100,000-$1M+ to spouse. Wrongful death: $100,000-$5M+ to family depending on relationship and state law.
Some states only allow spouse claims, others include children and parents. Usually capped at same limit as primary victim's non-economic damages. Must file separate claim in some jurisdictions.
Damages awarded to punish defendants for egregious conduct (gross negligence, fraud, willful misconduct) and deter similar conduct. Not compensatory but rather punishment.
Cases involving: intentional fraud, concealment of known dangers, reckless disregard for patient safety, repeated violations despite warnings, corporate profit prioritized over safety.
Jury discretion based on egregiousness of conduct and defendant's wealth. Supreme Court guideline: typically should not exceed 9:1 ratio of punitive to compensatory damages (State Farm v. Campbell, 2003).
Individual defendants: $100,000-$5M. Corporate defendants (medical devices, pharma, nursing homes): $1M-$100M+. Largest: Johnson & Johnson talc cases $8.9B punitive (later reduced to $2.1B).
Some states cap punitive damages (e.g., 3x compensatory, maximum $500,000). Not available in some medical malpractice cases. Federal tax code: punitive damages are taxable income.
Damages available to surviving family members when patient dies due to medical negligence, errors, or other preventable healthcare issues. Combines economic and non-economic losses.
Economic: medical expenses before death, funeral and burial costs, lost financial support, lost benefits (pension, insurance). Non-economic: loss of companionship, guidance, consortium, mental anguish of survivors.
Economic losses: projected earnings over life expectancy minus personal consumption. Non-economic: jury discretion based on relationship, age of decedent, life expectancy. Some states use survival action vs. wrongful death.
Child death: $1M-$5M+ (high non-economic loss despite low economic loss). Working age adult: $2M-$10M+. Elderly with limited earning capacity: $500,000-$3M primarily non-economic.
State wrongful death statutes specify eligible beneficiaries (spouse, children, parents). Some states cap total wrongful death damages. Survival action allows estate to recover decedent's pre-death losses.
No-fault compensation through National Vaccine Injury Compensation Program for injuries from covered vaccines. Funded by excise tax on vaccines, not general taxpayer funds.
Actual unreimbursed medical expenses (past and future), actual lost earnings (past and future), pain and suffering (maximum $250,000), death benefit ($250,000), attorney fees and costs (even if claim denied).
Special master determines damages based on medical records, expert testimony, life care plans, vocational assessments. More streamlined than civil litigation. Average award: $200,000-$500,000.
Minor vaccine reactions: $0-$50,000. Moderate injuries: $50,000-$250,000. Severe permanent injuries: $500,000-$5M+. Death: typically $250,000-$500,000. Attorney fees: typically $50,000-$200,000.
Must file within 3 years of first symptom (2 years for death). Only covers vaccines listed on Vaccine Injury Table. If reject VICP award, can file civil suit but loses VICP award.
False Claims Act (31 U.S.C. 3730) allows private citizens (whistleblowers) to file qui tam lawsuits on behalf of government for fraud against Medicare/Medicaid/federal programs and receive 15-30% of recovery.
Rewards for reporting: fraudulent billing, kickbacks, off-label marketing, unnecessary services, upcoding, unbundling. Whistleblower receives portion of: treble damages, civil penalties, settlement amounts.
If government intervenes in case: whistleblower receives 15-25% of total recovery. If whistleblower proceeds without government: 25-30% of recovery. Based on total government recovery, not just damages.
Small cases (e.g., individual provider fraud): $50,000-$500,000 to whistleblower. Large cases (e.g., hospital chain, pharma): $1M-$100M+ to whistleblower. Largest: $250M+ to whistleblowers.
Must be original source of information. Cannot be based on public information. Whistleblower must file under seal and serve on government. Anti-retaliation protections for employees who report.
Collective litigation where multiple victims of same healthcare issue (data breach, billing fraud, insurance violations) join together to settle claims and receive compensation.
Data breach settlements: credit monitoring services, cash payments for identity theft victims, reimbursement of out-of-pocket losses. Billing fraud: refunds of overcharges. Insurance violations: retroactive coverage.
Settlement fund divided among class members based on claim forms submitted and damages claimed. Attorneys typically receive 25-33% of total settlement plus expenses. Individual payouts often modest.
Data breach settlements: $1-$10 per person for credit monitoring, $25-$500 cash for documented losses. Billing fraud: refunds of specific overcharges. Large settlements: $50M-$200M total, divided among millions.
Individual payouts often small in large class actions. Must file claim form to receive payment. Deadlines for opting out if want to pursue individual claim. Settlement approval required by court.
If you were victim of healthcare fraud (billed for services not received, upcoded services, medically unnecessary treatment), Medicare/Medicaid will adjust your claims and you may receive refunds.
Refunds of: improper copayments for services not received, higher cost-sharing from upcoded services, deductibles applied to fraudulent claims. Adjustments to explanation of benefits (EOB) statements.
Medicare/Medicaid recalculates claims based on actual services provided vs. fraudulent billing. Refunds issued for patient portions (deductibles, copays, coinsurance) paid based on fraudulent claims.
Individual refunds typically modest: $100-$5,000 depending on extent of fraudulent billing. In large fraud schemes, aggregate patient refunds can total millions across thousands of beneficiaries.
Patients must report suspected fraud to Medicare/Medicaid fraud hotlines. Refund process can take months to years during investigation. Some patients may not realize they were fraud victims.
Learn from significant legal precedents and settlements that have shaped patient rights and healthcare accountability. These cases demonstrate the power of legal action to hold negligent parties accountable.
Johnson & Johnson baby powder and body powder products contaminated with asbestos causing ovarian cancer and mesothelioma in longtime users.
Opioid manufacturers and distributors fueled addiction epidemic through deceptive marketing, overprescribing incentives, and failure to monitor suspicious orders.
3M Combat Arms Earplugs Version 2 (CAEv2) sold to military were defectively designed and too short to properly fit in users' ears, causing hearing loss and tinnitus in service members.
Hackers accessed Anthem Inc. database containing personal information of 78.8 million current and former members and employees, one of largest healthcare data breaches in history.
Hackers accessed Premera Blue Cross systems for 9 months (May 2014-Jan 2015), stealing personal and medical information of 10.6 million members, one of longest undetected healthcare breaches.
Series of data breaches at Trinity Health, one of largest Catholic health systems, compromised personal and health information of over 3.3 million patients across multiple incidents.
Major pharmacy chains filled millions of suspicious opioid prescriptions without adequate due diligence, failing to serve as final check against diversion and contributing to opioid epidemic.
Cryogenic storage tank failures at multiple fertility clinics destroyed thousands of frozen eggs and embryos, devastating patients who relied on stored reproductive material for future family planning.
Physician staffing companies TeamHealth and EmCare systematically stayed out of insurance networks to charge higher out-of-network rates, sending surprise bills to patients who had no choice in provider selection.
Medicare Advantage insurers systematically denied claims for care that would be covered under traditional Medicare, using aggressive prior authorization and utilization review to reduce payments.
UnitedHealthcare imposed stricter prior authorization and medical necessity criteria for mental health and substance use disorder treatment compared to medical/surgical treatment, violating mental health parity laws.
Many hospitals failed to comply with CMS Hospital Price Transparency Rule requiring publication of standard charges, including negotiated rates with insurers.
Nursing homes failed to protect residents from COVID-19 spread through inadequate infection control, staffing shortages, lack of PPE, and poor communication with families, leading to tens of thousands of preventable deaths.
Hospice providers enrolled patients not terminally ill (prognosis >6 months), provided inadequate care, and kept patients on service after improvement to maximize Medicare reimbursements.
Major clinical laboratories submitted fraudulent claims to Medicare/Medicaid for medically unnecessary tests, kickbacks to physicians for referrals, and improper billing practices.
Blood banks and pharmaceutical companies distributed blood products contaminated with HIV and hepatitis viruses, infecting thousands of hemophiliacs and transfusion recipients.
Transplant recipients developed serious infections (HIV, hepatitis, bacterial infections) from improperly screened or processed donated tissue allografts (bone, skin, heart valves, tendons).
DePuy ASR metal-on-metal hip implant systems had extremely high failure rates (up to 49% at 6 years), releasing cobalt and chromium ions causing metallosis, tissue death, and need for revision surgeries.
Inferior vena cava (IVC) filters designed to prevent pulmonary embolism had high rates of fracture, migration, perforation of blood vessels, and inability to be retrieved, causing serious injuries and deaths.
Medtronic Sprint Fidelis cardiac defibrillator leads had design defect causing fractures at rate 5x higher than other leads, resulting in inappropriate shocks, failure to deliver life-saving shocks, and deaths.
Taking action requires following the proper procedures. Here's a comprehensive step-by-step guide to filing complaints with regulatory agencies and pursuing legal claims.
Thoroughly document all aspects of the healthcare issue including medical records, bills, correspondence, and timeline of events.
Begin immediately when issue occurs or is discovered. Document contemporaneously. Memory fades; document while details fresh.
Documentation is foundation of any complaint, claim, or lawsuit. Medical records are legal documents. Your personal account and supporting evidence critical for proving what happened.
Attempt to resolve issue directly with healthcare provider or facility through internal complaint process before escalating to external agencies.
File internal complaint within days to weeks of incident. Most facilities respond within 7-30 days. If no response in 30 days, escalate.
Many issues can be resolved at provider level. Creates paper trail. Some regulatory agencies require attempting internal resolution first. May prevent need for formal complaint.
Obtain complete copies of medical records and itemized billing statements to verify accuracy and identify potential errors or fraud.
HIPAA: providers must provide records within 30 days (can extend 30 days with notice). Request itemized bill before making payments. Billing errors: dispute within 180 days.
Medical records prove what happened. Itemized bills reveal billing errors and fraud. Need for complaints, appeals, lawsuits. HIPAA violation if denied access or excessive delays.
Report quality of care concerns to state health department (for facilities) or medical board (for individual physicians) for investigation and potential disciplinary action.
File as soon as possible while evidence fresh. Investigations typically take 3-12 months depending on complexity. Disciplinary proceedings can take 1-2+ years.
Protects future patients from dangerous providers. May result in license discipline. Creates official record. Does not provide compensation (need civil lawsuit for that).
If health insurance denies coverage for medically necessary treatment, file internal and external appeals to challenge denial and obtain coverage.
Internal appeal: file within 180 days of denial. Insurer decides within 30-60 days. External review: file within 4 months of internal denial. IRO decides in 45 days (72 hours if urgent).
Many denials overturned on appeal (30-40% success rate). Free external review. Insurance cannot retaliate. May avoid thousands in out-of-pocket costs.
If protected health information was improperly disclosed, accessed, or you were denied access to your medical records, file HIPAA complaint with HHS Office for Civil Rights.
File within 180 days of violation (OCR may accept late complaints for good cause). OCR review and investigation: several months to 1-2 years depending on complexity.
OCR can impose penalties $100-$50,000 per violation. Serious violations referred for criminal prosecution. Protects your privacy rights. May result in policy changes preventing future violations.
Determine deadline for filing medical malpractice lawsuit based on your state's statute of limitations and discovery rule to preserve legal rights.
CRITICAL: varies by state (1-4 years typically). Check immediately. Do not delay. Consult attorney well before deadline to allow time for investigation and pre-suit requirements.
Missing statute of limitations deadline = permanent loss of rights to sue. No exceptions except very limited circumstances. Must act within deadline to preserve claim.
Seek evaluation from experienced medical malpractice attorney to assess strength of claim, damages, and whether to pursue lawsuit.
Consult attorney as soon as possible after injury recognized. Allow time for investigation before statute of limitations expires. Case investigation: 3-6 months typical.
Malpractice cases complex, require expert testimony, expensive to litigate. Need experienced attorney. Many cases not viable economically despite injury. Early evaluation critical.
Obtain evaluation by independent physician to assess injuries, causation, prognosis, and whether prior care met standard of care.
Conducted after attorney takes case, before filing lawsuit. Allows 1-2 months for scheduling, examination, report preparation.
Expert medical testimony required in malpractice cases. IME provides independent assessment of injuries and causation. Critical for case valuation and settlement negotiations.
If health insurance denies coverage after internal appeal, request external review by independent review organization (IRO) for binding decision.
Request within 4 months of final internal appeal denial. IRO decision: 45 days standard, 72 hours expedited. Free process.
External review success rate: 30-40% of denials overturned. Binding on insurer. No cost. Avoids litigation. Provides independent medical review.
If affected by widespread healthcare issue (data breach, billing fraud, defective device), check if class action lawsuit filed that you can join.
Class action lawsuits: several years from filing to settlement approval. Claim filing deadlines: typically 60-180 days after notice. Monitor for notices if you may be affected.
Provides remedy when individual damages too small to justify individual lawsuit. Aggregates claims for negotiating power. Settlement approval ensures fairness. No attorney needed to participate.
If you have direct knowledge of healthcare fraud against Medicare/Medicaid, consult qui tam attorney about filing False Claims Act whistleblower lawsuit for government and receiving reward.
File ASAP before public disclosure. Seal period: 1-2+ years. Government investigation and litigation: 3-7+ years total. Large recoveries worth the wait (relators can receive millions).
Qui tam recovered $2.7B+ in healthcare fraud 2023. Relators received $400M+ in rewards. Protects taxpayer funds. Deters future fraud. Anti-retaliation protections for employees.
Depending on the type of healthcare issue, different regulatory agencies have jurisdiction. Here's a comprehensive directory of where to file complaints.
License and discipline physicians, physician assistants, and other medical professionals. Protect public from incompetent, unethical, or impaired practitioners.
Physician misconduct: gross negligence, repeated negligence, incompetence, substance abuse, sexual misconduct with patients, criminal convictions, fraud, practicing outside scope of license, unprofessional conduct, failure to meet continuing education requirements.
File complaint with state medical board (each state has separate board). Provide: detailed description of incident, dates, names of involved parties, medical records, supporting documentation. Can report anonymously in some states but named complaints investigated more thoroughly.
Board investigates complaint. May request medical records, interview witnesses, consult expert reviewers. Physician may respond. Board determines if violation occurred. Disciplinary actions: reprimand, continuing education, practice restrictions, probation, suspension, license revocation. Public record.
Find your state medical board: Federation of State Medical Boards (www.fsmb.org). Each state has online complaint portal or form.
Does not provide compensation to victims (separate malpractice lawsuit needed). Process can take months to years. Not all complaints result in discipline. Some states criticized for being physician-friendly and rarely revoking licenses. Confidentiality during investigation (most states).
Accredit and certify healthcare organizations. Evaluate compliance with quality and safety standards. Investigate complaints about accredited organizations.
Quality of care concerns at Joint Commission-accredited hospitals, nursing homes, home health agencies, labs: unsafe conditions, patient rights violations, medication errors, infection control problems, inadequate staffing, improper credentialing, accreditation standard violations.
Report complaint to Joint Commission: online form (www.jointcommission.org), email (complaint@jointcommission.org), fax (630-792-5636), phone (800-994-6610), mail. Provide: facility name/location, specific concerns, dates, your contact information (confidential).
Joint Commission reviews complaint. May conduct unannounced on-site survey if serious safety concerns. Facility must respond and create corrective action plan. Follow-up surveys verify compliance. Can place facility on accreditation watch or revoke accreditation (rare). CMS can terminate Medicare participation if accreditation revoked.
Joint Commission Complaint Hotline: 800-994-6610. Online complaint form: www.jointcommission.org/report-a-patient-safety-concern. Email: complaint@jointcommission.org
Joint Commission is private accrediting body, not government regulator. Deemed status: CMS accepts Joint Commission accreditation in lieu of Medicare certification survey (controversial). Criticized for advance notice of surveys and consulting relationship with hospitals. Complaints confidential, outcomes not always public.
Centers for Medicare & Medicaid Services regulates Medicare/Medicaid-participating providers. Investigates complaints about quality of care, billing, and compliance.
Medicare/Medicaid concerns: quality of care in hospitals, nursing homes, home health, hospice; improper billing; EMTALA violations (patient dumping); improper discharge; denial of care; facility safety; discrimination; privacy violations.
File complaint with 1-800-MEDICARE (1-800-633-4227) for beneficiary issues. Nursing home complaints: state survey agency or online at Medicare.gov/nursinghomecompare. EMTALA violations: state survey agency. Billing fraud: 1-800-HHS-TIPS (1-800-447-8477) or tips.hhs.gov.
CMS refers complaints to state survey agencies for investigation. Surveyors conduct on-site inspections, review records, interview staff and patients. Facility must submit plan of correction for deficiencies. CMS can impose remedies: civil monetary penalties, denial of payment for new admissions, temporary management, termination of Medicare participation.
1-800-MEDICARE (1-800-633-4227), TTY 1-877-486-2048. Online: Medicare.gov. Fraud: 1-800-HHS-TIPS or tips.hhs.gov. State survey agencies: find at Medicare.gov
Does not provide individual compensation. Focus on systemic compliance, not individual case resolution. Investigation timelines vary. Immediate jeopardy situations prioritized. Beneficiaries have separate appeal rights for coverage denials (5-level Medicare appeals process).
Enforce HIPAA Privacy and Security Rules, Section 1557 of ACA (non-discrimination in healthcare), and other civil rights laws in health and human services.
HIPAA violations: unauthorized disclosure of protected health information, denial of access to medical records, lack of breach notification, inadequate security safeguards, retaliation for exercising HIPAA rights. Discrimination: based on race, color, national origin, sex, age, disability in healthcare.
File complaint online at HHS OCR Complaint Portal (ocrportal.hhs.gov/ocr/smartscreen/main.jsf), by mail, by email. Must file within 180 days of incident (OCR may extend for good cause). Provide: description of violation, when it occurred, covered entity name, your contact information.
OCR reviews complaint for jurisdiction and timeliness. May seek corrective action from covered entity, conduct investigation, require compliance review. Resolutions: voluntary compliance, corrective action plan, civil monetary penalties ($100-$50,000 per violation, up to $1.5M annual cap). Serious violations referred to DOJ for criminal prosecution.
HHS Office for Civil Rights Complaint Portal: ocrportal.hhs.gov. Phone: 1-800-368-1019, TTY: 1-800-537-7697. Mail: U.S. Department of Health and Human Services, 200 Independence Avenue S.W., Room 509F, HHH Building, Washington, D.C. 20201
OCR investigates systemic violations, not individual case resolution or compensation. No private right of action under HIPAA (cannot sue for HIPAA violation directly). State law claims (negligence, invasion of privacy) may provide compensation. Criminal prosecutions rare.
FDA safety information and adverse event reporting program for medical products including drugs, biologics, medical devices, dietary supplements, cosmetics.
Adverse events: serious injury or death suspected to be associated with medical product, product quality problems, therapeutic failures, medication errors. For devices: malfunctions even if no injury. Can report suspected issues, does not need to prove causation.
Healthcare professionals and consumers can report. Online: www.fda.gov/medwatch. Phone: 1-800-FDA-1088. Mail: MedWatch form FDA 3500. Voluntary reporting (except device manufacturers must report under MDR). Provide: patient demographics, product details, adverse event description, reporter information (confidential).
FDA evaluates reports, adds to adverse event database. May investigate further, request medical records. Can lead to: safety communications, label changes, recalls, post-market studies, restrictions, withdrawals from market. Public database (FAERS for drugs, MAUDE for devices) with confidential info redacted.
MedWatch Online: www.fda.gov/medwatch. Phone: 1-800-FDA-1088 (1-800-332-1088). Fax: 1-800-FDA-0178. FDA Safety and Adverse Event Reporting: www.fda.gov/safety
Reporting does not prove causation (many reports are coincidental). Voluntary reporting subject to underreporting bias. FDA cannot provide medical advice or legal advice to reporters. Does not result in individual compensation. Separate medical device problem reporting for specific issues.
Vaccine Adverse Event Reporting System co-managed by CDC and FDA. Collects reports of adverse events after vaccination to detect potential safety signals.
Any adverse event after vaccination: serious events (death, hospitalization, disability, life-threatening), non-serious events, medication errors, vaccine administration errors. Can report even if unsure if vaccine caused event. Temporal association sufficient.
Online: vaers.hhs.gov/reportevent.html. Downloadable PDF form. Phone: 1-800-822-7967. Anyone can report: patients, parents, healthcare providers. Provide: vaccine information (manufacturer, lot number, dose), patient demographics, adverse event description and timing.
VAERS staff review reports, follow up for missing information, code events using MedDRA terminology. CDC and FDA physicians review for serious events. Data analyzed for patterns and safety signals. Public database searchable at vaers.hhs.gov (confidential info removed). Does not determine causation.
VAERS Online Reporting: vaers.hhs.gov/reportevent.html. VAERS Information: 1-800-822-7967. Email: info@vaers.org. VAERS does NOT provide medical advice; contact healthcare provider for medical questions.
Passive surveillance system: subject to reporting biases, underreporting, unverified reports. Cannot prove vaccine caused event (temporal association not causation). Denominator unknown (total vaccinations). Supplement with active surveillance (Vaccine Safety Datalink, CISA).
File claims for vaccine injuries for vaccines listed on Vaccine Injury Table. No-fault compensation system for medical expenses, lost earnings, pain and suffering, death benefit.
Vaccine injuries: Table injuries (specific adverse events within specified time after covered vaccines), off-table injuries (must prove causation). Covered vaccines: DTaP, MMR, polio, hepatitis A/B, Hib, varicella, influenza, meningococcal, HPV, rotavirus.
File petition with U.S. Court of Federal Claims, not VAERS. Attorney representation recommended (fees covered by program). Must file within 3 years of first symptom (2 years for death). Provide: medical records, vaccine records, itemized expenses, description of injury.
Petition filed in Court of Federal Claims. HHS reviews medical records. Special Master conducts hearing, considers medical evidence and expert testimony. Standard: preponderance of evidence. Table injuries: causation presumed. Off-table: must prove causation. HHS or petitioner can appeal. If compensation awarded, can accept or reject and file civil suit.
HRSA Office of Infectious Disease and HIV/AIDS Policy: 1-800-338-2382. VICP website: www.hrsa.gov/vaccine-compensation. Filing: U.S. Court of Federal Claims, 717 Madison Place NW, Washington, DC 20439. Find VICP attorney: vaccinelaw.com
Only covers vaccines on Vaccine Injury Table. Time limits: 3 years from first symptom, 2 years from death. If reject award, lose VICP compensation but can sue manufacturer (difficult due to immunity). Maximum $250,000 for pain and suffering, $250,000 death benefit. Average processing time 2-3 years.
License and inspect healthcare facilities including hospitals, nursing homes, assisted living, home health. Investigate complaints about quality of care, safety, and regulatory violations.
Healthcare facility problems: unsafe conditions, inadequate staffing, medication errors, abuse or neglect, infection control issues, improper discharges, food safety, environmental hazards, licensing violations, failure to follow care plans.
File complaint with state health department (each state has different process). Find state health department contact at CDC.gov or state government website. Provide: facility name and address, specific concerns, dates, your contact information (can request confidentiality).
Health department investigates complaint, may conduct surprise inspection. Surveyors review records, interview staff and residents, observe care. Facility must correct deficiencies and submit plan of correction. Enforcement: citations, fines, conditional license, license suspension/revocation, criminal referrals for abuse.
Find state health department: CDC.gov/publichealthgateway/sitesgovernance/index.html or state government website. State survey agencies: Medicare.gov/nursinghomecompare (nursing homes)
Complaint investigation does not provide individual compensation. Enforcement varies by state (some more aggressive than others). Facilities may have opportunity to correct before penalties. Follow-up inspections may be delayed. Serious violations (immediate jeopardy) prioritized.
HHS Office of Inspector General investigates fraud, waste, and abuse in Medicare, Medicaid, and other HHS programs.
Healthcare fraud: billing for services not provided, upcoding, unbundling, kickbacks, medically unnecessary services, false cost reports, identity theft using Medicare number, provider billing deceased beneficiaries, patient brokering, pharmacy fraud.
OIG Fraud Hotline: 1-800-HHS-TIPS (1-800-447-8477). Online: tips.hhs.gov. Email: HHSTips@oig.hhs.gov. Fax: 1-800-223-8164. Mail: Office of Inspector General, ATTN: OIG HOTLINE OPERATIONS, P.O. Box 23489, Washington, DC 20026. Can report anonymously.
OIG reviews allegations, conducts preliminary assessment. May investigate, refer to law enforcement (DOJ, FBI), or refer to CMS for administrative action. Investigations can lead to: criminal prosecution, civil lawsuits, exclusion from federal programs, civil monetary penalties, recovery of overpayments.
OIG Fraud Hotline: 1-800-HHS-TIPS (1-800-447-8477), TTY 1-800-377-4950. Online: tips.hhs.gov. Email: HHSTips@oig.hhs.gov. Fax: 1-800-223-8164. For qui tam FCA lawsuits, consult attorney (separate from OIG hotline).
OIG does not provide individual compensation to fraud victims (separate from qui tam False Claims Act lawsuits where whistleblowers receive rewards). Investigations confidential. May take years. Not all tips result in investigation or prosecution. No updates provided to tipster in most cases.
False Claims Act allows private citizens (relators/whistleblowers) to file lawsuits on behalf of government against those defrauding federal programs. Relators receive 15-30% of recovery.
Healthcare fraud against federal programs (Medicare, Medicaid, TRICARE, VA): false billing, kickbacks, off-label marketing, medically unnecessary services, false certifications, cost report fraud, research fraud, grant fraud. Must have direct knowledge, not public information.
Consult qui tam attorney (contingency fee typically 35-40%). Attorney files lawsuit under seal in federal district court, serves on DOJ and state AG. Must provide detailed factual allegations and supporting evidence. Complaint remains sealed during government investigation (typically 1-2 years, extensions common).
DOJ investigates (Civil Fraud Section or U.S. Attorney office). Government decides whether to intervene (take over case). If intervenes: relator receives 15-25% of recovery, government litigates. If declines: relator can proceed alone (25-30% of recovery). Settlement or trial. Relator attorney fees and costs covered.
DO NOT contact DOJ directly before filing qui tam lawsuit (public disclosure bar risk). Consult qui tam attorney: National Whistleblower Center (www.whistleblowers.org), Taxpayers Against Fraud (www.taf.org). Find qui tam attorney: search "qui tam lawyer" + your state.
Public disclosure bar: if fraud already publicly disclosed (government report, news, other lawsuit), relator must be original source. First to file rule: first qui tam case blocks later cases. Anti-retaliation protection for employee whistleblowers. Must have direct knowledge, not speculation. Statute of limitations: 6 years or 3 years from knowledge (max 10).
Collect, aggregate, and analyze confidential patient safety event information from healthcare providers to improve safety and reduce medical errors.
Patient safety events: medical errors, near misses, adverse events, hazardous conditions, system failures. Providers report to PSO as part of quality improvement efforts. Confidential and privileged (not subject to discovery in lawsuits).
Healthcare providers report to PSO they have contract with. Patients typically do not report directly to PSOs; report to provider patient safety/quality department or file complaint with regulatory agencies. PSO analyzes trends across multiple providers.
Provider reports patient safety event to PSO. PSO aggregates data from multiple providers, analyzes trends, identifies system vulnerabilities, provides feedback and recommendations. Patient safety work product (PSWP) is privileged and confidential under Patient Safety and Quality Improvement Act.
List of federally certified PSOs: www.pso.ahrq.gov/listed. Patients: report to hospital patient relations, risk management, or quality department, not directly to PSO. For complaints: use regulatory agencies listed above.
PSOs are for provider quality improvement, not patient complaint resolution or compensation. Patients should report to provider, regulatory agencies (Joint Commission, CMS, state health department), or file malpractice lawsuit. PSO reports confidential and cannot be used in litigation.
Regulate health insurance companies, investigate consumer complaints, enforce insurance laws, conduct market conduct examinations.
Health insurance problems: claim denials, delayed payments, surprise bills, inadequate provider network, discrimination, premium disputes, policy cancellations, violation of state insurance laws, mental health parity violations, ACA violations (state-regulated plans).
File complaint with state insurance department/commissioner. Find state department of insurance website. Provide: insurer name, policy number, description of issue, denial letters, supporting documents. Most states have online complaint forms.
Insurance department reviews complaint, contacts insurer, requests response. May facilitate resolution, require insurer to reconsider, issue order to insurer. Can conduct investigation, impose fines, require refunds, order policy changes. Some states have formal appeal/review process.
Find state insurance commissioner: NAIC (National Association of Insurance Commissioners) consumer information at content.naic.org/consumer.htm or search "insurance commissioner" + your state. Medicare Advantage: also file with 1-800-MEDICARE.
Self-funded employer plans (ERISA) generally not regulated by states (except stop-loss insurance); file ERISA claim and appeal or DOL complaint. State commissioner cannot award damages beyond requiring insurer to pay valid claims. May take weeks to months. Some states more consumer-friendly than others.
Compare healthcare dispute resolution and patient rights across different regions
Don't let healthcare violations go unaddressed. You have legal rights and multiple pathways to seek justice and compensation.