Governmental Oversight: CMS and OIG
HHS is responsible for
FDA (regulating food products and new drugs), CMS (implementing the nation's biggest health care programs), CDC (preventing the outbreak and spread of diseases), NIH (funding some of the most important medical research in the world)
HIPAA
Health Insurance Portability and Accountability Act
what is fraud?
- submitting false statements/information to obtain payment - accepting payment to induce or reward referrals for healthcare related items - making prohibited referrals for certain health services - billing for services by falsifying records that aren't allowed - billing for services at a higher level than actually provided
Medicare
65 yr+; financed by payroll taxes, Federal Insurance Contributions Act (FIDA), Self-Employment Contributions Act of 1954; covers > 40 million people; free if you worked and paid SS taxes for 10 years
What is the HHS largest health insurer?
Medicare (1 bil claims per year)
abuse
bending the rules; ex: improper billing practices
NIH (research)
biomedical and behavioral research domestically and abroad, has its own labs and clinics, trains young researchers, promotes acquisition and distribution of medical knowledge
Affordable Care Act
comprehensive health insurance; goals: make it affordable, accessible with higher quality, for families/seniors/businesses/taxpayers, including previously uninsured and americans with inadequate insurance
Medicare Part B
covers necessary dr services, preventive care, durable medical equipment, hospital outpatient services, lab test, x-rays, mental health care, home health and ambulance services; monthly premium and small deductible
Anti-Kickback Statute (AKS)
criminal offense to knowingly and willfully offer, pay, solicit, or receive any payment directly or indirectly to encourage or reward referrals of items or services reimbursable by a Federal healthcare program lab should only give supplies to physicians for appropriate and approved reasons lab must monitor the amount of supplies and make sure it matches the number of tests lab can't give free tests except if there is an error lab can't give free education to clients unless about services/policies lab can't give excessive or expensive gifts or entertainment to physicians lab can give discounts but the price must be able cost and at "fair market value"
error
a mistake; example is incorrect coding on claims
fraud
more than $30 billion a year
physical safeguards
physical barriers like fences, doors, gates, locks and file cabinets that protect our IIHI
Title II
prevents fraud and abuse, medical liability reform, administrative simplification- electronic data exchange, unique identifiers, code sets for healthcare plans, privacy, security
stages of contingency plan
recovery procedures, security planning, risk analysis
Patient's rights under HIPAA privacy rule
right to receive a copy of the Note of Privacy Practices (NoPP) review their medical record info request copies/restrictions/Confidental Communication file a complaint accounting of outside disclosures request an amendment
waste
an inefficiency; example: medically unnecessary service
individually identifiable health information
any health information that has something in it that might identify the individual: name, address, account/claim number, ss number, DOB, diagnosis, tests ordered, results
CMS also oversees
Children's Health Insurance Program (CHIP), HIPAA, CLIA
CLIA
Clinical Laboratory Improvement Amendments
what departments are of interest to clinical labs?
Department of Health and Human Services (CMS, FDA, CDC, NIH, OIG- oversee and implement CLIA, HIPAA, Compliance) Department of Labor (OSHA) Department of Transportation- alcohol and drug testing
OIG
Office of Inspector General
CMS
Centers for Medicare and Medicaid Services
Who investigates fraud?
OIG
Medicare Part C
allows private health insurance companies to provide Medicare benefits: Medicare Advantage plans- can choose their A and B coverage through an Advantage plan instead of original Medicare
HIPAA privacy officer
access to patient data on a need to know basis shredding records staff and students must complete ongoing education ongoing compliance penalties
CMS (services)
administration of Medicare (seniors) and Medicaid (needs-based)
Department of Health and Human Services (HHS)
agency for protecting the health of all americans; essential human services
Medicare Part A
hospital insurance; pays 80% of first 60 days in hospital; covers inpatient care in a hospital or nursing facility; must pay a yearly deductible
CMS and the HITECH Act
electronic health record (EHR) incentive programs, certified EHR technology, certification of EHR technology, updating of health information privacy and security regulations under HIPAA, meaningful use
whistleblowers
employees who sue their companies because they have detected illegal activities
types of improper payments
error, waste, abuse, fraud
Center for Biologics Evaluation and Research: Products for Rare Diseases
immune globulins, albumin, coagulation factors, plasma protein replacement factors, alpha1 anti-trypsin, c1-esterase inhibitor, antivenins, stem cells, gene therapy, vaccines, orphan drugs
HIPAA Security Rule
includes administrative safeguards, technical safeguards, physical safeguards
fraud
intentional deception; ex: billing for services that weren't provided
voluntary compliance program
lab has written standards/policies/procedures that instruct employees in the proper legal and ethical conduct must be adhered to appointed to a CO and a compliance committee mandatory training for all employees
monitoring and auditing
lab monitors and audits compliance activities, policies, and procedures to ensure they're being followed
CDC (research)
leads public health efforts to prevent and control infectious and chronic disease, injury, workplace hazards, disabilities, and environmental health threats; produces and distributes health info internationally
False Claims Act (FCA)
makes people liable for falsity or fraudulent claim; labs must not induce doctors to order unnecessary tests; cost reports: only appropriate costs; labs must follow all CLIA and OSHA regulations; failure to do so results in a FCA violation
FDA (regulation)
medical and food products; reviewing new medicines, inspecting food processing; comprised of chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, etc; performs blood bank inspections
Medicaid
single parents and their children, disabled, elderly
Physician Self-Referral Law (Stark Law)
social security act, US Criminal code; prohibits a physician from making a referral for certain services to an entity in which the dr has an ownership/investment interest or with which he or she has a compensation arrangement, unless an exception applies
Where does the majority of OIG's resources go?
the oversight of Medicaid and Medicare
technical safeguards
things like passwords, screen savers, computer access cards, ID scanners
Presidential Cabinet's role
to advise the president on any subject he may require relating to the duties of each member's respective office
HIPAA Privacy Law, Title I (the original purpose)
to ensure that an employee's health insurance, purchased through their employer could be continued at the employee's expense after loss and leaving current job.
HIPAA allows use of IIHI for these things without patient's signature
treatment: coordination of healthcare and related services by one or more provides payment: activities required to obtain reimbursement healthcare operations: audits, inspections, etc
Meaningful use
using digital medical and health records to achieve improvement of quality/safety/efficiency, reduce health disparities, engage patients and family, improve care coordination and population and public health, maintain privacy and security of patient health information
administrative safeguards
written policies and procedures that provide step by step instructions which have been put into effect to protect privacy