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