Ch. 6: OBRA'90
What is the primary goal of Omnibus Budget Reconciliation Act of 1990 (OBRA'90)?
To save money
Improving quality of drug therapy = reduce the costs of healthcare
Which amendment defines drugs as prescription and OTC?
What is the purpose of HIPPA and is enforced by___?
To improve the efficiency and effectiveness of the healthcare system
Enforced by "Department of Health and Human Services "
What is the purpose of Sherman's antitrust act?
To protect competitions, NOT competitors
Antitrust law: regulates business to promote healthy competition for consumers benefit
Which statue prohibits knowingly soliciting, receiving, or offering any remuneration in exchange for referrals or for furnishing any goods or services?
Anti-kickback statue
What are the three components of OBRA'90's framework?
1. Rebates: provide drug products to Medicaid at "BEST PRICE" and they are used to fund MEDICAID
2. Demonstration projects: Demonstrated cost effectiveness
3. DUR: It has three parts: Retrospective, Educational, and Prospective review
Which amendment requires drugs to be proven safe and effective?
**also requires clinical investigations to obtain informed consent of research subjects and reporting ADRs
Kefauver Harris Amendment = Drug efficacy amendment
What does HIPPA target?
2. National provider identities
3. Security of health information
4. Privacy of health information
What are the types of per se violations?
1. Price fixing: suggested price schedule
2. Boycotting: competitors agree NOT TO DEAL with another party
3. Tying arrangements: conditioning the purchase of one product on purchase of another
Which act requires manufacturers to report serious adverse events of dietary supplements?
The dietary supplement and nonprescription drug consumer protection act
What are the 3 components of prospective review?
1. Screening of prescriptions before dispensing
2. Patient counseling by the pharmacist
3. Pharmacist documentation (patient profile)
Which act is made in response to the costly hurdles companies face when developing drugs for RARE diseases (affecting <200 k people)?
Orphan drug act
*This gives companies 7 years of exclusivity to incentivize drug development
What does the New rule health information technology (HITECH) allows?
It allows a patient to request and receive all disclosures over the past 3 years including TPO
**Pt has a right to request a report of disclosures over the past 6 years, except for TPO
Who get exemptions from antitrust law?
1. Government actions
2. Collective lobbying efforts
3. Unions
What are the three functions of FDA?
1. Rulemaking
2. Issue guidance documents
3. Incorporate advice from standing advisory committees of outside experts
Which component of OBRA'90 framework evaluates whether DUR requirements would improve patient care and decreased costs
Demonstration projects
Which act states that industries seeking NDA are required to pay fee for applications and supplements when FDA review studies?
Prescription Drug User Fee Act (PDUFA)
Breach notification must notify individuals within ____ days after breach discovered if more than 500 individuals affected, must notify____
DHHS immediately
Which acts states that unlawful for sellers to discriminate in price between purchasers of like products when the effect could injure competition
Robinson-Patman Act
Which acts allows foods to contain health claims if approved by the FDA?
The nutrition labeling and education act
*scientific agreement
Manufacturer rebate to the state is the difference between manufacturer's ______ and ______
Average price and best price
Food and Drug Administration Modernization Act
Authorizations must comply with _____ act when instituting refill reminder or other company programs involving automated phone calling
Telephone Consumer Protection Act (TCPA)
Which act identifies patterns of failures and propose measures to eliminate patient safety risks?
Patient safety and quality improvement act of 2005
Which act improves drug development process by factoring patient experience data, and utilization of Real-World Evidence?
**accelerate approval of regenerative advanced therapies or antimicrobials for life threatening infections
The 21st century cures ACT