PHRD5045 - Chapter 6: Federal Regulation of Pharmacy Practice (Exam 3)

  1. first federal law directly regulating pharmacy practice standards
  2. primary goal of OBRA-90
    save money
  3. What must states establish in order to continue receiving federal funds for Medicaid?
    OBRA-90 standards
  4. "best price"
    lowest price at which manufacturers sell product to any customer
  5. OBRA-90 Rebates
    manufacturers required to rebate to the state the difference between the ave manufacturer's price and the "best price"
  6. DUR
    drug use review
  7. 3 types of DUR programs ***
    • 1) retrospective review
    • 2) educational programs
    • 3) prospective review
  8. Retrospective DUR
    • board of physicians & pharmacists review medication use data & compares to target criteria 
    • ("ideal drug tx vs actual use - should match)
  9. generates up-to-date drug utilization
  10. Pro-DUR
    • prospective DUR
    • provides opportunity to evaluate the prescribed drug therapy before the Rx is dispensed
  11. components of Pro-DUR (3)
    • 1) screening
    • 2) counseling
    • 3) patient profile
  12. Pro-DUR screening
    pharmacists must detect potential drug use problems before Rx is dispensed
  13. Pro-DUR counseling
    requires an "offer to counsel" patient or caregiver (must be done by pharmacist)
  14. Pro-DUR patient profile
    • requires pharmacy to obtain, record, & maintain a record of specified information about the pt 
    • review of profile critical to effective screening/counseling
  15. HIPAA
    • Health Insurance Portability and Accountability Act
    • overall goal to improve efficiency & effectiveness of the healthcare system
    • particular purpose to regulate privacy & security of PHI
  16. targets of HIPAA (4)
    • 1) uniform transaction & code sets
    • 2) national provider identities
    • 3) security of PHI
    • 4) privacy of PHI
  17. types of PHI (4)
    • electronic or hard copy health info that relate to:
    • - past, present, or future physical or mental health
    • - provision of care
    • - payment for care

    or could ID the pt
  18. when PHI must be provided (3)
    • 1) for purposes of Treatment, Payment, and Operations (TPO)
    • 2) at the patient's request
    • 3) at patient's personal rep's (PR) request if in pt's best interest
  19. limited data set
    minimum necessary PHI, excluding direct patient identifiers
  20. Minimum Necessary Requirement
    pharmacy may only disclose the minimum amount of PHI necessary to accomplish the objective
  21. 2 types of incidental disclosure events pharmacies  not responsible for if reasonable safeguards applied
    • 1) calling out pt name who is waiting for Rx
    • 2) 3rd party overhears RPh talking to another RPh or tech about pt
  22. 18 items considered identifiable
    • 1) names
    • 2) geographic subdivisions
    • 3) dates
    • 4) telephone number
    • 5) fax numbers
    • 6) email address
    • 7) SSN
    • 8) medical record number
    • 9) health plan beneficiary number
    • 10) account numbers
    • 11) certificate/license numbers
    • 12) vehicle identifiers
    • 13) device identifiers
    • 14) web URLs
    • 15) IP address numbers
    • 16) finger/voice prints
    • 17) full face photos
    • 18) any other unique identifieres
  23. acquisition, access, use, or disclosure of PHI in an unpermitted manner which compromises the security or privacy of the PHI
  24. if breach poses a significant risk, how must the pharmacy act?
    first class mail (or electronically if pt agreed) within 60 days after the breach was discovered
  25. provides federal health insurance for people 65+ and certain disabled persons
  26. 4 components of Medicare
    • Part A: Hospitalization
    • Part B: Physician services; and inj drug furnished by physician or outpt infusion center
    • Part C: alternative to B (Medicare Advantage)
    • Part D: Rx drug coverage
  27. CMS
    Centers for Medicare and Medicaid Services
  28. when can a plan use drug formularies?
    it must have a pharmacy & therapeutics (P&T) committee
  29. exceptions to formularies - all drugs must be covered (6)
    • 1) antidepressants
    • 2) antipsychotics
    • 3) anticonvulsants
    • 4) antiretrovirals
    • 5) antineoplastics
    • 6) immunosuppressants
  30. minimum a formulary must include (excluding exceptions)
  31. e-prescribing provision preempts...
    any state law that restricts the ability of prescribers to electronically transmit Medicare prescriptions
  32. when must plans pay pharmacy claims?
    • within 14 days of electronic submission or
    • within 30 days if claims submitted by another means
  33. how often must plans update their cost database?
  34. who must a plan's MTM services be developed by?
    jointly be pharmacist and physicians
  35. MTM plan requirements (3)
    • 1) may not require >3 chronic diseases to qualify
    • 2) must target at least 4/7 listed core chronic conditions
    • 3) may not require that the pt be on >8 drugs as min # of drugs taken to qualify
  36. any false Part D claim is a violation of...
    the Federal False Claims Act
  37. how long must pharmacies keep records for?
    10 years
  38. 6 categories for OBRA screening
    • 1) potential drug therapy problems due to therapeutic duplication
    • 2) drug-disease contraindications
    • 3) drug-drug interactions
    • 4) incorrect drug dosage/duration of treatment
    • 5) drug-allergy interactions
    • 6) clinical abuse/misuse
  39. 7 drug groups excluded from Medicare Part D
    • 1) weight loss/gain drugs
    • 2) fertility drugs
    • 3) ED drugs
    • 4) cosmetic/hair growth drugs
    • 5) cough/cold drugs
    • 6) vitamins/minerals (except prenatal & fluoride)
    • 7) outpt drugs requiring testing or monitoring
  40. 5 MTM services
    • 1) performing pt health assessments
    • 2) formulating rx drug treatment plans
    • 3) managing high cost specialty meds
    • 4) evaluating/monitoring pt response to drug tx
    • 5) providing education & training
  41. penalty for Medicare/Medicaid fraud/abuse
    $25,000/violation and up to 5 years imprisonment
  42. Stark Law
    • Physician Anti-Self-Referral Law
    • cannot make a prohibited referral, even without intent
  43. anti-kickback statute
    cannot knowingly and willfully solicit, receive, offer, or pay any renumeration in exchange for inducing referrals or for furnishing any goods/services
  44. Sherman Antitrust Act
    purpose is to protect competition (not competitors)
  45. market power
    • the amount of business that the defendant controls of all the available business in the geographic area
    • can vary depending on situation
  46. when is there grounds for Sherman Act action?
    only when the defendant possesses market power
  47. Rule of Reason
    court considers the present situation - purpose, nature, duration, effects, justification, as well as market power of involved entities
  48. Per Se Rule
    actions the US Supreme Court has ruled to violate the Act (situation, additional info not taken into consideration)
  49. boycotting
    agreement not to compete with another party
  50. "any willing provider" law
    • prevents exclusive contracts
    • contained in Medicare Part D
  51. when are joint ventures illegal?
    when purpose is to unreasonably restrain competition
  52. Robinson-Patman Act
    unlawful for sellers to discriminate in price between purchasers of like products when effect may injure competition unless cost justified
  53. cost justified
    savings to seller through economies of manufacture, sale, or delivery that justify the price difference
  54. definition of "own use"
    use is part of and promotes the hospital's intended institutional purpose in the care of its patients
  55. if an NPI engages in impermissible activity... (2)
    • 1) it must keep separate records & accounting
    • 2) manufacturer allowed to rely on NPI's certification that they will use the product for their "own use"
  56. Non-Profit Institutions Act
    exempts nonprofit schools, institutions, etc. from Robinson-Patman Act
  57. when is price discrimination justified?
    when the price is established in good faith to meet the equally low price of a competitor
  58. 340B Drug Program
    requires drug manufacturers to provide outpatient drugs at special reduced prices to designated covered entities serving underserved and uninsured populations
  59. PSQIA
    • Patient Safety and Quality Improvement Act of 2005
    • voluntary program through which healthcare providers, including pharmacies, share info related to patient safety events with patient safety organizations
Card Set
PHRD5045 - Chapter 6: Federal Regulation of Pharmacy Practice (Exam 3)
Federal Regulation of Pharmacy Practice