Law Exam 3

  1. OBRA-90
    first federal law directly refulating pharmacy practice standards
  2. Primary goal of OBRA-90
    to save money
  3. States and OBRA 90
    • law requires states to establish shtandards in order to recieve funding from medicaid
    • most states apply to all pt
    • some states apply OBRA provisions only to medicaid pt
  4. Rebates with OBRA 90
    • requires mfg to provide best price to medicaid program
    • requires mfg to rebate the state the difference between the amp and best price
  5. Best price
    lowest price at which they sell products to any customer
  6. Demonstration projects with OBRA 90
    evaluate wheter DUR requirements would result in improved pt care and decreased costs
  7. 2 types of DUR programs
    • retrospective review
    • prospective DUR
  8. Retrospective DUR
    • Each state must est DUR board of Dr and RPH
    • Board reviews med use data and compares to target criteria
    • board has authority to recommend and est educational programs for providers not meeting target
  9. Prospective DUR
    • evaluate prescribed drug before Rx is dispensed
    • DUR board can examin data to determine if drug use problems are being resolved or continuing
  10. Screening OBRA 90
    • must detect potential problems before rx dispensed
    • 7 categories of potential problems
  11. Computer software
    does not replace professional judgement
  12. Counseling under OBRA 90
    • requires an offer to counsel pt or caregiver
    • pharmacist choses content based on professional judgement
    • offer to counsel may be made by other personnel in some states
    • pt have right to waive counseling
  13. Meaning of phrase "common severe side effect"
    common or severe
  14. Patient profiles under OBRA 90
    • pharmacy to obtain, record and maintain a record specific to the pt
    • review pt profile before dispensing refills
  15. HIPAA
    health insurance portability and accountability act of 1996
  16. General purpose of HIPAA
    • improve efficiency and effectiveness of health care system
    • regulate privacy and security of health info
  17. HIPAA is enforced by
    department of health and human services
  18. HIPAA targets
    • est. uniform standards for electronic claims and data transmission to improve efficiency and lower costs
    • NPI codes
    • security and privacy of heath info
  19. Security requirements of HIPAA
    entities must develop physical, technical and organizational procedure safeguards in order to protect health info
  20. who must comply with HIPAA
    • covered entities: health plans and HCPs that conduct electronic transactions
    • may be exempt in non-healthcare parts of operations
  21. Protected health information
    • electronic and hard copies
    • past present or future physical or mental health
    • provision of care
    • payment for care
    • anything that can identify the patient
  22. Pharmacy must provide
    • notice of privacy practices
    • must be posted in a prominent and visible location
    • must be posted on website
  23. Pharmacy must make a good faith effort to
    • distribute notice to pt
    • obtain written/signed acknowledgement of receipt
    • only required once for each pt
    • cannot refuse treatment if pt refuses to sign
    • may be signed by personal representative
  24. Use and disclosure of PHI
    • purpose of treatment, payment and operations
    • must be provided upon pt request
    • may be provided to personal representative
    • may be pt's agent (use professional judgement)
  25. Pharmacy may disclose
    • only minimum amount of PHI necessary to accomplish objective
    • be able to justify use
  26. Pharmacies are not responsible for
    incidental uses and disclosures of PHI provided they applied "reasonable safeguards" to protect PHI
  27. If PHI is breached
    • all affected individuals must be notified
    • apply to unsecured PHI
  28. Breach
    aquisition, access, use or disclosure of PHI in an unpermitted manner which compromises security or privacy
  29. When a breach is not a breech
    • when use is unintentional and in good faith
    • when unauthorized person would not be able to retain PHI
    • when discloser is inadvertent between two authorized individuals
  30. Breach decision steps
    • determine if breach occurred
    • determine risk of breach
    • no need to act if no significant risk of financial reputational or other harm to the individual
  31. Use of PHI for marketing purposes
    • requires written patient authroization
    • refill reminders not considered marketing
  32. business associates
    now directly responsible and accountable to maintain PHI in the same manner as covered entities
  33. HIPAA training program requirements
    • pharmacies must train all members of department within a reasonable time of being hired
    • pharmacy must document each training
  34. Pharmacy must develope
    • policies and procedures to implement HIPAA standards
    • identify privacy officer
    • sanctions of workers who violate the rules
  35. Medicare
    • provides federal health insurance for people 65 and older and certain disabled individuals
    • administered by CMS
  36. four parts of medicare
    • A: hospitalization
    • B: physician services
    • C: alterantive to B called advantage
    • D: rx drug coverage
  37. Choosing a part D plan
    • several private plans approved by CMS
    • must choose a particular plan during enrollment period or be penalized
    • exception if current plan provides coverage as good as standard part D plan
  38. Covered part D drugs
    • All therapeutic categories and classes
    • At least 2 drugs from each class except certain classes where all drugs must be included
  39. Part D Formulary Changes
    • may only make changes at the beginning of the year or to include new drugs
    • must notify CMS, providers and beneficiaries of any drug changes
  40. Pharmacy access
    • may use mail order but cannot use them to replace retain pharmacy
    • plans must abide by "any willing provider" requirement
  41. mail order vs retain pharmacy
    beneficiaries may receive the same quantity of drugs at either mail order or retail
  42. E-prescribing and medicare D
    law requires that plans support e-prescribing and establish standards
  43. E prescribing and prescribers/pharmacies
    • e-prescribing is voluntary
    • in 2012 there will be penalties for not e-prescribing
  44. Pharmacy Reimbursement
    • pharmacies negotiate fee and product cost with each plan
    • pharmacies must inform pt of any price difference between covered drug and lowest price generic available
  45. Medication Therapy management
    • plan must provide a minimum level of MTM
    • pharmacy may receive pmt for providing MTM
    • eligible pt must have multiple chronic diseases with multiple covered drugs
  46. Any false Part D claim is a violation of
    Federal False Claim Act
  47. Fraud and abuse
    • plans and pharmacies must have plans est. by policies and procedures
    • pharmacies must certify data submitted is true
    • keep records for 10 years
    • pharmacy subject to audit
  48. Medicare regulation of hospital pharmacy
    • hospital must comply with conditions for participation
    • pharmacist supervision of pharmacy required
    • all pharmacy services must be delivered in accordance with standards of practice and relevant laws
  49. Eligibility in medicaid
    • indigent populations
    • blind
    • disabled
    • aged
    • families with dependant children
  50. Dual eligible pt
    covered by part D
  51. State medicaid program funded by
    state and federal government
  52. Medicaid covers
    • sever services
    • outpaitient Rx
  53. Written medicaid Rx
    • must be tamper resistant
    • prevent unauthorized copying
    • Prevent erasure or modificiation
    • prevent unauthorized use
  54. Medicare/Medicaid Fraud and Abuse laws
    • prohibit anyone making false claims to benefit for payment
    • prohibit knowingly soliciting or paying for referrals
  55. Penalty for medicare/medicaid fraud
    $25,000 and up to 5 years imprisonment
  56. Safe harbor procisions for medicare/medicaid fraud and abuse
    receiving and gifting hardware and software for e prescribing
  57. Long term care facility
    • hybrid between community and institutional
    • residents may self medicate if team approves
    • team determines where drug will be stored
    • self admin subject to evaluation
  58. Long term care facility drug therapy
    • must be free from unnecessary drugs
    • antipsychotics subject ot particular attn
    • must have PRN indications
  59. Error rate in LTCF
    must be less than 5%
  60. Pharmacy services in LTCF
    • required
    • procedures for aquiring, receiving, dispensing and administering
    • service must be provided in a timely manner
  61. LTCF Pharmacist consultation
    • facility must employ or use consultant pharmacist
    • pharmacist must keep records
  62. LTCF drug regimin review
    • pharmacist must review each residen'ts regimen at least once a month
    • irregularities must be reported to attending physician or nursing and acted on
  63. LTCF labeling requirements
    name of physician and resident not required on label but must be identified with the pkg to ensure correct administration
  64. Storage of drugs in LTCF
    • stored in locked compartments
    • key access determined by law and LTCF policy
    • CII must be locked separately unless using unit dose
  65. Sherman antitrust act
    • prohibits contract or conspiracy in restraint of trade
    • prohibits monopolies
    • protect competition not competitors
  66. Robinson-Patman Act
    • unlawful for sellers to discriminate in price between purchasers
    • may substantially injure competition
    • only if discrimination is cost justified
  67. Cost justification
    savings to the mfg through economies of mfg sale or delivery so as to justify the price difference
  68. NonProfit institutions act
    exempts non profit schools/institutions from act when using product for "own use"
  69. Own use
    • use is part of and promotes hospital's intended institutional purpose and care of its pt
    • PRDA decision
Card Set
Law Exam 3
Chapter 6