Law Exam 3

first federal law directly refulating pharmacy practice standards

to save money

• 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

• requires mfg to provide best price to medicaid program
• requires mfg to rebate the state the difference between the amp and best price

lowest price at which they sell products to any customer

evaluate wheter DUR requirements would result in improved pt care and decreased costs

• retrospective review
• prospective 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

• evaluate prescribed drug before Rx is dispensed
• DUR board can examin data to determine if drug use problems are being resolved or continuing

• must detect potential problems before rx dispensed
• 7 categories of potential problems

does not replace professional judgement

• 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

common or severe

• pharmacy to obtain, record and maintain a record specific to the pt
• review pt profile before dispensing refills

health insurance portability and accountability act of 1996

• improve efficiency and effectiveness of health care system
• regulate privacy and security of health info

department of health and human services

• est. uniform standards for electronic claims and data transmission to improve efficiency and lower costs
• NPI codes
• security and privacy of heath info

entities must develop physical, technical and organizational procedure safeguards in order to protect health info

• covered entities: health plans and HCPs that conduct electronic transactions
• may be exempt in non-healthcare parts of operations

• electronic and hard copies
• past present or future physical or mental health
• provision of care
• payment for care
• anything that can identify the patient

• notice of privacy practices
• must be posted in a prominent and visible location
• must be posted on website

• 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

• 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)

• only minimum amount of PHI necessary to accomplish objective
• be able to justify use

incidental uses and disclosures of PHI provided they applied "reasonable safeguards" to protect PHI

• all affected individuals must be notified
• apply to unsecured PHI

aquisition, access, use or disclosure of PHI in an unpermitted manner which compromises security or privacy

• 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

• 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

• requires written patient authroization
• refill reminders not considered marketing

now directly responsible and accountable to maintain PHI in the same manner as covered entities

• pharmacies must train all members of department within a reasonable time of being hired
• pharmacy must document each training

• policies and procedures to implement HIPAA standards
• identify privacy officer
• sanctions of workers who violate the rules

• provides federal health insurance for people 65 and older and certain disabled individuals
• administered by CMS

• A: hospitalization
• B: physician services
• C: alterantive to B called advantage
• D: rx drug coverage

• 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

• All therapeutic categories and classes
• At least 2 drugs from each class except certain classes where all drugs must be included

• 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

• may use mail order but cannot use them to replace retain pharmacy
• plans must abide by "any willing provider" requirement

beneficiaries may receive the same quantity of drugs at either mail order or retail

law requires that plans support e-prescribing and establish standards

• e-prescribing is voluntary
• in 2012 there will be penalties for not e-prescribing

• 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

• 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

Federal False Claim Act

• 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

• 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

• indigent populations
• blind
• disabled
• aged
• families with dependant children

covered by part D

state and federal government

• sever services
• outpaitient Rx

• must be tamper resistant
• prevent unauthorized copying
• Prevent erasure or modificiation
• prevent unauthorized use

• prohibit anyone making false claims to benefit for payment
• prohibit knowingly soliciting or paying for referrals

$25,000 and up to 5 years imprisonment

receiving and gifting hardware and software for e prescribing

• hybrid between community and institutional
• residents may self medicate if team approves
• team determines where drug will be stored
• self admin subject to evaluation

• must be free from unnecessary drugs
• antipsychotics subject ot particular attn
• must have PRN indications

must be less than 5%

• required
• procedures for aquiring, receiving, dispensing and administering
• service must be provided in a timely manner

• facility must employ or use consultant pharmacist
• pharmacist must keep records

• pharmacist must review each residen'ts regimen at least once a month
• irregularities must be reported to attending physician or nursing and acted on

name of physician and resident not required on label but must be identified with the pkg to ensure correct administration

• stored in locked compartments
• key access determined by law and LTCF policy
• CII must be locked separately unless using unit dose

• prohibits contract or conspiracy in restraint of trade
• prohibits monopolies
• protect competition not competitors

• unlawful for sellers to discriminate in price between purchasers
• may substantially injure competition
• only if discrimination is cost justified

savings to the mfg through economies of mfg sale or delivery so as to justify the price difference

exempts non profit schools/institutions from act when using product for "own use"

• use is part of and promotes hospital's intended institutional purpose and care of its pt
• PRDA decision