Federal Drug Law

Describe the provisions and requirements established by OBRA ’90

Prospective DUR

• Included 4 elements:

  • A. Prospective review 

  • B. Retrospective review

  • C, Application of standards

  • D. Education programs 

• Requires state to establish a DUR Board, which is made up of health practitioners

  • Responsible for B, C, and D elements of DUR 

• DUR Board Responsibilities

  • B. Retrospect Review

    • Evaluate claims data for medication use during a set period of time 

  • C. Application of standards

    • Compare claims data to establish standards for “ideal” medical use 

  • D. Educational programs 

    • When standards are not met, recommended educational programs to improve sub-standards practices 

      • Many targets physicians, providers, pharmacist, or all the above

• DUR board in Oregon = Oregon Pharmacy and Therapeutic Committee

  • Advised the Oregon Health Authority

    • Which Rx drugs should be included on any preferred drug list or formulary established by Health Authority 

    • On implementation of retrospective and prospective programs for the Oregon Health Plan 

  • 11 member volunteer committee of physicians (5), pharmacist (4) and consumer representatives (2, not MD or RPh)

  • OSU College of Program Drug Use Research and Management (DURM) group provides support for OHA pharmacy programs 

Describe the provisions and requirements established by OBRA ’90

Counseling

• Offer to counsel each patient who presents a prescription to be filled

  • Criteria to be established by each state, but must include:

    • Name and description of medication 

    • Route, dodge form, dosage, and duration of treatment

    • Common severe side effects/adverse effects and contraindication 

    • Techniques for self-monitoring drug therapy

    • Proper storage

    • Prescription refill information 

    • Action to take if a dose is missed 

  • patient may decline to be counselled

    • Decisions should be “informed and voluntary”

  • pharmacist is not required to document the offer to counsel or the patient’s refusal (may vary by state)

    • Documentation is REQUIRED in Oregon!

• Documentation, which should include “pharmacist comments relevant to the individual’s drug therapy”

  • REQUIRES a “reasonable effort” to obtain, record and maintain AT LEAST:

    • Name, address, phone number, age/DOB, and gender of the patient

    • PMH, allergies and reactions, and comprehensive list of medications and devices

    • Pharmacist’s comments relevant to the individual’s drug therapy

Recognize medication therapy problems for which RPh must screen during prospective DUR

• 3 main activities required for the pharmacist to complete

  • Review of prescription drugs, non-prescription drugs, and allergies for drug therapy problems 

  • Offer to [counsel] each patient who presents a prescription to be filled 

  • Documentation, which should include "pharmacist comments relevant to the individual’s drug therapy”

• Review of prescription drugs, non prescription drugs, and allergies for drug therapy problems 

  • Should include:

    • Therapeutic duplication 

    • Drug disease contraindications

    • Drug-drug interactions (including with non-prescription drugs)

    • Incorrect drug dosage or duration of treatment 

    • Drug-allergy interactions 

    • Clinical abuse/misuse 

• Offer to counsel each patient who presents a prescription to be filled

  • Criteria to be established by each state, but must include:

    • Name and description of medication 

    • Route, dodge form, dosage, and duration of treatment

    • Common severe side effects/adverse effects and contraindication 

    • Techniques for self-monitoring drug therapy

    • Proper storage

    • Prescription refill information 

    • Action to take if a dose is missed 

  • patient may decline to be counselled

    • Decisions should be “informed and voluntary”

  • pharmacist is not required to document the offer to counsel or the patient’s refusal (may vary by state)

    • Documentation is REQUIRED in Oregon!

• Documentation, which should include “pharmacist comments relevant to the individual’s drug therapy”

  • REQUIRES a “reasonable effort” to obtain, record and maintain AT LEAST:

    • Name, address, phone number, age/DOB, and gender of the patient

    • PMH, allergies and reactions, and comprehensive list of medications and devices

    • Pharmacist’s comments relevant to the individual’s drug therapy

HIPAA (and PHI)

HIPAA (1996)

• Cover 4 aspects of health information 

  • Transaction and code sets

  • National provider identities

  • Security 

  • Privacy 

National Provider Identification (NPI)

• 10-digit numeric identifier

  • Does not include information about you (initials, type of provider, etc.)

• All healthcare providers who are HIPAA-covered entities must get an NPI number

  • Individuals AND organizations

  • You are a “covered entity” if you, “electronically transmit health information in connection with a HIPAA standard transaction.”

• Benefits to CMS?

  • Uniformity, administrative simplicity, cost

HIPAA (and PHI)

Covered entities

• Originally included:

  • Health plans

  • Healthcare clearinghouses

  • Healthcare providers

    • Includes institutions and individuals 

• Now also included:

  • Many business associates of covered entities 

Security 

• Requires protection of patient information from unauthorized access, alteration, deletion or transmission

• Includes physical, technical, and organizational safeguards

  • Covered entities are free to develop their own measures and policies as long as they meet the objectives and standards of the regulations

Privacy 

Breaches and Exceptions 

• Definition: “acquisition, access, use, or disclosure of PHI in unpermitted manner that compromises the security or privacy of the PHI meaning that it poses a significant risk of financial, reputational, or other harm to the individual”

• NLM definition: Stands for Health Insurance Portability and Accountability Act of 1996 and its primary goal is to improve efficiency and effectiveness of the healthcare system and regulate the privacy and security of health information .

• Exceptions 

  • When the acquisition, access, use, or disclosure is unintentional and in good faith and does not result in further use or disclosure

  • When the unauthorized person to whom the PHI has been disclosed would not reasonably have been able to retain it

  • The disclosure is inadvertent between two authorized individuals at the same facility if the information is not further used or disclosed

Classifications of Violations

• Tier 1: UNINTENTIONAL

  • A violation that a Covered Entity or Business Associate was unaware of and could not have realistically avoided had a reasonable amount of care been taken to comply with HIPAA.

• Tier 2: REASONABLE CAUSE

  • A violation that a Covered Entity or Business Associate should have been aware of but could not have avoided even with a reasonable amount of care to comply with HIPAA.

• Tier 3: WILLFUL NEGLECT (w/ corrective action)

  • A violation suffered as a direct result of knowingly or intentionally mishandling PHI in cases where a Covered Entity or Business Associate has made an attempt to correct the violation.

• Tier 4: WILLFUL NEGLECT (w/out corrective action)

  • A violation of HIPAA attributable to willful neglect, where no attempt has been made to correct the violation by a Covered Entity or Business Associate

Penalties and Enforcement 

• Penalties for violating HIPAA can be severe.  

  • Fines differ based on circumstances:

  • Unintentional violations = $141 per violation (annual cap of $25,000)

  • Reasonable cause violations = $1,424 per violation (annual cap of $100,000)

  • Willful neglect violations = $14,232  per violation (annual cap of $250,000)

    • If corrected within 30 days

  • Willful neglect violations = $71,162 per violation (annual cap $1.5 million)

    • If not corrected within 30 days

• Violations that are intentional or involve fraud can be criminal offenses and punishable by fines and/or prison

• Increase in DHHS authority to investigate and sanction noncompliant entities 

Cleven

• Must protect patient information and cannot share it with 3rd parties without the patients consent 

• Info under HIPAA is PHI. All forms of health info that

1. Relate to the past, present, or future physical or mental health, the provision of care, or payment of care

2. Identify the patient or could reasonably be expected to identify the patient 

• Who can access PHI:

  • Must be provided to patient if requested

  • Must be provided to patients personal representative

  • Must be provided to patient's personal judgement applied

  • Disclosure to ORBOP for official purposes or healthcare professionals is allowed if authorized by a pharmacist and is deemed necessary for patient’s health or well-being 

• Who must comply → covered entities must comply

  • This includes healthcare providers that conduct electronic transactions (like billing insurance), as well as Health Care Clearinghouses 

  • Any company that provides services to a covered entity and has access to health information must also comply 

• All patients MUST receive a “Notice of Privacy Practices”

  • Must be provided in paper form, unless the patient consents to electronic transmission.

  • Must be posted in a prominent and visible location

  • Must be available upon request

• Pharmacies must “make a good faith effort” to distribute this notice to all patients.

Recognize how various federal laws regulate healthcare providers and apply this knowledge to practical scenarios.

Drug Supply Chain Security Act 

• Require to maintain secure, electronic, interoperable exchange for required information

  • Must exchange “standard commercial transaction” data (3Ts)

    • Transaction information (TI) - a record of the transaction between trading partners

    • Transaction statements (TS) - an attestation of authenticity 

  • Must allow partners to verify product identifier

  • Must be able to store and promptly retrieve required information and produce a TI record tracing the product back to the manufacturer 

• Retain all record of transaction for at least 6 yrs (electronically) 

• Impact on pharmacies:

  • Store-to-store sales of prescription drugs are required to comply with the tracing requirements of the act

    • Sale of a small quantity of a drug to fill a patient need (i.e. a prescription) is exempt

  • Compounded products (503A and 503B) are exempt

  • Limited distribution to a practitioner for office use is exempt

  • Distribution for emergency medical reasons

Medicare/Medicaid Fraud and Abuse Laws 

False Claims Act 31

• Knowingly presenting our causing to be presented a false or fraudulent claim for payment or approval

  • Short: Knowingly faking a claim or transaction

    • Example: Running a medication through a patient’s insurance to see how much it would cost without actually having a prescription for that medication.

• Knowingly making, using, or causing to be made or used a false record or statement material to a false or faudulent claim

  • Short: Knowingly making a fake document to cover up a fake claim

    • Example: Filling a prescription that you know is fake and submitting the claim to insurance

Anti-Kickback Statute 42

• Knowingly and willfully soliciting, receiving, offering or paying any remuneration in exchange for inducing referrals or for furnishing any goods or services paid for my Medicare or Medicaid

  • Short: Giving something to someone with the intention of getting their business or referral of business in return

    • Example: Giving gift cards to a Medicare/Medicaid patient if they transfer their prescriptions to your pharmacy

• “Safe harbors” – limited practices that don’t violate this law

  • Example: Waiving the copay for an indigent patient (check state laws first!!)

The Stark Law (Physician Anti-Self-Referral Law)

• Short: Prevents providers from referring Medicare or Medicaid patients to an entity (or business) with which they (or a family member) have a financial relationship.

• Example: “You’re gonna need to have that spot on your skin evaluated.  My brother is a dermatologist and I can get you an appointment with him.”

• Example: “You’re gonna need to have that spot on your skin evaluated.” (if your brother is a dermatologist in the area, you might be breaking the law...)