Exam 1 - Lecture 3 Flashcards
3 major points of OBRA
- Mandated changes in pharmacy practice going beyond oversight of drug distribution to include the detection and resolution of problems with drug therapy
- required DUR and patient counseling
- Required offer to counsel
Basic Framework of OBRA (3)
DUR
Patient counseling
Demonstration projects
Demonstration projects OBRA
goal to determine through scientific studies where outcomes of patient care improve and costs decrease when pharmacists are paid to provide DUR services to patients
if they do, likely to increase compensation gov provides for these services
3 Parts of DUR process
Retrospective review
Educational Programs
Prospective Review
Prospective Review
Pharmacists required to find out necessary info about the patients and their meds BEFORE dispensing occurs
requires active resolution of problems through comprehensive review of a patients prescription order at the point of dispensing
3 prospective review components required by OBRA
- screening of prescriptions before dispensing
- Pt counseling by pharmacist
- pharmacist documentation of relevant info
Retrospective Review must include….
- DUR review board of MD and RPh oversees it
- Develop ideal dug therapy criteria
- Data review med use over a particular time period and compare to idea drug therapy criteria
- ID areas of improvement such as clinical abuse/misuse
Prospective Review should include screening for….
- potential drug therapy problems due to therapeutic dup
- drug-disease CI
- Drug-Drug Interactions
- incorrect drug dosage or duration of drug treatment
- drug-allergy interactions
- clinical abuse/misuse
Education Program requirements
- must provide for active and ongoing educational outreach programs on common drug therapy problems, sing data provided by the state drug use review board
Examples of education programs….
Face-to-face visits by experts
symposiums attended by professionals involved in medication use
Written materials delivered to HCP
Patient counseling
Pharmacists must OFFER to discuss with each pt or caregiver matters that in the pharmacists professional judgment are significant
What has to be required in patient counseling
- Name & Med description
- Dosage form, Dose, Route of admin, duration
- Special directions/precautions/admin
- Common sever SE, ADR, DI
- Techniques for self-monitoring drug therapy
- Proper storage
- Prescription Refill info
- Actions to be taken in event of missed dose
Patient Waiver to counseling
Patient has right to waive the counseling
2 Main goals of HIPAA
- provide continuous health insurance coverage for workers who lose or change their job
- reduce admin burdens and costs of healthcare by standardizing electronic transmission of admin and financial transactions
Other goals of HIPAA
- Combating abuse, fraud, and waste in health insurance and healthcare delivery
- improving access to long-term care services and health insurance
HIPAA Title 2
- directs US Dept of HHS to establish national standards for processing electronic Healthcare transactions
- Req Healthcare organizations to implement secure electronic access to health data and to remain in compliance with privacy regulations set by HHS
HIPAA compliance requirements include….
- Every Healthcare entity must have NPI
- HCO must follow standardized mech for electronic data interchange in order to submit and process insurance claims
- HIPAA privacy rule = national standards to protect patient health info
- HIPAA security rule = standards for patient data security
- HIPAA enforcement rule = establishes guidelines for investigations into HIPAA compliance violations
HIPAA privacy rule
Established 1st national standards in US to protect patients personal or protected health info
also guarantees patients right to receive own PHI on request
Covered entities under HIPAA privacy rule
Health Care providers
Health Plans
Health Care Clearinghouse
Business Associates***
** must have written business associate contract or arrangement that specifies what associate has been engage to do and requires them to comply with HIPAA**
Examples of Business Associates includes….
- 3rd party admin that assists w/ health plan claims processing
- consultant performing utilization reviews for hospital
- Health care clearinghouse that translates a claim from a nonstandard format into a standard transaction on behalf of a health care provider, and forwards the processed transaction to a payer
4 Independent medical transcriptionist that provides transcription services to a physician
What info is protected under HIPAA
- Individual Identifiable PHI under the privacy rule
2. includes digital, oral,paper info
Does de-identified data have restrictions to its use or disclosure?
Nah
What is considered PHI under HIPAA?
- a patient’s name, address, birth date and Social Security number;
- an individual’s physical or mental health condition;
- any care provided to an individual; or
- information concerning the payment for the care provided to the individual that identifies the patient, or information for which there is a reasonable basis to believe could be used to identify the patient.
Are records subject to or defined in the Family Educational Rights and Privacy Act considered PHI?
Nah
including employment records, education info too
Administrative Requirements under Privacy Rule
- Privacy official responsible for developing and implementing policies and procedures
- Training all employees, incl volunteers and trainees
- Appropriate safeguards
- complaint process
What to do if PHI is disclosed in violation of its policies and procedures?
covered entry must mitigate to the furthest extent actionable any harmful effects
What must Notice Provision include?
A. Notice must include:
1. How covered entity intends to use information 2. Legal duties of covered entity to protect PHI 3. Statement of patient right’s and how to exercise 4. Statement that patients can complain to covered entity 5. A person in covered entity to contact regarding HIPAA issues
B. Notice must be posted in conspicuous place
C. Good faith effort to provide notice and obtain written acknowledgment
HIPAA security Rule
establishes national standards for securing patient data that is stored or transferred electronically
requires placement of safeguards, physical and electronic, to ensure the secure passage, maintenance and reception of PHI
What is Permitted use and Disclosure
Permitted use and disclosure for certain health care operations (45 CFR 164.501) without the consent of the patient (i.e. authorization) are defined in 45 CFR 164.506(c)(4) “Uses and disclosures to carry out treatment, payment, or health care operations.”
3 requirements of that need to be meet for covered entity to share PHI with over covered entity include….
- Both CEs must have or have had a relationship with the patient (can be a past or present patient)
- The PHI requested must pertain to the relationship
- The discloser must disclose only the minimum information necessary for the health care operation at hand. Under HIPAA’s minimum necessary provisions, a health care provider (hereafter “provider”) must make reasonable efforts to limit PHI to the minimum necessary to accomplish the purpose of the use, disclosure or request. (45 CFR 164.502(b))
Minimum Necessary Requirement
requires covered entities to take reasonable steps to limit the use or disclosure of, and requests for, protected health info to the minimum necessary to accomplish the intended purpose
When does Minimum Necessary Requirement not apply?
- Disclosures to or requests by a HCP for treatment purposes.
- Disclosures to the individual who is the subject of the information.
- Uses or disclosures made pursuant to an individual’s authorization.
- Uses or disclosures required for compliance with the (HIPAA) Administrative Simplification Rules.
- Disclosures to the Department of Health and Human Services (HHS) when disclosure of information is required under the Privacy Rule for enforcement purposes.
- Uses or disclosures required by other law.
Which section of HIPAA privacy rule provides standards for de-identification of info?
Section 164.514(a)
Sections of the Privacy Rule that contain the implementation specifications that a covered entity must follow to meet the de-identification standard
Sections 164.514(b) and (c)
Valid Authorization
is a detailed document that gives covered entities permission to use protected health information for specified purposes, which are generally other than treatment, payment, or health care operations, or to disclose protected health information to a third party specified by the individual.
To be a valid Authorization, it must specify….
- a description of the protected health information to be used and disclosed;
- the person authorized to make the use or disclosure;
- the person to whom the covered entity may make the disclosure;
- an expiration date, and, in some cases;
- the purpose for which the information may be used or disclosed.
Exceptions to marketing?
- Face-to-face communications
- Case management
- to recommend treatment or alternative treatment
- Services offered by pharmacy or health plan
Medicare Title XVIII Social Security Act of 1935
Purpose: Federal Gov effort to provide healthcare for elderly (65+) and disabled
Four parts: Part A = hospital insurance Part B = Physician services Part C = Medicare Advantage, allows managed care plan Part D = RX benefit implemented in 2006
Part D drugs benefit info
- Covers RX drugs for medically accepted indications, also includes biologics, insulin, and medical supplies associated with admin insulin
- Part D may use formulary to incorporate drug tiers and variable copays, DUR, PA, Quantity limits etc
If plan uses formularly, then it must have…..
Pharmacy and Therapeutics Committee
- majority of committee must be practicing pharmacists and physicians (1 of each)
- pharmacist and physician must have expertise in care of elderly and disabled
- no conflict of interest
Exceptions of classes where all drugs have to be covered part D
Antidepressant Antipsychotics Anticonvulsants Antiretroviral Antineoplastic Immunosuppresants
Formulary must generally include….
all therapeutic categories and classes of drugs but only needs to cover atleast 2 in each category
Excluded drug classes in Part D
- Weight loss or gain meds
- Fertility promotion
- ED
- Drugs used for cosmetic purposes or hair growth
- Cough and cold drugs used to treat symptoms
- Outpatient drugs for which manufacturer has testing or monitoring requirements
- Vitamins and Minerals
Exceptions to Vitamin and Mineral Exclusions Part D
Prenatal
Niacin
Fluoride Preparations
Certain Vitamin D formulations
Pharmacy access: Urban
90% of beneficiaries within 2 miles of participating pharmacy
Pharmacy access Suburban
90% of beneficiaries within 5 miles of participating pharmacy
Pharmacy access: Rural
70% of beneficiaries within 15 miles of participating pharmacy
Other pharmacy access info
Plans can use mail-order, but not to replace location requirements
plan must provide provisions for out of network when necessary
“any willing provider” = any pharmacy that meets terms and conditions can participate
COPs info
Conditions of Participation
Federal requirements from medicare for any hospitals that wish to admit medicare patients
Pharmacy has to be directed by a registered pharmacist or drug storage area under competent supervision
What are the Conditions of Participation….
- Hospital must employ full-time, part-time or consultant pharmacists to supervise and coordinate pharmacy department activities
- A pharmacist must supervise the compounding, packaging, and dispensing of drugs
- Drugs and Biologics must be kept in locked area
- Quarantine area for out-of-date products
- When a pharmacist is unavailable, only personnel designated by the medical staff and pharmaceutical service may remove drugs from the pharmacy
- Formulary must be developed
- Abuses and losses of controlled substances must be reported
Medicaid eligibility is determined based on…..
income and assets
What does Medicaid cover?
all or part of several services.... • Inpatient and outpatient hospitalization • Laboratory and x-ray • Skilled nursing facility care • Physician care • Home health are • Dental care
Who does Medicaid provide for?
Blind
Disabled
Aged
Members of Families with Dependent Children
Tamper Resistant Prescriptions
Federally, law requires that written prescriptions for covered outpatient drugs that are paid for by Medicaid be executed on a tamper-resistant prescription form.
Exclusions for Tamper Resistant Prescriptions
ones that are transmitted from the prescriber to pharmacy verbally, by fax or through an e-prescription
3 characteristics to be considered tamper resistant
- One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form;
- One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription pad by the prescriber;
- One or more industry recognized features designed to prevent the use of counterfeit prescription forms.
Four goals of Inspector General’s Strategic Plan
- fight fraud, waste and abuse
- promote quality, safety, value
- secure the future
- advance excellence and innovation
Office of Inspector General Info
- Division of US Dept of HHS
- Established in 1976
- to fight waste, fraud, abuse in Medicare, Medicaid, and other HHS programs
Medicare Fraud and Abuse Laws
False Claims Act
Anti-Kickback Statute
Physician Anti-Self-Referral Law (Stark Law)
False Claims Act (FCA) 31 U.S.C. §§ 3729-3733
Prohibits:
Knowingly = presenting or causing to be presented a false or fraudulent claim for payment or approval
Knowingly = making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim
Penalties: Civil fines and Criminal Fines/Prison
Anti-Kickback Statute 42 U.S.C. § 1320a -7b
Anti-Kickback Statute prohibits knowingly and willfully soliciting, receiving, offering, or paying any remuneration (including kickback, bride or rebate) in exchange for inducing referrals or for furnishing goods or services paid for by Medicare / Medicaid
Physician Anti-Self-Referral P.L. 101-239; 103-66 1989 (amended 1993)
- Ethics in Physician Referral Law- commonly known as Stark Law (sponsor was California Congressman Pete Stark)
- Aims to reduce the overuse of healthcare services and reduce costs to Medicare / Medicaid
- Generally- the law prohibits physicians (dentists, podiatrists, chiropractors, optometrist) from referring Medicare/Medicaid patients to entities where the physician (or immediate family member) has a financial interest
- Note: Unlike the AKS statute, the violation does not need to be knowingly and willfully. Violations can result in significant fines and exclusions from Medicare and Medicaid programs.
Examples of services that fall under the Physician Anti-Self- Referral law
- Clinical Laboratory Services
- Radiology Services (MRI, CT Scan, Ultrasound)
- Radiation Therapy Services and Supplies
- Outpatient Prescription Drugs
- Inpatient and Outpatient Hospital Services
