Pharmacy Law Midterm

NYS Drug Take Back Act PBH §§290-294- what did this Act require ?

-Onsite collection receptacle or drop-box reasonably accessible to all residents, Accepts any drug without regard to where they were made. -Requires certain manufacturers to accept and dispose of covered drugs => City with population > 125,000 (have to have at least one receptacle in an area with at least 125,00 ppl)~NYC, Buffalo, Rochester, Yonkers, Syracuse, not albany -Manufacturer, individually or jointly, must pay for all administrative and operational fees associated with the drug take back program: Collecting , Transporting, Disposing of unused drugs -CSs? -Programs must be approved, Must report to NYS annually -Separate from ESAP - for syringes + needles -Participation of authorized collectors besides pharmacies shall be voluntary -All drug take back program operators shall notify other potential authorized collectors of the opportunity to serve as an authorized collector for the drug take back program. (hospitals)

What are Contracted Labs(503B)?

-Outsourcing Facility's Quality Unit still responsible for approval/rejection of products. -Suggested FDA Guidance on: ensure lab we are using are following these requirements -Contract Manufacturing Arrangements for Drugs -Quality Agreements

All Pharmacies involved in the NYS drug Take Back Act (program) shall provide for the safe collection of drugs using what methods of collection (including independents with 10 or more pharmacies)

-Prepaid mailing envelopes meeting federal standards ($$) ~. Pharmacies with a mail-back collection as part of the drug take back program shall provide a voucher for a prepaid envelope upon dispensing a covered drug. -Such voucher shall include information on the drug take back and safe drug disposal methods -On site collection, dropbox or receptacle meeting federal standards -Signage prominently displayed advertising such drug collection to consumers

What are Validations of sterilization operations(aspectic drug processing 503B)?

-Use of biological indicators Steam Sterilization (Autoclave) -Dry Heat Sterilization (Oven) -Filtration-Filter Integrity Tests

DEA Rules Federal Only Drugs - NYS Non Control

-Verbal/fax you may dispense what the physician wrote for -Must sign, date File in III, IV, V file -Up to 5 refills/6months -Must be inventoried at the time of initial scheduling. Note: It may go on NYS Scheduling at any time. -Practitioner may give samples - Fed law says yes, NYS says no -Nurse (or agent) may phone in the prescription -Control 3, 4, or 5 - FEDERAL lets you have one transfer of an Rx

What is a Master Production Record?

-Written procedures for production to ensure strength, quality, purity. -Clear criteria for manufacturing products - steps of process and who makes the product, have to document every step -Deviations must be documented and justified. -Investigate how and why it occurred => route cause analysis -Batch records must be retained. -Hold times must be assessed and limited.

503A facility characteristics

-compound per a patient Rx -dispensed directly to patients

503b outsourcing facility characteristics

-large scale -Go directly to hospital, clinic, doc office and administered there -They do not directly see patients -Not pursuant to RX, don't see/have patients

What does Pharmacist Counseling of HIV PEP entail?

-refer to provider for follow up care to receive full eval of exposure, receive HIV testing, & obtain Rx for full 28Day therapy (since we can only dispense 7 day supply via standing order) -Pharmacist will document counseling & referral info -Private area to counsel with Non-judgmental attitude, Know the risks for each type of exposure -The current recommended regimen Including any issues with current meds the patient is taking -Emphasize Importance of 28 days, Adherence , Take same time every day -RPh or designee establish an appointment for patient with the medical care provider...Call medical provider or whoever they are going to go to (list of providers that take patients for this) ~ make sure patient makes appt & GOES to the appt (Provider Name, address, Date and time of appointment) If pt already has a provider - still call them and make sure that they have an appointment & go. If cannot reach provider give patient names, address, contact info of 3 providers -Provide brochure -Must see provider within 1-3 days, Contact and make sure the pt went there for the appointment -Explain the signs of early HIV infection -Pharmacists or designated should contact the HCP who will provide follow-up care. (Standing order to provide 3 providers available within patient's insurance network) -Contact the provider after 3 days to make sure the patient went to appt ! -No HIPPA requirement

What is Default Beyond-Use Date (BUD)?

-similar in USP 797 -Used in lieu of a Stability (most facilities utlize stability studies) Study -Conservative -Short term storage -Not validated -Dependent on dosage form and batch size -difficult to manufac

What are Quality agreements with a 503B?

-they must be in place with suppliers -they outline requirements that they have and share with their suppliers

Why are Laboratory Controls used for 503B products?

-used to ensure the reliability of the tests. -Ensure tests using are validated and meet expectations of FDA and USP (written procedures developed and followed) -ensure use of appropriate analytical methods and equipment -Documentation practices. -Record keeping.

117th Congress Pharmacy & Medically Underserved Areas Enhancement Act~ What does it entail?

-would include pharmacists on the list of recognized healthcare providers. ("physician extender") -Allow pharmacists in underserved areas to bill Medicare Part B for services within pharmacists' state scope of practice delivered to Medicare beneficiaries that are furnished by a pharmacist in a health professional shortage area & would be covered under Medicare if furnished by a phyisician. -IT allows pharmacists to be reimbursed at 85% of the physician fee schedule (physician extender like NPs & PAs) -offer health care services such as health and wellness screenings, immunizations and diabetes management by authorizing Medicare payments for those services where pharmacists are already licensed under state law to provide

503B defines bulk drug substance as...

...any substance that is represented for use in a drug and that, when used in manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug...

How many NYS reg pharmacy techs per pharmacist, if properly trained, may cmpnd in a community pharmacy?

0, techs cannot compound registered techs can in hospitals, not in LTC or in pharmacies owned by the hospitals or community Techs can make IVs in hospital as long as registered

Data 2000- Not more than _____ day(s) supply of medication can be administered to a patient at one time, Treatment may not be carried out for more than __________ hours.

1 days medication supply Treatment may not be carried out for more than 72 hours, The 72-hour period cannot be extended

How many Supervising Pharmacists per pharmacy required?

1, has full control of pharmacy Must be full time, 30 or more hours a week Vicarious Liability / Respondeat Superior

How often is CPR training required?

1-2 years (depends how long your training is good for)

'B' non violent felony

1-3, max 25 yrs

Letter to Practitioners 2/13/2019. §3331(8)- No opioids shall be prescribed to a patient initiating or being maintained on opioid treatment for pain which has lasted more than ______ months. This does not apply to what kinds of pain?

1. 3 months or past the time of normal tissue healing, unless the medical record contains a written treatment plan that follows generally accepted national professional or governmental guidelines (If they are addicted to a CS we cannot fill the Rx) 2. patients who are being treated for cancer that is not in remission, who are in hospice or other end-of-life care, or whose pain is being treated as part of palliative care practices

How many patients can a physician see initially if they have training to prescribe buprenorphine? & How many can they see after one year with DEA # with the letter _________?

1. 30 2. 100 3. X

What does training for immunization entail? (for student pharmacist)

1. Admin immunizing agents (harmless saline solution into recipients) 2. how to handle emergencies (anaphylaxis & needle stick injuries) 3. how to keep records of immunizations

What did Biden's BBBA entail/include? (6 things)

1. Allows fed gov to negotiate prices for some high cost Rxs (50 drugs) under Medicare B&D- effective June 2025 2. Requires inflation rebates to limit annual increase in drug prices in Medicare and private insurances- Effective 2023 (require drug manufac. to pay a rebate(pay the difference to Medicare) to the fed gov if their prices for single source drugs and biologicals covered under Med Part B & D increase faster than rate of inflation) 3. Caps out of pocket spending for Medicare Part D enrolles- 2024 4.Limits cost sharing for insulin for Medicare + private insurance ($35/mo copay) 5. Eliminates cost sharing for adult vaccines covered under Part D- effective 2024 6. Repeals Trump's drug rebate rule- 2026

U.S. Department of Health and Human Services Public Readiness and Emergency Preparedness Act (PREP Act) amendments

1. Authorizes state-licensed pharmacists to order and administer vaccines to individuals ages 3 through 18 years 2.Authorizes licensed/registered pharmacy interns and technicians acting under their supervision to administer vaccines Vaccines to individuals ages 3 through 18 years 3.COVID-19 vaccines to those age 3 years and older 4.Increase access to vaccines 5.Decrease the risk of vaccine-preventable disease outbreaks

What can be used for compounding in a 503B

1. Bulk drug substances -must follow list established by secretary (not estab yet, current interim list) -use substances in category 1 -(can manufac any commercially avail prod if on) drug appears on drug shortage list AND must have .... an applicable USP monograph, bulk drug sub manufac by an establishment & registered with FDA & has valid certificate of analysis 2. Ingredients that arent bulk drug substances (must comply with standards of USP or NF if monograph exists)

Attempts of contacting the patient once a recall notification comes in to the pharmacy made by(3 ppl)?

1. Corporate office personnel (chain) 2.Personnel at the pharmacy 3.document when contact attempts are made

Treatment of Heroin and Opioid Addictions requires all practitioners who treat humans are allowed to prescribe CS's if they have ______ & complete how many hours of coursework Q_____years

1. DEA# 2.complete 3 hours of coursework on pain mgmt, palliative care & addiction 3. 3 yrs

What does a PEP standing order entail? What is required? (8 things)

1. Name, license # and signature of physician or nurse practitioner 2.Name and license # of pharmacist OR name and address of pharmacy that employs or under contract. 3.Time period standing order is effective 4.Name and dose of PEP Meds 5.the types of exposure for which PEP may be dispensed 6.A review of the ideal and max length of elapsed time after exposure for which the PEP med may be dispensed (DISCUSS WITH PATIENT MANDATORY, written into law) 7.Method by which Pharmacist shall document services delivered, including counseling and referral information provided to the individual ( Keep records of who you referred to, when, the time, etc (required !)) 8. Pharmacist must Screen patient to make sure type of exposure meets the criteria and meds can be dispensed within time frame

EPT Rx label on bottle must be labeled with pharmacy's ... (5 items)

1. Name/addy 2.directions 3.Date of delivery 4.name of med 5.strength *EPT must be written in the body of the prescription form

Naloxone Co-Payment Assistance Program (N-CAP) covers for what formulations (3)

1. Narcan intranasal 4mg 2.Naloxone used for intranasal administration 1mg/2ml Luer-Jet pre-fill glass syringes 3.Naloxone IM 0.4mg/ml in 1 ml single use vials

Requirements for Outsourcing Facility Design (5)

1. Processing and controlled areas must be clean & free of visible signs of filth, dirt, mold or mildew, insects, etc. (important to producing sterile products) 2. Damaged, dirty, or discolored HEPA filters should not be used. 3. Sterile drugs should be produced in ISO 5 air quality or better (ie a clean room w hood) 4. Designed and operated with cascading air quality to protect ISO 5 zone. 5. Zone immediately adjacent to ISO 5 must be ISO7 or better.

PBH §280-B: Unused Prescription Donation and Redispensing Program Key Points

1. Rx drugs redispensed shall be inspected by Rph 2.Donors & recipients are voluntary 3.products must be in tamper evident packaging or in unit dose/multidose packaging to be redispensed 4. Do not redispense Rx if it shows evidence of adulteration or misbranding, tampered packaging, will expire before use by patient, or excluded from program 5. A recipient entity may also be a donor entitity (charitable orgs) 6.Recipient entities shall give priority for redispensing to patients who are indigent, uninsured, or under-insured. 7.A redispensed prescription drug shall not be resold by any person or entity. However, this subdivision does not bar the payment of reasonable processing fees.

Biosimilar caveats to use...

1. Substituted products must be interchangeable. 2.Prescriber expressly indicated on the Rx that substitution is prohibited 3.Label must indicate the name, strength and manufacture of the interchangeable 4.Within 5 business days, the pharmacist or designee must contact the prescriber to inform him/her of the product's name and manufacturer Via electronic medical record, electronic Rx communication, or Facsimile (if above not available)/Verbal Pharmacist does not have to communicate when there is not interchangeable product avail or when refills are for the same prod originally dispensed

Medicaid §515.2: False Claims. What is this? Submitting or causing to submit a claim:

1. Unfurnished medical care, service or supplies 2.An amount in excess of established rates or fees 3.At a frequency or in an amount not medically necessary 4.Amounts substantially in excess of customary charges or costs to the general public -Cannot charge someone for something cheaper than you bill to Medicare/Medicaid for -Can charge the same or more NOT CHEAPER ! (i.e Medicare = $30, cannot charge $25!) 5.Cannot bill before service is completed → can bill for ONE Shringix shot (1 at a time)

PBM may not prohibit or penalize a pharmacist/pharmacy from disclosing ___________ to an individual purchasing an Rx or ______________ through what clause?

1. cost 2.Availability of any therapeutic equivalent alternative medications or alternative methods of purchasing the prescription medications not limited to paying a cash price 3.GAG

What are exceptions to giving naloxone (certain settings patients are in) 3 of them

1. hospice 2.mental health facility : article 31 of mental hygiene law 3. general hospitals or nursing homes

What are HHS Requirements for certified Pharmacists(&interns) to Give Childhood Vaccinations

1. must be approved or licensed by FDA 2. must be ordered & admin according to CDC ACIP immun. sched 3.Licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) 4. a current certificate in basic cardiopulmonary resuscitation (CPR) 5.Must inform the childhood-vaccination patients and the adult caregivers of the importance of a well-child visit with a licensed primary care provider 6.Must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines 7.Must complete at least two hours of ACPE approved, immunization-related continuing pharmacy education during each State licensing period

What are some other requirements of pharmacists when it comes to EPT?

1. must counsel patients (we are protected from liability) on potential ADRs & allergies, pregnancy, Sx persist or worsen 2.give patient info materials for sexual partners about EPT 3.dispense in pre packaged partner pack (best) 4. counsel to Abstain from sexual activity for at least 7 days after treatment to decrease chance of reinfection (males have no Sx, females do) 5. Consult healthcare provider for complete STI evaluations

PBH §280-C Pharmacy Audits by PBMs: Manager responsibilities?

1. on-site audits of a pharmacy not allowed during first three calendar days of a month 2. notify the pharmacy in writing or its contracting agent no later than fifteen days before the date of initial on-site audit (by mail with return receipt request OR electrionically with electronic receipt confirmation) 3. Limit audit period to 24 months after date a claim is submitted/adjudicated by PBM 4.provide the pharmacy or its contracting agent with the final audit report no later than sixty days after the initial audit was provided to the pharmacy or its contracting agent. *refer to notes for more

The Synchronization of Multiple Medications Article can only be done ONCE, unless... (2 reasons)

1. prescriber changes dosage or freq 2. prescriber prescribes a different drug *if non-adherent & falls out of sync, cannot resync them

To become an immunizer as a student pharmacist, what needs to be done?

1. receive a certificate of administration from the NYSED (attested by school to NYSED~ specific form by the dean of school) 2.obtain a limited pharmacy intern permit 3.Obtain training approved by the Commissioners of Education and Health- Must be within 3 years preceding application for a certificate of administration. 4.Current cardio-pulmonary resuscitation techniques (CPR) 5.Must have BBP training every year! 6.Training course associated with the PharmD pursuant to the requirements in §63.9(b)(3)(ii)

DEA RED FLAG EXAMPLES

1."Pattern prescribing" ~ Prescriptions for the same drugs and the same quantities coming from the same doctor 2.Prescribing combinations or 'cocktails' of frequently abused controlled substances ~ Opioids with BZDs 3.Geographic anomalies 4.Shared addresses by customers presenting the same day 5.The prescribing of controlled substances in general 6.Quantity and strength questions 7.Paying cash 8.Customers with the same diagnosis code from the same doctor 9.Rx written by doctors for infirmaries not consistent with their area of specialty 10.Fraudulent prescriptions

With the first opioid Rx to a particular patient each year , the prescriber must prescribe an opioid antagonist when any of the following are present:

1.History of substance abuse disorder 2.High dose or cumulative prescriptions that result in 90 morphine milligram equivalents or higher per day 3.Concurrent use of opioids and benzodiazepine or nonbenzodiazepine sedatives

If the Commissioner of Health in conjunction with the NYSED determines that an immunization May be safely administered by a licensed pharmacist within their scope of practice, AND Is needed to prevent the transmission of a reportable communicable disease that is prevalent in NYS, OR is a recommended immunization for such patients who...

1.Meet age requirements 2.Lack documentation of such immunization 3.Lack evidence of past infection 4.Have an additional risk factor or another indication as recommended by the ACIP of the CDC

FDA shall convene and consult an advisory committee on compounding with ____#_____ voting members knowledgeable in fields of pharm compounding, manufac, pharmacy, medicine, etc

12 Representatives shall include those from: NABP, USP, pharmacists, physicians, and patient and public health advocacy organizations.

Some1 ordered a rx and never picked it up... how many days before put back

14

Rules for Regulation of PBMs - S3762 (Breslin) A1396 (Gottfried)?

Amends Public Health Law 280-A to define the range of activities of a PBM This bill requires that PBMs be licensed by the NYS Insurance Department and confirm to standards established by the Insurance and Health Departments → ensures transparency

Purchase of Prescription Drugs S3566 (Breslin) A5854 (Joyner) Signed Dec 31st 2021 (takes effect immediately) includes what?

Amends insurance law& Mail order pharmacy Must offer the same reimbursement to any non-mail order pharmacy as to the mail order for coverage of Rxs 1. all must be in network participation 2. non-mail order agrees to same reimbursement 3.patients option 4.removes other non-competitive requirements

Verification of each lot not needed in a 503B if component is...

An approved finished human drug product Purchased directly from an FDA registered Manufacturer or Distributor that has not repackaged the product Examined to verify the label Examined upon arrival for shipments package integrity

Graduates of non registered (NR) and nonaccredited (NA) programs shall be authorized to begin an internship on after passing...(foreign grads) (3)

An initial exam or exams acceptable to the BOP, Meet curricular and practice areas THEN: The NR & NA graduate must complete ≥ 12 months of full-time experience in an approved internship program THEN: The NR & NA graduate may be admitted to an addition exam or exams acceptable to the BOP for measuring the applicant's knowledge regarding curricular and practice areas

Unacceptable Practices

An unacceptable practice is conduct by a person which is contrary to: § Official rules and regulations of the department § Published fees and rates § Official rules of the Dept of Health, Education and Mental Hygiene § Regulations of the Federal HHS à Social Security Act

Per NYS Law: How many NYS registered pharmacy technicians are allowed to serve on the NYS Board of Pharmacy?

2

How many hours are required & approved by ACPE for continuing pharmacy education during each state licensing period (CE) by a pharmacist in order to administer childhood vaccines?

2 hours at least

A nurse phones in a prescription for Belsomra 10mg #100. Sig 1 hs. Code A. 2 refills.How many refills can the patient have?

2 refills (as written on Rx) Code A = NYS law, so means nothing

How long is a legislative cycle?

2 years Federal "session 1 &2" If bill is not passed, it must be reintroduced Q2Y with updated info and new bill #s (not automatic, new sponsors needed) An ODD YEAR always starts the cycle.

'D' violent felony

2-7 years

Punishment Article 177 NY Penal Law- 'A' violent felony

20-25 years or life

117th Congress H.R.3 Elijah E. Cummings Lower Drug Costs Now Act... when was this first introduced?

2019

Federal Register July 8, 2016~ Physicians are now allowed to have up to _______ patients in their office with additional credentials

275 ! - must have 100 patients prior -Board certified in addiction medicine or psychiatry by American board of addiction medicine or american board of medical specialties -cerfieid by american society of addiction medicines -practicing in qualified practice setting

Full treatment for PEP is _______ days but a standing order only covers the first _________ days

28 days 7 days

How many hours of training is required & approved by ACPE by a pharmacist in order to administer childhood vaccines?

2o hours of a training program at least

What Schedule is buprenorphine (fed)?

3

A licensee with a registration beginning on or after Jan 1, 2023 MUST complete ______ hours of Continued Education in compounding

3 Must be consistent with current compounding standards as determined by the NYSED. Live or self-study

How many days does the pharmacy have after being notified of the recall from manufacturer, wholesaler, FDA etc to let patient know?

3 day window of notification begins once the pharmacy is notified of the recall

'C' violent felony

3 ½ to 15 years

if the SP of a pharmacy becomes sick or disabled(including pregnant), a new SP must be assigned if the SP is not back to work within how many days?

30

The Synchronization of Multiple Medications Article has a pro-rated cost sharing rate of <_________ days supply?

30 insurance has to pay for it ONE TIME, once a month if on chronic medications. One time link them all together and insurance pays for this

Change in address=> notify PSSNY NY BOP within how many days

30 days notice

Buprenorphine. What is the maximum days supply that can be written?

30 days supply

Per NYS Law: How many unlicensed pharmacy technicians per pharmacist may you have in an Article 28 facility? (Not including cart filling)

4

How many hours of CE were required prior to the addition of the compounding CE credits

45

Credit from passing scores on each licensure required exam lasts ______ years from the exam date

5 years

How long are records kept for (prescriptions? )

5 years

'B' violent felony

5-25 yrs

How long must you keep (prescription) records for an infant? (same as adult)

6 years HIPAA 5 yrs NYS 6 yrs Medicaid Immunization - rest of lives is just recommended from APHA (don't need to)

Practitioners may not prescribe MORE THAN A __________ day's supply of any C2,C3 & C4 for initial consult/acute pain

7 day supply * if >7, call them

Change in SP=> notify PSSNY NY BOP within how many days

7 day's notice Owner's responsibility Fines begin > 7days for everyday thereafter SP should also notify to protect liability

Per NYS Law: What is the maximum length of elapsed time after exposure for which the HIV Post Exposure Meds may be dispensed?

72 hours

Laws take effect _________ days after it becomes a law

90

One of the most serious "white collar" or non- violent crimes in the New York Penal Code.

A "B" felony carrying a mandatory minimum term of incarceration, Enterprise Corruption, pursuant to New York Penal Law 460.20, is punishable by up to 25 years in prison and is often associated with organized crime and RICO offenses Racketeer Influenced and Corrupt Organizations Act (RICO) Anti-mafia act

What is the Unused Prescription Donation and Redispensing Program?

A donor entity may donate unused rx drugs to a recipient entity, directly or through a third-party intermediary Must be secure → ensuring the privacy of whom the drugs were initially dispensed to or intended to be dispensed. Prescription drugs redispensed under this section shall be inspected by a pharmacist or other licensed health care provider as provided by regulations.A redispensed rx drug shall not be resold by any person or entity. However, this subdivision does not bar the payment of reasonable processing fees.

What is Enterprise Corruption?

A person has knowledge of the existence of a criminal enterprise and the nature of its activities, and being employed by or associated with such enterprise, cannot turn your back on this if you know it's happening (a)intentionally conducts or participates in the affairs of an enterprise by participating in a pattern of criminal activity; or (b) intentionally acquires or maintains any interest in or control of an enterprise by participating in a pattern of criminal activity; or (c) participates in a pattern of criminal activity and knowingly invests any proceeds derived from that conduct, or any proceeds derived from the investment or use of those proceeds, in an enterprise → billing out false things/prices Covers Medicare, Medicaid, and private insurance

United States v. Kershman, 555 F.2d 198 [United States Court Of Appeals, Eighth Circuit, 1977 & Corresponding Responsibility 21 U.S.C. § 829

A pharmacist is required to exercise sound professional judgment when making a determination about the legitimacy of a controlled substance prescription... The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. "A pharmacist also needs to know there is a corresponding responsibility for the pharmacist who fills the prescription. The person knowingly filling such a purported prescription, as well as the person using it, shall be subject to the penalties provided for violations of the provisions of law related to controlled substances."

False Claims Acts: A-D

A. Knowingly presents or causes to be presented, a false claim B. Knowingly makes, uses or causes to be made or used, a false record or statement materials C. Conspires to commit a violation D. Has possession, custody or control of property or money used by the Government and knowingly delivers, or causes to be deliver, less than all that money or property Stolen property = stealing drugs from local hospitals

What is abuse?

Actions that may directly or indirectly result in unnecessary costs to the Medicare program · Involved payment for items or services when there is not legal entitlement to that payment and the provider has not knowingly and/or intentionally misrepresented facts to obtain payment · Ex. misusing codes on a claim, charging excess ively for services

C4 federal, NYS non controlled (7)

Alfaxalone (Alfaxan) Brexanolone (Zulresso) Eluxadoline (Viberzi) Lemborexant (Dayvigo) Locaserin (Belviq) Solriamfetol (Sunosi) Suvoresant (Belsomra)

Wholesale level recall defined

All levels from manufacturer to wholesaler May include pharmacies if manufacturer sells to pharmacy directly Varies with product

117th Congress H.R.3 Elijah E. Cummings Lower Drug Costs Now Act ~ What did this Act say?

Allow US HHS to negotiate lower prices on expensive Rxs and Insulin directly with pharmaceutical companies (25 drugs in 2024). If companies refuse to negotiate, they face civil and tax penalties The Negotiated price is the Upper limit - we pay the highest for Rx drugs in US compared to other countries. Manufacturers must give rebates if price increases for covered drugs > rate of inflation Cap Medicare beneficiaries' out of pocket drug costs at $2,000 Because people cannot afford it !

A patient with an opioid dependency is admitted to a hospital, being in a car accident. May a practitioner prescribe, and a pharmacist dispense an opioid agonist (buprenorphine or methadone)?

Allowed by federal and state law - addition is secondary to injury If they're on methadone therapy for opioid addiction - allowed by bothfederal and state law

Situation: If the prescriber wants an interchangeable product to the brand and you are out, you may give the brand at a price that does not exceed the price or the interchangeable. If it is an emergency then you may dispense the brand name at the brand name price. What is an Emergency considered? What would you have to do ?

"Any condition requiring alleviation of severe pain, which threatens to cause disability or take life if not promptly treated..." Pharmacist must record date, hour & nature of emergency on back of Rx

A nurse phones in a prescription for Belsomra 10mg #100. Sig 1 hs. Code A. 2 refills. How many can you fill the Rx for?

#100 - A nurse can call in a federal control (30 d supply = NYS, federal = whatever practitioner indicates on Rx - fax, verbal, electronic, written)

NYS Opioid Stewardship Act §3323- What is the Total Stewartship Program ?

$100,000,000 per year! - has not happened yet To support programs operated by the NYS Office of Alcoholism and Substance Abuse Services (OASAS) such as Opioid treatment, recovery, prevention and education, Support PMP Will charge pharmacists more → don't wanna carry them since we cannot charge pt more

Naloxone Co-Payment Assistance Program (N-CAP) ~ up to $______ for each Rx dispensed will be billed

$40 each Rx dispensed No individual enrollment is necessary Pharmacies participating in the NYS AIDS Drug Assistance Program are eligible to participate

Equipment and Containers of a 503B facility ~ what is the word that is associated with this shit?

(VALIDATION)

Controlled substances may be prescribed for, or administered or dispensed to an addict or habitual user for medical use in what situations (3)

(a) during emergency medical treatment unrelated to abuse of CSs (b) who is a bona fide patient suffering from an incurable and fatal disease such as cancer or advanced tuberculosis; (c) who is aged, infirm, or suffering from serious injury or illness and the withdrawal from controlled substances would endanger the life or impede or inhibit the recovery of such a person.

The Synchronization of Multiple Medications Article Effective Jan 2020 allows for covered synchronization(by insurance) provided that...

*OPTIONAL agreement btwn patient, pharmacist & doctor 1. Meds are covered by the plan (can be done once per Rx) 2.Meds are used for chronic illness (with refills) 3.Meds are not CII's, or CIII-containing hydrocodone (HC = all C2s) 4.Meds meet all specific prior authorization at the time of synchronization 5.Meds do not have quantity limits or dose optimization criteria or requirements that would violate fulfilling synchronization 6.Rx is a formulation that can be effectively split over required short fill periods to achieve synchronization

'E' violent felon

- no jail, probation, 1 ½ to 4 years

What are 503B's specific labeling requirements

-"This is a compounded drug" or "This is a repackaged drug" -"Not for resale" -If not dispensed pursuant to a patient-specific prescription: "Office Use Only" -Information to facilitate Adverse Drug ----Event Reporting ***Have to be on every unit drug product distributed*** Controls to prevent label mix-ups Labeling examination for accuracy -Specific requirements in DQSA Records must include specimens of all labels used

Naloxone in Governor's Budget Part HH says that Any licensed pharmacy in NYS that dispenses controlled substances must maintain a minimum stock of a 30- days supply of both: (naloxone)

-An opioid antagonist medication -An opioid partial agonist medication for treatment of opioid use disorder any combination of meds and doses 480 mg /month Must have at least one version in stock

EXAMPLES OF FRAUD

-Drug Diversion -Benefiting from bribery -Automatic refills (Waste) -Switching drugs -Billing schemes: Billing for non existent Rxs, Billing brand name when generic dispensed, Billing multiple payers

Quality Assurance Activities of a 503B facility. What is a Quality Unit?

-Ensure procedures are followed & quality drug product is produced -QU: indpendent of production -SOP established and followed -Governor's approval and release of finished drug product

Pharmacy Fraud Key Indicators Federal and State False Claims Acts (theres a shit ton)

-False or fictitious claims submissions -Billing for non-existent prescriptions -Improperly billing compounded prescriptions -Catastrophic coverage manipulation -Bait and switch drug pricing -Billing brand when generics dispensed -Improper prescription drug switching -Billing for services not rendered -Insufficient proof of delivery -Not processing returns to stocks -Billing PBMs for prescriptions not filled or picked up -Failure to provide negotiated prices of a drug to a beneficiary -Improper payments for excluded drugs -Illegal marketing schemes -Overcharging -Enrollment fraud -Use of dummy DEA/NPI's -Are the prescriptions being altered? -Quantity changes or DAW changes -Forged signature logs -Prescription splitting - if person geet #100 on Rx - only fill #30 so they have to fill more ⇒ you get paid for more fillings -Not crediting for destroyed items -Are the dispensed drugs expired, fake, diluted or illegal?

Wha is Aseptic Drug Processing?

-Individual training on aseptic technique, cleanroom behavior, gowning, etc. -Individuals must pass 3 successful, successive media fill simulations~Growth media broth -Continuing education and requirements, must be requalified twice a year

What are Media Fill studies (a part of aseptic drug processing 503B) ?

-Must be representative of batch size and incorporate worst case scenarios. -Operators have to do and also for any type of aseptic manipulation or compounding

Buprenorphine Amendment signed into law by governor - what did this say ?

-Office of Alcoholism and Substance Abuse Services (OASAS) -Each insurance policy MUST Provide coverage for immediate access to a 5 day emergency supply of certain Rx medications and prohibiting prior authorization for an Rx buprenorphine for opioid addiction detox or maintenance treatment of a substance use disorder (management of opioid withdrawal and/or stabilization) -Emergency Condition - do not have to wait for treatment for substance use disorder Acute symptoms of severe pain or expectation of severe pain which may result in: Placing the patient in serious jeopardy, Serious impairment to such person's bodily functions, Serious dysfunction of any bodily organ or part of such person , Serious disfigurement of such person -

117th Congress H.R.3 Elijah E. Cummings Lower Drug Costs Now Act ~ has this been passed yet?

NO

Do student pharmacists have to be on a standing order for immunizations?

NO Authority & responsibility comes from pharmacist

Can a regular insurance company come & copy records?

NO Insurance company only can if looking at certain ppl

Rx is written for 30 tablets with 12 refills (Noncontrolled). May I give 90 upon patient request?

NO violation unless provider is called (need providers OK to change anything)

Are federal controlled only, NYS non-controlled medications on the PMP?

NO (state law) These Follow FEDERAL LAW ONLY* → had to inventory the day it went to federal law! (state law = requiring inventory)

May a technician add alcohol to an acne preparation?

NO - no appropriate

Can pharmacists administer travel vacccines under Immunization Expansion Chapter 555?

NO mention of travel vaccines

Can C2s be partially filled? (Comprehensive Addiction and Recovery Act of 2016) Title 7

NO not in NYS federally yes

Since Fioricet (Butalbital/ASA/Caffeine) is not listed as CS w/ the DEA, are all generics exempt from scheduling?

NO ~ NYS recognizes the DEA list in 10 NYCRR 80.3 (2) Have to apply to be non control or control the DEA maintains an except Rx product list and each manufac must apply for its specific products to be exempted from scheduling

FDA Guidance Documents for 503b and mfg/lab facilities ~ are these regulations (law?)

NO, just guidance doc Outline FDAs expectations in plain language FDAs current thinking on a topic - may change more frequently than code of regulations Should be viewed as recommendations unless statutory requirements are cited FDA does intend to develop specific cGMP requirements for Outsourcing Facilities

NYS legislation: S728 (Hoylman) / A2198 (Gotfried)~ what was added to HIV prophylaxis?

NOT PASSED ! ALlows pharmacist to dispense PRE EXPOSURE (standing order? ) Pharmacist must provide for a least a 30-days supply but no more than 60 days supply, Only 7 days for post now (Bottles only come in qty of 30, $100 each) Must also provide information on importance of having a health care provider(provide list of clinics/physicians)

current Good Manufacturing Practices (cGMP)~ what are these & who uses them (503B) ? What CFR Subparts are apart of this?

NYS + Federal inspect based on this For Finished Pharmaceuticals: 21 CFR(code of fed regulations) 210 Subparts: status & applicability of cGMPs 21 CFR 211 Subparts: Framework to setting up requirements to produce high quality drug product: general provisions, organization, personell, buildings, equipment, containers, production process, packaging and labeling, distribution, lab controls, records, returned products cGMP Sections: Sterility assurance General safety of compounded products: e.g. Sub Potency, Super Potency Labeling or product mix-ups Quality Assurance Activities Facility Design, Control Systems and Procedures for Maintaining Suitable Facilities Environmental and Personnel Monitoring Equipment, Containers, and Closures Components Production and Process Controls Release Testing Laboratory Controls Stability/Expiration Dating Packaging and Labels Reserve Samples Complaint Handling

Records must be kept for _____years

NYS patient records 5 yr HIPAA for 6 yr Medicaid - 6 yr DeA = 2 yr - (follow stricter law of 5yr) -Medicare Part D = 10 YEARS -Medicare Fed Gov = 2 YEARS -CE = 6 YEARS -immunizations = LIFE OF PATIENT

Comprehensive Addiction and Recovery Act of 2016 Title 1 allows for a standing order of what medication?

Naloxone - standing order => can give without an Rx now in NYS

Dispensing Label for Naloxone. Requirements?

Name of recipient/patient Prescriber Name Naloxone formulation and concentration Date Dispensed Refills: 5(recommended) "Dispensed per standing order" "Use as directed" "Trained opioid overdose responder"

Can a vendor pharmacy dispense methadone to a nursing home (class 3a facility) for Medication Assisted Treatment (MAT)?

No Yes in hospitals; no in NH - would have to send to clinic, not EMERGENCY in NH

A patient wants you to fill their reminder pill box

No - putting in unlabeled container (by law you cannot do that)

Per NYS law: Are NYS registered pharmacy technicians, if properly trained, allowed to vaccinate in a community pharmacy?

No not in NYS (but yes in fed PREP act)

Opioid Overdose Prevention Programs: Naloxone dispensing. Does it need a prescription?

No prescription may be dispensed to anyone who requests it State-wide standing order Harm Reduction Coalition: "Dispensing Naloxone" You must have received training to dispense naloxone

Are Rxs from VA on the PMP?

No, that is a federal facility and this is state law (PMP)

Does a supervising doctors name need to be on a CS prescription written by a resident?

No. interns residents, or foreign physicians may prescribe CS under DEA# of institution and code #(or suffix) assigned to them by the institution .The Rx does not need to be transmitted or written w/ supervising practitioners name or DEA #

How long can you refill a prescription?

Non controlled - can refill more than a year (insurance rule of thumb is a year but not official) It depends - if insurance companies allow it, can do more than a year (not the law) Fill stuff under your professional judgment - if says 2 yrs, can do 2 yrs Chronic diseases - should check w/ them NYS RX do NOT expire after a year (unless control)

What is a biological product? (NYS regulation of biosimilars)

Not exactly the same but highly similar to each other Can substitute if highly similar to each other Same company, same drug, same biological, different lot # => may be a little bit different in NYS

Class 3 recalls defined

Not likely to cause any adverse health consequence e.g., unapproved dye used

Chain pharmacy with a shared database. May I access the patient's record?

Not without the patient's express consent (written or electronic), not just verbal permission, pt's sig must be on it

What are Reserve Samples?

Once > 10,000 units produced of a given product formulation in a 6 month period, reserves must be collected. -Must be stored under labeled conditions -Held for >30 days beyond the Expiration Date -Quantity must be at least enough necessary for all tests required at release, except for sterility and pyrogen testing

How Do I Know the Noncompliance Won't Happen Again?

Once noncompliance is detected and corrected, an ongoing evaluation process is critical to ensure the noncompliance does not recur. Monitoring activities are regular reviews which confirm ongoing compliance and ensure that corrective actions are undertaken and effective. Auditing is a formal review of compliance with a particular set of standards (e.g., policies and procedures, laws and regulations) used as base measures PREVENT, DETECT< REPORT< CORRECT, MONITOR AND AUDIT

OQ stands for what (equipment 503B)

Operational Qualification

Personnel Monitoring @ 503B facility ~ what do they monitor?

Operators' gloves: daily or per shift Operators' gown/garb ~Forehead, Arms, Chest, Mask Everything they are wearing must be sampled routinely

What is waste?

Overutilization of services or other practices that directly or indirectly result in unnecessary costs to the Medicare program · Not considered criminally negligent action but rather misuse of resources

Regulation of PBMs S3762 (Breslin) A1396 (Gottfried) - what did this bill entail?

PBMs have a duty to the covered individual and health plan to services with care, skill, prudence, diligence, professionalism and the best interest of the individual. This bill requires PBMS be licensed by the NYS Insurance Department and confirm to standards established by the Insurance and Health Department for transparency. Full disclosure to plans and providers with whom they contract Bars the substitution of prescribed drugs, if not allowed by physicians

HIV Post Exposure Prophylaxis (PEP) Which one, pre or post, is allowed in NYS? & what supply PEP allow a pharmacist to dispense ???

POST 7 day's supply of a starter pack Very $$$ tho, only can get in packs of 30 → only get reimbursed for the 7, not the whole pack so lose alot of money Pharmacists don't carry a lot because dispense out 7 & the rest of the pack sits on shelf (waste $) -> trying to get them made into 7 day packs

If dispense 30 methadone, assume it is for what?

Pain (does not have to state this)

What is considered acute pain?

Pain resulting from disease, accidental or intentional trauma or other cause, that the practitioner reasonably expects to last only a short period of time. Not chronic pain Not cancer pain Not hospice or end-of-life care Not palliative care practices

117th Congress 2021-2022 HR 5376: Biden's Build Back Better Act (BBBA)~ was this passed?

Passed House

Fed C3, NYS noncontrolled? (1)

Perampanel (Fycompa)

PQ stands for what (equipment 503B)

Performance Qualification

Class 1 recalls signed into NYS law in 2019 (all pharmacy venues) ~ for patients currently taking a class 1 recalled drug, what do pharmacists have to do?

Pharmacist must make reasonable attempts to contact the patient by phone or mail

Medicaid: Hiring of sanctioned persons

Pharmacist who lost medicaid license -- cannot be hired as a pharmacist to dispense to medicaid patients (exist everywhere)

Insurance allows under The Synchronization of Multiple Medications Article for Multiple Medications & Chronic Illnesses that pharmacists can do what to denial codes?

Pharmacists may override denial codes for early refills for the purpose of synchronization(still get paid if too early) Dispensing fees must be paid in full for each Rx dispensed regardless of any prorated copay or fee paid for alignment services. No hospital service corporation or health service corporation providing drug coverage shall deny coverage for the dispensing of medication for partial fill when it is for purposes of synchronization.

NYSED Online Vision Registry

Pharmacists, Staff supervised by pharmacists MAY now conduct vision screening tests No special registration is needed by the pharmacy

EPT-What is required on rx?

Pharmacy Name/address Directions Date of delivery Name of medication, Strength

EPT-Who can write the rx?

Physician, midwife, NP, PA

What immunizations were pharmacists allowed to administer to ADULTS (>/=18 yo) PRIOR TO THE EXPANSION?????

Pneumococcal Acute herpes zoster Meningococcal Tetanus/Diphtheria/Pertussis INFLUENZA

What is required in a Stability Study in a 503B facility ?

Potency tests must be 'Stability Indicating' -Verification that strength is maintained through expiration -Evaluate critical quality characteristics of the finished drug product -Verification that product will remain sterile through expiration -Must evaluate 1 batch of each drug product. -Up to one year of expiration date can be utilized

Which items do NOT have to be on the label for med from a pharmacy for EPT?

Prescriber addy

What "books" are involved with Biosimilars

Products listed in the "Purple Book" or the "Orange Book" Federal law regulates the above 'books' and what is 'interchangeable' between biosimilars (NY has own regulations now)

PBMs cannot charge or collect from an individual a copay that exceeds the total submitted charges by the pharmacy (for which the pharmacy is paid). If an individual pays a copayment, the pharmacy shall retain the adjudicated costs and the PBM shall not redact or recoup the adjudicated cost. (PBMs may not require pharmacists to charge a copayment higher than the amount reimbursed) What does this essentially prohibit????

Prohibits "clawbacks" (DIR FEE) by PBMS that reduce the adjudicated cost.

What is Expedited Partner Therapy (effective 2021)

Provide patients with prescriptions for treatment of partners Rx must say EPT above the name of therapy and dosage Providers may provide Rxs to partners without a medical evaluation or clinical assessment PAPER !!! (not electronic)

How often is BBP (blood borne pathogen training) required ?

Q year

When must you go through the will call section to take out those Rxs that patients have not picked up?

Q2wks

How often do pharmacists renew their registration ?

Q3Yrs

Complaint Handling for 503B compounding facility

Quality Unit must evaluate complaints related to product quality => Adverse Event Reporting if necessary find route cause of this Resolve and address for future manufacturing

Retail level recall defined

Recall to a level immediately preceding the consumer. Pharmacies Physicians Nursing homes Hospitals Varies with product

If patient was sexually assaulted & comes in for EPT, what should you do?

Refer to the emergency room. Not required to report to authorities by law - but encouraged to do so

Prohibited Acts of 503A compounding pharmacies:

Regular compounding or inordinate amounts of essentially copies of commercially available products...This does not include a change made for an identified individual patient that produces a significant difference as determined by the prescriber. Compounding of drug products that present demonstrable difficulties Potential to reasonably demonstrate an adverse effect on safety or efficacy. FDA has not identified any yet.

What needs to be included for Release Testing of finished products in 503B?

Release specifications must be established for each finished drug product & met specifications prior to release -Potency -Sterility -Endotoxin -pH -Visible particulate -Sub-visible particulate -Appearance

Federal Controlled C4 Benzo, NYS non controlled? (1)

Remimazolam (Byfavo)

Immunization Expansion Chapter 555 removes what restriction of provider practices?

Removes the county restriction of provider practices in that same county or adjoining ***Must NOW be a physician/NP licensed, registered and have a practice in NYS

NYS Opioid Stewardship Act §3323 ~ what does this Act require?

Requires manufacturers, distributors and importers licensed in NYS as of 1/1/2017 to report transactions of opioids going back to 1/1/2017 -Must report all opioids sold or distributed to or within NYS to the NYS DOH BNE. -Payments (based on rateable shares) from each manufacturer and distributor, Does not include dispensing -Includes intra-company transfers between divisions, affiliates, subsidiaries, parent or other entity under complete common ownership and control -Does not include controlled substances surrendered to reverse distributors or donated to recipient entities or third party intermediaries pursuant to unused RX drug donation and redispensing programs. -Does not include opioids manufactured and sold or distributed outside of NYS. -Does not include entities pursuant to Article 32 of mental hygiene law or Article 40 of PBH.

What did the Senate Bill 957 Public Law 117-29 require? (signed into law July 2021)

Requires the Department of Veterans Affairs (VA) designate periods ppl can dispose of controlled substances medications at VA medical facilities with an onsite pharmacy or a physical location dedicated for law enforcement purposes. The bill also authorizes the VA to carry out public information campaigns regarding the designated disposal periods

Conditions for compounding 503A facility

Resident state must have entered into a memorandum of understanding (MOU) with the FDA MOU: addresses inordinate distribution of compounds interstate & complaint handling. MOUs have never been developed. - Now working with NABP If no MOU: interstate distribution of compounded products must not exceed 5% of total prescription orders dispensed or distributed Puts limits on what can be distributed across the country

Title 1 - Compounding Quality Act defines pharmacies under section ________ of the FDCA & created a new entity known as a(n)-___________________ Facility aka __________

Section 503A Outsourcing Facility 503B

Control Systems and Procedures for Maintaining Suitable Facilities in 503B?

Sterile operations must be separate from other operations Procedures for sanitation: Responsibility, schedules, methods, equipment, and materials Large cleanroom equipment must not obstruct air vents/flow Must establish limits, monitor, and utilize alarm systems to detect excursions: Pressure differentials, Room humidity, Room temperatures

Buprenorphine Amendment signed into law by governor ~ were copays/coinsurance's required?

Subject to copay or coinsurance To hold over before prior auth takes effect No additional copays/coinsurance - ONLY ONE CO-PAY When patient is prescribed up to a 30- days supply in the same 30-day period in which they received the emergency 5- days supply Managed care providers shall not require prior authorization for an initial or renewal prescription for buprenorphine or injectable naltrexone for detoxification or maintenance treatment of opioid addiction unless the prescription is for a non-preferred or non-formulary form of the drug

False Claims

Submitting or causing to submit a claim: § Unfurnished medical care, service, or supplies § An amount more than established rates or fees § At a frequency or in an amount not medically necessary § Amounts substantially more than customary charges or costs to the public

The new update on PBM regulations requires that PBMs doing business in NY must register with who & how often do they have to renew?

Superintendent of Insurance Renew every 3 year SI with Commissioner of Health will establish minimum standards Addressing conflicts of interest, deceptive practices, anti-competitive practices, unfair claims practices and protection of consumers

What did the Fed False Claims Act say?

Suppliers of goods to the Union Army were defrauding the federal government Primarily used as a tool for combating health care fraud and abuse, most notably, Medicare and Medicaid billing fraud. The Social Security Act and CMS regulations and guidance govern the Medicare program, including parts C and D. Part C and Part D sponsors must have an effective compliance program which includes measures to prevent, detect and correct Medicare noncompliance as well as measures to prevent, detect and correct fraud, waste, and abuse. Sponsors must have effective training for employees, managers and directors, as well as their first tier, downstream, and related entities

Class 2 Recalls defined

Temporary or medically reversible consequences Serious health effects remote e.g., wrong strength labeled

What did the BBBA change regarding Elimination of cost sharing for adult vaccines?

The BBBA would require that adult vaccines covered under Medicare Part D (needed to prevent illness) that are recommended by the Advisory Committee on Immunization Practices (ACIP), such as for shingles, be covered at no cost. ( no copay) This would be consistent with coverage of vaccines under Medicare Part B, such as the flu and COVID-19 vaccines, (+ hep B & pneumococcus) which are vaccines for patients at high or intermediate risk to treat an injury or exposure to a disease

If there is a mistake who is responsible?

The dispensing pharmacist

"Know the Lowest Price Act" and the "Patients' Right to Know Drug Prices Act" prevents what clause?

The pharmacy GAG clause (+ clawbacks) A gag clause is charging pts a high copay when the drug was much less. The gag clause prevented the pharmacist from discussing cash prices with patients who have insurance Rx coverage

How are Whistleblowers Protected and Rewarded if they file a qui tam?

The qui tam provision of the FCA allows the person (known as the "realtor") pursuing the action to share in any money recovered. With government assistance: 15 to 25% of the total recovery. Without government assistance: 25 to 30% of the total recovery The FCA also prohibits an employer from retaliating against employees who report what they reasonably believe to constitute fraud

What are Biosimilars?

These are not drugs, but complex entities Not identical but 'highly similar' NYSED will keep a list of products on their website.

What did the Drug Quality & Security Act of 2013 pass in its 2 part Bill?

Title 1- Drug compounding facility: compounding quality Act Title 2-Drug Supply Chain Security: Track & trace

NYS Opioid Stewardship Act §3323 PASSED WHY?

To battle the opioid crisis - opioid TAX essentially Fines $1,000/day up to $1M per incident Effective July 1, 2018 through June 30, 2024

Deficit Reduction Act of 2005

To slow spending in Medicare and Medicaid Creates financial incentives for states to enact anti-fraud legislations, Gives states an additional 10% of the damages recovered

Deficit Reduction Act of 2005

To slow spending in Medicare and Medicaid Creates financial incentives for states to enact anti-fraud legislations

Affordable Care Act

Tough new rules and sentences for criminals: The law increases federal sentencing guidelines for health care fraud by 20-50% for crimes with over $1 million in losses Enhanced screening: Providers and suppliers who may pose a higher risk of fraud or abuse are now required to undergo more scrutiny, including license checks and site visits. State-of-the-art technology: To target resources to highly suspect behaviors, the Center for Medicare & Medicaid Services now uses advanced predictive modeling technology New resources: The law provides an additional $350 million over 10 years to boost anti-fraud efforts

Affordable Care Act

Tough new rules and sentences for criminals: The law increases federal sentencing guidelines for health care fraud by 20-50% for crimes with over $1 million in losses. -Enhanced screening: Providers and suppliers who may pose a higher risk of fraud or abuse are now required to undergo more scrutiny, including license checks and site visits. -State-of-the-art technology: To target resources to highly suspect behaviors, the Center for Medicare & Medicaid Services now uses advanced predictive modeling technology. -New resources: The law provides an additional $350 million over 10 years to boost anti-fraud efforts.

Federal False Claims Act: Penalties 31 U.S.C. § 3729

Treble damages (damages equal to three times the amount of the false claims), civil penalties of up to $11,000 to $50,000 per claim and exclusion from federal health care programs. In addition, the federal government may impose administrative sanctions of up to $5,500 plus twice the amount of the false claim under the Federal Program Civil Remedies Act of 1986 (31 U.S.C. § 3801).

What did the BBBA change regarding the drug rebate rule of Trumps Administration?

Trump =no rebates, biden=rebates prohibit implementation of trumps November 2020 final rule would have eliminated rebates negotiated between drug manufacturers and PBMs or health plan sponsors in Medicare Part D by removing the safe harbor protection currently extended to these rebate arrangements under the federal anti-kickback statute. This rule was slated to take effect on January 1, 2022, but the Biden Administration delayed implementation to 2023 and the infrastructure legislation signed into law on November 15, 2021 includes a further delay to 2026

Mainstreaming Addiction Treatment Act of 2021 status & current regulation

Trump tried to pass but was vetoed by Biden Still need a waiver to prescribe buprenorphine in NYS + federally

What pres made Clawbacks illegal & what law was it ?

Trumpy CMS Proposed Rule 42 CFR Parts 422 and 423 January 12, 2022. It moves all pharmacy price concessions, including retroactive DIR fees, to the point-of-sale to benefit patients with lower out-of-pocket costs. The negotiated price would be the lowest possible reimbursement a pharmacy will receive in total for a particular drug. PBMs can still receive rebates from manufacturers

503 A must comply with USP 795 & USP 797. What are each of these?

USP<795> (non-sterile compounding) <797> (sterile compounding)

Medicaid: Bribes and Kickbacks

Unless disclosed to the client and department and reflected in the claim the following are unacceptable: Soliciting or receive either directly or indirectly any payment (cash or in-kind) In return for services rendered In return for purchasing, leasing ordering or recommending any medical care or services In return for referring a client to a person for medical care or services or supplies

Bribes and Kickbacks

Unless disclosed to the client and department and reflected in the claim the following are unacceptable: § Soliciting or receive either directly or indirectly any payment (cash or in-kind) · In return for services rendered · In return for purchasing, leasing ordering, or recommending any medical care or services · In return for referring a client to a person for medical care or services or supplies

How to Clean and Disinfect 1SO 5 area

Use sterile disinfectants and lint-free sterile wipes. Use of sporicidal disinfectants must be used in ISO 5 areas. Suitability, efficacy, and limitations of the disinfecting agents should be monitored routinely. Sanitation program and disinfectant selection and use should be modified based on environmental monitoring data.

DEA RED FLAGS? What should we as pharmacists consider when any of these things occur/happen?

Use your professional judgment Although the DEA stresses the law, we must take care of the patient Do not look at all patients with suspicion as most prescriptions are for legitimate use. These flags are not stop signs

Consumer level recall defined

User level - have to contact the patients when we find out Get RX from patient Includes all levels of distribution Varies with product

How can PEP be dispensed (2 ways)?

Via a physician's or nurse practitioner's patient specific (Rx) or non-patient specific order (standing order)

What is Qui Tam? (Whistleblower)

What Is Qui Tam? The qui tam provision of the Federal False Claims Act (FCA), or "Lincoln Law," empowers whistleblowers (also known as a qui tam relator) who have firsthand knowledge of frauds or violations against the government to report them to the appropriate officials. The provisions also incentivize whistleblowers with awards for their cooperation in working directly with government investigators, often in the capacity of a confidential informant. Switching zantac tablets for zantac capsules → bigger reimbursement for capsules Switching generic drugs for higher reimbursement This is medicaid fraud

Can you give refills of buprenorphine?

YES

Is 503B exempt from FDA approval process?

YES Traditional pharmacies have to follow FDA approval process to use the drugs

If the name, address, & DOB of the sexual partner is available for EPT, is it required to be on the Rx?

YES if not avail, its ok to still fill EPT law overrides the requirement that prescriptions include a patient's name, address, and age

Can you have more than one technician per pharmacist if the tech is PTCB certified?

YES - 4 techs per pharmacist anywhere you go But in hospital - only 2 registered/certified techs per pharmacist in that ratio per pharmcist (out of the 4) ~ registered by the state Combos: 3 unlicensed + 1PCTB certified, 2 unlicensed + 2 certified, 4 certified, etc

Can Medicare/Medicaid copy records?

YES - written in regulations

Can NPs and PAs prescribe buprenorphine? (Title 3 Comprehensive Addiction and Recovery Act of 2016)

YES in NYS

Are clawbacks illegal?

YES in NYS they are ex) charge pt 60$ for drug, costs $80 → get $20 from insurance → but insurance says they aren't going to give you the $20

Regulation of PBMs S3762 (Breslin) A1396 (Gottfried) ... was this signed into law? What law did it Amend?

YUP, Nov 2021 Amends Public Health Law 6280-a to define the range of activities of a PBM

Adverse Event Reporting in a 503B facility~ is this required?

Yea not required for pharmacies Anything that happens to a patient after receiving a compounded product can be considered an ADE

Is marijuana on the PMP?

Yes - C1 federally, illegal to prescribe; let certified pts PICK UP medical marijuana

Can you transfer a syringe/needle Rx?

Yes - considered NON-controlled substances

Can a buprenorphine Rx for Substance Use Disorder (SUD) be refilled?

Yes - it is a C3 (common) 5 refills wi 6 months time

May I transfer a prescription to another pharmacy if it was not filled at my pharmacy?

Yes, for non controlled only...the original Rx stays at your pharmacy and any other refills that was on that original Rx (do not need providers okay) One filling at a time

What if the patient is a minor? Can you discuss it with him/her regarding EPT?

Yes. Allow minor to consent to treatment Importance of follow-up care => Recommended to send them to Emergency room We are not allowed to discuss any details related to exposure with minor's parents or guardians without permission from minor

Can a vendor pharmacy dispense Suboxone® to a nursing home (class 3a facility) for Medication Assisted Treatment (MAT)?

Yes. The federal Drug Addiction Treatment Act of 2000 (DATA 2000) allows a practitioner to prescribe, administer or dispense a controlled substance approved by the FDA for narcotic addiction.

What is a *"Interchangeable biological product"

a biological product licensed by the United States Food and Drug Administration pursuant to 42 U.S.C. Section 262(k)(4) as set forth in the latest edition or supplement of the United States Food and Drug Administration Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, sometimes referred to as the "Purple Book," or a biological product determined by the United States Food and Drug Administration to be therapeutically equivalent as set forth in the latest edition or supplement of the United States Food and Drug Administration Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the "Orange Book."

What is the NABP Clearing House

a national database of disciplinary information from NABP's member states and jurisdictions. It houses information reported by the member boards of pharmacy on actions taken. This info is used to determine the acceptability & qualifications of pharmacists who request the transfer of exam scores and licenses into other states or jurisdictions

How does the NABP Clearing House apply to you?

a safety net if you are licensed in >1 state or apply to be licensed in another state. these reports allow boards to screen for licensees who have failed to uphold professional and public safety standards and make informed decisions regarding who qualifies to practice pharmacy in their respective state.

What is CLass A felony?

aggravated murder, terrosim, kidnapping, aggravated ennterprise corrptuoon, murder in 1st and 2nd degree, major drug trafficing

How often must Sec. 503B - Outsourcing Facilities register with the FDA?

annually

May a pharmacy carry CBD Oil?

anywhere can carry + sell CBD oil if licensed + registered in NYS

How often do 503B facilities need to obtain HEPA filter certification

at least twice a year HEPA filter integrity tests, Particle counts, Air velocity checks Airflow studies (smoke study) conducted under dynamic conditions. Show that serile air flow reaches all working areas where compounding is done

Currently, which controlled substance is the only approved medication a pharmacist may dispense for treatment of substance use disorder (pursuant to an Rx issued by practitioner)

buprenorphine

Pharmacy Interns Article 137 §6806 authorizes a pharmacist immunizer to delegate the administration of vaccines to who?

certified pharmacy intern A pharmacy intern may receive a certificate of administration if he/she provides satisfactory evidence to the NYSED: Techniques for screening patients, Obtaining informed consent, Techniques of administration, Indications, Precautions, Contraindications

ISO Classification of Particulate Matter in Room Air~ what ISO is required?

class 5 100 particle count

Environmental Monitoring for presence of non-viable particles in 503B? what are those?

come from non-microbial source that can lead to contamination of drug product

Environmental Monitoring for presence of viable particles in 503B? what are those?

comes from a microbial source and can support or sustain microbial growth/proliferation

Medicaid §515.2: Unacceptable Practices. What is this?

conduct by a person which is contrary to: Official rules and regulations of the department, Published fees and rates, Official rules of the Dept of Health, Education and Mental Hygiene, Regulations of the Federal HHS( Social Security Act)

Anti-Kickback Stature Social Security Act

criminal offense to knowingly and willfully offer, pay, solicit or receive any remuneration to induce or reward referrals of items or serves reimbursable by a federal health care program.

Sec. 503B - Outsourcing Facilities... what do they compound?

engaged in the compounding of sterile drugs for Humans Can compound sterile and non sterile drugs May or may not be registered as a pharmacy

NYS Education Law amended law to add Outsourcing Facilities (identical to fed language DQSA) Requirements:

essentially same requirements Must be registered with the FDA under section 503B Statute states registration is required, but the Board of Pharmacy is requiring inspection by FDA before registration approval May not dispense or distribute a patient-specific prescription unless also registered as a pharmacy. Requirements to follow the FD&C Act

compliance is whos responsibility

everyones PREVENT -Operate within your organization's ethical expectations to PREVENT noncompliance! DETECT & REPORT -If you DETECT potential noncompliance, REPORT it! CORRECT -CORRECT noncompliance to protect beneficiaries and to save money!

Medicaid: Unacceptable Recordkeeping

failing to maintain or make available for purposed of audit or investigation records to fully disclose the claim

What vaccines are covered under Medicare Part D?

flu, Tdap, Shingles, pneumo, chickenpox

Punishment Article 177 NY Penal Law~ voilations by pharmacists means what?

go to prison + can never be 1 again :(

A training program for pharmacist's administering vaccines to children includes...

hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines

When do the new Biosimilar rules expire?

in 5 yrs

Risk based inspection frequency... are they in person ? What are the inspections like?

in-person after temporary halt due to COVID-19 Typically unannounced, but due to COVID they are announced Last 1 week up to a month Look at manufac hx, compliance hx

What is Abuse?

includes actions that may, directly or indirectly, result in unnecessary costs to the Medicare Program. Abuse involves payment for items or services when there is no legal entitlement to that payment and the provider has not knowingly and or/intentionally misrepresented facts to obtain payment Misusing codes on a claim Charging excessively for services Billing things you did not have any intention of billing

What vaccines are covered under Medicare Part B?

influenza, pneumo, hep B, covid

PBH §280-A Pharmacy Benefit Managers ~ Appeals

investigate and resolve disputes regarding multi-source generic drug pricing. Pharmacy has right to appeal 30 days following the initial claim submitted for payment Phone number and email address for person responsible for processing appeals PBM must send an electronic mail message acknowledging they received appeal, 7 days for a determination of appeal ****Accepted: adjustment will be made ****Denied: the PBM must supply the NDC# of therapeutic equivalent drugs that are available for purchase by the pharmacy in this state.

Compliance Program in NYS~ ARticle 16 or 31?

mental health

What is a PBM?

middle man from insurance co to pharmacy

What criteria must components meet for a 503B?

must meet appropriate specifications that may include: Identity, strength, purity, particle size, sterility, endotoxins, etc. Each lot must be verified COA & Testing If they don't meed specifications -- product is rejected

'E' non violent felony -

no jail, probation, 1 ⅓ to 4 years

'C' non violent felony

no jail, probation, 1-2 years to 15 years

'D' non violent felony

no jail, probation, 1-3 to 7 years

Cannabidiol (Epidiolex) Schedule?

non controlled

503B Facility ~ Must be supervised by a pharmacist, is there a specific ratio or number?

nope just 1 supervising pharmacist overseen by pharmacist; making decisions/following operation produces

Failure to Disclose

o Having knowledge of any event affecting the right to payment of any person o Concealing or failing to disclose the event with the intention that a payment be made when not authorized or in great amount than due.

117th Congress Pharmacy & Medically Underserved Areas Enhancement Act~ did this pass?

only introduced

What is Waste?

overutilization of services, or other practices that, directly or indirectly, result in unnecessary costs to the Medicare Program. Extravagant, careless or needless expenditures Waste is generally not considered to be caused by criminally negligent actions but rather the misuse of resources.

Immunization Expansion Chapter 555 ~ the new immunizations(recommended by ACIP) added are for what age? & for patient specific or non-patient specific orders?

patients ≥ 18 Pursuant to a patient specific AND OR Pursuant to a non patient specific order Authorizes certified pharmacists (certified interns) to administer, pursuant to a patient-specific or a nonpatient-specific order by a licensed physician or a certified nurse practitioner Who must be licensed, registered and have a practice in NYS

NYS Drug Take Back Act PBH §§290-294 amends what law?

public health law

Which indiv vaccine is NOT allowed to administer in NYS?

rabies ... New York State-licensed pharmacists, certified by the New York State Department of Education to vaccinate, can provide influenza, pneumococcal, meningococcal, herpes zoster and tetanus, diphtheria and pertussis (Td or Tdap) vaccines to persons 18 years of age and older. hepatitis A and B, human papillomavirus, measles, mumps, rubella and varicella to people over the age of 18.

What do you have to do if you want to reorganize the room or add equipment to the ISO5 zone (503B) ?

recertification

What is a recall?

remove products that are misbranded, adulterated, or harmful

What did the Mainstreaming Addiction Treatment Act of 2021 Try to change?

removes the requirement that a health care practitioner apply for a separate waiver through the DEA to dispense certain narcotic drugs (e.g., buprenorphine) for maintenance or detoxification treatment (i.e., substance use disorder treatment). It would allow pharmacists to prescribe buprenorphine according to their states' scope of practice laws. It would increase patients' access to MOUD and help address stigma and treatment gaps, particularly in underserved communities

if someone failed compounding exam and had a pending application for licensure- what can they do?

submit a form prescribed by the NYSED, which will review to determine whether the candidate meets the revised requirements for licensure on or after that date.

Immunization Expansion Chapter 555 removes _________ making the law permanent

sunset :)

NYS Opioid Stewardship Act §3323- Manufactuers & Distributers must provide detailed records to NYS... what does this include & what drugs are not included in this

total number of morphine milligram equivalents (MME's) sold or distributed Not including Buprenorphine, Morphine, Methadone

If dispensing 1 tablet STAT of methadone, assume it is for what?

withdrawal/addition

How many hours of LIVE CE concerning compounding must be taken by a pharmacist for each renewal practice?

zero - live or self study

Compliance Program in NYS~Receive or expect to receive Medicaid reimbursement of $_________ over a ________ month period

≥ $500,000 12 month

Sec. 503A - Pharmacy Compounding definition

As used in this section, the term "compounding" does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling. All compounds must be for an 'identified individual patient' -- Rx is required for the person Even if state law permits "Office-Use" prescriptions. Compounding must be by a licensed pharmacist or physician. In limited quantities prior to receipt of a valid prescription. (batching) → ultimately require rxs for batching, even if not before. Based on the history of orders.

Factoring?

Assigning payments to a factor or receiving payment through any person who compensation is not related to the cost of processing a claim.

Compliance Program is this federal or NYS law?

BOTH

Is False Claims Act state or federal?

BOTH

Federal C5, NYS non controlled? (3) - Bright Centered Lamp

Brivaracetam (Briviact) Cenobamate (Xcopri) Lasmiditan (Reyvow)

Ingredients that CAN be used in compounded preparations in a 503A(3)

Bulk Drug Substances - powders that are active pharm ingred. Finished Drug Products Inactive ingredients

What is the Interim List? 5o3A or 503b?

Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Includes substances WITHOUT monographs, which have been nominated and are under evaluation

Prohibition on Wholesaling for all sourcing facilities (503B) ~ what does this shit mean?

Cannot manufac large batches and sell products to other entities, for them to re-sell for us We can dispense on large scale to hospitals or clinics but cannot distribute in order to redistrib or be sold somewhere else "The drug will not be sold or transferred by an entity other than the outsourcing facility that compounded such drugs. This paragraph does not prohibit administration of a drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 503(b)(1).

Packaging for 503b

Capable of ensuring sterility and integrity until administered to patient

Class 1 recalls defined

Causes serious, adverse health consequences or death e.g., Lindane in cough syrup (child's death)

Do pharmacy intern immunizers need supervision ? Can they sign records with their own name only?

Certified pharmacy intern May only administer immunizations under the immediate personal supervision of a certified pharmacist. All records must be countersigned by a pharmacist immunizer

What chapter is associated with the immunization Expansion authorizing certified pharmacists & interns to administer more vaccines?

Chapter 555

What disease states are covered by the EPT regulations?

Chlamydia, Gonorrhea, Trich

NYS False Claims Act: Penalties Article 177: Health Care Fraud Degree 5: What Class is this? & What does it mean?

Class A Misdemeanor Intent to fraud a health plan Knowingly and willfully provides materially false information Omits material information for the purpose of requesting payment Due to above, receives a payment he/she is not entitled

NYS False Claims Act: Penalties Article 177: 1st Degree

Class B Felony Commits health care fraud in the fifth degree +, Receives payments within one year exceeding $1,000,000 in aggregate From a single health care plan

NYS False Claims Act: Penalties Article 177: 2nd Degree

Class C felony Commits health care fraud in the fifth degree +, Receives payments within one year exceeding $50,000 in aggregate From a single health care plan

NYS False Claims Act: Penalties Article 177: 3rd Degree?

Class D felony Commits health care fraud in the fifth degree +, Receives payments within one year exceeding $10,000 in aggregate rom a single health care plan

NYS False Claims Act: Penalties Article 177: 4th Degree. What Class is this? What does it mean?

Class E felony Commits health care fraud in the fifth degree + Receives payments within one year exceeding $3,000 in aggregate From a single health care plan

Health Insurance Portability and Accountability Act of 1996 (HIPAA)~

Concerning the billing and payment for services and products to patients. Fraud will involve patient privacy issues. HIPAA HiTech violations Billing false claims using patients' PHI without their knowledge Fines may involve several hundred thousand dollars

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Concerning the billing and payment for services and products to patients. Fraud will involve patient privacy issues.

Other Medicaid Violations

Conspiracy - Making any agreement, combination or conspiracy to defraud the program Receiving additional payments Excessive services Failure to meet recognized standards Client deception Denial of Services- to a recipient based in whole or in part upon the recipient's inability to pay a copayment for medical care, services or supplies Unlawful discrimination Factoring -Assigning payments to a factor, or receiving payment through any person who compensation is not related to the cost of processing a claim. Solicitation of clients Through inducements

Conversion

Converting a medical assistance payment, or any part of such payment, to a use or benefit other than for the use and benefit intended by the medical assistance program.

Medicaid: Conversion?

Converting a medical assistance payment, or any part of such payment, to a use or benefit other than for the use and benefit intended by the medical assistance program.

Drug Disposal DEA regulations ~ kiosks, bags & form 41 covers for what facilities ?

Covers nursing homes, community pharmacies, hospitals etc. If kiosk in pharmacy - anyone can use and drop off If kiosk in NH - ONLY for NH resident's medication disposal

Anti-Kickback Stature Social Security Act (42 USC §1320a-7b, §1128B)- criminal law

Criminal offense to knowingly and willfully offer, pay , solicit or receive any remuneration(value) to induce or reward referrals of items or serves reimbursable by a federal health care program (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients). if a physician or medical provider uses any payment or compensation to encourage a patient to come to their office, or to encourage another medical provider to refer patients to their office or facility, that is a kickback.

What things do not apply to 503A compounding products?

Current Good Manufacturing Practices (cGMP) Products labeled with adequate directions for use Go through New Drug approval process (NDA, etc).

Buprenorphine, what conditoin code would it get?

D = "damn I'm in a lot of pain" chronic or incurable

Federal Change (not NYS change) regarding the transfer of Controls

DEA Federal allows transfer of electric Rxs for C2-5 between retail pharmacies for 1 initial fill (NOT PAPER). NYS only allows non-controls to be transferred

Expansion of Childhood Vaccines During COVID-19 According to HHS Show~ in 2020 the CDC reported a RISE or DROP in routine childhood immunizations during covid?

DROP families staying at home

What does PBM DIR Fees stand for

Direct & Indirect Remuneration Fees

Electronic Prior Approval PBH

Directs the Commissioner of Financial Services to develop a standard prescription drug approval form in electronic form for all participants in the health care system Universal Streamlines prior approval process An organization shall permit the enrollee and the enrollee's designee to change the preference at any time.

Do you need to cross out the patient's information when putting the bottle back up on the shelf ?

Do not have to - was not dispensed out - can but it back on the shelf have to use by 6 mos

Federal C2, NYS Noncontrolled? (2)

Dronabinol oral solution (Syndros) Olicerdine (Olinvyk)

Do 503B's have to report to the FDA what they make? If so, how often?

Drug report Initially and semi-annually thereafter Report everything we are mfg - list of all products to FDA

What CANNOT be used for compounding/is prohibited from compounding in 503B?

Drugs withdrawn or removed because unsafe or not effective data Drugs that are essentially a copy of approved drugs Drugs presenting demonstrable difficulties for compounding List not yet created, FDA is working on right now FDA has strict regulations for quality and safety

Why can Patients come to the pharmacy with a PAPER EPT RX in NYS when e-prescribing is required by law for all Rxs ?

E-prescribing mandate has been waived for EPT Rxs in NYS (can use paper Rxs) until March 24, 2022, renewed annually

If the aggregate batch size over a 6 mo period is </=5k units under non-sterile compounding drug products, would you use Default BUD(no testing) or BUD based on Stability Testing?

Either or When >5k Units, only stability testing BUD can be used

If the aggregate batch size over a 6 mo period is </=1k units under sterile compounding drug products, would you use Default BUD(no testing) or BUD based on Stability Testing?

Either or when >1k, only stability testing BUD can be used !

Requirements of equipment, containers, & presterilied or non-sterilized items?

Equipment must be capable of performing its intended functions (IQ, OQ, PQ) & Surfaces must not be reactive, additive, absorptive, if contacting the product. Verify suitability of container/closure system for finished drug product Verify that the integrity of container/closure is able to maintain sterility over the expiry period. Pre-sterilized (ready-to-use, sterile, non-pyrogenic) items: Must ensure sterility and cleanliness at time of use, verify package integrity upon receipt & review certificate of quality and analysis Non sterilized items: validate sterilization and depyrogenation processes

Deficit Reduction Act of 2005 State False Claims Acts Criteria: (4)

Establish liability to the state for false or fraudulent claims At least as effective in rewarding and facilitating qui tam actions Records are sealed for 60 days for review by State Attorney General Civil penalty not less than federal FCA

Pharmacy Required Information Sheet Controlled Substances October 22, 2016

Every patient dispensing for controlled substance the pharmacist must provide the patient with information about the.... 1. Dangers of misuse and potential risk for addiction to controlled substances 2. The physical and behavior warning signs of addiction 3. Available alcohol and drug addiction treatment resources 4. Proper disposal guidelines for unused controlled substances Information must be provided in languages other than English as deemed appropriate by the NYS Commissioner of Health (up to the 10 most common languages in NYS).

Do items made in 503B have expiration dates? What is this called?

Everything they make has assigned Expiration Dates Beyond Use Date (BUD) with Limited Stability Testing Items require stability STudies

Immunization Expansion S4807 (Stavisky) A6476A(Hyndman) ~ what did this expansion allow

Expands the # vaccinations that pharmacists can administer in NYS Establishes Chapter 555 Law takes effect 90 days after it is signed into law Signed into law November 2, 2021 Took effect January 31, 2022 Emergency rule expires April 10, 2022

Immunization Expansion S4807 (Stavisky) A6476A(Hyndman) Effective Jan 31st 2022 allows for what expansions to vaccines?

Expands the # vaccinations that pharmacists can administer in NYS Establishes Chapter 555 (ACIP) recommended vaccines for patients ≥18 yo Removes the county restriction of provider practices in that same county or adjoining Removes sunset bill -- Makes law permanent!

What if the patient comes back (EPT) and does not follow up with the provider?

Explain the importance to patient Refer to the emergency room. (can always do this)

What are PBM DIR Fees ?

Extra fees put on the pharmacist ONLY THis includes fees to belong to the network, service fees, admin fees, reconciliation fees Cycle: dispense drug to patient=> reimbursement for the drug from PBM on day 14 => day 90, DIR clawback for med already dispensed => Pharmacy loses $ (into donut hole quicker)

Risk factors of inspections of a 503B facility

FDA can show up at any time (not offered exemption) Look at... Compliance history Recalls Inherent risk of drugs compounded Whether the facility has been inspected within the last 4 years Whether facility intends to compound drugs that appear on the shortage list

Unacceptable Recordkeeping

Failing to maintain or make available for purposed of audit or investigation records to fully disclose the claim

Medicaid: Verificiation of MA eligibility?

Failing to use the Medicaid Eligibility Terminal (MET) verification procedure, Have to make sure they show their medicaid card to you when they pick up a medication Failing to use the card swipe capability of the MET in a significant number of cases Failing to post orders for medical care, services or supplies in the electronic Medicaid eligibility verification system (EMEVS) Failing to clear prescription or fiscal orders which are required to be posted to EMEVS

EPT is recommended for men who have sex with men... True or False ?

False

Penicillin/beta-lactam products can be prepared in the same facility or physically in the same space as other compounded medications. True or False

False. must be prepared in a separate facility or physically separated space. To px cross-reactivity in NON-BL products

A licensed PA may write a standing order in NYS to give authority to pharmacist to immunize

False... only NP & Physicians can

3 ways that an Rx can be transferred?

Fax, verbal or electronic

Which law does not support/talk about qui tam?

Fed Controlled Substance Act

Whistleblower Protection laws...

Federal & NYS False Claims Act New York State Labor Law Social Security and Medicare Part D from ACA NOT Controlled Substances Act!!!!!!!

Who is Required to Have a Compliance Program in NYS?

Federal law requires everyone to do this!

A nurse phones in a prescription for Belsomra 10mg #100. Sig 1 hs. Code A. 2 refills. How many can you fill the Rx for?

Federal only drug, nurses can call in controlled substances. Can fill whatev the doctor writes for (100)

Data 2000 21CFR §1306.07(b) allows practitioners to do what?

Gives physicians flexibility to treat patients undergoing withdrawal. methadone This section allows a practitioner who is not separately registered as a narcotic treatment program or certified as a waivered DATA 2000 physician, to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient's referral for treatment

NYS False Claims Act Article 13 of the NYS Finance Law

Governs claims submitted to state and local government agencies. Violations of this law may be punished by treble damages and penalties of $6,000 to $12,000 per claim

Medicaid: Failure to Disclose?

Having knowledge of any event affecting the right to payment of any person Concealing or failing to disclose the event with the intention that a payment be made when not authorized or in great amount than due.

Immunization Expansion Chapter 555 - what immunizations were added?

Hepatitis A Hepatitis B HPV Measles /Mumps/ Rubella/Varicella COVID-19

Compliance Program in NYS~ ARticle 36?

Home health care

Compliance Program in NYS~ ARticle 28?

Hospitals, Nursing homes, RHCF, etc

What immunizations were pharmacists allowed to administer to CHILDREN (2-18 yo) PRIOR TO THE EXPANSION?????

INFLUENZA

PBH §280-B: Unused Prescription Donation and Redispensing Program- What did this say it would allow (dumbed down)? (has not come into law yet)

If pts have extra meds, not ones dispensed to pts, but at NH, hospitals, community as long as within date → sent to depot and re-dispensed to ppl who need them (Must be in original container - not emergency kit boxes) "A donor entity may donate unused prescription drugs to a recipient entity, directly or through a third-party intermediary, in a secure manner, ensuring the privacy of any individuals for whom the prescription drugs were initially dispensed or intended to be dispensed."

May a technician reconstitute an antibiotic in community pharmacy?

In community - NO Pharmacist has to do that b/c too many mistakes were made

Fraud Enforcement and Recovery Act of 2009 (FERA)

Increases funding for federal financial fraud enforcement and expands liability under the False Claims Act

Fraud Enforcement and Recovery Act of 2009 (FERA)

Increases funding for federal financial fraud enforcement and expands liability under the False Claims Act Anyone who makes a false statement or claim to virtually any recipient of federal funds and Anyone who knowingly retains a government overpayment, whether or not the entity used a false statement or claimed to do so.HAVE TO CLAIM overpayment by government!!!

IQ stands for what (equipment 503B)

Installation Qualification

Prohibited Ingredients by the FDA in 503A

Items found on FDA's list of drug products that have been withdrawn or removed from the market because unsafe or not effective:

What does felony mean?

JAIL bb

What is Fraud?

Knowingly and willfully executing, or attempting to execute ("intentional")

What is fraud?

Knowingly and willfully executing, or attempting to execute ("intentional") a scheme or artifice to defraud any health care benefit program; or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any health care benefit program.

How often do pharmacists renew their licenses?

Licensed for life

Other name for Federal False Claims Act

Lincoln Law

False Statements

Making or causing to be made any false, fictitious, or fraudulent statement or misrepresentation of material fact in claiming a medical assistance payment o Inducing or seeking to induce the making of any false, fictitious, or fraudulent statement or misrepresentation of material fact

Medicaid: False Statements?

Making to causing to be made any false, fictitious or fraudulent statement or misrepresentation of material fact in claiming a medical assistance payment Inducing or seeking to induce the making of any false, fictitious or fraudulent statement or misrepresentation of material fact

Know the Consequences of Noncompliance!

Mandatory Training or Retrain => disciplinary action => termination Your organization is required to have disciplinary standards in place for non-compliant behavior. Those who engage in non-Compliant behavior may be subject to any of the following If you do something wrong you have to be retrained in hopes you will do things right after being re trained, they won't FIRE YOU

NYS Drug Take Back Act PBH §§290-294- How is this paid for?

Manufacturers must also pay costs incurred by the state in the administration and enforcement of the drug take back program. No manufacturer may charge a point of sale or other fee to consumers or a fee that could be passed onto consumers to recoup their costs of the drug take back program. All costs of pharmacies or other authorized collectors shall be paid or reimbursed by the manufacturer, jointly or individually, as part of the drug take back program.

What did the BBBA change regarding limiting of cost sharing for insulin?

Medicare beneficiaries can choose to enroll in a Part D plan participating in an Innovation Center model in which enhanced drug plans cover insulin products at a monthly copayment of $35 in the deductible, initial coverage, and coverage gap phases of the Part D benefit Participating plans do not have to cover all insulin products at the $35 monthly copayment amount, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting)

Bulk Drug Substances (BDS)... if drug substance does not have a monograph & is not a component of an approved drug, the following are required...

Must appear on the '503A List' - those allowed by FDA OR most recent Interim List (Category 1) FDA to consult with USP to identify these BDS Manufacturing establishment must be registered with FDA, and Bulk Drug Substance must be accompanied by a valid Certificate of Analysis (CoA)

As a student immunizer, are you required to ask permission before giving a vaccine?

Must ask patient, or person on their behalf, for permission If patient refuses, then the pharmacist must immunize A licensed pharmacy intern with immunization privilege may now do anything a pharmacist can do under the supervision of a pharmacist immunizer

Treatment of Heroin and Opioid Addictions §3309-a- Handouts provided to pharmacies registered by NYS

Must be given at the time of dispensing with any controlled substance May be given electronically to the consumer if they request On OASAS website, Order form

What testing is needed for Bulk Drug and Inactive Substances of 503B?

Must be tested to verify conformity with specifications, and Send sample out to third party lab, have all testing that manufac said they did & have it verified (if receive product for them that they are going to use to compound) Must be accompanied by a C of A Reliability of C of A must be verified at least annually for actives and every 2 years for inactives, and At least one identity test is conducted, and Label and package integrity is verified.

Bulk Drug Substances (BDS)~ What is this (503A)

Must be the active ingredient If USP/NF monograph exists, the BDS must comply. If monograph does not exists:Drug substance must be a component of an 'Approved' drug.

What is involved with environmental monitoring?

Must establish alert and action limits based on EM data i.e. Qualification study and ongoing EM data Thorough description of sampling (air, surface, etc.), test methods (growth media, exposure times, incubation times, etc.), and alert and action limits.

What to do if using powder drugs in 503B?

Must manage cross-contamination risk Prepared in segregated areas

Environmental Monitoring~ how often must this occur 503B?

Must occur during all production shifts. At least daily in ISO 5 areas during operations.

Licensure by endorsement aka Pharmacist issued a license in another state~ what must they do to get licensed in NYS

Must pass an exam of the laws, rules and regulations and professional conduct pertaining to the practice of pharmacy in NYS Need not have experience requirement (Had to work at least a yr in a state to be licensed in NYS was removed)