PHAR 515 - Exam #2

Mail Service Options

Frequently offered by prescription benefit plans. Enrollees typically offered some sort of incentive to use that pharmacy, such as paying lower cost-sharing amounts and being able to obtain greater quantities (day supply).

What system is used to classify plans?

%Covered health expenditures and cap limits exist for each plan base on %FPL earnings.

Know the four indicators used to define "medically underserved area".

1. Provider per 1,000 population ratio 2. %Population at 100% of the FPL 3. %Population age 65 and older. 4. Infant mortality rate.

What percentage of Americans live within 5 miles of a community pharmacy?

90%.

General information about disease management including the way pharmacists are paid for the service.

A system of coordinated health care interventions for defined patient populations with chronic conditions. Inter-professional in nature. It focuses on a specific disease in which patient self-care efforts are significant (asthma, diabetes, HTN). It addresses patient's drug & nondrug therapy, lifestyle modifications. Pharmacists often have had difficulty obtaining adequate compensation for managing a patient's drug-related needs. Physician bills for the entire team and then the pharmacist gets payment from the physician. No third-party interaction here.

How is a single source drug reimbursement different from a multi-source drug reimbursement?

AWP is used as a pricing index for single source drugs. Often calculated as AMP - a specified percentage discount. Multisource drugs: MAC is used, so pharmacies want to find the cheapest generic available. If it is a DAW, you treat it as a single source drug.

AAC

Actual acquisition cost. The actual amount paid by a pharmacy to a supplier for a product. Rarely used for determining reimbursement amounts under rx benefit plans.

What are cost-sharing subsidies?

Additional financial help with deductibles, copayments and coinsurance. Available for individuals under the silver plan. Income between 100% and 250% FPL.

The biologic control act (1902)

At the time anti-toxins (e.g. diphtheria) were made by inoculating a horse with the disease, then bleeding the horse for their blood serum, which was then injected into humans. In 1901, 13 children died from horse serum contaminated with tetanus. The Biologics Control Act to establish standards for vaccines and anti-toxins.

AMP

Average manufacturer's price. The average price paid by wholesalers to manufacture for drugs distributed through retail pharmacies or by retail pharmacies that buy directly from manufacturers.

AWP

Average wholesale price. A suggested list price for products purchased from wholesalers by pharmacies. Pharmacies usually purchase drugs at a lower amount than AWP.

What is the percent of coverage of health expenditures for each type of plan under the Act.

Bronze covers 60%, Silver covers 70%, Gold covers 80%, and Platinum covers 90% of health expenditures.

Distinguish white bagging from buy-and-bill, and discuss advantages and disadvantages from the physician perspective. (focus on in-class discussion)

Buy and bill: Purchase, administer, and then bill. The provider purchases the medication on behalf of the patient, and bills the patient or health plan accordingly. White bagging: Physician administered drugs are dispensed by a specialty pharmacy for a specific patient, shipped to the physician for administration, pharmacy bills to insurer under pharmacy benefit and the physician neither buys nor bills for the drug. Advantage: a. Lower burden on maintaining inventory of expensive, short shelf life drugs. (no need to worry about product expiration) b. Avoid the financial risks associated with payer denials. c. Possibly better cash flow: physicians do not need to purchase expensive drugs beforehand. d. More of an integrated health team approach where pharmacies bear more of the pharmacotherapy responsibility Disadvantages: a. Physicians lose revenue previously generated from drugs b. Difficult to make last minute adjustments to mixture, dosage of a drug administration . (e.g., response to the patient's last treatment, patient lab results, contraindications present on the day administration is scheduled.) Possible delay in administration, another office visit. Also, it can lead to product waste. c. Physicians may refer their white-bagging patients to hospital outpatient departments -> potentially disrupting the continuity of care. d. It could decrease the physician's office efficiency: (e.g., prearrange scheduling for delivery and patient arrival, Physician's office has to deal with different specialty pharmacies/wholesalers, on top of primary wholesaler they work with.)

Know key words of pharmacy practice models such as clinical pharmacy and pharmaceutical care.

Clinical pharmacy is product-based care and pharmaceutical care is patient-centered care. Clinical pharmacy is a core component of pharmaceutical care. Clinical pharmacy: widely adopted during the 60's, 70's, and 80's. Product based care, focused on the application of knowledge, patient counseling, therapeutic drug monitoring, "by pharmacist". Pharmaceutical care: introduced in 90's by Hepler & Strand. Introduction of "patient-centeredness", patient centered care, outcome oriented, requires inter-professional cooperation, disease management, MTM.

If the US legalizes the reimportation of the prescription drugs, what concerns arise? What will be the drug manufacturers' behavior in response to this policy?

Concerns: increase in counterfeit drugs, some properties may lose profit, quality assurance concerns, labeling and language issues, lack of information. Drug manufacturer's behavior: They might not cooperate. They might limit supply to countries that pay a lesser amount for a drug.

MTM

Continues to increase as our capacity of pharmacists to fill our roles increases. Most contracted through OutcomesMTM network.

Know the positive and negative effects of drug price-control policy.

Countries with a price control policy: due to a limited amount of budget allocated on health care, they keep drug prices down. They may pay less for an innovative drug, but the introduction of an innovative drug is delayed and restrictions are placed on patient eligibility.

MTM: The law that introduced MTM, goal of MTM, CMS guidelines for MTM service and eligibility, five core elements of MTM.

Created under the Medicare Prescription Drug Improvement and Modernization Act of 2003. A rx drug plan under Medicare Part D shall have in place a MTM program. The goal is to optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse events, including adverse drug interactions. The Center for Medicare & Medicaid Services (CMS) stated that this is NOT those services typically provided as part of the drug dispensing process in a pharmacy (dispensing, screening Rx's and counseling patients); nor is it a disease management program (e.g. cholesterol screening). CMS does not provide clear MTM guidelines apart from eligibility guidelines. Those with multiple chronic disease states and those taking multiple medications and those who spend more than the amount specified by the secretary of health and human services on rx medications (4,044 in 2019). Within the guideline, each payer develops its own criteria for patient eligibility. Five core elements: MTR or medication therapy review where patient presents all current meds and RPh assesses meds. for the presence of any problems. PMR or personal medication record which is a record of all patient's meds for use by the patient. MAP or medication-related action plan document for patient to use in tracking progress for self-management. Intervention/referral if a med problem is present. Documentation and follow-up for evaluating patient progress and billing purposes.

How will hospital reimbursement be changed under this proposal?

DRG codes go away. The hospital would get 4 checks a year from the federal government and that is their income for the year. Different hospitals get different amounts on their checks.

Describe open channel drug distribution system and know pros and cons.

Drug manufacturers choose this system to maximize access to the patient. Use multiple drug wholesalers to drive distribution to hospitals, physicians, and retail pharmacies. Applies to most of the drugs in the market. Most patients obtain drugs through this distribution. Pros: maximizes access to drugs for patients with relatively common conditions/diseases. Cons: Drug manufacturer have little control over inventory. Information delivery about prescribing patterns or patient outcomes is delayed. (Hard to forecast demand).

What is the employer mandate? I will not ask you about the number of employees, but you should know the intent of the employer mandate.

Employers required to provide coverage and can be penalized (taxed) if their employees need to buy health insurance on the ACA market.

EAC

Estimated acquisition cost. An estimate of the AAC that is commonly used to determine the reimbursement amount for product cost under rx benefit plans.

The overall guiding principles behind the Affordable Care Act.

Expand health insurance among the uninsured. Impose more free-market rules on health plans. Expand quality controls on health care delivery. Reform private health insurance. Shift health care to a more patient-centered care model.

How are retail pharmacies reimbursed for prescription drugs under Medicaid (for single source and for multisource drugs)? Describe FUL.

FUL = Federal upper limit. Exists because Medicaid is a joint state federal program. Medicaid matching funds to states are limited to payments that cannot exceed the FUL for multi-source drugs. Calculated using AMP. Published by the CMS. Many states use the FUL as the MAC, or it has to be lower than the FUL. For single-source, the AWP is used as a pricing index.

General information about patient counseling including the way pharmacists are paid for the service.

Final responsibility for following the instructions belong to the patients. Required documentation (yes or no) with signature to indicate whether the patient accepted the offer to provide counseling. Follow-up is not required. No formal compensation mechanism: dispensing fee does not cover counseling.

Understand fixed costs and variable costs of drug industry. How does the cost affect their drug pricing behavior?

Fixed cost: A cost that does not change with an increase or decrease in the amount of goods produced. Does not matter based on if it is 10 shoes being made or 100 shoes being made. E.g. cost to design, office desk, printer, website design. Variable cost: A cost that changes following to the quantity of goods produced. E.g. costs of material, labor, duties, transportation. Unit price is set higher than the marginal cost (amount that it costs to make a product). Innovator drugs have large fixed costs and relatively small variable costs.

Understand rebates - you will not be asked to calculate the rebate amount but you need to understand two types of rebates and how they are different.

Flat Rate rebate: Use the flat rate. Rebate based on a fixed percentage of the wholesale acquisition cost (WAC). Market Share rebate: more common. Manufacturers make payments to PBMs based on the market share that each PBM achieves for the drug product. Market share is increased by the PBM's promotion of the drug. (preferred formulary status and lower co-pays).

How did specialty pharmacy grow big in a drug distribution system? Explain this from producer, payer, and consumer perspectives.

From Manufacturer Perspective (Producer): Consistent access to data through specialty pharmacy. How drug is prescribed, patient drug adherence, etc. Inventory is better controlled through limited distribution. Reduces distribution costs. Easier to predict market needs. Greater access to patient through specialty pharmacy. Finding copayment assistance or alternative coverage for the patient. Training patients on how to self-administer drugs. From Patient Perspective (Consumer): Access to specialty drug is quick (often no delay in shipment). 24-hour access to pharmacists to answer questions. Finding patient assistant programs for those with financial barrier. Member education on drug use. Refill and monitoring calls. Clinical programs such as disease management. From Insurer Perspective (Payer): Payers are gradually moving specialty drug coverage from medical to pharmacy in order to control costs. From buy and bill (medical benefit) to white bagging (pharmacy benefit) (physician administered drugs are dispensed by a specialty pharmacy for a patient, shipped to the physician for administration, pharmacy bills to insurer under pharmacy benefit and the physician neither buys nor bills for the drug). Payers receive data from specialty pharmacy about how those expensive drugs are utilized. Effect of cost-control mechanisms.

Collaborative practice agreements

Gives the RPh the ability to prescribe. Delegated by a prescriber. ■Example: Immunizations (in some states) ■Example: Point-of-care testing ■Example: Washington State's "21 minor ailments" -Offer short-term, immediate treatment for 21 minor ailments and conditions

What is Texas v. The United States?

Group of 20 states led by Texas filed suit against the fed. Gvnt. Seeking to have the ACA declared unconstitutional. The current federal gvnt. Has taken a position of agreement with the filing. 17 states led by California have taken up the defense of the ACA along with the HOR. Federal judge declared it unconstitutional, will likely go to supreme court. Unconstitutional b/c under the individual mandate, there is no longer a penalty.

What an Accountable Care Organization?

Grouping or PCP's, specialists, hospitals, and other HCP legally joined (doesn't have to be a health system) and covering a minimum of 5,000 beneficiaries. Have a defined process for establishing evidence-based medical practice, coordinate care and report on the quality of patient-centered care. Base payment reduced where there are excessive readmissions. Reduced payment based on top 25% of hospital-acquired conditions, like infection. Payment for physician services, hospital care, rehab, follow-up. Quality measures reported each quarter with additional money to top 25% who achieve target.

What powers will the Secretary of HHS have?

Has broad authority to establish eligibility for benefits, enrollment, benefits provided, participation standards and qualifications, levels of funding, methods for determining amounts of payments, and planning for capital expenditures and professional educational funding, negotiates prices with drug manufacturers for covered drugs. Power over patents and exclusivity and may procure drugs directly.

Know common characteristics of specialty drugs.

High cost (>670/month, CMS definition). Usually costs more. Treats rare conditions. Many are injectables (not all). Commonly produced through biotechnology (not always). Requires therapy management by HC professionals due to high incidence of adverse effects and compliance problems requiring monitoring and dosing adjustments (required by FDA through REMS).

What are the key drivers of specialty drug trend?

High cost per patient: Manufacturer price increases for existing drugs. Annual drug costs ranges from $15,000-$250,000 per patient. Increasing utilization: Flourishing drug pipeline. Earlier use of biologics in treatment regimen. Approval for additional new indications.

How do pharmacy and medical benefits differ?

In hospital and they receive drug, they will use part A coverage and it is based on DRG. In pharmacy, they will use part D and they will be mainly product-based reimbursement through pharmacy benefit. In outpatient/office, they will use part B coverage, and that is a medical benefit based on service-reimbursement. Pharmacy: Bill and dispense. Purchase, bill, and then dispense. NDC is the drug coding used. Specific for drug name, manufacturer, form, strength, and container. Copayment or coinsurance for drug. Better coverage for generic, quantity limits, PA's, step therapy. Medical: Buy and bill (this is in a physician's office). Purchase, administer, and then bill. HCPCS coding specific for drug class, but not specific to manufacturer, strength, or package size. Has to do with the active ingredient. Copayment for office visit. Often no cost-share for the drug. No price differentiation between generic and brand, ER or IR. Generally weaker control.

Of all the RPh, the most practice where?

In the community setting there is 57%. Most of those are in community pharmacies/drug stores. Next in food and beverage stores and then in general merchandise stores.

How are retail pharmacies reimbursed for prescription drugs under Medicare?

Individuals can get rx drug benefits thru stand alone part D (PDP) or medicare advantage rx plan (MA-PD). Both are administered by private ins. companies, which reimburse through PBM's. Exactly the same as all of the private sector.

What is short-term, limited duration (STLD) coverage? How does it differ from standard ACA coverage?

Insurance providers can provide employees with insurance that is not quality healthcare and does not meet the ACA requirements. This is short-term limited duration plans. Lesser cross-section of coverage and lower premiums. Now up to 12 months, with possible extension to 36 months. Can charge higher premiums based on the health status, exclude coverage for pre-existing conditions, impose annual or lifetime benefits, exclude specific categories of treatment, require higher OOP expenditures. Intended to cater to young beneficiaries offering very low premiums and high deductibles.

What gaining the "provider status" means for pharmacist, current efforts in different pathways.

It is a reimbursement term. Attaining "provider status" means that pharmacists are able to make claims directly to the third-party payer for services they provide, and the value of those services are properly recognized. Pharmacists to fill in the gap for primary care. Target federal pathway and amend the law related to Medicare part B. Amending Social Security Act related to Medicare that does not list pharmacists as a provider. State pathway: it is a state law that defines who pharmacists are and what they do. Venues to achieve provider status can be categorized as provider designation, scope of practice, and recognition by payers. If you hear news about a state making success in provider status for pharmacists, it means improvement has been made in one or more of these three areas. State goes beyond just reimbursement.

Rationale from product-based care to patient-centered care

It is important that the patient takes the drug in the right way. Patient compliance. Understand patient's health background and cultural context improves adherence. Patient's QOL became more important with prevalent chronic conditions (look at slide #10). Managed care's cost containment strategy. Focusing on preventative care to at-risk patients is cheaper than treating patients after they develop a serious illness.

Understand different bargaining powers of different countries (including the US) and the impact on drug pricing.

Leads to differential pricing. Manufacturers are willing to reduce price to: - Countries that cannot afford to pay much for drugs - Countries with a single payer system - Countries with a price-control policy (e.g., Canada, Europe) People in the US are, on average, wealthier and want access to innovative drugs as soon as possible. - No price-control policy - The single largest market for innovative drugs is the US (33.9% of the world). If a country has greater bargaining power, they might pay less for a certain drug.

Quantity Limits

Limits on the number of days' supply or number of dosage units (e.g., tablets, capsules) of medication allowed per prescription and or time period.

Formularies

List of medications covered by a TPP. Tiered copays utilized, where Different levels of copays based on the medications formulary status - lower copays charged for generics, higher copays for preferred-brands, and even higher copays for non-preferred-brands.

Distinguish MTM and patient counseling.

MTM focuses on all of the rx drugs/supplements that a patient takes and follow-up is required. Patient-centered. Payment limited to Med part D and a few state and private payers. Patient counseling focuses on that rx drug and rx drugs only and the time that the drug is dispensed. Follow-up is not required. Product-based. No compensation really. More so the product cost + dispensing fee.

Describe limited drug distribution.

Manufacturers put their specialty drugs in exclusive or limited networks where they only allow dispensing from few specialty pharmacies or wholesalers. Applied to specialty drugs in the market. Patients with rare conditions/diseases obtain drugs through this method.

Spread Pricing

Markups between insurer and pharmacy. PBMs bill the health plan more for a prescription claim than the pharmacy is reimbursed for its product costs and dispensing services. Can be concerning depending on what the difference is.

MAC

Maximum allowable cost. A maximum amount per unit of medication that TPPs will pay pharmacies for multisource drugs (drugs with at least one generic alternative). A pharmacy's reimbursement for product cost cannot exceed the MAC amount regardless of the pharmacy's actual cost for the medication. Provides incentive for pharmacies to use less expensive generics rather than brand-name drugs.

How Medicaid was affected by ACA.

Medicaid expansion. All low-income non-elderly or legal immigrants will be covered. Standardizes 133% of the FPL as the cut point for eligibility. States will receive 100% federal supplemental funding for additional Medicaid costs through 2016, then decreases to 90% by 2020. States could opt in or out of the Medicaid expansion.

What unique characteristics will Medicare for All bring with it?

Medicaid usually covered nursing home costs, but now Medicare would. Normally you would buy a supplemental plan privately in addition to Medicare, but now you don't have to. Forgoes all state funding to Medicaid with all expenses from the federal government. No cost sharing. No private health insurance of any kind. No over-and-above plans like medicare advantage allowed. No pay for performance, but instead a single fixed budget for institutions - "global budgets".

Changes in the last few years

More flu shots coming from community pharmacies. Small increase in vaccinations nationwide. Some technicians administering vaccines. MTM program expansion. CareSource, a Medicaid managed care plan, offered comprehensive MTM to all members in 2012. CareSource reported a $4.40 to $1 return on investment for health care expenditures

Changes from 2004-2014

More pharmacist graduates. Could say less demand for jobs. RPh are now able to take on other functions b/c we have enough people. Immunizations, POC testing for chronic disease management and wellness screenings/physical assessments.

Under OBRA '90, pharmacists are expected to offer an explanation of the prescription drug regarding...?

Omnibus Budget Reconciliation Act of 1990. Regarding purpose, proper administration (length of therapy, special directions for us, proper storage, refill instructions), common adverse effects, potential interactions, contraindications to the use of the drug, guidance on steps to take given specific outcomes.

Understand the purpose of group purchasing organizations.

Organizations formed to bring together a number of health organizations (including pharmacies) in the community or hospital setting to provide volume for leveraging purchases. Without a GPO, pharmacies must negotiate with each manufacturer for contract pricing. A group of institutions may join and establish their own GPO.

Independent pharmacy

Pharmacist-owned and privately held.

What is PBM and what is its function?

Pharmacy Benefit Manager and they administer drug benefit programs. They are a type of TPP. They contract with retail pharmacies to create a network of pharmacies from which patients can purchase their rx. They develop and manage the formulary. Utilization, cost management, and cost reduction processes. Claims processing and provider payment.

What are the premium subsidies that exist for the ACA

Premium tax credit subsidies are available to individual b/w 100% and 400% of the FPL. $12,060 for 1-person household and $24,600 for a 4-person household. Provided as a refundable tax credit on federal income tax; or can be advanced directly to the insurance company.

What is the equation of prescription payment from PBM to the pharmacy?

Prescription payment from TPP = Product cost + dispensing fee - patient cost share.

What other provisions were included in the ACA that affect private insurance?

Preventative services without cost sharing - no cost to the patient. Dependent coverage for children up to 26 y.o. No lifetime ins. Cap limits/no annual limits. No pre-existing condition exclusions. Ins. Companies may use individual v. family, age, geography, tobacco use. Limits on the annual deductibles for beneficiaries. Waiting period for beginning of coverage limited to 90 days - no more than this. Prohibits plans from rescinding coverage except for fraud. Required preventative care and screening for women without cost-sharing or copayment (including contraception with religious organization exception).

Understand price sensitivity in a relation to the level of competition in a drug market. What does it mean that people are sensitive or not sensitive to price? Also understand graphs discussed in the class.

Price sensitivity: price elasticity of demand. This is the market response to a price. People are sensitive to price because the competition is high when there are many alternative choices available. Apple example. Low price and tons of people trying to buy. Raise price and there will be less people willing to buy the good. Y-axis is price and x-axis is people willing to buy the good. The slope is not very steep. People are less sensitive to price when there are few or no alternatives possible. Low competition occurs. As shown below. Slope is way steeper.

What are the roles of drug wholesalers? Why pharmacies use them?

Prime vendor concept. Reduced number of invoices. Payment relationship with a primary company increases volume and creates opportunity for financial incentives. Pharmacies use them because they have less contracts to make with each manufacturer like they used to in the past. Less paperwork, and it is easier. Can reduce inventory with multiple deliveries per day from wholesaler, improving cash flow.

Soothing syrup

Product contained morphine, sodium bicarbonate, spirits, and aqua ammonia. Many infants died from its use.

Describe pharmacy practice behaviors under product-based care and patient-centered care.

Product-based care: Patient-counseling. Product based payment. Patient-centered care: Mandatory counseling. Disease management. MTM. Product based payment and MTM pay.

Prior authorization

Programs used to allow access to certain medications for patients who meet specified criteria. Must get approval from the insurance plan before patients can receive the medication. Causes delay in patient access to medication.

Rebate with drug manufacturer

Rebates are given to PBMs by manufacturers to encourage PBMs to increase the market share for a particular medication. Single source drug manufacturers give rebates to PBMs. Multi-source generic drug manufacturers give rebates to pharmacies.

What is medical loss ratio?

Requirement that insurance companies spend 80% of premiums collected on health care for beneficiaries or provide back in rebates. May not spend it on marketing, administrative, and CEO salaries.

The "individual mandate", how is it enforced in the original version of the ACA and what is the current state of that enforcement?

Requires US citizens and legal residents to have qualified health care coverage. Went into effect 2014. Those who do not pay a tax penalty based on a flat tax or % of income up to the cost of the "Bronze" plan. Current state of enforcement: there is no penalty for not having insurance, but the individual mandate has not been repealed.

What do PBMs do to control drug costs and increase the revenue?

Revenue comes from insurer and drug manufacturer. PBM's take the difference b/w what they reimburse to pharmacy and what they bill to insurer. PBM's get rebates from drug manufacturer. PBM's try to reimburse less to the pharmacy. .Spread Pricing .Rebate with drug manufacturer .Formularies .Prior Authorizations .Quantity Limits .Step therapy .Generic Drug Use .Mail Service Options

What is REMS? How does it work?

Risk evaluation and mitigation strategy. Beyond the professional labeling to ensure that the benefits of a drug outweigh its risks. Manufacturers develop REMS, FDA approves them. FDA can require REMS for a drug with potential serious adverse side effects. The manufacturer needs data on how drugs are distributed, prescribed, dispensed, and taken. Otherwise, the drug is not approved or thrown away from the market by the FDA. 2/3 of existing REMS have only a medication guide. 1/3 require elements to assure safe use (ETASU). Most extensive element of the program and sometimes HC professionals need to check lab values before dispensing a drug. Most specialty drugs require ETASU.

Community pharmacy is an umbrella term for...

Supermarket pharmacy, general merchandiser pharmacy, drug store (retail and chain and independent community pharmacy).

What is Medicare for All Act of 2019 (HR 1384)? What coverage exists under it? What impact on copays, coinsurance, etc?

Take Medicare and where it says over the age of 65, you just remove that. Does away with private health insurance and eliminates any direct patient payments toward health care, such as copayments, coinsurance, deductibles, and premiums. Covers medical, dental, vision, and long-term nursing home care, rx, mental health, and substance abuse.

If drug manufacturers were required to charge a uniform price for prescription drugs across countries, would the US benefit from price reduction? And why? What will happen to other countries?

The US would not benefit from price reduction. The prices for other countries would be raised to match what the US pays. The other countries will have a raised price, and they will struggle more to pay the prices for the drugs. Manufacturers lose the least amount of money. The other countries have a limited governmental budget for health care, and some countries do not have the ability to pay. Overseas patients who need the drug will be worse off.

Price sensitivity & differential pricing is about what?

The demand.

Step Therapy

Use of a prescribing pattern set by protocol based on the stage of illness or treatment effectiveness. Typically, the most cost-effective drug is used first, followed by alternative therapies.

Generic Drug Use

Use of less expensive generically equivalent medication in place of a prescribed brand-name medication. Some plans are mandatory. Other plans use incentives such as lower patient cost sharing.

What is a qualifying plan? What services need to be provided by a qualifying plan

What must be included for a quality health insurance plan. Ambulatory care services, ER visits, hospitalization, maternity and newborn, mental health substance abuse, rx drugs, rehabilitation services, lab services, pediatric services, and preventative health and chronic disease state management.

Distinguish white bagging from brown bagging, and discuss potential risks or concerns related to brown bagging. (focus on in-class discussion)

White bagging: Physician administered drugs are dispensed by a specialty pharmacy for a specific patient, shipped to the physician for administration, pharmacy bills to insurer under pharmacy benefit and the physician neither buys nor bills for the drug. Brown bagging: A process where the patient is responsible for bringing the medication to the site of administration. After being dispensed to patient, physicians have no knowledge of drug handling and storage conditions prior to administration. Safety and integrity of the medication is not assured. This becomes a potential liability issue. b. Patient may decide to administer drug themselves and potentially harm themselves. c. Patient may share (or resell) medication with someone else. d. Patient can lose the drug or forget to bring it to the appointment. e. It takes longer for a patient to carry the drug/make appointment than for a pharmacy to directly ship it to the physician's office. It is possible the optimal timing of the drug administration may be missed due to the delay caused by brown bagging.

WAC

Wholesale acquisition cost. Manufacturer's published list price for sale of a drug (brand or generic) to wholesalers. Wholesalers usually do not pay this, but some lesser amount because they buy in bulk. Drug manufacturer's MSRP.

Rationale for pharmacist to obtain provider status

With newly insured individuals under the ACA, there are great needs for primary care service providers. Large part of primary care patients have chronic disease that are managed by chronic medications. Pharmacists can serve as part of primary care, but they can't justify role without provider status. Reimbursement moving towards pay-for-performance through coordinated care, team-based approach. Yet, appropriate payment model is not established for pharmacist.

Food and Drug Act (1906)

•A group of corporations form the Beef Trust around this time as a monopoly over certain types of food. •An expose at the time called: "The Jungle" writes of deplorable food packing practices. Examples include injecting rotting ham with formaldehyde to reduce odor, using pigs that have died of cholera for lard, using cattle too sick to stand for canned beef. •The Food and Drug Act of 1906 is enacted prohibiting the manufacture, sale or transportation of adulterated or misbranded or poisonous food, drugs, medicines or liquors. •This creates what we know today as the Food and Drug Administration (FDA)

The Volstead Act (1920)

•Carries out the 18th amendment and prohibits intoxicating beverages and regulates alcohol use in science •Alcohol was a common carrier in many medicinal products prepared and dispensed by the pharmacist •The Act establishes the pharmacy as the sole outlet for liquor •The "Liquor License" is established by the feds and the idea of a limited number of them in an area •With a prescription, one could go to the local pharmacy and obtain whiskey for "medicinal purposes •Established in Chicago, Walgreens grows from 20 to over 500 stores during prohibition, crediting the "Milkshake"

Poison Prevention Packaging Act of 1970

•Gives the Consumer Product Safety Commission the authority to require special packaging of household products to protect children from poisoning. •Manufacturers required to perform packaging tests: Pairs of children 42 - 51 months given 5 minutes to open the package. No more than 15% should be able to open it. If they cannot, they are given a visual demonstration and another 5 minutes to open the package. Package is considered "child-resistant" if not more than 20% of 200 children tested can open the package. •The packaging is then tested on a panel of adults aged 50 to 70. 90% of this group must be able to open and, if appropriate close the pack.

Harrison Narcotic Tax Act of 1914

•In the wake of the Spanish-American war, the United States took over governing the Philippine Islands, which included a Spanish system for managing narcotic abuse. •Additionally, world-wide issues related to opium abuse, lead to the enactment of the Harrison Narcotic Tax Act. •Manufacturers, importers, pharmacists and physicians handling or prescribing narcotics (opium, morphine, heroin) needed to be licensed and taxed. •Required a prescription for narcotics

Comprehensive Drug Abuse Prevention and Control Act (1970)

•More commonly known as "The Controlled Substances Act" •Creates the modern day schedule of controlled substance including Schedule 1 through 5 •Schedule II agents must be ordered using the DEA Form 222 •Specific requirements for schedule drug prescriptions set forth, as well as fax, e-prescribing, transfer and partial fill •Record keeping, inventory and theft requirements

Durham-Humphrey (1951)

•Officially creates the prescription only category or drugs, or legend drugs, which must carry the label: "Federal law prohibits dispensing without a prescription." •Refills require an authorization. •Non-Rx drugs require adequate directions and warnings. •Minimum label requirements on an Rx

Elixir Sulfanilamide (1937)

•Sulfanilamide is an antibiotic, used at the time to treat throat infections and had been used safely in powder and tablet form for some time. •There was a demand for a liquid form, particularly for children. •The chief chemist and pharmacist for the Massengill Company found that it would dissolve in diethylene glycol. It was then flavored with raspberry. •No law required testing at the time. 240 gal were shipped. •Deaths began to be reported featuring kidney failure, nausea, vomiting, severe pain and seizures. •Nearly the entire FDA staff (~200) were sent to the field to track down the sales force, physicians and pharmacists. •234 gallons + one pint recovered, but over 100 deaths occurred. •The pharmacist would eventually commit suicide.

Kefauver-Harris Amendment (1962)

•Thalidomide developed by a German drug company and used there as well as in Europe, Africa and Canada as a sedative and for morning sickness •The FDA did not give approval due to Francis Kelsey concern that it may pass through the placental barrier (perceived to be un-breached by most scientists then) •After 6 years of use, it is linked to over 10,000 cases of birth deformities including phocomelia. •Safety and effectiveness must be proven to the FDA •Adverse events must be reported to the FDA •Advertisements to physicians must balance risks and benefits •FDA given jurisdiction over Rx drug advertising •Modern day drug approval process (Phase 1 - 4) Adds efficacy to the safety component of the FDA.

Food, drug, and cosmetic act of 1938

•The Sulfanilamide disaster adds to the motivation of Congress to pass the Food, Drug and Cosmetic Act of 1938 •Extends control to cosmetics and devices •Requires new drugs be proven safe •FDA begins to identify and enforce drugs that require an Rx although no express classification is yet created. •FDA may require Rx where drugs are habit-forming or unsafe unless supervised by a health care practitioner •Removes Sherley requirement of fraud in misbranding •Authorizes factory inspections

Sherley Amendment

•The Supreme court in United States v. Johnson (221 US 488) rules that the Food and Drug Act does not prevent companies from labeling remedies with any manner of false claims. •Congress responds with the Sherley Amendment, which prohibits labeling medicines with false claims to defraud the purchaser. It becomes difficult legislation to enforce due to the need to prove fraud. Fraud requires: •A false statement •Knowledge that is it false •Intent to deceive •Reliance on the statement by the consumer •Injury as a result

What do community RPh do?

■Dispense prescription medications -Workflow process in a community pharmacy ■Counsel patients -Offer expertise in the safe use of prescriptions -Provide advice on healthy lifestyle ■Provide immunizations ■Conduct wellness screenings ■Supervise pharmacy technicians and interns ■To some extent, manage the business of pharmacy

Tech-check-tech

■First introduced in 2007 for hospital pharmacies to implement tech-check-tech programs per approval of the Iowa Board of Pharmacy ■March 2014: approval granted for expansion into community pharmacy settings ■October 2016: National Association of Chain Drug Stores (NACDS) partnering with the Pharmacy Society of Wisconsin to explore tech-check-tech in the community pharmacy setting

Enhanced MTM

■Nov 1, 2015: CMS is "granting basic, stand-along prescription drug plans (PDPs) the flexibility to design enhanced MTM programs that include interventions beyond the traditional approach" ■Plans may expand range of MTM activities ■Enhanced MTM pilot will begin on January 1, 2017 for a five-year performance period ■Goal: Identify if additional payment incentives and regulatory flexibilities will engender enhancements in the MTM program: improving therapeutic outcomes while reducing cost

Statewide protocol

■Oregon: Prescribing birth control products (Jan 1, 2016) ■Pharmacists can prescribe transdermal and oral contraceptives to women 18 years of age or older, or younger than 18 if have had a previous prescription from a physician ■Must first check blood pressure, complete a questionnaire ■Pharmacists must first attend a training course (5-hour) ■Benefits: access to care, especially in rural Oregon Up to 12 - 14 states that do this now.

Independent pharmacist prescribing

■Pharmacists can PRESCRIBE drugs, drug categories, or devices that are specifically authorized in rules adopted by the board... ■Limitations include conditions that: -Do not require a new diagnosis -Are minor and generally self-limiting -Have a test that is used to guide diagnosis or clinical decision-making and are CLIA-waived -In the professional judgment of the pharmacist, threaten the health or safety of the patient if not immediately dispensed

Pharmacogenomics

■Pharmacogenomics: the study of drug-gene interactions ■PGx testing: Rite Aid announced on 11/12/15 testing at ~4000 pharmacies ■Shortly after launch, FDA intervened with vendor Harmonyx after ruling tests were "patient-initiated" and were therefore "direct-to-consumer" which required a different approval process ■Harmonyx Diagnostics is now no longer offering testing services ■Many other pharmacogenomics laboratories still offer testing

POC Testing

■Point-of-care testing for chronic and infectious disease -Hemoglobin A1C -Cholesterol -Influenza -HIV -Streptococcal pharyngitis - ■Potential for therapy initiation and/or referral per protocol/collaborative practice agreements

What are the potential jobs?

■Staff pharmacist ■Pharmacy manager ■Non-dispensing (clinical) pharmacist ■Pharmacy supervisor/district manager ■Clinical services leader

How to get into community pharmacy practice.

■Technician job +/- certification? ■Right out of school? ■Internships? ■Residencies? ■Added degrees? ■Professional organization involvement? -APhA -NCPA -NACDS ■Board certification (Board of Pharmaceutical Specialties)?

Telepharmacy

■Via video technology, several community pharmacies in the Midwest operate without an on-site pharmacist physically present ■Currently, often operated in smaller towns ■Good: improve access ■Bad/good: more emphasis on pharmacy technicians in the dispensing process ■Bad: potential to spread prescription volume in a way that could adversely impact pharmacy business