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DEA National Prescription Drug Take-Back Day

Do you have expired or unused prescription medications in your medicine cabinet? Each year millions of prescription medications are misused, and often obtained from friends and family. Safely dispose of your unwanted medications at the next National Prescription Drug Take-Back Day on April 27, 2019 from 10 AM to 2 PM! Visit DEATakeBack.com to find a location site near you and learn more about Drug Take-Back Day. Previous National Drug Take-Back Day events have collected an average of over 400 tons of medications at over 5,000 sites nationwide.

Certain medication that cannot be taken at the collection sites are liquids, needles, sharps, and anything that can be pressurized such as inhalers. Examples of medicine that can be taken at collection sites are any over-the-counter drugs and controlled or noncontrolled medications in tablet, capsule, or patch form.

If you cannot make it to the scheduled event to dispose your medication, you can use the DEA’s collection site locator to find authorized collectors in your area all year-round.

CVS Unveils HealthHUB®

In mid-February 2019, CVS Health unveiled their new HealthHUB® store concept at three pilot locations in Houston, TX.  The new concept represents CVS Health’s effort to “transform the consumer health care experience in America.”  According to CVS Health, these stores will “offer a broader range of health care services, new product categories, digital tools and on-demand health kiosks, trusted advice and personalized care. With the new format over 20 percent of the store is now dedicated to health services, including new durable medical equipment (DME) and supplies and new product and service combinations for sleep apnea and diabetes care.”  This new concept is the first strategic concept coming from CVS Health’s acquisition of Aetna, which was completed in November 2018.

I first saw this reported by MMR (Mass Market Retailers), an industry journal, and wondered what retailers thought of CVS Health’s approach to improve their position as a health care provider in a retail outlet.  Accompanying the article was a picture of a wide-open space in the HealthHUB® location.  My first thought was that retailer traditionalists will see all that empty space and wonder how will health care services “sales” generated in that space be enough to maintain a decent “sales per square foot” figure?  My next thought was has CVS thrown that old thought process out of the window with this new concept?

USA Today reported that “traditional retail sales at CVS are increasingly less important to the company’s finances,” which evidently allows them to free up all that space seen in the picture.  USA Today said that in the first nine months of 2018 retail product sales were less then one-third of its prescription sales in that period.  Think about it – how many bottles of aspirin, tubes of first aid cream and boxes of bandages need to be sold to equal the revenue a single health care service will generate?

“Sales per square foot” is likely still important to CVS Health, but they are betting on health care services to drive that figure.  This concept is likely the future of pharmacy and healthcare increasing patient convenience and access.  Pharmacy retailers need to look at their business from a new perspective and determine how providing health care services will work for them.  CVS Health has the benefit of being aligned with a health care provider (Minute Clinic) and a payer (Aetna).  Other retailers have included clinics in there offering.  Being associated with an insurer should help drive patients to those HealthHUB® locations.

With prescriptions for high priced pharmaceuticals going to specialty pharmacies, retail pharmacies need to position themselves for the future, which all of a sudden is now!

Dave Schuetz, RPh.

 

Read more:

https://cvshealth.com/thought-leadership/cvs-health-testing-new-healthhub-store-format

https://www.massmarketretailers.com/cvs-health-unveils-new-concept-store/

https://www.usatoday.com/story/money/2019/02/13/cvs-concept-store-introduced-space-health-care-services/2845846002/

 

Posted March 2019

Medicare Part D Opioid Safety Alerts

As the nation continues to battle the opioid epidemic, CMS has implemented new Medicare Part D opioid policies in 2019. These new policies make pharmacists responsible for identifying potential risks and relaying that information to prescribers. The following safety alerts will be applied to specific opioid prescriptions:

  • Seven day supply limit for opioid naïve patients: Patients who have not filled an opioid prescription in the past 60 days will be limited to a seven day supply on a new opioid prescription. A hard edit will stop the pharmacy from processing these prescriptions without an override or authorization from the plan. Prescribers can request a coverage determination in advance if they believe patients will need a longer course of treatment. Prescribers are encouraged to re-assess the patient before prescribing additional opioid therapy following the seven day course of treatment. The goal is to limit opioid use for acute pain.
  • Opioid care coordination alerts: When a patient presents one or more opioid prescriptions resulting in a cumulative morphine milligram equivalent (MME) greater than or equal to 90 MME per day, an alert will be triggered at the pharmacy. The pharmacist should contact the prescriber to confirm intent and document the discussion before entering an override code. Plans have the option to implement a hard edit at a cumulative 200 MME per day. The goal of these care coordination safety alerts is to make prescribers aware of patient opioid usage, especially when patients see multiple prescribers.

Health plans, prescribers, and pharmacies will need to work together to ensure patients are receiving adequate pain management treatment while limiting the potential for opioid abuse.  PHSI also expects the Medicare Part D safety alerts to become standard offerings in the commercial sector.

Additional information and resources for patients, prescribers, and pharmacists is available at https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/rxutilization.html.

 

Published February 2019

Biosimilar Listing in the Drug Compendia – GPI and GSN Identifiers

Currently, approved biosimilars are not interchangeable with the original biologics according to the FDA.  Drug compendia such as Medi-Span and FDB represent biosimilars as unique compared to the original biologic by classifying them in separate  GPIs and GSNs (clinical formulation IDs).  This is different than small molecule products where similar products (including B-rated products) are classified in the same GPI or GSN.

Future Scenarios

What will happen with interchangeable biosimilars when approved by the FDA?  Will Medi-Span and FDB group those in the same GPI or GSN as the original biologic?  Will they continue to differentiate interchangeable products in unique GPIs and GSNs?

If the drug compendia decided to keep the unique GPI and GSN classification for interchangeable biosimilars, PHSI would suggest the following methodologies to group biosimilars and innovator biologics together:

  • Using Medi-Span data, the GPI-8, Product Strength, and Dosage Form would group all biosimilars and the original biologic together.
  • Using FDB data, the Enhanced Therapeutic Classification (ETC), Strength, and Dosage Form groups all biosimilars and the original biologic together.

Another enhancement could be to create a common code linking interchangeable products (like the FDA’s Orange Book therapeutic ratings for small molecules).  This would differentiate biosimilars from interchangeable products within the proposed grouping methods above.

 

Contact PHSI with your questions and challenges with biosimilar drug compendia classification.

 

Published January 2019

Impact of the Opioid Crisis Response Act

On October 24, 2018, President Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities, or the SUPPORT for Patients and Communities Act. This bill, referred to as the Opioid Crisis Response Act, will have direct impacts on an array of areas within pharmacy and healthcare settings including The Centers for Medicare and Medicaid Services (CMS), the states themselves, naloxone prices, and patient education.

Some of the provisions from the bill that will impact pharmacy include:

  • Prescriptions for controlled substances that are covered drugs under Medicare must be transmitted through electronic prescription programs
  • Medicare prescription drug plan sponsors must establish drug-management programs for at-risk beneficiaries
  • Each state must establish a qualifying prescription drug monitoring program (PDMP) and require health care providers to check the PDMP for a Medicaid enrollee’s prescription drug history before prescribing controlled substances to the enrollee
  • CMS must report on the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in a prescription drug plan under Medicare or Medicare Advantage (MA)
  • CMS must provide Medicare beneficiaries with educational resources regarding opioid use and pain management, as well as descriptions of covered alternative (non-opioid) pain-management treatments
  • CMS must develop an action plan to provide recommendations on changes to the Medicare and Medicaid programs to enhance the treatment and prevention of opioid addiction, as well as coverage and payment of medication-assisted treatment
  • CMS must also publish a report that includes an evaluation of price trends for opioid overdose-reversal drugs (e.g., naloxone) and recommendations on ways to lower consumer prices for such drugs
  • The bill also establishes criteria for individuals who are identified as at-risk beneficiaries for prescription drug abuse as qualifying participants in medication therapy management (MTM) programs under the Medicare prescription drug benefit
  • Medicare and MA prescription drug plan sponsors must annually disclose information to enrollees about the risks of prolonged opioid use, as well as coverage of nonpharmacological therapies, devices, and non-opioid medications

Many of these measures aim to improve patient education about the dangers of opioids and encourage the use of opioid alternatives. In 2017 alone, nearly 50,000 overdose deaths relating to opioids occurred. Educating patients through services such as MTM and suggesting alternative pain management therapies could go a long way in reducing that number. The bill also provides increased access to treatment for opioid addiction as well as other provisions all aimed at reducing opioid related deaths and protecting patients. CMS has released a tip sheet for preventing and combating opioid overuse as well as new opioid related policies in Medicare D beginning in 2019. More information can be found at https://www.cms.gov/Medicare/Prescription-Drug-coverage/PrescriptionDrugCovContra/RxUtilization.html

PHSI believes that while the passage of this bill plays a pivotal role in beginning to address the crisis, additional legislation is required to continue to slow and resolve the opioid epidemic. For example, requiring prescribers to electronically prescribe controlled substances for all patients would force adoption of the two factor authentication and minimize controlled substance diversion through paper prescriptions. The SUPPORT Act is one important component in a multifaceted plan to address the opioid crisis.  PHSI expects that the opioid epidemic will continue to be a relevant issue in both pharmacy and healthcare settings. The coming months will provide valuable insight into just how much of an effect the Opioid Crisis Response Act can have.

Posted: January 2019

A Primer on Partial GPIs and FDB Supersets

Drug compendia are excellent resources that are used either directly or indirectly by almost all stakeholders in the pharmaceutical industry. Two of the leading drug compendia providers are Wolters Kluwer (Medi-Span) and First Databank (FDB). Pharmaceutically equivalent products are those that share the same active ingredient(s), strength/concentration, dosage form, and route of administration. Both compendia group pharmaceutically equivalent products together. Medi-Span groups these products using the 14-character Generic Product Identifier (GPI) field, while FDB groups pharmaceutically equivalent products together using a five-digit Generic Code Number, or GCN. There are some therapeutic categories that drug compendia find challenging to code, and they require procedures outside of the normal categorization process.

Nutritional Supplements, Vitamins, and Devices
What happens to the hundreds, if not thousands, of unique vitamins, nutritional supplements, dietary management products, medical foods, and devices? Do the compendia create unique GPIs and GCNs for each of these slightly different products? The short answer is no. Due to the character-length limitations of GPIs or GCNs, it is impossible for the compendia to assign unique identifiers to each product formulation; thus, partial GPIs and FDB Supersets were born.

Medi-Span refers to partial GPIs as a general description of the product based on the therapeutic classification system. Partial GPIs can be identified and differentiated based on the presence of asterisks before and after the GPI Name, which is essentially the product’s generic name. Examples of GPI Names for partial GPIs include *Nutritional Supplement Caps** and *Blood Pressure Monitoring – Device***. Placing products in a partial GPI indicates to users that products are like one another, albeit not pharmaceutically equivalent. Similarly, FDB has created FDB Supersets, which group similar but not pharmaceutically equivalent products together. This is most commonly seen in the device space, such as with GCN 94200 that groups Medical Supplies and DME (durable medical equipment).

Partial GPIs and FDB Supersets can cause confusion in the marketplace. For organizations doing GPI/GCN crosswalks, it can be difficult to map these products from one compendium to another. When doing a GPI to GCN crosswalk (or a GCN to GPI crosswalk), products with partial GPIs or FDB Supersets may have a one-to-many relationship. Additionally, some physicians may choose to search for products by therapeutic category, and this can prove challenging if a product is in a partial GPI for FDB Superset, due to the vast number of products appearing. Finally, a partial GPI or FDB Superset could serve as an indicator to a payer that a product is not a typical drug and may affect formulary placement and/or coverage.

Understanding partial GPIs and FDB Supersets is important for manufacturers, especially those making vitamins, dietary supplements, medical foods, medical devices, and/or durable medical equipment. Other stakeholders should be familiar with these product identifiers to properly code their systems to ensure the business intent is captured correctly.

Published January 2019

A Review of the Express Script (ESI) Flex Formulary

Overview:

Last month, Express Scripts announced that they will be introducing a new Flex Formulary, which is expected to mirror the Express Scripts National Preferred Formulary (NPF) as a starting point.  The new Flex formulary will allow ESI to easily add new, lower cost products in the middle of a plan year as they are introduced into the market.  The Flex formulary will be adjusted when authorized generic products or lower cost brand NDCs launch.

ESI states that they will evaluate the lower-cost alternatives and determine whether they obtain preferred or non-preferred status.  If added, ESI can adjust the formulary to exclude the corresponding brand or other brand products within that therapy class.  Authorized generics (AGs) of hepatitis C treatments Epclusa and Harvoni recently launched, and these AGs are expected to be the first products evaluated under the new formulary.  Likewise, a new, lower-cost NDC of Repatha recently become available; it will likely be evaluated for inclusion as well.  With the Flex formulary, employers can choose to cover the new, lower-priced option or continue to cover the original brand formulary product, which would likely have a rebate yield impact.  This provides flexibility for those who favor a lower net cost or those who are rebate driven.

Analysis:

The Flex Formulary creates more opportunity for authorized generics in brand-only categories and maybe a viable option for pharmaceutical manufacturers launching into a crowded market when their product doesn’t offer clinical superiority.  It may also usher in more Repatha-like strategies where brand manufacturers launch a new, lower-priced NDC of the same branded product.  In the past, brand manufacturers could feel safe when they had achieved formulary placement for a given calendar year.  With the Flex formulary, there will be volatility for brand manufacturers competing in crowded brand-only categories.  Having a drug covered at the beginning of the year does not guarantee coverage throughout the plan year; the brand’s coverage may be re-evaluated, should a competitor choose to launch a lower cost NDC or an authorized generic. Although not expressly noted in press releases, PHSI anticipates the formulary could also be evaluated if an ANDA generic is approved and introduced

The Flex formulary may be most beneficial for patients in high deductible or coinsurance-based health plans, as they will see the most savings from new, lower priced products.  The Flex formulary could create disruption for patients throughout the plan year, as a medication covered at the start of a plan year could become non-formulary in the same calendar year.   This will require more vigilance on the part of the healthcare providers to understand which products are covered/preferred at any given time.  If ESI’s Flex Formulary is successful, we may see other PBMs adopting this methodology in the future, changing the way we think about drug coverage, manufacturer contracting and product marketing strategies.

 

Posted December 2018

Small Businesses Can Make a Large Impact

As Small Business Saturday quickly approaches, it is important to support the small businesses inside our communities.  When I think of small businesses, what normally comes to my mind are local coffee shops, restaurants, and bakeries.  I don’t normally think of pharmacies, but independent pharmacies are a very important small business to consider supporting, not just on Small Business Saturday.  I’m guessing I’m not the only one who missed the independent pharmacy train, so it might be helpful to shed some light on just how important they are to our communities.

In Pennsylvania alone, there are a total of 960 independent pharmacies that employ over 9,000 people full-time.  The total sales in PA are almost $3.5 billion, with over $260,000,000 of that total from non-pharmacy products.  That’s $3.5 billion dollars that stays in our local communities.  Not to mention that more than 80% of independent pharmacies nationwide are located in communities with a population of 50,000 or less, which provides access to health care services to areas that are underserved and would otherwise have to travel far distances to access health care.  To put that into perspective, only 8 cities in Pennsylvania have more than 50,000 residents.  The money you spend at a small business goes towards Susie’s mortgage, who lives down the street from you, or towards Bill’s son’s college fund, who goes to school with your child.  The fate of small businesses can be secured with the support of those in our communities.

Not only do independent pharmacies provide income and health care to local communities, they provide personalized and unique services that are less accessible with big chain stores.  Without the fast-paced prescription cycle, independent pharmacists can spend the time to properly counsel and educate patients on their medications and disease states.  Independent pharmacies are also usually the first to create and implement new programs to improve adherence and patient health.

So, when Small Business Saturday rolls around this year, consider supporting your local independent pharmacy by stopping in and discovering what unique services it offers to benefit you.  In turn, your business will benefit the pharmacy and your community.  It’s a win, win, win!

 

Written by Kelsey Miller, LECOM Pharm.D. Candidate 2019

 

Published November 2018

Pharmacist eCare Plans: The Care Plan of the Future?

Pharmacist eCare Plans are one specific type of electronic care plan designed to allow pharmacists and other health care providers to collaborate and individualize treatment for each patient. The Pharmacist eCare plan follows the Joint Commission of Pharmacy Practitioners (JCPP) patient care process of collect, assess, plan, implement, and follow up: monitor and evaluate. Some goals of the Pharmacist eCare plan include improving health outcomes related to medication use and coordinating care with other health care providers by generating and electronically sharing these care plans.

Advantages of the Pharmacist eCare plan include:

  • Utilizes technology already established in pharmacy workflow
  • Implementation by pharmacies wherever they see fit
  • A standardized data format allowing for quality assurance and interoperability
  • Integrates pharmacists and their medication related care plans into a patient’s comprehensive care plan
  • Option to design care plan at basic or advanced level

Community, hospital, and long term post-acute care settings often utilize Pharmacist eCare plans. As of the end of May 2018, over 235 pharmacies throughout the North Carolina Community Pharmacy Enhanced Services Network (CPESN) are participating in a large-scale model test and have created over 30,000 Pharmacist eCare plans.

PHSI predicts that the Pharmacist eCare plan will experience increased implementation in the industry once patient results are published by CPESN based on the North Carolina pilot.  Pharmacist ECare plans may provide an additional revenue source for pharmacies and pharmacists for their roles in the patient care process. The implications of payer reimbursement for the capture of clinical data and an expanded opportunity for pharmacists to validate and cement their role in the patient care process will make the adoption rate of the Pharmacist eCare Plan interesting to follow.

 

Published October 2018

E-Prescribing Preferred Name (EPN)

The National Council for Prescription Drug Programs (NCPDP) SCRIPT standard version 10.6 is the approved format currently used for electronic communications between prescribers and pharmacies.  The drug name is one attribute included in the information transmitted between these entities.  Surescripts recently published guidance describing their preferred format for the drug name to be included in these transmissions. Surescripts guidelines recommend that the E-prescribing Preferred Name (EPN) contain the following elements and conditions:

Element Description
Product Name Required element displaying the branded name so pharmacy can determine the prescribed product
Salt Conditional element as part of the product name when appropriate
Drug Delivery Device Conditional element for products that can only be distinguished by the delivery device
Strength Required element except for medical devices (i.e. lancets) where strength is not applicable
Strength Unit Required element except for medical devices (i.e. lancets) where strength is not applicable
Route Conditional element for products that can only be distinguished by the route of administration
Dosage Form Required element except for medical devices (i.e. lancets) where dosage form is not applicable

 

More detailed recommendations include the use of hyphens to separate similar elements (i.e. combination products), specific spaces, permitted abbreviations, and abbreviations to avoid.  The EPN maximum length is 105 characters.  Prescribed products may also be identified through other data fields.  Another field for a drug NDC or RxNorm Concept Unique Identifier (RxCUI) is included in the SCRIPT format to provide a second method to specify the product.

Surescript’s EPN guidelines are detailed with a goal of communicating the patient specific prescribed product.  Surescripts advises vendors to populate the drug name field from a compendia source.  Commercial compendia established editorial policies for the drug name long before the introduction of EPN, so the compendia drug name fields do not mirror the EPN guidelines.  For example, the drug names are in a different order or may exclude an EPN naming element.  The RxNorm Prescribable Name is available from the National Library of Medicine as an alternate compendia source for the EPN.  PHSI has identified that the RxNorm Prescribable Name does not mirror the EPN.  While PHSI supports all efforts to provide clarity in the issuance of prescriptions to reduce medication errors and maximize efficiency, there is no currently available reference source that follows the new Surescript EPN guidelines.

 

 

Published October 2018