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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

PHSI Celebrates Women Pharmacist Day

 

Women Pharmacist

We are proud to celebrate Women Pharmacist Day here at Pharmacy Healthcare Solutions, Inc.!  Pictured above are PHSI pharmacists Ashley Ellek, Ann Johnson, and Melissa Krause.

PHSI joins in celebrating National Pharmacist Month, with a special focus on October 12th, which is Women Pharmacist Day.  October was chosen, as it coincides with National Pharmacist Month.  The 12th was chosen to celebrate the first female pharmacist in the United States, Elizabeth Gooking Greenleaf, who had 12 children.

Digital Therapeutics: The Future of Healthcare

What are digital therapeutics?

According to the Digital Therapeutics Alliance (DTA), whose members include health technology companies, pharma companies, and others, “digital therapeutics” (sometimes abbreviated “DTx”) are:

“Clinically-validated solutions [that] may be used as standalone interventions or in association with other treatments to engage patients and improve the overall quality, cohesion, outcomes, and value of healthcare delivery.”

Another way of describing digital therapeutics would be technology as a treatment or combined with a drug or device to monitor or improve patient outcomes.  The DTA lists a variety of conditions for which patients may benefit from the use of digital therapeutics solutions, including:

  • Respiratory
  • Cardiovascular
  • Endocrine
  • Mental health conditions

Digital therapeutics pose multi-faceted challenges for a variety of stakeholders, including FDA, the drug compendia, CMS and other payers, prescribers, pharmacies, and patients.  It remains unclear under what pathway(s) digital therapeutics will be approved.  For example, the FDA has established a dosage form called “tablet with sensor.”  This was presumably created for Abilify MyCite®, as it appears to be the only FDA approved product with this dosage form today.  However, not all digital therapeutics have a drug component.  In PHSI’s view, digital therapeutics may include a variety of potential combinations, such as:

  • Technology built into a drug, such as the recently approved Abilify MyCite®
  • Technology built into a device
  • Drug + app (Rx or OTC)
  • Device + app
  • App alone, such as Pear reSET

One area of focus is how the drug compendia will list digital therapeutics.  Their decisions to depict these innovative treatments in the databases will influence prescribers issuing prescriptions and/or orders, payers adjudicating claims for these items, and pharmacies dispensing them.

Once digital therapeutics are commercially available and listed in the compendia, payers may be presented with the decision of whether to cover these solutions as an insured benefit, and if so, whether they fit under the pharmacy or medical benefit, or perhaps a different coverage approach.

Prescribers and pharmacies will need to understand their role in the provision of digital therapeutics.  For solutions that combine a drug with a device, app, or other technology component, it will be important to be able to differentiate the digital therapeutic from other products that may be similar but do not contain the technology.  For digital therapeutics solutions that do not contain a drug, the process for transporting the digital solution from its creator into patients’ hands is less well defined.

PHSI continues to work with companies creating digital therapeutics to help them understand the implications of how their solution(s) may fit within the existing health IT infrastructure and welcomes the opportunity to explore new innovations to bring this technology into the market.

 

Published: October 2018

New Part D Negotiating Strategy: Indication-Based Formulary-Design

CMS released an August 29th memo indicating that Part D plans could implement indication-based formulary design for the 2020 contract year.  Indication-based formulary design already exists in the commercial space, but CMS notes that this will be a new negotiation tool for Part D plan sponsors.

Under the current system, Part D plans can use prior authorizations or step edits to vary the drug approval criteria based on patients’ indications.  For example, in the Health Plan Management System July 25th memo, CMS states that a Part D sponsor may require that a specific tumor necrosis factor (TNF) blocker (e.g. Humira) be used for plaque psoriasis patients before approving a non-preferred agent (e.g. Cimzia).  However, a different TNF blocker (e.g. Enbrel) trial may be required before the non-preferred agent (e.g. Cimzia) is approved for a rheumatoid arthritis patient.  Although the approval criteria can differ based on indication, current policy dictates that an on-formulary drug is covered for all FDA-approved indications, assuming the indication is not a Part D excluded indication.

Under the new approach, on-formulary coverage may be determined based on specific indications.  Only certain indications will be considered on-formulary for the given drug, while other indications will not be covered.  For non-formulary-indication coverage, a patient or provider would need to submit an exception request to the health plan; this is identical to the process currently needed for a non-formulary drug to be covered.  Although a Part D sponsor can exclude drug coverage for an indication, they must provide formulary coverage for another therapeutically similar drug for that indication.  For example, a Part D plan may indicate that a specific TNF blocker (e.g. Remicade) is considered non-formulary for plaque psoriasis, since other TNF blockers (e.g. Humira, Cimzia) are on-formulary for this plaque psoriasis indication.

Medicare Part D plans wishing to implement indication-based formulary coverage will need to submit this information to CMS.  In order to capture the indication information, CMS will use a standardized terminology system, with Medication Reference Terminology (MED-RT) being referenced in the August 29th memo.  The submitted information will need to be put into Health Plan Management System (HPMS) file layouts and used to update the Medicare Plan Finder so that beneficiaries and physicians can accurately search for and compare plan formulary information.  CMS has indicated that detailed submission instructions will be provided to Part D sponsors in subsequent guidance.

Stakeholders should expect to see indication-based utilization management on 2020 Medicare formularies, especially for crowded drug categories with many competing brand manufacturers.  Indication-based coverage will be more prevalent in the specialty drug space, where prescribers are typically already including the indication when prescribing.  If indication-based coverage is implemented in the small molecule space, it may require a shift in prescriber habits, since many physicians do not currently include indications on these prescriptions.  The indication would be required to determine whether or not the drug was covered, and if not included, could result in numerous call-backs from pharmacies.  With the coming changes, having accurate formulary lookup tools in EHRs for prescribers to reference will become increasingly important.

By Ann Johnson

 

Published October 2018

DEA Drug Take-Back Day

Mark the calendar because October 27, 2018 from 10 AM to 2 PM is National Prescription Drug Take-Back Day! Each year thousands of unwanted prescription medications are left in medicine cabinets or thrown away and end up in the wrong hands. This event will allow YOU to take part in keeping the community safe by responsibly disposing of your unwanted medications.

Visit DEATakeBack.com to find a location site near you and learn more about Drug Take-Back Day.

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.

DEA_TakeBack2018_DigitalBillboard_1400x400_Eng

PQA Opioid Core Measure Set

The Pharmacy Quality Alliance (PQA) has released performance measures to create metrics that measure and help address the opioid epidemic.  The PQA Opioid Core Measure Set includes 4 measures that can be analyzed to help ensure safe and appropriate prescribing of opioids. The fours measures are:

  • Use of Opioids at a High Dosage in Persons without Cancer (OHD)
    • Proportion of individuals with daily dosage >120 MME for 90 or more consecutive days
    • Excludes hospice and cancer patients
    • Used in both Medicare Part D Patient Safety and Medicaid Adult Core Set
  • Use of Opioids from Multiple Providers in Persons without Cancer (OMP)
    • Proportion of individuals with four or more prescribers AND four or more pharmacies
    • Excludes hospice and cancer patients
    • Used in Medicare Part D Patient Safety
  • Use of Opioids at High Dosage and from Multiple Providers in Persons without Cancer (OHDMP)
    • Proportion of individuals with daily dosage >120 MME for 90 or more consecutive days, AND patients who received opioid prescriptions from four or more prescribers AND four or more pharmacies
    • Excludes hospice and cancer patients
    • Used in Medicare Part D Patient Safety and planned for 2019 Part D display page
  • Concurrent use of Opioids and Benzodiazepines (COB)
    • Percentage of patients 18 years and older with concurrent use of prescription opioids and benzodiazepines for 30 or more cumulative days
    • Excludes hospice and cancer patients
    • Used in Medicare Part D Patient Safety and planned for 2021 Part D display page, also used in Medicaid Adult Core Set

These 4 measures have been utilized by the Centers for Medicare & Medicaid Services (CMS), which are reporting all four PQA opioid measures in their Medicare Patient Safety reports.  The Part D display page will incorporate the measure assessing high dosage and multiple providers (OHDMP) in 2019. The Medicaid Adult Core Set of 2018 includes PQA’s opioid high dosage (OHD) and concurrent opioid and benzodiazepine (COB) use measures.

The PQA has formed a taskforce that is developing 3 new measures focused on initial opioid prescribing. These 3 measures relate closely to the recent opioid guidelines from the CDC advising providers to what to avoid the following when starting opioid therapy:

  • Percentage of patients with Long-Acting/Extended Release Opioids prescriptions
  • Percentage of patients with 50 or greater morphine milligram equivalents (MME) per day
  • Percentage of patients with more than 7 days’ supply

These 3 new measures will be completed and added to the Opioid Core Measure Set in 2019 for providers to assist in ensuring appropriate use of opioids.

According to the CDC a dose of 20-50 MME/day is considered a low dose.  The risk of death and overdose is directly proportional to the MME amount and a higher MME has not shown to reduce pain over time. Therefore, higher doses will increase the risk of harm to the patient without providing any benefit of pain relief. The Veterans Health Administration (VHA) reported between 2004 and 2009, patients who died of opioid overdose were prescribed an average of 98 MME/day. To put this in perspective 50 MME/day is equivalent to:

  • 50mg of hydrocodone (10 tablets of hydrocodone/acetaminophen 5/300)
  • 33mg of oxycodone (roughly 2 tablets of oxycodone sustained-release 15mg)
  • 12mg of methadone (<3 tablets of methadone 5mg)

Providers should refrain from starting a patient on long acting formulations of opioids to decrease the risk of dependency and overdose. However, the OHD, OMP, OHDMP, and COB measure sets may be considered too liberal to change patient outcomes.   A patient who has an opioid abuse problem can easily be under the proposed thresholds and therefore the results of each measure may exclude patients with opioid problems.  These metrics will likely be refined once the they are used and evaluated in the market.

 

Published September 2018

“What Happens When We Run Out of NDC Numbers?” – FDA Announces Public Hearing

Just over a year ago, I wrote an article published in Computer Talk for the Pharmacist titled “What Happens When We Run Out of NDC Numbers?”  Many may have thought that there was still plenty of time to address the issue of running out of NDC labeler codes or that maybe this was not an immediate concern.

Now there is an indication that this issue is real.  The FDA announced a public hearing November 5, 2018 to consider the future format of the NDC.  A change will be necessary when the agency runs out of 5-digit labeler codes.  The FDA states it is aware that any modification to NDC format or length will impact all systems that use the NDC.

In my article last year, I posed several questions to start a discussion regarding this issue.  Length and utilization of alphabetical characters were two topics to consider.  The FDA is proposing four options regarding NDC length and some general questions to contemplate while studying the options.  PHSI encourages our readers to review the options and ask themselves the questions posed by the FDA.

FDA’s options A and B are the status quo, but at some point, the FDA will start assigning 6-digit labeler codes which will result in NDCs in five different configurations – the three currently used: 4-4-2, 5-3-2, and 5-4-1, plus two new configurations: 6-3-2 and 6-4-1.

FDA option C converts the current FDA 10-digit NDC to the 11-digit NDC format used by pharmacies and in claims processing systems.  When the FDA runs out of 5-digit labeler codes, it will begin assigning 6-digit labeler codes to be used in 6-3-2 and 6-4-1 formats.  A potential concern with this option exists because it could possibly lead to an identical 11-digit NDC for two different products, one with a 6-digit labeler code and the other with a 5-digit labeler code.

FDA option D has the FDA “harmonizing” NDC assignment by moving to a uniform NDC in a 6-4-2 format at a future date.  This results in every current 10-digit NDC being converted to a 12-digit NDC.  The FDA will give the industry time to prepare for this major change, but the industry MUST be ready when it is time for the FDA to assign the first 6-digit labeler code and requires NDCs to be presented in the 6-4-2 format.

I like Option D because it is the change that will take the industry well into the future without needing to resolve potential issues caused by Options A, B, and C.  However, I question if there is going to be expansion of the NDC and all the fields that accommodate the NDC, why not take it further, such as up to the 19 digits already allocated in the NCPDP standard?

For example, using the same format basis used now, create an 8-8-3 format.  Even though the addition of a digit to each section of the NDC exponentially increases the number of NDCs available, there may be a need to differentiate newer products (e.g., a radiologic, or a new dosage delivery system) at the product or package size level requiring an extra digit or two.  Sometime in the future there might be a move toward real harmonization of the various identifiers for health care products, such as the NDC and the UDI, which might require an extra digit or two to help with harmonization and differentiation.  It is also possible one or two digits would be needed to identify a product number as an NDC or UDI (like the UPC value used to do that), which might require the creation of a fourth partition.  These are ideas that stakeholders using NDC numbers need to consider when thinking about their response to the FDA options.

The industry needs to assess this situation, voice their position on each option, and consider the lead time required to implement any of the changes required by the final resolution.  I mentioned in my article last year that it would be better if the industry initiated the effort as opposed to the government.  Now the government is facilitating a discussion.  In one response, NCPDP’s Maintenance and Control Work Group has reactivated its NDC Scarcity Task Group to prepare comments on the proposed FDA options.  It is important the industry participates to prevent a government mandate with an aggressive timeline that does not meet industry needs.

By Dave Schuetz

 

Published September 2018

 

2018 Fall Newsletter:

Formulary Exclusion Lists for 2019

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Medicare Part B Allowing Step Therapy

The Centers for Medicare & Medicaid Services (CMS) announced a change in guidance on the use of step therapy on Part B drugs in Medicare Advantage plans.  In 2012, CMS prohibited the use of step therapy on Part B drugs.  CMS reversed that decision and will now permit the use of step therapy.

The CMS change becomes effective January 1, 2019 and allows the use of step therapy for new patients initiating therapy on a Part B drug.  Patients receiving Part B drugs today are excluded from the step therapy requirements.  The existing exception process for Part B drugs allows beneficiaries to bypass the preferred product for medically necessary conditions.

This change will allow Part B plans to guide therapy to preferred products for new patients.  By regulation, the Medicare Advantage plan’s preferred option in the step therapy must be a covered Part B or Part D drug.

Biosimilars may experience increased use on Medicare Advantage plans if they receive preferred placement in the step therapy protocol.  Originator biologics remain available to those receiving treatment before the step therapy implementation or for medical necessity exceptions.  Medicare Advantage plans use of step therapy on Part B drugs may accelerate biosimilar uptake in the future.

 

Published September 2018

Medication Adherence Metrics

The two most widely used approaches for calculating medication adherence are medication possession ratio (MPR) and proportion of days covered (PDC).

MPR
The MPR is likely to overestimate adherence levels because the formula does not account for early refills. Using MPR to measure adherence can produce outcomes greater than 100. Consider if a patient were to pick up their prescription for 30 tablets of atorvastatin 40mg taken once daily and came back to the pharmacy 25 days later to refill this prescription. In this case, the patient would be five days early picking up their atorvastatin refill. The sum of days’ supply for all fills in the refill period is 30 while the number of days in the refill period would be 25. MPR would be 1.2. This problem was resolved by the PDC adherence measurements.

PDC

PDC caps the adherence rate at 100 because the PDC accounts for patients that refill their prescriptions early. The overlapping days’ supply on an early refill will be moved forward to the first day that the patient would not have medication from their previous prescription fill. PDC has been endorsed by Pharmacy Quality Alliance (PQA). The Centers for Medicare and Medicaid Services (CMS) have incorporated PDC as the medication adherence metric for plan ratings. PHSI recommends use of the PDC when calculating patient adherence.

 

Published June 2018