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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 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

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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

Increasing Naloxone Access

In April 2018, U.S. Surgeon General Jerome M. Adams issued a statement urging more Americans to carry the opioid overdose reversal agent, naloxone. This recommendation was not aimed exclusively at illicit drug users, rather it targeted patients taking prescription opioids, family and friends of someone taking an opioid, and community members who encounter individuals at risk for opioid overdose. Within his statement, Dr. Adams said: “knowing how to use naloxone and keeping it within reach can save a life.”

The emergent need to address opioid abuse in the U.S. has magnified as the number of related deaths has soared in recent years. The number of annual deaths to opioid overdose has doubled since 2010 and quadrupled since 1999. Over 42,000 Americans lost their lives to opioid overdose in 2016. As a result, President Trump released an October 2017 statement declaring the opioid epidemic a public health emergency. Of note, 77% of overdose deaths occur outside of a medical setting, with more than half occurring at home. The fact that so many overdose deaths occur away from medical settings shows the potential impact that increasing naloxone distribution could have.

The pharmacy industry is well poised to help increase access to naloxone.  All 50 states have passed naloxone access laws as of 2017, allowing measures to make the drug easier to obtain, including access to naloxone without a doctor’s prescription in most states. Many pharmacies have seized the opportunity of these laws and make naloxone available for purchase without a prescription where permitted.

Efforts to combat the opioid epidemic are multifaceted.  The Surgeon General’s statement highlights the importance for all of us to take action and potentially acquiring naloxone to have readily available if needed.  No one knows when that time may come but being prepared by having naloxone available will save lives.

 

Published April 2018

Drug Take Back Day is April 28th!

National Prescription Drug Take Back Day is Saturday April 28th, 2018 from 10 AM to 2 PM, to take back unwanted prescription drugs.  This will be the 15th National Take Back Day, which aims to provide a safe, convenient and responsible means of disposing of prescription drugs while educating the public about the potential for abuse of prescription drugs.  For more information on Drug Take Back Day and to find a collection site near you, please visit https://www.deadiversion.usdoj.gov/drug_disposal/takeback/.

 

Published April 2018

Hospitals Forming New Generic Labeler

Intermountain Healthcare along with several other hospitals announced the creation of a not-for-profit generic drug labeler.  This new entity intends to sell generic pharmaceuticals for use in hospitals where supply availability has been challenging and costs have risen.  The U.S. Department of Veterans Affairs is also involved but has provided no financial support.  Hundreds of hospital systems have inquired about the new venture and over one thousand hospital systems may eventually participate.

The not-for-profit labeler targets the first quarter of 2019 to begin supplying product.  The new venture plans to deliver up to 20 products.  The hospitals expect to save money by signing long term agreements.

Marc Harrison, MD, President and Chief Executive Officer of Intermountain Healthcare stated in an interview that if the issues with generic pharmaceuticals ended today, the hospitals would stop the project because it would be unnecessary.

PHSI’s Assessment

These hospital systems underestimate the challenges ahead.  Established competition already exists and will not disappear.  The laws of supply and demand are a primary factor in current product availability and cost; whether the generic manufacturer has a profit motive is not a primary factor.  For-profit generic manufacturers have the incentive to produce and sell products where there is sustainable demand and profitably pricing opportunities.  Generic manufacturers are not ignoring their customers and planning on limiting their product sales.  There are challenges with access to quality active pharmaceutical ingredients (API), FDA regulations, and quality injectable manufacturing capacity.  Manufacturing generic injectable products is difficult and requires substantial investment to create and maintain a production facility.  When experienced manufacturers have challenges with manufacturing sterile injectables, how will an upstart project without experience do any better?

Do you think this new venture will succeed?

 

Published March 2018

Outcomes Based Agreements (OBAs)

Through value-based drug contracts, payments for medications are based on the value they provide to patients. Value-based contracts can include indication-based pricing, outcomes-based agreements (OBAs), and cost cap-based contracting. OBAs have gained publicity for their innovative approach to pharmaceutical contracting. OBAs tie the compensation for a medication with the clinical performance/outcome in a specific patient population. Manufacturers are motivated to participate in OBAs by increased market access for their products, while payers are motivated by risk sharing with the manufacturer.

The biggest challenge for both manufacturers and payers is identifying and measuring outcomes. The outcome measurement must accurately reflect the drug’s intended effect and be readily available. Surrogate markers such as LDL and A1C may be used as they are more easily measured and tracked. Once manufacturers and payers agree on an outcome measure, they must determine how the metric will be monitored. The operating cost to monitor the outcomes must be evaluated. Because of these constraints, the number of OBAs currently implemented in the U.S. are limited. Products that have established OBAs include Harvoni, Repatha, Kymriah, Luxturna, and Entresto.

OBAs are expected to grow and their use will likely be restricted to high cost, brand drugs with specific and measurable outcomes. Further use of OBAs can help to assess the economic impact of costly new therapies on patient outcomes and overall health spending with a focus on pharmaceuticals.

Do you think that OBAs will decrease spending on prescription drugs or healthcare as a whole? What drugs do you think would be ideal candidates for OBAs? What other benefits do OBA’s provide for payers?

 

Published February 2018

Transition to UDI: Get Ready!

The UDI (Unique Device Identification) is a global identification system replacing the NHRIC or NDC number used with medical devices. Manufacturers establish the device identification (DI) portion of the UDI using standard codes like the GTIN (Global Trade Item Number), which is a 12, 13 and 14-digit identifier. The FDA UDI regulations require that medical device packaging labels have a UDI and the device have a permanent marking bearing the UDI, if it can be used more than once.

Device manufacturers must also submit UDI data to the FDA’s Global Unique Device Identification Database (GUDID). The National Library of Medicine provides public access to the GUDID via this website: https://accessgudid.nlm.nih.gov.

All medical devices are subject to the UDI regulation unless an exception or alternative applies.  High risk devices (Class III) and devices licensed under the PHS Act, were to comply with the labeling regulation by September 24, 2014.  Medium risk devices (Class II) were to comply by September 24, 2016.  Class I and unclassified devices were originally required to comply by September 24, 2018.  However, the FDA extended its enforcement discretion for Class I and unclassified devices to September 24, 2020.

The UDI regulation states that on the date a device must bear a UDI the manufacturer/labeler may no longer provide an NHRIC (National Health Related Item Code or HRI) or NDC (National Drug Code) number on the label of the device or on any device package. This situation creates transition issues if all supply chain participants are not prepared. To further complicate this issue, beginning on September 24, 2018, the manufacturer/labeler may no longer provide an NHRIC or NDC number on the label of the device or on any device package regardless of the class of device.  Recognizing market challenges presented, the FDA stated that it “does not intend to enforce the prohibition against providing NHRIC and NDC numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021.”

The labeling portion of the regulation can be found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.57.

Pharmacies need to consider how the implementation of the UDI will affect their business systems and workflow. Organizations need to ask the following questions:

  • Does your organization fully understand the implications of the UDI regulation and guidance on your systems and business processes? The deadline for the transition from NHRIC and NDC numbers for devices is September 24, 2021.
  • How is your pharmacy IT team or software vendor addressing the implementation of UDI so that systems will be ready to use the UDI before the compliance date?
    • How are they addressing the transition from using a pseudo-NDC or NHRIC (a.k.a., HRI) number to the Device Identifier (DI) part of the UDI? When will the pharmacy system’s product file (i.e., drug file, item file, etc.) be updated to handle an identifier that is not in an NDC format? What provisions are the drug compendia making in their product database to utilize UDI? When will the pharmacy system be ready to submit UDI on insurance claims?
  • Do your pharmacies have bar code scanners that can read bar codes associated with the UDI? Will bar code scanners need to be updated or replaced to read a UDI bar code, which may be in a different bar code format? What are the costs associated with these options?
  • Will your pharmacy system be ready to use a UDI bar code if a manufacturer/labeler converts before the compliance date?
  • When will your PBM partners be ready to accept claim transactions with UDI numbers?
  • How will implementation of the UDI affect:
    • Inventory management systems?
    • Downstream data collection, such as third party claims reconciliation systems and data warehouses?
    • Interfacing systems, such as POS?
  • What training is required for pharmacy staff for the transition to UDI numbers and the technology changes that will be needed?
  • Has your organization assigned a “point person” for understanding UDI regulations, the implementation timeline and how to use and understand the GUDID database?

PHSI recommends that you begin proactive planning to help prepare your organization and minimize the potential disruption to your business practices. Now is the time to begin discussions with internal resources and external partners that will be impacted by these changes or you will end up reacting to these changes on an external timeline.

 

Published February 2018

When Do Brand Medications Cost Less Than Generics?

Loss of Exclusivity (LOE) for brand medications and the introduction of generics sets in motion activities to quickly convert new and existing prescriptions to the newly approved generic. Electronic Medical Records (EMR) and pharmacy dispensing systems are designed to prompt physicians and pharmacy staff that a new generic is available. The purpose of these system prompts is to reduce costs for patients and payers. However, there are exceptions when brand medications cost less than generics, which may impact prescribing and dispensing activities. Traditional Fee for Service (FFS) Medicaid plans like New York and Tennessee maintain a subset of brand products on their formularies post LOE for physicians and pharmacy to prescribe and dispense. The mandatory brand rebate (23.1%) plus the Consumer Price Index (CPI) penalties may extend discounts in excess of 80% of the brand WAC discount. The CPI penalty is a cumulative percentage calculated by taking the difference between the WAC price increase in a given year and the corresponding annual rate of inflation. For instance, if the inflation rate is 3% and a manufacture increases price 10%, the CPI penalty will be 7% for that year, and then increases each year if the manufacturer continues to increase price greater than the base CPI rate (i.e.: 3%).

Generic pharmaceuticals that have limited competition (i.e.: 180 day exclusivity periods) are not heavily discounted. While pharmacies buy generics for less than their innovator products, payers can dictate which product is to be dispensed. The rebates that the traditional Medicaid plans realize for these selected brands generate lower cost to the state than generics. Therefore, NY and TN Medicaid plans will reject the generic and prompt the pharmacy staff to use the brand product.  As additional generic suppliers enter the market and price falls, these Medicaid plans will align with generics and no longer prompt pharmacies to dispense brands.

Commercial payers and PBMs may follow a similar model for some high-profile brands where the rebates generated from the brand make economic sense to keep the brand on formulary post LOE. In this situation, commercial patients pay a generic copay either through the plan design or a copay buydown program sponsored by the pharmaceutical manufacturer. Otherwise, there would be no patient savings and only the plan sponsors would benefit.  We have also seen these programs when the LOE event is in the middle or end of the calendar year and the payer/PBM choose to maintain formulary position until the new plan year to minimize patient disruption.

These scenarios are still exceptions to the “generics first” mantra that payers/PBMs and pharmacies employ. Pharmacy workflow is disrupted when pharmacy staff select and submit a generic claim only to learn that they need to redo the prescription and submit the brand product. The next time you see a Medicaid or commercial payer maintain a brand on formulary post LOE, you now understand why these tactics are being used.

 

Published January 2018