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Arine’s Virtual Pharmacist Platform Seeks to Decrease Medication Errors

Arine offers a Virtual Pharmacist platform designed to ensure patient safety and reduce human medical error costs. The platform uses a clinical database to continuously identify and resolve drug therapy problems in a patient’s medication therapy regimen. The platform does this by gathering information about the patient, which includes EMR data, lab results, medical and pharmacy claims, quality and risk data, and data obtained from a tailored patient-facing questionnaire. Arine’s Virtual Pharmacist uses the patient information to generate automated medication recommendations based on the latest available clinical guidelines. The medication recommendations are sent out to all providers involved in the patient’s healthcare regimen via their preferred method of communication. The software also provides recommendations on how to lower costs based on a payer’s drug coverage criteria, while reducing out-of-pocket costs for patients. The Virtual Pharmacist checks with the providers to confirm implementation of the recommendations and has the capability to track its own results. The platform uses actual cost and utilization data to demonstrate ROI and measure the clinical and economic impact of the delivered recommendations.

Unlike a traditional pharmacist, the “Virtual Pharmacist” does not work with patients one-on-one.  Instead, Arine targets health systems, and. the Virtual Pharmacist platform allows for the information of thousands of patients to be easily retrieved and reviewed by healthcare professionals, all while continuously monitoring the information with its own clinical database for prescription optimization.

Desert Oasis Healthcare (DOHC) has already partnered with Arine in hopes of improving patient care and decreasing medication costs for their 60,000 members. The partnership provides pharmacists, nurses, physicians, and other care team members access to the Arine software platform. State Medicaid Agencies may also partner with Arine, and the Oklahoma Health Care Authority has expanded its medication optimization program in 2019. Clinical pharmacists can use Arine’s platform to improve services to SoonerCare (Oklahoma Medicaid) high-risk, high-cost members. Medication errors can cost over $20 billion annually, but hopefully with growing innovative technology like Arine’s Virtual Pharmacist platform, a cost reduction can be realized.

 

Posted: March 2021

Medicare Part D Plans Required to Support Electronic Prior Authorization

Regulations concerning the Medicare Prescription Drug Benefit program’s (Part D) e-prescribing requirement under the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT Act” will be put into practice.  These newly adopted standards for Part D e-prescribing will ensure secure electronic prior authorization (ePA) requests and response transmissions.

The SUPPORT Act authorizes the Centers for Medicare & Medicaid Services (CMS) to require ePA capability for processing prior authorization requests by Medicare Part D Plans for Part D-covered drugs prescribed to Part D-eligible individuals. (more…)

The Battle Continues Over 340B

In November, we published a post detailing how several drug manufacturers would no longer be providing 340B drug pricing to most contract pharmacies.  As we predicted, the Department of Health & Human Services (HHS) reacted to this move, issuing an eight-page advisory opinion on contract pharmacies under the 340B drug program.

This guidance was published on December 30th and can be found here.  Within the HHS publication, the Office of the General Counsel (OGC) reiterated that contract pharmacies are acting as agents of the covered entity.  Furthermore, HHS notes that “manufacturers’ rationale for precluding the use of contract pharmacies is not supported by the language of the statue and leads to absurd results.”  HHS concludes by saying that drug manufacturers are required to deliver covered outpatient drugs to contract pharmacies and charge covered entities no more than the 340B ceiling price for those drugs.

On January 12th, three manufacturers sued HHS over this advisory opinion, with each company filing a separate lawsuit.  The manufacturers claim that the advisory opinion contradicts the 340B program statues and does not require manufacturers to recognize contract pharmacies.  On the other side, the American Hospital Association (AHA) and similar groups have also sued HHS to get the agency to clamp down on these manufacturers.  Getting sued from both sides, HHS will likely act on this issue and defend themselves in court.  With the 340B program seeing exponential growth in the past decade, it was only a matter of time before this issue came to a head.  PHSL will continue to monitor the situation and provide updates.

 

Posted January 2021

Emergency Use Authorization (EUA) Product vs FDA-Approved Product

The COVID-19 pandemic prompted the rapid development of diagnostic testing products to identify patients with the virus and vaccines to protect patients from contracting the virus.  This rapid development created broad awareness of the FDA’s Emergency Use Authorization (EUA) authority to help protect the public in health emergencies.  The number of products that received EUA in 2020 appears to exceed the number of EUAs seen for Anthrax, Ebola, Zika, or other health crises prior to this pandemic. EUAs are needed because the typical approval process takes too much precious time, prolonging a public health emergency.  Looking forward to when these products receive FDA approval for non-emergency use, there are industry considerations to facilitate a smooth transition from utilizing EUA products to using FDA-approved products.

Currently, EUA tests and vaccines are provided free of charge.  However, it is likely that once the same product receives FDA approval for commercial use, pharmaceutical manufacturers will charge for these products.  Therefore, for the purposes of inventory tracking, patient profile management, and claims submission, it is important that EUA product does not become confused with the FDA-approved commercial product.

To accomplish that, manufacturers should obtain an NDC for the commercially approved product that is different than the NDC given to the EUA product.  The product code of the NDC (middle segment) and/or the package size identifier of the NDC (last segment) should change in a way that clearly distinguishes between the EUA and approved product.  National Council for Prescription Drug Programs (NCPDP) encourages manufacturers to obtain new NDCs in this situation.

Since the NDCs for EUA products are listed by the drug compendia with no associated cost, the new NDC can be listed with the cost determined by the manufacturer, without affecting the EUA NDC. Different NDCs will provide the means for proper claims submission, indicating the product that was utilized, and allows the healthcare provider to log the appropriate product on the patient’s profile.  This will also help to track and separate inventory of unapproved EUA products in the channel before and after FDA approval of the commercial product.

Lastly, and most important, obtaining a new NDC for approved commercial products will help ensure there is no delay or denial for vaccine administration because of confusion stemming from EUA and FDA-approved product represented by the same NDC.

 

Posted: December 2020

Amazon’s Pharmacy Announcement

Three years ago, we wrote an article describing Amazon’s options in the pharmacy market and expected challenges.  Their announcement this morning confirms a number of our expected services, and we were three years ahead of time!  Please see our previous article at:

http://phsirx.com/wp-content/uploads/2017/10/SeptOct_Viewpoints_2017.pdf

Program Highlights

Amazon Pharmacy has been able to enroll in third party plans and will be accepting these prescriptions.  However, the focus appears to be on the cash market. They have partnered with Inside Rx to offer discount cash prices.  This appears to prevent losing margin dollars on third party prescriptions by avoiding the lower of clause in many third party agreements.  For insured patients, Amazon will provide patients with both their insurance copay and the cash pay amount, enabling them to choose the lower cost fill option.

Amazon will be leveraging Amazon Prime membership by offering free 2-day shipping on prescriptions compared to free 5-day shipping or $5.99 2-day shipping for non-Prime patients.  Amazon will offer their branded discount card for use at retail pharmacies, giving them additional information and opportunity to market to those patients.  It’s unclear why a retail pharmacy chain would want to support these programs.  Finally, Amazon Pharmacy is not including Schedule II controlled substances in its pharmacy offering at this time.

What impact do you think the Amazon Pharmacy will have on the market?

 

Posted November 2020

The Growing Concern of Medical Bankruptcy

Having health insurance may not always be enough to ensure that Americans can afford their medical expenses. The Affordable Care Act (ACA) had a positive impact on the number of people who have health insurance but did not affect the yearly percentage of people who filed for bankruptcy due to medical issues. Bankruptcy effects an estimated 530,000 families in the United States each year, with approximately two-thirds citing medical issues as a key contributor to their financial problems. These factors may include the high cost of medical care or the time required to be off work due to a medical condition.

A 2020 Gallup and West Health survey showed that 50% of American adults are concerned that a household health event could lead to the need to file for bankruptcy. This is an increase of 5% in just one year. The percentage of non-white adults who are concerned about medical bankruptcy has increased from 52% to 64% during this same period. Individuals aged 18-29 expressed a 12% increased concern, and adults 30-49 expressed a 9% increase in reported concerns over the possibility of having to file for bankruptcy due to medical expenses in the same one-year period.

Individuals who file for bankruptcy are not the only ones struggling from rising medical costs. A survey conducted by Bankrate reported that 75% of all workers in the United States say they are living paycheck to paycheck. This limits their ability to save for unexpected medical expenses or other emergencies. The COVID-19 pandemic has worsened the medical debt crisis for those that are uninsured and individuals who have lost their jobs due to business closures.

A 2019 KFF (Kaiser Family Foundation) Health Tracking Poll shows that 69% of Americans believe that reducing health care costs should be a priority for the president and Congress, second only to the economy. In the presidential election, differing health care coverage approaches allowing for expanded coverage was an important topic of discussion.  While the approaches to handling this growing issue may differ, pharmacists are perfectly positioned to help patients lower prescription drug costs.  Whether through evaluating product substitution alternatives, applying copay cards, or researching available patient assistance programs, pharmacists are the forefront.  A solution to minimize medical bankruptcy is not clear cut and will likely require cooperation among all industry stakeholders.

 

Posted November 2020

HRSA Response to Manufacturer 340B Changes

In September, several drug manufacturers announced that they would no longer be providing 340B pricing to most contract pharmacies.  You can read about those actions in our Fall 2020 Newsletter.  In response to those manufacturer actions, Apexus, the 340B Prime Vendor Program, published a sample form for covered entities to report instances where covered outpatient drugs are not available at a 340B ceiling price and/or are charged at the incorrect 340B ceiling price.

The form specifically asks if the issue reported is limited to a contract pharmacy purchase.  This question could help Apexus target where availability or pricing issues are specifically related to the recent manufacturer changes.  The form also asks the reporting party to note if purchasing is affected by a shortage-related issue, relates to a specialty drug, or is subject to limited distribution.  These questions may identify availability or pricing issues unrelated to recent manufacturer 340B actions.

Perhaps most telling is the instruction to “contact the wholesaler and manufacturer directly to determine the reason for unavailability and/or to document incorrect pricing” prior to submitting the form.  Per the form, “HRSA investigates allegations of non-compliance brought to its attention and will follow-up with all parties once the issue is reviewed.”  The form also asks if the covered entity has verified that the product is a covered outpatient drug, as listed on the Medicaid Drug Rebate Program file.  While this step is not listed as “required,” it may help to further validate a covered entity claim.

Completed forms, along with manufacturer and/or wholesaler responses, are to be emailed to HRSA.  Based on the availability of this form and its uptake and use by covered entities, HRSA may begin to quantify the extent and impact of manufacturers’ refusal to provide 340B pricing to all contract pharmacies.  Stay tuned as this chess match continues.

 

Posted November 2020

Ohio Provider Status for Pharmacists

On January 4th, 2019, the Governor of Ohio signed into law SB 265, which gave pharmacists provider status in the state and allowed Ohio pharmacists to perform services and receive payment after successful credentialing. Ohio’s Medicaid and Managed Medicaid programs are in the initial phases of including pharmacists as providers.

In April, United Healthcare Community Plan of Ohio announced that it would begin working with two independent community pharmacies in Ohio to expand access to care and help improve health outcomes in Ohio. During the COVID-19 pandemic, United Healthcare utilized the expertise of pharmacists to focus on caring for patients transitioning out of hospitals, assisting patients with the management of their chronic diseases (e.g. High Blood Pressure, Diabetes, etc.), helping to prevent adverse events, and optimizing therapies. This program also enabled pharmacists to bill and receive reimbursement for providing services using existing CPT codes for evaluation and management, virtual check-ins, and transitional care management.

Ohio’s Centene managed care organization, through Buckeye Health Plan, launched a program in June 2020; during the initial phase, participating pharmacists worked with physicians at a health system and two federally qualified health centers.  Pharmacists served patients living with chronic conditions through monitoring and adjusting medication, demonstrating medical equipment use, ordering lab tests, and providing preventative care, including vaccinations.

CareSource, an Ohio Managed Medicaid plan, announced a provider status program focused on two independent community pharmacies near Dayton, Ohio: an independent pharmacy in a rural community, Camden Village Pharmacy, and an inner-city independent pharmacy, ZIKS Pharmacy. The pharmacists in this pilot program will focus on CareSource patients that have been identified as being at high-risk or in need of care for tobacco cessation, opioid management, diabetes, and/or asthma. The CareSource pharmacist provider status pilot will also be added to the Value-Based Reimbursement opportunity that was released by CareSource in January 2020. This will allow pharmacists the ability receive payment for increasing the quality of care of patients.

The Ohio Department of Medicaid announced they will create provider identification numbers for pharmacists in January 2021.  The Ohio Department of Medicaid has begun compensating pharmacists for conducting COVID-19 testing.

Ohio pharmacists will not be included as providers for Medicare plans until federal changes occur.  Commercial plans may choose to include pharmacists as providers but are not required.  Will we see other states following Ohio’s lead? Are you advocating for this type of change in your state?

https://www.pharmacytoday.org/article/S1042-0991(20)30871-9/fulltext

 

Posted October 2020

Recognizing Pharmacists’ Contributions During American Pharmacists Month

American Pharmacists Month represents a celebration of pharmacists across the country to appreciate their hard work, dedication, and their contributions for improving patient health outcomes. Pharmacists provide massive contributions to health care and the well-being of communities. They are the most patient-accessible primary health care professionals. This year more than ever, front-line pharmacists are of particular importance to patients and communities during the COVID-19 pandemic.

Whether filling medications in community pharmacies, managing patient regimens in the ICU, or working to develop and deliver a vaccine, pharmacists continue to play an important role in managing and preventing the spread of COVID-19. The American Pharmacist Association (APhA) aims to commemorate and bring awareness to the wide array of traditional and new services pharmacists provide.

These are just a few of the ways pharmacists are fighting COVID-19:

  • Offering Point-of-Care testing for COVID-19 to help alleviate future surges of infections
  • Providing and advocating for immunizations
  • Encouraging patients, especially those with an increased risk of severe illness, to use curb-side pickup and home delivery services
  • Compounding hand sanitizers
  • Managing medications and ensuring quarantined patients have adequate supplies
  • Educating communities
  • Checking in on patients with chronic conditions who struggle to access their primary care providers during the pandemic

The challenges of the pandemic allow pharmacists to showcase their skills and shine a light on their importance in the healthcare system. The emergence of new roles and innovative practices for pharmacists will likely arise post-pandemic to further improve patient and population health.

To get involved in recognizing and celebrating the pharmacists of our country, use the link below to access ASHP’s engagement calendar of National Pharmacist Month events:

https://www.ashp.org/Pharmacy-Practice/Resource-Centers/Public-Relations/National-Pharmacy-Week/Engagement-Calendar

 

Posted October 2020

National Prescription Drug Take Back Day

The next National Prescription Drug Take Back Day, sponsored by the Drug Enforcement Administration (DEA), is scheduled for Saturday, October 24, 2020 from 10:00 am to 2:00 pm. Based on the 2019 National Survey on Drug Use and Health, 9.7 million Americans misused controlled prescription drugs in the previous year, a slight decline from the numbers reported in 2018. Having unused medications at home has been shown to contribute to this misuse. The previous Take Back Day scheduled for April 25, 2020 was cancelled due to coronavirus concerns, which may have left you or your patients with medications to get rid of. This event is a safe, convenient, and responsible way to dispose of unused, unwanted, or expired prescription drugs at locations in communities throughout the country. Take your pills and patches for disposal to the event on October 24th. Sites cannot accept liquids, needles, or sharps. The drug take back service is free and anonymous, no questions asked.

The last National Prescription Drug Take Back Day held in October of 2019 collected 441.5 tons of medication at 6,174 participating sites across the country.

You can search for a participating Drug Take Back Day disposal site near you by visiting https://takebackday.dea.gov/

If you are unable to attend the National Prescription Drug Take Back Day, you can dispose of your medications at a year-round pharmaceutical disposal location. Visit the U.S. Drug Enforcement Administration Diversion Control Division at https://apps2.deadiversion.usdoj.gov/pubdispsearch to locate a site near you.

 


 

Posted October 2020