DEA Launches SORS as Vehicle to Report Suspicious Drug Orders
The DEA launched
the Suspicious Orders Report System
Online, a centralized database required by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT Act. The purpose of the database is for DEA-registered distributors to report suspicious orders pursuant to the law. The SUPPORT Act states the term "suspicious order" may include, but is not limited to: an order of a controlled substance of unusual size; an order of a controlled substance deviating substantially from a normal pattern; and orders of controlled substances of unusual frequency under the law. Pharmacies will only need to report to the database if they are registered distributors with the DEA.
FDA Issues Statement on Increasing Patient Access to Generic Drugs
To help improve access to medications, Food and Drug Administration (FDA) has granted full or tentative approvals to 1,171 new generic drugs in fiscal year 2019, the agency announced in a
. The statement acknowledges that increasing access to generic drugs requires consumers to have confidence in the safety and quality of these medications. Further, FDA noted that its scientific review and assessment process has found that generic medications perform the same way in the human body and have the same active ingredients as their counterpart name brand medication. FDA also notes that it continues to monitor the safety, effectiveness, and quality of generic medications even after the medications meet the agency's high approval and manufacturing standards.
"The value of our generic drug program runs deep, and we are engaged in a number of efforts to help ensure the program remains vibrant," FDA writes in the statement. "We're encouraged to see that the pipeline of generic drug applications is strong and that there is ongoing interest in the development of generic versions of complex drugs and of other drugs with inadequate generic competition."
The agency added that they expect to publish additional guidelines and take other important policy steps related to this issue in the coming months.
HHS Announces Guide for Appropriate Tapering or Discontinuation of
Long-Term Opiate Abuse
The United States Department of Health and Human Services (HHS) has published a new guide for clinicians intended to provide guidelines for tapering or discontinuing long-term opioid use. The guide, titled
HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics
, covers important issues to consider when changing a patient's chronic pain therapy. The guide also lists issues to consider prior to making a change, when initiating the change, and as a patient's dosage is being tapered, including the need to treat symptoms of opioid withdrawal and provide behavioral health support.
"Care must be a patient-centered experience. We need to treat people with compassion, and emphasize personalized care tailored to the specific circumstances and unique needs of each patient," said ADM Brett P. Giroir, MD, assistant secretary for health in a press release. "This Guide provides more resources for clinicians to best help patients achieve the dual goals of effective pain management and reduction in the risk for addiction."
Updated Medicare Plan Finder is Up and Running
CMS has launched a redesigned
Medicare Plan Finder
to help its 60 million beneficiaries shop and compare Medicare Advantage and Part D plans. The new plan finder, updated for the first time in a decade, walks users through the Medicare Advantage and Part D enrollment process from start to finish and allows people to view and compare many of the supplemental benefits that Medicare Advantage plans offer.
The updated plan finder also provides beneficiaries and their caregivers with a personalized experience through a mobile-friendly and easy-to-read design that will help them learn about different options and select coverage that best meets their health needs.
In 2019, CMS added nearly 600 Medicare Advantage plans with average premiums declining to their lowest levels in six years. Over the past three years, average Part D basic premiums have decreased by 13.5 percent, from $34.70 in 2017 to a projected $30 in 2020. Open enrollment begins Oct. 15.
Less Than Half of Adults Plan to Get Flu Vaccine
Flu season is rapidly approaching, but even as agencies such as World Health Organization and Centers for Disease Control and Prevention (CDC) emphasize the importance of the flu vaccine as a way patients can protect themselves, less than half of patients actually get the vaccine. In fact, according to CDC, only 40% of United States adults received a vaccination for the flu in the 2017-2018 season, while about 63% of children received the vaccine.
Many Americans believe that flu vaccines do not work, or that they have significant side effects, according to ABC News. Health care providers, including pharmacists, may be able to help correct these misperceptions by prompting a discussion with patients and reminding them that even partial protection is better than no protection. For example, those who receive the vaccine are likely to have a less severe and shorter illness, even if they still get the flu.
Providers can also use materials provided by CDC in their
2019-20 HCP Fight Flu Toolkit
, which is available for free on the CDC website, to facilitate productive conversations with patients and to improve flu vaccination rates.
FFF Offers Flu Vaccine Posters at No Charge
PFOA vendor partner, FFF Enterprises
understands the importance of communicating the value of getting vaccinated with your patients. They are offering new flu resource posters at no charge for your stores.
Flu posters are available in
English, Spanish, Mandarin, Tagalog, Japanese, Korean and Vietnamese.
Complete Your 2019 Fraud, Waste and Abuse Attestation
by December 31st
Please take a moment to complete your 2019 FWA Attestation. All attestations must be completed before the end of the year to remain in compliance with CMS and our contracted PBMs. If you have already completed your attestation, thank you!
How to Complete the Attestation
CMS has developed a standardized FWA training education module, available on their Medicare Learning Network. You will need to create a CMS account to access the training.
Why FWA Attestation Matters
CMS provides guidance and specific requirements to participate in Medicare Part D. In order to continue to participate in Medicare Part D Plans and service Medicare patients, all Provider personnel must complete training each calendar year.
Non-compliance could result in your exclusion from Medicare Part D participation.
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(FPN) Federation of Pharmacy Networks
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(NCPA) National Community Pharmacists Association
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Boards of Pharmacy
(NASPA) National Alliance of State Pharmacy Associations
With holidays fast approaching and 2019 drawing to a close, a short update on PFOA is in order.
In October, PFOA sent representation to NCPA's annual meeting in San Diego. We found new vendors, brought back educational materials and met with key people in the industry. If you would like more information, we will share the reporting that we have put together. Please provide your request to your PFOA sales representative.
In November, staff members attended the ECRM technology show for pharmacy. The staffers were very impressed with new products and services offered by the vendors and PFOA will vet and present several to the Vendor Committee before rolling out to the membership.
PFOA continues to reorganize our reporting process that allows improved efficiencies. We have also revamped some of our rebate reporting for our members, better allowing them to know where and how they earn these rebates.
Flu season is ramping up and it is important to make sure to capture the last of the immunization opportunities as well as having prescription products related to those that get the flu. Using your social media, in store promotion and bag stuffers can assist in highlighting some of this as well as having on hand the appropriate OTC and HBA items in prominent places.
We are in the middle of Medicare sign up season and an independent pharmacy should be equipped to help their patients choose the appropriate program.
Fraud waste and abuse reporting should be considered and completed.
Contact PFOA for more information on any of these areas.
I thank you for being a member of PFOA and allowing me the honor of being its executive director.
Antibiotic-Resistant Infections More Common than Previously Estimated, CDC Reports
The Centers for Disease Control and Prevention (CDC) has updated its estimate that antibiotic-resistant bacteria and fungi are responsible for more than 2.8 million infections and 35,000 deaths in the United States each year. These estimates rely on data sources not previously available, and show that there were nearly twice as many annual deaths from antibiotic-resistant infections as CDC originally reported in 2013.
The new report, Antibiotic Resistance Threats in the United States, establishes a new national baseline of infections and deaths from antibiotic-resistant germs and categorizes the top antibiotic-resistant threats based on level of concern to human health. The report also outlines progress made in reducing antibiotic-resistant infections, which were reduced by 18% overall and by nearly 30% in hospitals. However, the agency emphasizes the importance of continued vigilance. Included in the report is a section for health care providers that includes suggestions for preventing infections and improving antibiotic prescribing.
In a press release, CDC outlines several actions they will continue to take to address antibiotic resistance. These include ongoing work with state and local partners to expand the national response and prevention capacity and working with private industry stakeholders to enhance product and surveillance capabilities.
"The new AR Threats Report shows us that our collective efforts to stop the spread of germs and preventing infections is saving lives," says Robert R. Redfield, MD, director of the CDC, in the press release. "The 2013 report propelled the nation toward critical action and investments against antibiotic resistance. Today's report demonstrates notable progress, yet the threat is still real. Each of us has an important role in combating it. Lives here in the United States and around the world depend on it."
Annual Snapshot of Community Pharmacy is Here
NCPA Convention attendees got a first look at the 2019 NCPA Digest, sponsored by Cardinal Health, the annual barometer for independent community pharmacy owners to quantifiably measure themselves against their peers and their competitors. The Digest provides a summary of selected financial and demographic information that illustrates the independent community pharmacy market and the valuable services these pharmacies deliver to their patients and is the most comprehensive report on independent community pharmacy available. This year's Digest also establishes the role of the steadily growing CPESN® USA network of clinically integrated pharmacies in efforts to change the pharmacy payment model.
Among the important statistics in this year's Digest:
- 91 percent of community pharmacies are offering some type of medication adherence program, aligning the interest of patients, payers, pharmacists, and plans.
- 79 percent offer medication synchronization services.
- 76 percent provide flu immunizations.
- 57 percent perform blood pressure monitoring.
- 53 percent furnish durable medical goods.
- 65 percent of all independent community pharmacy owners donated to at least five local organizations in 2018
Local Pharmacies Pushed to Brink by Pharmacy Benefit "Monopolies" (PBMs), National Survey Shows
A substantial majority of independent pharmacies say they may close their doors in the next two years, and the main culprits are multi-billion-dollar corporate middlemen who are shaking them down for fees on medicines long after the point of sale, according to a new survey by the
National Community Pharmacists Association (NCPA)
, released today.
"Neighborhood pharmacies are being mugged in broad daylight and no one in Washington is doing anything about it," said
NCPA CEO B. Douglas Hoey
. "If Congress or the administration don't act soon, we're going to see a wave of layoffs and store closures that will leave many patients stranded without access to a local pharmacist."
According to the survey, 58 percent of independent pharmacists say they are somewhat likely or very likely to close their doors in the next two years if things don't improve. Another 19 percent aren't sure they'll be around then. A nearly identical number (59 percent) rate the health of their business as somewhat poor or very poor.
"These are staggering numbers," said Hoey. "Local pharmacies are on the brink, and this should be a blaring siren for every policymaker in Washington who cares about these local businesses, the jobs they provide, and the patients they serve.
Their main problem, respondents say, are direct and indirect remuneration fees, known as DIR fees. The fees are imposed by pharmacy benefit managers (PBMs), which are large corporations in the middle of the pharmacy supply chain that are nevertheless invisible to most patients and policymakers. That's because they work behind the curtain for insurance plans, including Medicare and Medicaid, to negotiate which drugs will be covered, steer patients into pharmacies of their choosing, require drug makers to 'pay to play' to be covered by the plans, dictate how much pharmacies must charge for the drugs and, incredibly, PBMs also decide how much to claw back from pharmacies long after the point of sale.
Sixty-three (63) percent of local pharmacies say the back-door pharmacy DIR fees are their biggest problem. A substantial percentage (22 percent) say decreasing reimbursement is their top problem.
"Eighty-five percent of all prescriptions filled in the US are controlled by three PBMs. Together they exert monopoly like control on pharmacies," said Hoey. "And that's how you end up with local pharmacies being forced to lose money on prescriptions. No business can survive that way, and based on this survey, many won't."
Things are so dire that 48 percent of local pharmacies say they expect to reduce staff in the next year. Thirty-one (31) percent will try to hang onto the employees they have currently. Only five percent think they'll create new jobs. Independent pharmacies, which outnumber any of the big box chain companies, employ hundreds of thousands of Americans and are often the only healthcare source for underserved communities.
In the next 12 months, 77 percent of local pharmacists say they'll be forced to try to cut costs by reducing the amount of money and support they give to community organizations. Thirty-six (36) percent say they'll reduce hours of operation; thirty-three (33) percent will cut services.
"Local pharmacies do a lot more for their community than dispense pills," said Hoey. "These are small business owners who volunteer their time, donate to civic groups, employ their neighbors, and serve patients for whom, in many cases, the local pharmacist is the only healthcare provider around. The PBMs are forcing them to make some very unfortunate decisions, and potentially millions of people will be affected."
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