In 2015, the owner and pharmacist-in-charge of Lane Pharmacy passed away. The Pharmacy, however, carried on as nothing had happened. Allegedly, the Pharmacy continued to operate without a pharmacist. This “unusual” Pharmacy operated until 2017, when the California Board of Pharmacy received a complaint that non-licensed individuals were dispensing medications. The Board investigation revealed that pharmacy technicians continued to operate the pharmacy after its owner’s death and that these non-pharmacists purchased and signed for drug deliveries, including controlled substances.

To determine the amount of controlled substances purchased and illegally dispensed, the Board partnered with the Drug Enforcement Agency (DEA). The joint investigation showed that the pharmacy purchased its controlled substances mostly through Cardinal Health (dba Parmed Pharmaceuticals LLC).

On March 1, 2019, the Board filed Accusation against Cardinal alleging violations of:

  • Health & Safety Code 11209: no person shall deliver controlled substances to a pharmacy unless a pharmacist signs a receipt; and
  • 16 Cal. Code of Regulations 1783(a): a wholesaler must furnish dangerous drugs only to an authorized person. Prior to furnishing dangerous drugs to an unknown person, the wholesaler shall contact the Board to confirm that the recipient is an authorized person.

The Board alleges that Cardinal delivered the drugs despite obvious red flags: the former pharmacist no longer accepted the deliveries, and instead deliveries were signed by several people using the deceased pharmacist’s name. Cardinal allegedly failed to spot this issue or failed to inquire into the suspicious activity.

The case illustrates that proper policies and procedures on drug delivery and training staff on spotting red flags is a must if you operate a wholesale pharmacy business.  To avoid similar allegations from the Board (and potentially DEA), a wholesaler must document who accepts the products and scrutinize any deviations from the standard procedure.

 

 

   In 2018, CMS proposed a Medicare rule that would eliminate retroactive DIR fees. One of the rationales for the rule was a colossal growth of DIRs between 2010 and 2017. During this period of time, DIRs grew by 45,000%.

As a result of this aggressive “performance enforcement” by PBMs, many pharmacies are reimbursed below cost and many have closed their doors. The American Medical Association has published a study showing that many patients with cardiovascular problems cannot access their medications due to significant pharmacy closures across the country. (Access the study).

The proposed rule would implement a definition of ‘‘negotiated price’’ that is intended to ensure that the prices available to Part D enrollees at the point of sale are inclusive of all pharmacy price concessions. In CMS’s opinion, this rule will be in line with the Trump Administration Blueprint to lower drug prices and reduce out-of-pocket costs.

CMS explained that when price concessions are applied to reduce the negotiated price at the point of sale, some of the concession amount is apportioned to reduce beneficiary cost-sharing. In contrast, when price concessions are applied after the point of sale, as DIR, the majority of the concession amount accrues to the plan, and the remainder accrues to the government. For further discussion on this matter, please see the CMS Fact Sheet from January 19, 2017 ‘‘Medicare Part D Direct and Indirect Remunerations.’

According to CMS, pharmacy price concessions applied as DIR can lower plan premiums and increase plan revenues, result in cost-shifting to beneficiaries and the government, and reduce consumer and government knowledge about the true costs of prescription drugs. To avoid such outcomes, CMS has issued the proposed rule and is expected to rule on it shortly.

In addition, most DIR fees have migrated into private plans. While the legality of these fees is questionable, the ambiguity surrounding such DIRs is troublesome. Many pharmacies do not understand what the fees are for, how they are allocated, and do not request the break-down of DIR fees.

For example, in 2015 – when I first started researching the issue – the following DIR fees were in place:

 

DIR No DIR
The majority of Caremark plans calculated DIRs as:

1. a difference between adjudicated amount and contractual rate, or

2. 2.75%-9.5% of ingredient cost

OptumRx
Catamaran

DIR was $2.80

Some Caremark plans
Some ESI plans

DIR was $3.25

Majority of ESI plans
EnvisionRx

DIR was $5

Prime Therapeutics

DIR: $2

If you ask me now, I will not be able to tell you how DIRs are currently calculated and which plans/PBMs do not implement DIRs. This ambiguity and lack of any explanations make conducting pharmacy business impossible. As a pharmacy owner or a manager, you are entitled to reports describing all DIRs and how they are calculated. Your PSAO should be able to obtain this information directly from the PBMs and guide you through your contractual obligations. The problem is… many PSAOs also have no idea about how DIRs are calculated.

 

 

This month, I will be presenting a series of webinars organized by Nova Biomedical aimed to educate healthcare practitioners on what constitutes off-label use of blood-glucose meters (BGM). My part of the presentation will focus on the risks associated with the off-label use of BMGs and the ways to avoid potential liabilities.

Why did we choose this topic?

According to the FDA’s statistics there were thousands of serious injuries in critically ill patients due to the erroneous glucose meters’ readings. During the most recent FDA’s public meeting on BGM, FDA stated that BGM have one of the highest number of device adverse events reported per year.

A number of adverse events reported to the FDA resulted in deaths in the healthcare settings. The investigations showed that most of these patients were acutely ill, medically fragile, and were taking medications that interfered with glucose measurements (e.g. some patients were receiving Extraneal, and some were on maltose-containing substances). Patients were treated with insulin doses that were guided by falsely elevated results. Insulin is a high-alert medication, meaning that it bears a heightened risk of causing significant patient harm when used in error. Inappropriate insulin dosing may result in hypoglycemia, coma, and even death.

A part of the problem is that healthcare providers are using glucose meters, which are unable to distinguish between glucose and other sugars. As a result, in 2008 – after receiving a report of a patient who suffered irreversible brain damage following an aggressive insulin treatment – FDA mandated that BGM labels state that the product was not evaluated for use with the critically ill (if that’s the case). FDA issued warning letters to manufacturers reminding of this new labeling requirement.

In 2016, FDA issued a guidance differentiating between self-monitoring blood glucose test systems for over-the-counter (OTC) use and point of care use of the meters in the professional healthcare settings.

Following FDA’s recommendations, the New York State Department of Health, the Veteran’s Health Administration (VHA), and CMS each issued communications alerting labs, the public, and others of the patient safety and regulatory consequences of the off-label use of point-of-care BGM on critically ill patients. New York initially got involved because two patients died in the state’s hospital based on erroneous glucose reading.

What’s the problem with the off-label use of BGM?

The problem with BGM is that most of OTC meters migrated into the clinical setting,

but the manufacturers continued to seek FDA clearance for these devices as intended for home use. By obtaining OTC clearance, the BGMS devices were automatically waived (under CLIA). However, manufacturers generally performed accuracy studies more suited to an OTC population rather than a sicker hospitalized population. Accuracy studies were performed in a relatively healthy, ambulatory population even though the devices were used in a wide variety of patient populations.

Therefore, FDA created two classes of GM with two different classification codes.  And FDA encouraged manufacturers of hospital use BGMS to seek FDA clearance and CLIA waiver for use in all hospital patient populations. As FDA stated in its guidance, self-monitoring readers are intended for use at home not in healthcare settings. And FDA requires an additional warning on the self-monitoring meters that they are not intended for use in professional settings. Self-use meters should not be used on critically ill patients in healthcare setting due to a high risk of error. Continuing to use meters that were intended and designed for self-monitoring may subject healthcare providers to unnecessary legal exposure.

What is off-label use of a medical device?

In a nutshell, using a device for a non-cleared indication constitutes an off-label use. If you use BGM for purposes or in populations beyond the “Intended Use,” you are using it off-label. Intended use is what had been cleared or approved by the FDA and you can usually find it in the package inserts or device manual.

FDA’s 2016 guidance reemphasized the need for clinical testing in “vulnerable” patient populations to support clearance for use of glucose meters in such populations. Manufacturers of blood glucose meters should study their devices in each sub-population for whom the device is labeled. And the meters should be used only in those sub-populations in which the device has been studied and for which the device has a labeled indication. Otherwise, the devices are used off-label.

CLIA requirements

The CMS administers CLIA and has delegated the authority to FDA to assign all in vitro diagnostic tests to one of three CLIA complexity categories: high complexity, moderate complexity, and waived.

Glucose blood reading is a waived test if you follow the manufacturers’ instructions. All testing should strictly adhere to “intended use” or “limitations of the procedure,” which are described in the device’s manual or the insert. If a device has “Intended use” or “limitations” that state that the product has not been evaluated on critically ill patients and you are using it in a healthcare setting on critically ill patients, you are engaging in a non-waived testing or off-label. You are modifying the test. By default, it becomes a high complexity test and you must meet additional CLIA regulatory requirements.

What are some other legal consequences when you use BGM off-label?

 If off-label use results in patient’s injury, the patient or the estate is likely to bring a legal action against the healthcare provider for medical malpractice (also called negligence). Patient’s attorney will analyze and scrutinize the standard of care used. When the device was used off-label when other safer alternatives existed, the patient will argue that the provider breached the standard of care (especially considering FDA’s guidance on the topic as well as CMS, VA, and some state health departments’ warnings regarding inaccurate BGM reading in healthcare settings).

To succeed under a negligence theory for off-label use, a patient must establish that the prescriber has deviated from the standard of practice. As far as I know, more and more hospitals and providers stopped using BGM not intended for critically ill patients due to the error rate. We also have guidance from federal and state agencies to stop using GM which are not specifically intended for vulnerable population groups. All these makes plaintiff’s job of proving a deviation from the standard of care much easier.

Additionally, the doctrine of informed consent requires that health care providers disclose the nature of a proposed procedure, its benefits and risks, as well as any feasible alternatives. If a health care provider uses a BGMS off-label and does not inform a patient of the known risks of an inaccurate glucose reading, there is a risk that the patient’s consent does not meet the informed consent standard.

Physicians usually do not disclose to patients if a drug or device prescribed is for off-label use. As a result, patients often bring claims for lack of informed consent arguing that if they knew that the drug was not approved for a particular use – they would not had taken it in the first place.

Courts, however, do not require physicians to disclose, through an informed consent process, the off-label use of a drug or device. Courts usually hold that off-label prescribing is a “matter of medical judgment.” This position was confirmed by the U.S. Supreme Court, holding that “physicians can prescribe approved items for any use they deem reasonable.”

But, if a patient can establish that the non-disclosure was material to the patient’s decision, the patient may prevail under the informed consent theory. And under the theory of respondeat superior or vicarious liability, the medical facility could be liable for these and other actions of its physicians, nurses, staff or laboratories with respect to the off- label use of BGMS in critically ill patients.

 

Some other compliance risks associated with the off-label use of BGM in critically ill population:

– potential issues with CLIA-waived status;

– losing Medicare reimbursement because you are not properly performing a high complexity testing;

– issues with state agencies (e.g. Medicaid’s reimbursements and citations).

To recoup all the above, using a device off label when there is no justification and where there is evidence that using such device may lead to serious injuries, may cause legal actions and Board’s investigations. It may also affect federal accreditation and reimbursements. To learn more about the webinars and how you can join, please contact our office.

 

 

 

More and more states are mandating e-prescribing. Some states require e-prescribing only for CII controlled substances, some for all controlled substances, and some require e-scripts for all medications.

States with current e-Rx mandate laws are:

    • Connecticut (e-prescribing for controlled substances only, no penalties for non-compliance)
    • Maine (e-prescribing for controlled substances only, penalties provided)
    • Minnesota (all prescriptions, no penalties)
    • New York (all prescriptions, penalties)

State with future e-Rx mandate laws are:

    • Arkansas (e-prescribing for controlled substances only, provides for penalties, starts in 2021)
    • Arizona (CIIs only, no penalties, starts in 2020)
    • California (all prescriptions, starts January 1, 2022)
    • Iowa (all prescriptions, starts in 2020)
    • Kentucky (e-prescribing for controlled substances only, starts in 2021)
    • Massachusetts (e-prescribing for controlled substances only, starts in 2020)
    • New Jersey (EHR must be able to accept, process, and transmit prescriptions for CIIs, starts May 1, 2019)
    • North Carolina (applies to highly abused CIIs and CIIIs, starts January 1, 2020)
    • Oklahoma (e-prescribing for controlled substances only, starts in 2020)
    • Pennsylvania (e-prescribing for controlled substances only, starts October 24, 2019)
    • Rhode Island (e-prescribing for controlled substances only, starts in 2020)
    • Tennessee (CIIs only, starts in 2020)
    • Virginia (for opioids only, starts in 2020)
    • Wyoming (e-prescribing for controlled substances only, starts in 2021)

States with pending legislation on e-prescribing:

  • Colorado (CII-IV only)
  • Florida (all prescriptions)
  • Kansas (all controlled substances)
  • Michigan (all prescriptions)
  • Missouri (all prescriptions)
  • South Carolina (all controlled substances)
  • Texas (all controlled substances)
  • Washington (all prescriptions)
  • West Virginia (all prescriptions)

If you are not in one of the above states, it is likely that your state will be added to this list next. If not, e-prescribing is unavoidable anyway because Medicare will require all Part D scripts to be transmitted electronically starting in 2021.

The Drug Enforcement Administration (DEA) has allowed e-prescribing since 2010. But a practitioner must use a EPCS-certified software. In order to be EPCS-certified, the system must meet strict DEA requirements for credentialing, software certification and dual factor authentication (among others). Therefore, it is important to know your vendors, their certifications, and their audit records. Surescripts – for example – is one of the platforms facilitating e-prescribing. However, the company was investigated and charged with illegal monopolization of e-prescription markets. Read FTC’s announcement here.

While e-prescribing is supposed to resolve ambiguities in prescriptions, sometimes it creates them. For example, e-prescriptions have “Notes” section. Prescribers may add additional information that is relevant in this field. This field, however, is often a source of miscommunication. For example, “Notes” may state “dispense 60 tablets” but there is already a quantity field indicating 60 tablets. This creates some uncertainty regarding the prescriber’s intent and therefore a pharmacist must call to verify and resolve the uncertainty. In addition, pharmacy must train staff and offer tech support at all times. And when dealing with any healthcare technology, it must comply with HIPAA and all relevant regulations, such as security breach notification and similar state laws. If you work with e-scripts, what are your hurdles?

 

Is CBD a drug, a dietary supplement, or food (or all/none)? Can it be marketed under any of these labels?

Recently, the FDA clarified one aspect of this puzzle: CBD products should not be marketed as drugs unless they went through a rigorous regulatory scrutiny.

This month, the FDA – together with the FTC – issued warning letters to three CBD manufacturers making unsubstantiated medical claims about their products’ ability to treat various conditions. For example, some of the claims included such statements as:

  • “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”

  • “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”

  • “Cannabidiol May be Effective for Treating Substance Use Disorders.”

  • CBD may be used to avoid or reduce withdrawal symptoms.”

Note that none of the manufacturers used concrete statements, such as “CBD cures/helps /relieves, etc.” They were simply stating that there is a possibility that CBD may relieve the symptoms or improve a condition or is a treatment option. Even in this form, such statements constitute health claims. The FDA must pre-approve all health claims, and requires that they be supported by evidence from scientific studies.

If you are thinking: how about the Farm Bill that was recently signed? Know that it has not changed the way how the FDA looks at health-claims on non-approved (by the FDA) products.

Agriculture Improvement Act of 2018 (the Farm Bill) established a new category of cannabis classified as “hemp” – defined as cannabis with extremely low (no more than 0.3%) concentrations of the THC. The Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law.

Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. The FDA – however – is struggling with hemp classification and marketing requirements. It will hold a public hearing on May 31 to discuss CBD health claims and whether they are justified and explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed. If you are in the CBD business, this is your opportunity to be heard.

On multiple occasions, the FDA stressed that it now treats CBD products as any other FDA-regulated product. Therefore, the FDA requires a CBD product that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce.

The FDA also announced that it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements. This is because CBD and THC are active ingredients in FDA-approved drug products (e.g. Epidiolex) and were the subject of substantial clinical investigations before they were marketed as food. In such situations, with certain exceptions that are not applicable here, the only path that the FD&C Act allows for such substances to be added to foods or marketed as dietary supplements is if the FDA first issues a regulation, through notice-and-comment rulemaking, allowing such use.

There is no clear definition – however – of “unauthorized claims” that would put CBD companies at risk of enforcement actions. The FDA hopes the stakeholders submit additional scientific and researched evidence of the CBD’s potential at its May 31st hearing.  Meanwhile, if you are a producer or manufacturer – do not make any health-related claims on your products. The only claim which you can currently make is “claims of well-being” (e.g. statements that a product can “make you feel better”). Such claims do not require FDA’s pre-approval.

This week I want to offer you an illustrative video “Pharmacoeconimics” prepared by a pharmacy owner – Loren Pierce – describing how DIR fees are killing his business.

In the video, Loren explains and shows his financial reports illustrating that in:

  •  2017, the pharmacy paid a total of $212,000 (1.2% of sales) in DIR fees;

  •  2018, $642,000 (3.8%); and

  • January, 2019, PBMs withheld $76,000 in DIR fees, which constituted 5.1% of his total sales.

If you are a pharmacy owner, your DIR reports show similar numbers. DIR fees are rising without any justification and proper accounting.

PBMs explain that DIRs are mandated by federal requirements to lower medication cost and improve adherence. However, DIRs are not accomplishing these goals. Medication costs are still rising and PBMs report increased profits each year. Independent pharmacies – on the other hand – are going out of business or sell files to chains who can absorb the loss due to the volume. Many pharmacies are facing a dilemma: to accept these PBM contracts reimbursing below cost or turn away Medicare beneficiaries, who constitute a large chunk of business. The video could be accessed here.

Please join me for a live webinar, “Opioids and Other Controlled Substances: Minimizing the Risks in Prescribing, Dispensing and Administering” scheduled for Wednesday, April 17, 1:00pm-2:30pm EDT.

I will be speaking on new regulations and practices pertaining to TeleHealth and e-prescribing. My co-speakers include: Kerry B. Harvey, Member at Dickinson Wright; Lindsay P. Holmes, Attorney at BakerHostetler and Dennis A. Wichern, Managing Partner at Prescription Drug Consulting.

Currently, I have 10 complimentary passes for clients and colleagues. To take advantage of this offer, please email me directly (nmazina@pharmhealthlaw.com) and I will provide you a code to join. Hope you can tune in and take advantage of this great program.

Last Thursday, a federal judge dismissed a lawsuit brought by pharmacies alleging that Express Scripts, Inc. (ESI) used prescription data to forcibly switch patients from their retail pharmacies to ESI’s own mail-based pharmacies. The judge ruled that ESI used the patient data appropriately under the agreements with the pharmacies.

Pharmacies brought claims against ESI for (1) attempted monopolization, (2) unfair competition, (3) breach of contract, (4) breach of implied covenant of good faith and fair dealing, (5) interference with prospective economic advantage, (6) violation of the uniform trade secrets act, and (7) fraud. The core of all the claims was ESI’s conduct of collecting and using prescription data to boost its mail-order operations.

The judge, however, held that the conduct was not prohibited and in fact was expressly allowed under the terms of the agreement with the pharmacies.

ESI’s agreement with the pharmacies (including pharmacy manual, collectively “Agreement”) states that ESI is the owner of all information it obtains through the administration and processing of any and all pharmacy claims submitted by pharmacies. The agreement also identifies ESI’s “mail service dispensing” and provides that pharmacies shall cooperate in coordinating pharmacy benefits.

  1. Breach of contract claim

Pharmacies asserted numerous HIPAA violations when ESI used the patient data to switch those patients to mail order. The complaint alleged that patients did not authorize a switch to mail order, but only learned that their prescriptions were switched to mail order when they attempted to refill the prescriptions at local pharmacies. Pharmacies argued that ESI has breached the Agreement, which provides that the parties shall comply with all applicable laws.

The judge dismissed this claim holding that no private cause of action exists under HIPAA, even under a contract claim.

   2. Breach of implied covenant of good faith and fair dealing

Pharmacies alleged that ESI breached its duty of good faith and fair dealing owed by using the patient information supplied pursuant to contracts’ requirements in order to take customers away and move them into ESI’s mail order pharmacy.

The court dismissed the claim holding that the agreement with the pharmacies permitted ESI to fill mail order prescriptions through its own mail order pharmacy.

  3. Attempted Monopolization

Pharmacies alleged that ESI’s conduct eliminated competition by barring pharmacies from competing for refills and prohibiting patients from purchasing their refills from local pharmacies. Pharmacies claimed that ESI ensured that only its mail order could refill patients’ prescriptions by switching patients to mandatory mail order. Pharmacies pointed to the fact that ESI has quintupled its mail order revenues and quadrupled the number of prescriptions they fill via mail order in just 4 years.

The Court dismissed the claim holding that pharmacies failed to plead enough facts to establish this claim. It also found “nothing inherently anticompetitive in [pharmacies] purported inability to compete with ESI for refills.”

  4. Fraud

Pharmacies argued that ESI’s omission of the information that ESI intended to switch patients to its mail-order service constituted fraud by omission. The court dismissed holding that pharmacies failed to properly allege fraud.

  5. Tortious Interference

The Court held that pharmacies did “not allege any unauthorized actions by Defendants that caused Plaintiffs harm. Rather, as outlined, Defendants’ actions were sanctioned by the parties’ agreements, particularly the Provider Manual’s provisions giving ESI ownership over the customer information.”

   6. Unfair Competition and Uniform Trade Secrets Act

Pharmacies alleged that customer information is a protectable trade secret. And ESI used pharmacies confidential information “to compete unfairly with Plaintiffs.” The court dismissed holding that customer lists and customer information do not constitute protectable trade secrets. Moreover, as the court previously held, ESI was the owner of and had the right to use this information in the manner alleged.

It is unclear whether the pharmacies plan to appeal the decision. Considering a long string of negative cases holding for PBMs in similar contractual disputes, it seems unlikely.

Several PBMs now require their in-network pharmacies assisting prescribers with Prior Authorizations (PAs) to have written policies and agreements with the prescribers on how PAs are prepared and submitted.

Preparing PAs is a time-consuming and tedious process. Often, prescribers are not willing to invest their staff’s time and resources into preparing and submitting them. To streamline the PA process and to ensure the continuity of care, many pharmacies offer PA assistance. Pharmacies, however, are also financially interested in PAs being timely submitted to PBMs and their reimbursement directly depends on which medication is dispensed. PAs are usually necessary for more expensive medications or medications that are not on PBMs’ formulary lists. Therefore, several PBMs have conducted – and are still conducting – audits targeting PAs and medical necessity of medications prescribed.

During these audits, PBMs discovered cases of (1) improper monetary compensations for signing or preparing PAs; (2) pharmacies that sign PAs on behalf of prescribers; (3) prescribers that sign PAs for patients they have never seen. As a result, some pharmacies have lost their contracts with PBMs and facing monetary recoupments and even criminal investigations. Many PBMs require an agreement between the pharmacy and the prescriber describing the PA procedure.

What PBMs are looking for: there should be a legitimate medical need for PAs. Needless to say, no money should be exchanged between the prescriber’s office and the pharmacy for preparing PAs. PAs should be prepared for the benefit of mutual patient only. Often PBMs scrutinize PAs on whether other alternatives were available and how PAs were prepared. Therefore, the pharmacy should have a clear policy on how to prepare and submit PAs.

The PAs policy and procedure (and the agreement with the prescriber) should specify that the pharmacy is acting as the prescriber’s agent in preparing and submitting the PAs (creating “limited agency”). At no time, a pharmacy should sign a PA. It can prepare and prepopulate the form but never sign it, even if authorized by the prescriber.

The policy should also describe emergency situations when a PA may not be practical to obtain and when a pharmacy may dispense first and obtain the PA at a later date.

Improperly performed PAs may also implicate kickbacks. In 2010, the Office of Inspector General (OIG) issued an opinion focusing on PAs. The opinion described that preparing PAs free of charge for prescribers may violate the anti-kickback statute:

“When a party in a position to benefit from referrals provides free administrative services to an existing or potential referral source, there is a risk that at least one purpose of providing the services is to influence referrals,”

The OIG concluded that as long as no payments (or any other rewards) are made to physicians, no assurances to physicians or patients are made that the PA would be approved, and the service is provided for the benefit of the mutual patients only – the provider [pharmacy] has a legitimate business interest in offering uniform pre-authorization services.

While pharmacies may continue witnessing enhanced PA reviews by PBMs, proper policies and agreements with the prescribers may help avoid terminations, recoupments, and possibly government investigations.

I am pleased to announce that I will be speaking in an upcoming Strafford live webinar, “Opioids and Other Controlled Substances: Minimizing the Risks in Prescribing, Dispensing and Administering” scheduled for Wednesday, April 17, 1:00pm-2:30pm EDT.

Because of your affiliation with my firm, you are eligible to attend this program at half off. As long as you use the links in this email, the offer will be reflected automatically in your cart.

Our panel will guide healthcare counsel on the legal challenges and liability risks facing practitioners and pharmacists related to prescribing and dispensing controlled substances. The panel will discuss the enforcement environment and steps to minimize legal risks.

After our presentations, we will engage in a live question and answer session with participants so we can answer your questions about these important issues directly.

I hope you’ll join us.

For more information or to register >

Or call 1-800-926-7926
Ask for Opioids and Other Controlled Substances on 4/17/2019
Mention code: ZDFCA