Category: Uncategorized

Independent pharmacies are on the front lines in the fight against COVID-19. NYS Governor Andrew Cuomo recognized their efforts in a recent press conference, stating, “The pharmacists have lines going out the door, and they’re showing up every day, day after day.” Independent pharmacies are integral in the fabric of our communities, with many treating generations of families, supporting local charities, and consistently going the extra mile to help us when we need it most.

Unfortunately, many independent pharmacies have been destroyed by the market power of largely unregulated pharmacy benefit managers (PBMs) who regulate the same provider networks they compete in, with predictable anti-competitive results that have decimated community pharmacy. The COVID-19 pandemic is an opportunity for independent pharmacies to remind consumers and regulators of how they excel and providesuperior products and services as well as their deep commitment to their communities.

The COVID-19 pandemic and its impact on our lives has led to the unprecedented implementation of emergency measures being taken by the federal and state governments to relax regulation onpharmacies and pharmacists and expand their role in responding to the pandemic. These emergency measures include the suspension of regulations and expansion of services, including: 

1. Authorizing emergency refills
2. Allowing pharmacists to refill prescriptions early based on professional judgment
3. Remote pharmacy practice for pharmacists and technicians
4. Mobile pharmacies and clinics
5. Ability to serve patients via delivery (including mail), drive through, curb-side pickup, and automated pickup kiosks
6. Waiving signature requirements for receiving drugs
7. Waiving technician-to-pharmacist ratios
8. Compounding hand sanitizer
9. Dispensing chloroquine, hydroxychloroquine, and azithromycin
10. Reusing personal protective equipment (PPE)
11. Extending inventory reconciliation reporting
12. Deferring license renewals and continuing education requirements

The expanded role of pharmacies during the pandemic provides an opportunity for independent pharmacies to shine and provide the full range of professional services that are often prohibited by either law, regulation, or by the PBM middlemen who increasingly constrict pharmacy services (such as delivery) to commoditize the profession of pharmacy to their own economic advantage.

While these are all welcome measures, the government should also ensure consumers are able to freely access the pharmacy of their choice and ensure that the pharmacy is reimbursed, at the very least, for the cost of acquiring the medication and a reasonable professional fee and relief from the retroactive clawbacks imposed by PBMs that have plagued them. This basic relief has not yet been addressed, even as the strain on pharmacy resources has increased.

We caution pharmacies to maintain good hygiene in their recordkeeping to ensure proper documentation and practices, as PBMs will undoubtedly increase their audits; fraud, waste, and abuse investigations; and accompanying recoupments for any noncompliance. We are also concerned with the havoc that may be caused by direct and indirect remuneration (DIR) and generic effective rate (GER) fees due to dispensing during this time by pharmacies. The urgency of the pandemic environment will someday subside, leaving in place the usual dynamics of retrospective auditing and judgments by auditors and payors.

Barclay Damon represents pharmacies across the United States. Its attorneys are actively monitoring the changing landscape and are experienced in handling issues arising out of pharmacy relationships with PBMs. We are here to assist and support younow during the rigors of the current health crisis and always.

If you have any questions regarding the content in this alert,please contact Linda Clark, Health Care Controversies Teamleader, at lclark@barclaydamon.com; Brad Gallagher, counsel, at bgallagher@barclaydamon.com; or another member of the firm’s Health Care Controversies Team.

We have a specific team of Barclay Damon attorneys who are actively working on assessing regulatory, legislative, and other governmental updates related to COVID-19 and who are prepared to assist clients. You can reach our COVID-19 Response Team at COVID-19ResponseTeam@barclaydamon.com.

BY: Staff

Payor formulary placement and reimbursement amounts are the two most important aspects of a manufacturer’s success in the marketplace – they create pharmacy demand which in turn leads wholesale customer demand and pricing.

So your product receives FDA approval – what needs to happen before your first sale?

Payor Coverage Decision

The very first step in having a product covered is to file the NDC with the FDA. Next, it is important for manufacturers to add the product to product compendias (MediSpan, Red Book, First DataBank, Gold Standard etc.) because that is how payors find out about new products. Under Federal law, payors have 90 to 180 days from the marketing approval date (PDUFA date) to decide on covering a product.

It is extremely important for small manufacturers to reach out payors to ensure proper coverage. The most benefit will come from targeting specific individuals at the biggest payors – of the roughly 342 million managed care lives, about 274 million (80%) are managed by one of top 10 payors.

1. Pharmacy directors ; always a pharmacist as a lead over the entire program ;
2. Actuary – value assessment committee (financial) – talk about disease overall 
   *PLEASE BRING BIM model – *
   must have value proposition – do a study with me…

During the discussion, there should be three focus points:

1. PROBLEM: Presenting the epidemiology involving the product sets up the conversation. The discussion should be non-branded information where the disease area and mortality is covered.
2. SOLUTION: The product is introduced and clinical trial information is presented.
3. COST: Payors are most interested in the Return on Investment – it is crucial to provide a Budget Impact Model (BIM) on how there will be cost-savings over other products in the same therapy class; specifically, how it will reduce the Per Member Per Month cost.

High Cost/Reimbursement Drugs

The size of the largest payors makes it difficult for them to audit all products that make it on their formularies. This creates an opportunity for rogue companies to introduce excessively expensive products with equally high reimbursement. PBMs focus on “Per Patient Per Month” costs, which averages cost across patient populations. Therefore, if the therapeutic class doesn’t have diabetes-type volume, it may take PBMs roughly 12 to 18 months for the PBM’s to “catch up” to these problem products – possibly even longer.

Parallel Review for Devices with CMS

In 2011, FDA and CMS introduced the Parallel Review Pilot Program (Parallel Review), which established a mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDA’s approval and the subsequent CMS national coverage determination (NCD).  In October 2016, the FDA and CMS announced the Parallel Review program will be fully implemented and extended indefinitely.

Parallel Review has two stages:

1. FDA and CMS meet with the manufacturer to provide feedback on the proposed pivotal clinical trial within the CDRH Pre-Submission Program.
2. FDA and CMS concurrently review (“in parallel”) the clinical trial results submitted in the PMA or De Novo request.