Tricare has released new rules relating to how they will cover compounds. Read the rules here.
On Tuesday, June 3, 2014, Express Scripts (ESI) announced the launch of its comprehensive compounding management strategy.
- This strategy will affect all patients in employer plans for which ESI is the pharmacy benefits manager
- No health plans, public employees or Medicare/Medicaid lives will be affected
- ESI is including every employer plan in the program; therefore, employers must opt out to be excluded from the program
What is in the ESI compounding management strategy?
- ESI will target 1,000 products (APIs and non-APIs)
- ESI believes these 1,000 products account for 95% of compounding spend under ESI employer plans
- ESI is claiming that this strategy will ELIMINATE 95% of compounding spend for clients who accept and fully implement the program
- These products will be moved to a non-formulary tier, meaning that the patient will have to pay the FULL cost for the compound out-of-pocket, or go through a very rigorous appeals process to have it covered
- This process will be difficult for patients and prescribers to navigate, making it easier for prescribers to switch the patients to a different product
- The 1,000 products will constitute an “EXCLUDED” list, which ESI will manage
- ESI will continue to review and monitor ALL compounding ingredients based on cost, AWP increase, status (API vs. OTC), etc., for inclusion in the excluded list
- ESI will also create an “INCLUDED” list of products that are exempt from exclusion based on specific requirements such as short supply, necessity, etc.
- Examples include: Tamiflu, HRT and progesterone
- Both lists will be managed in accordance with FDA alerts and client requests
How is ESI planning to roll this out?
- ESI plans to roll out its compounding management program in three phases:
- Phase 1 – Early adopters switch date is July 15, 2014 without patient pre-notification
- Phase 2 – Patients notification on July 15 with a 60-day pre-notification and switch on September 15, 2014
- Phase 3 – Union groups and large employers switch date is January 1, 2015
- ESI plans to communicate to pharmacies soon to advise them of the changes and inform them how to verify whether a product is covered or not
- Pharmacies will receive instructions but will not be allowed to dispute the program
What is PCCA doing about this?
- PCCA is focused on protecting the profession of compounding pharmacists and we’re in the process of developing next steps
- We are also talking with industry associations about possible coordinated approaches
- As updates are available, we’ll be communicating these to you via email, the Apothagram and at protectmycompounds.com
What can members do today?
- Stay informed
- We will be updating members via email and at protectmycompounds.com on PCCA next steps and strategies
On November 27, 2013, President Obama signed into law the Drug Quality and Security Act (DQSA). For much of 2014, the industry will be dealing with the impact of this new legislation as the FDA establishes the rules by which this law will be put into practice. There may also be additional legislation on the horizon, addressing how compounded preparations are used in veterinary medicine. As a summary, the compounding provisions of the new law essentially reinstate section 503A of the Food, Drug and Cosmetic Act, written in 1997, minus the advertising restrictions deemed unconstitutional by Federal Courts. It also created section 503B, which establishes a new voluntary category of compounders called “Compounding Outsourcing Facilities.” This new type of FDA-regulated business has its feet planted in both the pharmacy and the manufacturing worlds. For more information, click here.
As expected, on Saturday, September 28, the House voted on HR 3204 which passed by voice vote. We expect the Senate to hotline the bill early the week Oct 28.
September 27, 2013
A bipartisan, bicameral agreement on compounding has been linked to the track-and-trace bill, known as the “Drug Quality and Security Act” (HR 3204). Leaders from the House Energy & Commerce Committee and Senate Health, Education, Labor & Pensions Committee made the announcement September 25, and released bill language late that night. Revisions to the bill were made the following day. Proponents in the House are trying to pass the bill under “suspension of the rules”, meaning they need two-thirds of the House to support the track and trace/compounding compromise. We expect this could happen as soon as tomorrow, Saturday September 28.
In conversations with key legislators, PCCA was able to get clarification in the bill which allows compounding pharmacies to elect to become “outsourcing facilities” on a voluntary basis. This is an important change as the first draft of the bill was ambiguous on this point. With the voluntary election provision, the bill paints a clear picture as to why a pharmacy may elect to become an outsourcing facility and, more importantly, shows that the FDA cannot force a pharmacy to become an outsourcing facility because of some arbitrary rule the FDA would feel it could enforce.
There are some additional improvements made to this bill over the Senate Bill 959. HR 3204 does not provide exemptions for certain types of pharmacy practice nor does it require pharmacies practicing under 503(A) to report their compound activities to the FDA when compounding for drug shortages. PCCA would have hoped for additional revisions to 503(A) to modernize a fifteen year old piece of legislation to reflect the current state of pharmacy compounding. If the current legislation is signed into law, we will continue discussions with our legislators about this issue.
After carefully reviewing the legislative options, we believe the bill could still have unintended consequences, however, we also believe opposing or delaying the bill would give other interests the opportunity to negatively influence the bill even further. Therefore, PCCA has decided to be neutral regarding the “Drug Quality and Security Act”.
PCCA is committed to remaining an active participant in legislative issues and continue to represent our members and their patients to ensure access to compounded medications.
We recently sent a survey on what PCCA members would do and how S. 959 would affect their businesses.
The results of the survey showed that 4 in 10 of the pharmacies would be required to abandon the pharmacy profession under the terms of S. 959. While the bill claims to improve the safety of compounded medications, it would force many compounding pharmacies to make choices that would decrease the safety of compounded medications if they want to continue filling prescriptions for their patients. It would also reduce patient access to critical compounded preparations, often not found elsewhere, while forcing pharmacies to accept burdensome new rules and costs, forcing painful cuts in local jobs.
PCCA will be issuing a press release with the survey findings which will highlight the impact of S. 959 on patients and the industry.
On September 12, 2013, Representatives Morgan Griffith of Virginia (R-VA), Diana DeGette (D-CO) and Gene Green (D-TX) released a draft of a House Resolution 3089 called the “Compounding Clarity Act of 2013”. PCCA has put this document together as a factual overview of some of the key points of the bill for their member pharmacies and their patients. The full text of the bill can be found here.
PCCA has reviewed the proposed bill and summarized it here.
Our efforts have paid off for now. Delay means more time for the public/Senate to hear the truth about S.959.
Even though proponents of Senate Bill 959 (legislation relating to compounding) pushed for considerations of the legislation this week, the bill has been delayed and will be voted on sometime after Labor Day. Congress is currently out of session until September 9.
Thank you to all who made calls and sent emails to your Senators and encouraged your patients, co-workers and practitioners to do the same. We believe that the combined proactive efforts of our compounding pharmacist members and PCCA-the only supplier actively engaged in this debate, dating back all the way to January-has made a difference. But our job is not over yet.
The bill creates an environment that would unduly restrict access to personalized medications, even when they provide the best treatment options for patients, as determined by their physicians.
The August district work period is an ideal time to invite your Senators to tour your practice and let them know the impact that their vote will have on your business, employees and the health of your patients. Also, consider attending a town hall meeting with your lawmakers near where you live or work. Your lawmaker’s website will typically have a listing of any town hall meetings scheduled in August, or you can call their local office and ask whether any are scheduled. Many lawmakers schedule one or more of these meetings in August, and it is an ideal time to express your concerns with the legislation.
Be sure to check ProtectMyCompounds.com for updates or background materials on the legislation
The Senate recently published an FAQ on S.959. In it, they attempt to clarify many issues raised by the bill but fall short of telling the whole story regarding the unintended consequences that would occur if the bill were passed.
S.959 has strayed from its original intent to increase the quality and safety of compounded medications and to try to prevent another New England Compounding Center (NECC) tragedy from happening by inserting Federal oversight into the practice of pharmacy. PCCA and many others believe that this will severely restrict patient access to needed, sometime life-saving, compounded medications.
The Senate FAQ document tries to divert attention away from the reality of the consequences of what will really happen, so we’ve taken the FAQ document and added our perspective regarding the factual language of what’s in the bill.
Summary of our response:
- If S.959 is passed as written, it will decrease patient access to compounded medications and negatively affect healthcare for hundreds of thousands, if not millions, of patients.
- S.959 addresses the false assumption that the FDA does not currently have oversight authority over compounding pharmacies acting as manufacturers when in fact, the Agency already has that authority. The FDA already has criteria for determining when an alleged pharmacy is manufacturing drugs, not compounding them.
- The bill inserts the FDA directly into the practice of medicine, removing the ability of the prescriber to decide what is best for their patient.
- Clarification on how S.959 will worsen the national problem of drug shortages, affecting scores of Americans.
- The bill currently offers many exemptions to certain types of pharmacies, including pharmacies located in health systems and those pharmacies administered by Pharmacy Benefit Managers. PCCA believes that, in order to be effective, any new regulations should be applicable to all practices of pharmacy.
- The bill will directly affect the free trade of compounded medications for pharmacies near state borders.
A broad coalition of medical and conservative groups opposes U.S. Senate bill S.959. Read the full news release by clicking the link below.