Support increased patient access to targeted drug delivery (TDD) therapies

Ask your Congressional representatives to take action today. 

Currently, the Centers for Medicare and Medicaid Services (CMS) does not allow pharmacists to bill Medicare directly for patient-specific TDD therapies.

Current CMS policy limits patient and physician choice. This class of medications, which are individually compounded for each patient, can be expensive, leaving physicians and patients at real financial risk under the current CMS policy. The result: Patients across the country have limited access to this important alternative to oral opioids. 

Tell your Congressional representatives why it’s important for CMS to return to direct pharmacy billing for TDD therapies. Complete the form letter below. 

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Are you a patient or a provider?

RE: Centers for Medicare and Medicaid Services (CMS) Change Request 7397

I write to focus your attention on a critically needed change in the method of Medicare reimbursement for implanted pain pump medications. As a patient utilizing a pain pump, I am looking for your support to help increase patient access to alternatives to high doses of opiates: alternatives that improve quality, safety and outcomes while reducing healthcare costs.

Physicians may prescribe an implanted pain pump for patients with severe chronic pain. Pain pumps can help lessen chronic pain and muscle spasticity caused by cerebral palsy, multiple sclerosis, stroke, brain injury, spinal cord injuries, cancer and several other systemic conditions. This method of delivery also helps avoid the abuse and diversion that have plagued the use of oral opioids. Because the pump delivers medication directly to the spinal area, side effects are significantly reduced as compared to oral opioids and patients need to only receive 1/100th to 1/300th of the typical oral dose.

Unfortunately, in 2011 the Centers for Medicare and Medicaid Services (CMS) issued a policy change (Change Request 7397) that reversed 20 years of precedent. Prior to the issuance of CR 7397, pharmacists could bill Medicare directly for these customized medications. Pharmacies are now prohibited from billing directly, leaving physicians no option but to “buy and bill.” However, physicians, for the most part, do not participate in “buy and bill” for this therapy. This is for a variety of reasons, including laws in 27 states that prohibit the practice, regulations governing the storing and managing of controlled substances and the financial risk to their practices. When providers are unwilling or unable to bill for the drugs, patients like me are left responsible for the bills—even though these medications are covered by Medicare.

Given the extraordinary opioid crisis taking place in our country and the enormous burden this policy places on patients, I urge you to ask CMS to reconsider the decision and reopen the issue of reimbursement for medication used in implanted pain pumps in the 2021 Physician Fee Schedule or other upcoming regulations.

I appreciate your consideration and urge you to contact me if I can provide more information.

RE: Centers for Medicare and Medicaid Services (CMS) Change Request 7397

I write to focus your attention on a critically needed change in the method of reimbursement for targeted drug delivery (TDD) therapies. As a clinician devoted to finding the best solutions for our patients, I am also dedicated to supporting patient care and patient access to alternatives to high doses of opiates. Alternatives that improve quality, safety and outcomes while reducing healthcare costs.

Physicians may prescribe an implantable pain pump for patients with severe chronic pain. Pain pumps can help lessen chronic pain and muscle spasticity caused by cerebral palsy, multiple sclerosis, stroke, brain injury, spinal cord injuries, cancer and several other systemic conditions. This method of delivery also helps avoid the abuse and diversion that have plagued the use of oral opioids. Because the pump delivers medication directly to the spinal area, side effects are significantly reduced as compared to oral opioids and patients need only receive 1/100th to 1/300th of the typical oral dose.

Unfortunately, in 2011 the Centers for Medicare and Medicaid Services (CMS) issued a policy change (Change Request 7397) that reversed 20 years of precedent. Prior to the issuance of CR 7397, pharmacists could bill Medicare directly for these customized medications. Pharmacies are now prohibited from billing directly, leaving physicians no option but to “buy and bill.” However, physicians, for the most part, do not participate in “buy and bill” for this therapy. This class of medications, which are individually compounded for each patient, are expensive, leaving physicians at real financial risk. Further complicating matters, in 27 states, the “buy and bill” model is prohibited. Even the cost barrier associated with compounded medications makes the option unavailable to a majority of physician practices who, as a result, are unable to offer TDD therapies to patients, limiting options to traditional systemic opioids. Therefore, this policy change has restricted patient access to a vital therapeutic option and an alternative to oral opioids.

HHS recently published its best practices task force report. That report highlighted TDD therapy as an alternative to opiates. That report also directed CMS to break down regulatory barriers that drive physicians to use systemic opiates because of reimbursement. Making the requested change will break down those barriers and provide another option for physicians and patients. Given the extraordinary opioid crisis taking place in our country, I urge you to ask CMS to reconsider their decision and reopen the issue of reimbursement for medication used in implanted pumps in the 2021 Physician Fee Schedule or other upcoming regulations.

I appreciate your consideration and urge you to contact me if I can provide more information.