Diabetic Testing Supplies Rules, Efficacy Draw AAFP Concern

April 18, 2016 02:15 pm News Staff

Diabetes is a common, costly and deadly disease, which means patients living with the chronic illness need accurate diabetic testing supplies to control their health.

[Diabetic woman testing blood with finger pricking device]

That's why on April 13, the AAFP sent a letter(3 page PDF) to HHS Secretary Sylvia Burwell expressing the Academy's concerns with the burdensome Medicare requirements for prescribing diabetic supplies and growing concerns with the efficacy of unbranded diabetic testing supplies.

Decreasing Prescribing Burdens

The letter, signed by AAFP Board Chair Robert Wergin, M.D., of Milford, Neb., first called on CMS to simplify Medicare's rules for prescribing diabetic supplies in order to streamline the process for physicians and their patients.

"Family physicians simply want to be able to prescribe efficiently and effectively what their diabetic patients need to help manage their condition in a way that maintains their health," the letter said. "Unfortunately, the current Medicare rules surrounding prescription of diabetic supplies impede this goal and add no discernible value to the care of such patients."

Story highlights
  • On April 13, the AAFP sent a letter to HHS Secretary Sylvia Burwell expressing the Academy's concerns with the burdensome Medicare requirements for prescribing diabetic supplies and with the efficacy of unbranded diabetic testing supplies.
  • The AAFP also urged HHS to prevent durable medical equipment suppliers from contacting patients directly about buying supplies that the patients don't want and physicians didn't prescribe.
  • Finally, the letter addressed the Academy's concern about the safety of patients who receive unbranded or inaccurate glucose diabetes testing supplies from mail-order diabetes suppliers under the CMS competitive bidding process.

For example, the letter explained that to obtain Medicare glucose testing supplies, a physician needs to write a detailed order with the patient's name, description of items provided and specific frequency of the testing ("as needed" or "PRN orders" are currently not acceptable), length of the needed prescription, physician's signature and date the order was signed. And if the start date is different than the order date, it must be included, as well.

On top of this, documentation also is required to show that

  • the patient has a documented diagnosis of diabetes and is being treated by a physician for the condition;
  • the glucose monitor, related accessories and supplies are ordered by the physician responsible for the patient's diabetes management, and records are maintained that reflect the care and include the medical necessity for the prescribed frequency of testing;
  • the patient or caregiver has successfully completed training or is scheduled to begin training in the use of the glucose monitor and supplies;
  • the patient or caregiver is capable of using the test results to assure appropriate blood glucose control; and
  • the glucose monitor is designed for home use.

Furthermore, if physicians prescribe blood glucose testing supplies in quantities above the maximum monthly allowances, Medicare requires documentation to show that

  • the coverage criteria above are met;
  • the supplier's files contain a copy of the treating physician's order;
  • the patient has nearly exhausted the supply of test strips and lancets, or exhausted the useful life of one lens shield cartridge previously dispensed;
  • the treating physician's order for testing frequency exceeds utilization guidelines and the medical record documentation supports the need for testing frequency above utilization guidelines;
  • the treating physician has seen the patient and evaluated his or her diabetes control within six months of the date of the order for the quantities of supplies exceeding utilization guidelines; and
  • the physician/supplier's records contain a copy of the patient's testing log or other physician records, such as a narrative statement, that adequately documents the patient's testing frequency.

The letter explained that although glucose testing and other diabetic supplies are often an identified area of Medicare claims processing errors and physicians play a role in fraud prevention, the current requirements "have become overly burdensome with little to no value added to the actual care of the diabetic patient."

"Ideally, it should be acceptable for a physician to write for 'diabetic supplies,' which would encompass syringes, needles, test strips, lancets, glucose testing machine, etc., with only a need to provide a diagnosis and an indication such a prescription is good for the patient's lifetime," the letter said.

As long as physicians clearly describe the frequency, the AAFP said they should be able to write the generic terms for these prescriptions.

"In practice, the documentation requirements are onerous to our members and consume valuable physician time that is not germane to the actual care of the patient. Clearly, the documentation requirements add administrative cost to both Medicare and the family physician and diminish the opportunity for better diabetic care. Family physicians' time is better spent helping patients manage their diabetes, not providing additional paperwork to justify what the patient needs," the letter said.

The Academy pointed out that in recent years, CMS has reconsidered rules in an effort to benefit patients and physicians while maintaining the integrity of the Medicare program. "We expect that by streamlining this process, patients will have better outcomes at a lower cost to the program," the letter said.

Stopping Unsolicited Requests

The letter also urged HHS to prevent durable medical equipment suppliers from contacting patients directly about buying supplies that the patients don't want and physicians didn't prescribe.

"These suppliers encourage patients to request potentially unneeded equipment from their physicians," the letter said. "Meanwhile, these suppliers also repeatedly contact physicians with unsolicited requests to get their items prescribed. The AAFP opposes these unsolicited requests unless such equipment has been prescribed and discussed between the physician and the patient."

Questioning the Efficacy of Unbranded Diabetic Testing Supplies

Finally, the letter expressed the Academy's concern about the safety of patients who receive unbranded or inaccurate glucose diabetes testing supplies from mail-order diabetes suppliers under the CMS competitive bidding process.

"We have heard from members that some durable medical equipment suppliers have switched from using branded to unbranded meters and glucose strips as a way to increase their profits," the letter said.

In response, the AAFP calls for

  • the FDA to better enforce existing regulations during the approval and post-marketing surveillance processes,
  • the FDA to have the authority to immediately remove inaccurate strips from the market and
  • the FDA and CMS to better communicate about the quality and safety of blood glucose monitoring systems sold under the CMS competitive bidding program.

"Taking these steps," the letter said, "would help prevent potential beneficiary disruption to the care plan for blood glucose testing."

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