July 30, 2012 VIA EMAIL TO DMEPOS@cms.hhs.gov Elliot Klein Centers for Medicare and Medicaid Services 7500 Security Boulevard Mail Stop C5-03-17 Baltimore, MD 21244-1850 RE: Inherent Reasonableness of Medicare Fee Schedule Amounts for Non-Mail Order (Retail) Diabetic Testing Supplies [CMS 1445-N], 77 Fed. Reg. 38,067, (June 26, 2012). Dear Mr. Klein: As CMS is considering cutting payments to pharmacies for diabetic testing supplies purchased through retail settings, NCPA would like to take this opportunity to share the views and concerns of our members. NCPA represents the interests of pharmacist owners, managers, and employees of more than 23,000 independent community pharmacies across the United States. NCPA has a strong interest in this issue because independent community pharmacies serve as a critical access point for DME supplies, especially diabetes testing supplies. According to a 2011 NCPA member survey, 69% of our members provide DME products to patients. I. NCPA s Primary Points 1. NCPA believes that Inherent Reasonableness could be used as a substitute for competitive bidding but we are concerned that CMS is using the mail order reference prices as a test of reasonableness for retail pharmacies, an entirely different segment of the market. Independent community pharmacies cannot purchase diabetes test strips at the same prices as large self-warehousing chains or mail order suppliers. Community pharmacies do not have the volume of diabetic testing supply business and have to purchase a wider variety of products. Having said that, there are not great margins on these products (some independents actually provide these products as a loss leader), and given all the other costs of participating in the Part B program, reduction in payment might defeat CMS goal of maintaining access through community pharmacies. 2. Even within retail community pharmacy, there are different costs to purchase diabetic testing supplies for chains and independents. Independents purchase at higher costs, yet tend to offer a higher level of services for diabetic patients, such as therapeutic shoes and diabetes self-management training courses, as examples.
3. CMS has presented no evidence that the current fee schedule is grossly excessive as compared to the cost to independent pharmacies to purchase these supplies. If CMS is using mail order rates as the basis for determining retail community pharmacy reasonableness, we have data from our pharmacies which shows that current rates are reasonable compared to the cost to purchase the products. 4. CMS has taken a narrow view that savings and success for diabetic patients means driving down per unit costs. This is completely contrary to the integrated care models approved and being promoted by the health care system, including Medicare, Medicaid and the private sector. 5. CMS is wasting millions of dollars on mail order diabetes testing supplies that are automatically shipped to patients that are never used. Waste is rampant in Medicare Part B mail order diabetes testing supplies. CMS turns a blind eye to this fact in its holy grail pursuit of lower mail order DTS prices. NCPA has included as an attachment to this letter countless examples of unused diabetic testing supplies that are handed in as part of drug take back programs offered by independent pharmacies. One should look no further than the One Year Implementation Update to Round 1 published this past April to see the large amount of waste being generated by mail order supplies. II. The Role of Community Pharmacists in Combating Diabetes Community pharmacists are indispensable to helping combat diabetes, whether it is the counseling they offer, the medications they dispense, the lifestyle modification classes they provide, or the wide variety of testing supplies they carry. Community pharmacists have always played an active role in helping patients cope with diabetes through prescription management, dispensing supplies such as glucose meters and therapeutic shoes, and vital diabetes education services. From face-to-face counseling to the medications they dispense, independent community pharmacists play an essential role in improving health care outcomes and decreasing long-term health care costs. However, that dynamic will be harmed if these small business pharmacies are forced to walk away from a pricing structure for diabetic testing supplies that only a large self-warehousing chain pharmacy or mail order supplier can make work. Independent community pharmacists must already comply with multiple criteria in order to sell diabetic testing supplies including: obtaining expensive DME accreditation; possessing a surety bond; paying to obtain the actual product; complying with extremely burdensome documentation requirements; and working with a secondary payer in order to receive payment; all the while receiving much slower than-normal payments. In addition to all of these requirements CMS is proposing cutting pharmacists payment. If CMS goal is to drive retail pharmacy out of the program, it s working. But independent pharmacy is a provider you can least afford to lose. III. Cuts to Diabetic Testing Supplies Will Impact Medicare Beneficiaries Access Pursuant to 42 CFR 405.502(h)(1), CMS is required to consider the potential impact on quality [and] access before utilizing its IR authority. 1 1 See 42 CFR 405.502(h)(1). Page 2
If small business independent pharmacies are forced to leave the Part B program due to drastic cuts in the fee schedule, their patients will be forced to obtain diabetes supplies by other means and suffer a significant negative impact to their health. This significant impact is certainly to be felt disproportionately in rural areas. Independent community pharmacies are far more likely than chain pharmacies to operate in traditionally underserved and rural areas where patient accessibility is a deep concern. It is unacceptable to force beneficiaries to travel an extensive distance to obtain diabetic testing supplies. One does not have to look much further than the results of CBP to witness the drastic decrease of suppliers and the kinds of DTS brands in the supply chain. Prior to the CBP, each MSA was represented by hundreds of DMEPOS suppliers. Whereas, after the CBP, only 356 DMEPOS suppliers were awarded contracts and allowed to serve beneficiaries. 2 The result of this drastic decrease in suppliers of DTS is that beneficiaries can no longer obtain the DTS brand chosen by their physician from the pharmacists of their choice. A study conducted by the American Association of Diabetes Educators (AADE) entitled, Competitive Bidding Program for Mail-Order Diabetes Testing Supplies: Product Availability Survey, looked at the range of DTS offered by mail order suppliers to Medicare beneficiaries by surveying suppliers in the nine competitively bid areas. 3 AADE found that of the nine brands that OIG identified as the top mail order DTS brands by percent of market share, mail order contract suppliers only cover an average of 1.44 brands only 16%. 4 From these findings, AADE concluded that beneficiaries in competitive bidding areas do not have access to most brands available in the market, or to brands most commonly prescribed by physicians and selected by beneficiaries. 5 Thus, as our Medicare population continues to grow, the amount of suppliers that can provide DTS to beneficiaries as well as the number of brands offered in the supply chain continues to decrease. According to a October 2011 survey that NCPA conducted of over 800 independent community pharmacists regarding negative consequences for a sharp reduction in payment for diabetes test strips, 84% of the pharmacies said they would likely drop out of the program if forced to either (1) take a reduction in payments for diabetes testing strips, or (2) take a competitively-bid chain or mail order price to continue to provide Medicare diabetes testing supplies. In addition, 81% of respondents said that their average Medicare patient visits the pharmacy two or more times a month for counseling. The message from our survey is clear: drastically reducing payments for diabetes testing supplies to independent community pharmacies is financially unsustainable for these pharmacies and will diminish access to diabetic testing supplies. Moreover, 81% of independent community pharmacies regularly deliver diabetes testing supplies to patients (often free of charge) with 28% making 30 or more deliveries per month to different beneficiaries. Pursuant to CMS regulation, CMS has defined mail order item to include an item delivered to the beneficiary s home. By doing so, CMS is prohibiting pharmacies from delivering diabetes test supplies to homebound and frail Medicare patients. Also of grave concern, beneficiaries in assisted living facilities rely on home delivery by their independent community pharmacists to obtain diabetes testing supplies, which will no longer be allowed once the national mail order program begins. NCPA believes this was a severe oversight by CMS and urges CMS to revisit its proposed definitions of the terms mail order item and non-mail order item. 2 See https://www.cms.gov/medicare/medicare-fee-for-service-payment/dmeposcompetitivebid/contract-supplier-lists.html. 3 Competitive Bidding Program for Mail-Order Diabetes Testing Supplies: Product Availability Survey (November 2011). 4 Id. 5 Id. Page 3
Asking frail homebound patients, as well as those in assisted living facilities, to visit a store front to obtain their supplies while having their other medications delivered to their place of residence makes absolutely no sense. IV. CMS Basis for Cuts is Flawed CMS bases its decision to cut reimbursement via the IR process on the assumptions that (1) retail pharmacies and mail order pharmacies purchase DTS at the same cost; and (2) the savings seen in placing mail order DTS in the CBP due to waste will also be present within the retail sector. In fact, CMS is using the information from the Round 1 Rebid for mail order supplies in determining that the fee schedule amounts in retail are grossly excessive. CMS states in the notice of the IR meeting, [a]lthough we recognize that there are pricing differences between mail order and non-mail order diabetic testing supplies because of the delivery methods for these supplies, information about the prices of mail order diabetic testing supplies can inform the analysis of prices for non-mail order diabetic testing supplies because several key cost components are identical for both, such as product acquisition costs and administrative costs, including claims processing and paperwork costs. CMS is acting under the assumption that there is no difference in purchasing in different pharmacy channels, and as such, CMS is viewing mail-order prices as reasonable for the retail sector. That is simply not the case. Product pricing in the retail and mail order channels is in fact different. While CMS has presented no evidence that the current fee schedule prices are inconsistent with the purchasing costs for community pharmacists, independent community pharmacies cannot purchase diabetes test strips at the same prices as large self-warehousing chains or mail order pharmacies. Contrary to CMS statements, there are different costs for acquiring the product. Since CMS uses the quantity of 50 test strips for the basis of pricing for the CBP, NCPA also looked at acquisition costs for community pharmacists for multiples brands of 50-count test strips. According to data that NCPA has collected, independent community pharmacists average acquisition costs for multiple brands of 50-count test strips is multiple times more than the average supply fee schedule reimbursement for the Round 1 Rebid CBP (which was $14.62). Moreover, only 6%-8% of an average independent pharmacy s annual sales come from DMEPOS. With the low margin on those supplies and drastic price reductions, many independent pharmacists will likely be forced out of the program and terminate sales of DTS. Furthermore, the products which independent pharmacies and mail order stock are also very different. Community pharmacists are motivated to stock products which local physicians prescribe and local beneficiaries prefer. Thus, community pharmacists play a key role in the spectrum of providing tailored, personal care to the beneficiary. Due to the customized treatment that diabetes demands, DTS should not be treated as interchangeable. On the other hand, mail order suppliers promote a limited range of products based on having the lowest cost, and generally direct beneficiaries to these products. From its study AADE concludes, that [u]nder the CBP, contract suppliers have powerful incentives to maximize profit margins by purchasing and offering a limited range of products, and only the lowest cost products available. 6 Thus, the range of products offered between retail and mail order differs, the acquisition costs of these products differ, and the choice available to beneficiaries also differs. 6 Competitive Bidding Program for Mail-Order Diabetes Testing Supplies: Product Availability Survey (November 2011). Page 4
Furthermore, CMS continues to tout savings from placing mail order DTS in the CBP. In fact, CMS stated in its Notice of the IR meeting that, based on the results of the competition for mail order diabetic testing supplies in nine Competitive Bidding Areas and a review of other pricing information for diabetic testing supplies in general, we believe the savings potential for non-mail order diabetic testing supplies is significant. Even if CMS is correct that the Round 1 Rebid resulted in a reduction in DTS waste through a reduction in overutilization of DTS, such a reduction was only measured with regard to mail order suppliers. The fact that CMS found that beneficiaries had excess mail order supplies prior to the Round 1 Rebid reinforces our position that mail order waste, not retail waste, for DTS is the major waste problem in Medicare Part B. NCPA also has severe concerns what other pricing information CMS has access to and seeks more transparency from the Agency in this regard. Accordingly, a similar reduction in DTS utilization may not be apparent, once the CBP expands to retail pharmacy. In contrast to mail order suppliers, small retail pharmacies do a better job of monitoring when and how often patients need refills and when and how often patients testing regimens change. Mail order, on the other hand, through its auto-refill policies, generates substantial stockpiling waste of DTS for patients and measures adherence through whether an auto-refill was delivered, not whether it was actually and appropriately used by the patient. Medicare Part B pays for billions of dollars each year in diabetes test strips the majority of which are dispensed through mail order. These strips help beneficiaries maintain proper glucose levels. Yet, community pharmacists continually hear stories from patients about how the mail order company continues to send strips to the beneficiary, even if they don t need them. Some patients indicate they have closets full of these strips! This means that either the mail order company is disregarding stop orders and has placed the person on automatic renewal even if they don t need the strips, or the person is not testing correctly, which could lead to further diabetes complications. Also, many patients will take their mail order supplies to an independent pharmacist, looking to the pharmacist to offer face-to-face guidance and counseling. This is a lose-lose situation for Medicare and the beneficiaries. Medicare pays for strips that aren t needed, while patients are not being managed well because they are getting their strips from a mail order firm rather than being managed by their community pharmacist. V. Conclusion Independent community pharmacists are working hard to provide the best care and access to beneficiaries while working with CMS to improve quality of care and drive down long-term costs. The facts are, with drastic cuts to reimbursement for diabetic testing supplies, beneficiaries will no longer have access to the care they need and deserve. For CMS to assert that there are no differences in acquisition costs or services provided between mail order suppliers and retail pharmacies is insulting. Since only 6%-8% of an average independent pharmacy s annual sales are from DMEPOS, independent community pharmacists generally sell diabetic testing supplies to provide a service to beneficiaries and not because of profit. Even CMS in the preamble to its 2010 Proposed Rule on competitive bidding noted the value of a licensed pharmacist [being] on hand to offer guidance and consultation to the beneficiary. This is not just an issue of convenience - this is about providing reasonable access to beneficiaries. If beneficiaries do not have reasonable access to their diabetic testing supplies, this decreases adherence, decreases the quality of care that beneficiaries receive, and drives up the overall costs of health care. We all have an interest and a part in making certain that beneficiaries have access to their diabetic testing supplies that they need. Page 5
As such, CMS must do its part not to disrupt the ability of beneficiaries to obtain their choice of DTS from their choice of supplier. NCPA is willing to meet with you to discuss our data further. If you have any questions, please contact me at (703) 683-8200 or john.coster@ncpanet.org. Sincerely, John M. Coster, Ph.D., R.Ph. Senior Vice President, Government Affairs Page 6
Examples of Waste in Diabetes Supplies through Mail Order Liberty Medical testing supplies. Wasteful! They send too much to the patient without them requesting it! These testing supplies were brought in by a customer who had already called and asked the mail order company to stop sending her father's testing supplies since he already had more than he could ever use. There was over $3500 in strips, another $500 in lancets and another $100 in testing solutions. 2 meters and 3 lancing devices. She said she had already thrown out several other boxes in the past to make room. We advised her to call the Medicare fraud waste and abuse hot line... she has received two more shipments since that time. Page 7
Examples of Waste in Diabetes Supplies through Mail Order 30 boxes of test strips and 15 boxes of lancets for a Medicare patient = $1,500 The picture represents my mother s diabetes medications that were auto shipped to her from Liberty mail order pharmacy during a 2 year period. The cost for these products represents $442.50 per year of waste in the system that you and I as taxpayers paid for. Multiply this by the number of diabetic patients in this country, over 21 million, and the numbers are astronomical: $9.3 Billion in potential waste and abuse in the diabetes community alone when provided by mail order companies. Page 8