Access-to-Care Exception 
The access-to-care CMP exception allows the provision of items that promote access to care and pose a low risk of harm to patients. An item promotes access if it improves a patient’s ability to obtain items and services payable by Medicare, such as smoking-cessation programs, nutritional counseling, or disease-specific support groups.

The rule warns that drug compliance rewards do not meet the exception (although, they may be otherwise permitted). Also, rewards, such as providing movie tickets when a patient attends an appointment, do not promote access to care. An item poses a low risk of harm if it, among other things, is unlikely to increase costs through overutilization or improper utilization.

The rule clears up that pharmacy offerings are not automatically deemed a “low risk of harm” even though pharmacies only dispense drugs pursuant to a prescription, which ensures medical necessity, warning that pharmacies “are no less likely to … encourage overutilization and inappropriate utilization” by encouraging a beneficiary to switch to more expensive drugs.

However, the rule reiterates the need to avoid the overall increase in health care costs. For example, a cost to the government might increase because of prescribed drugs, but overall health care costs may decrease because the patient will be managing a condition with a drug rather than risking hospitalization.

Retail Reward Discounts 
The rule clarifies the existing retail rewards statutory exception and incorporates it into regulation. The exception protects “coupons, rebates, or other rewards” from a retailer that are made available on equal terms to the general public, regardless of health insurance status.

The rule clarifies that pharmacies, whether big box or stand-alone, can be “retailers” because they sell items (drugs). However, the rule cautions that pharmacies may have trouble qualifying if they only sell items reimbursable by federal programs. The exception prohibits rewards that can only be earned or received by purchasing an item or service reimbursable by federal health care programs.

For example, rewards cannot be given for transferring prescriptions because that ties earning the reward to purchasing an item reimbursed by federal programs. Similarly, the exception is not met if a pharmacy had a rewards program that offered 2 points for every dollar spent on prescription co-pays, but 1 point for every dollar spent elsewhere in the store.

Likewise, a co-pay waiver reward would be unacceptable, but a coupon that could be used on anything in the store, including co-pays, would be acceptable. Bonus Guidance Also through the rule, HHS updated the CMP nominal-in-value exception. Items that are nominal in value are not considered remuneration under the CMP; therefore, they do not need to meet an exception.

The thresholds were raised from $10 per item and $50 in the aggregate per patient on an annual basis to $15 and $75, respectively. The rule also spells out how to calculate the value of a lottery or raffle entry under the CMP. The amount of the “winnings” should be divided by the number of entries, and each participant is deemed to receive the value of their entries. If the value to the participant is under the nominal-in-value threshold, there is no CMP violation.

Next Steps for Specialty Pharmacies 
The rule provides detailed guidance on safe harbors and exceptions permitting certain patient benefit programs utilized by many SPs. However, each element of the safe harbor or exception must be met to gain protection. SPs should consult with legal counsel on the effect of the rule on their existing patient benefit programs to ensure compliance and explore opportunities for additional offerings.


Specialty Pharmacy Times previously published this article on February 13, 2017. The original publication may be accessed with a free login by visiting Specialty Pharmacy Times.