Healthcare can be very expensive.  That is why many bleeding disorders patients use co-pay assistance programs to help afford their medication.  Such assistance programs cut down the out-of-pocket cost of prescriptions. For example, if a prescription is $1,000, the co-pay assistance might cover $900.  The patient would then pay $100 out of their own pocket. Previously, the full $1,000 was applied to a patient’s deductible or out-of-pocket maximum. But in recent years, health insurance companies have changed that.

Now insurance companies often refuse to count patient copay assistance toward a patient’s deductible. This is called a copay accumulator adjustor. As a result, many patients have to pay thousands more out-of-pocket each year than they used to.  And if patients can’t afford that, many go without their essential medication.

Current update:
On September 29, a U.S. District Court for Washington, D.C. changed the rules on copay accumulators.  The HIV and Hepatitis Policy Institute, two diabetes groups and three patients filed a court case against the US Department of Health and Human Services (HHS).  The advocates argued against a 2021 rule called “Notice of Benefit and Payment Parameters”. This rule allowed insurers to not count patient copay assistance toward a patient’s deductible or out-of-pocket maximum.

The rule relied on contradictory interpretations of “cost-sharing”.  Worse yet, insurance companies themselves could decide if they counted copay assistance.  As a result, the Court declared the rule unenforceable.  This sent regulation back to the previous 2019 version.  The court also sent the 2021 rule back to HHS so they could reinterpret what “cost-sharing” means themselves.

Why is this important?
Insurers will now have to follow the 2019 rules for health plans until HHS complete its review. The 2019 rules allow copay assistance to count, unless there is a generic equivalent.  Self-insured and ERISA plans are also included in the ruling. State laws still apply, of course. Any state laws banning copay accumulators for state-regulated plans are still on the books.

Is the fight to protect patient copay assistance over?
Not yet.  While the court’s ruling is a great start, HHS still has a chance to ‘reinterpret’ the 2021 rule. We can’t be sure that when they come back, it won’t be a different version of the same.  Additionally, rules can be changed by future administrations.  Laws passed by Congress are much more permanent and difficult to repeal. Even more, the Biden administration has 60 days from the court ruling to appeal the decision.

UPDATE: Note- On 11/27/23, the Biden administration, however, has taken two separate steps to undermine this ruling. First, in an unusual “motion to clarify,” the government announced that it categorically will not enforce the Court’s ruling. Second, the government has filed an appeal with the United States Court of Appeals for the D.C. Circuit.

How can I help support the effort?

  • Send a letter urging HHS Secretary Javier Becerra and the U.S. Department of Labor NOT to appeal the ruling!
  • Ask HHS to issue guidance to their agencies to enforce the previous 2019 rule.
  • And finally, keep up the pressure on our representatives in the U.S. Senate and House to support the HELP Copays Act! We need a more permanent solution that protects all patient copay assistance.

    To show your support, sign our petition at: