Tuesday, December 27, 2005

OIG, PAP, GSK, Part D, and other confusions

We knew that the implementation of Medicare Part D would be a nightmare. We even knew some of the characters in the nightmare. What we didn't count on was that one of the mainstays of access to HIV medications would get the evil eye from a federal kickback law and start flaming out.

The patient assistance programs (PAPs) of various pharmaceutical companies have been used and abused throughout the HIV epidemic. They have been a life preserver for low-income clients who needed help while one or another public assistance program has worked to get its act together enough to add a needed medication or while the individual client was otherwise at risk of sinking in the seas of confusion that surround access to HIV medications. (That was my attempt to avoid mixing metaphors when I really wanted to say "at risk of falling through the cracks." [sigh]) PAPs have also been the standard goto when public assistance programs have fallen short of funds or otherwise been unable to add a medication to their formulary: "It's OK. Clients can get the drug from the company's PAP."

Now it seems the Office of the Inspector General, in an effort to head off potential problems in the future, has issued some guidelines about the use of PAPs by people who are eligible for Medicare Part D. The guidelines talk a lot about what hard work it is to figure out all the ways that PAPs can get into trouble once the Medicare prescription drug benefit becomes a reality, but they persevere in the face of that difficulty to reach the conclusion that giving help to the needy might cost the government more money, so drug companies should stop it already. (Oh, dear, did my sarcasm show there?)

In essence, the OIG is saying that giving assistance to a Medicare Part D-eligible client, either by giving a free medication or providing assistance with co-pays or premiums, would influence the client's choice of medication in favor of the drug company offering the medication. That, in turn, would mess around with Medicare's costs, because the client would not choose a cheaper medication that is just as effective. If any of this were to happen, it would, the OIG opines, look suspiciously like a kickback and make the drug company (but not the Medicare client) subject to prosecution. This doesn't apply, the OIG allows, to otherwise uninsured clients nor to Medicare-eligible clients who have not yet enrolled in a Part D prescription program.

This leads to a couple of questions:
  • What happens to Medicare-eligible clients who sign up for a prescription plan that does not include--or drops--a medication that is an integral part of his/her HIV medication regimen?
  • What happens to Medicare-eligible clients whose income is greater than 150% of federal poverty guidelines, who do not receive any of the "extra help" that those with lower incomes are provided by Medicare, but who still can't afford the out-of-pocket costs associated with this program?

The answers to those questions don't look good right now. If the pharmaceutical companies have to exclude these clients from their PAPs, there are very few places for them to go. In Texas, that is likely to be the public hospital districts or a program like The Assistance Fund. Since there is only one program like The Assistance Fund in the state, we could see some people start to fall through the cracks (or do I mean "sink in the seas of confusion"?).

While most of the drug companies that provide medications for the Texas HIV Medication Program are taking a wait-and-see attitude toward this special advisory from the OIG, one (GlaxoSmithKline) has become an early adopter. According to a letter issued by Chris Viehbacher, President of US Pharmaceuticals for GSK:

As a result of guidance issued by the Office of Inspector General at the US Department of Health and Human Services, GlaxoSmithKline has decided to make changes to the eligibility criteria for Bridges to Access. After January 1, 2006, patients who have enrolled in Medicare Part D drug plans will no longer be eligible to receive medicines through Bridges to Access. Medicare-eligible patients who have not yet enrolled in Medicare Part D may continue to receive assistance from Bridges to Access through May 15, 2006, the end of the initial enrollment period. After May 15, any patient who is Medicare-eligible will not be eligible to receive products through Bridges to Access. Over the coming months we will investigate other options that may allow us to offer assistance in compliance with Office of Inspector General guidelines.

Oh, dear. Let's hope the other companies drag their feet a bit more on this one. While we don't want anyone to get caught up in the kickback issue, HIV medications do present some special concerns that the OIG's guidance doesn't consider:

  • Limited medication choices due to (existing or potential) viral resistance;
  • Few cheaper alternatives for current medications (few generics, not widely available);
  • Extremely high cost-sharing burden for low-income clients within first four months of fiscal year;
  • Lack of federal assistance for clients between 150% and 333% of federal poverty guidelines (333% of FPG is the national average for financial eligibility for AIDS drug assistance programs; 200% is the cut-off for Texas).

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