By Bill Peckham
Ezra Klein reports that today Senate majority leader:
Reid released "the Manager's amendment (pdf)," a single piece of legislation that contains hundreds of amendments within it. This way, there is one big vote changing the bill rather than dozens, or even hundreds, of smaller votes.
This is the final amendment to HR 3590 the Patient Protection and Affordable Care Act, the Senate's version of health reform slowly working its way to a vote. The hope was that Senator Durbin would get immunosuppressant drug coverage into the Manager's amendment without a "pay for" mandating the inclusion of oral drugs in the dialysis payment bundle, which is the choice the House made a little over a month ago.
Unfortunately, the Manager's Amendment does not include any language relating to immunosuppressant drug coverage. There is, however, Section 10336 which calls for a GAO study of including in the dialysis payment, payment for dialysis related oral drugs (Page 249 - 250 PDF link):
SEC. 10336. GAO STUDY AND REPORT ON MEDICARE BENEFICIARY ACCESS TO HIGH-QUALITY DIALYSIS SERVICES.
(a) STUDY.—
(1) IN GENERAL.—The Comptroller General of the United States shall conduct a study on the impact on Medicare beneficiary access to high-quality dialysis services of including specified oral drugs that are furnished to such beneficiaries for the treatment of end stage renal disease in the bundled prospective payment system under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) (pursuant to the proposed rule published by the Secretary of Health and Human Services in the Federal Register on September 29, 2009 (74 Fed. Reg. 16 49922 et seq.)). Such study shall include an analysis of—
(A) the ability of providers of services and renal dialysis facilities to furnish specified oral drugs or arrange for the provision of such drugs;
(B) the ability of providers of services and renal dialysis facilities to comply, if necessary, with applicable State laws (such as State pharmacy licensure requirements) in order to furnish specified oral drugs;
(C) whether appropriate quality measures exist to safeguard care for Medicare beneficiaries being furnished specified oral drugs by providers of services and renal dialysis facilities; and
(D) other areas determined appropriate by the Comptroller General.
(2) SPECIFIED ORAL DRUG DEFINED.—For purposes of paragraph (1), the term ‘‘specified oral drug’’ means a drug or biological for which there is no injectable equivalent (or other non-oral form of administration).
(b) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.
I have to believe this means oral drugs will not be included in the PPS required by MIPPA.
As to the immunosuppressant coverage piece, the hope now is that when they bring the House's HR 3962 and the Senate's HR 3590 bills to conference, the immunosuppressant coverage from the House Bill will pass through to the final bill and in the process the House's oral drug pay for will be replaced by the Senate's oral drug GAO study. That would be a great outcome.
The Congressional Budget Office thinks that adding oral drugs to the bundle will save money - $100 million over 10 years - but I can now say, after evaluating the idea in the context of commenting on the PPS, I'm confident that isn't true. Providing Medicare Part B beneficiaries medically appropriate, universal access to these oral drugs would come at a cost not reflected in current use and therefor current reimbursement. You can't save money you're not spending.
I hope that "other areas determined appropriate by the Comptroller General" will include evaluation of specific examples, from categories of current Part B beneficiaries (e.g. those with drug coverage through work, those with drug coverage through a retirement plan, those with drug coverage through low income plans, those without any drug coverage) to determine how the proposal would impact each group. How would adding binders to the bundle change their access to these drugs?
The Comptroller General should conduct case studies of current Part B beneficiaries with drug coverage under Part D to evaluate the appropriateness of their current use. I believe such an analysis would reveal that current coverage inappropriately limits the use of these effective and important medications. Current Part D copays and the “donut hole” have a profound impact on beneficiary's behavior. Evaluating future reimbursement based on current usage understates the need because under today's reimbursement nephrologists working closely with their patients will forgo prescribing medically appropriate drugs due to their financial cost and the patient's lack of adequate insurance coverage.
I didn't know all that two months ago, but after hours and hours spent thinking about and discussing the idea with scores of people I now have a well informed opinion. I adapted those last two paragraphs directly from the comment I filed last Tuesday. CMS did the dialysis community a great favor by including oral drug under the PPS. There is no way, as a community, we CKD advocates could have come to understand the implications of the seemingly simple idea of adding "specified oral drugs" to Medicare's dialysis treatment payment. We now know that the problems are much deeper than the questions of logistics specified for study under Section 10336.
Thanks to CMS's PPS oral drug trial balloon the entire CKD advocacy community can enumerate numerous challenges that arise from paying for binders and calcimimetics through Part B. From Congress's point of view the big problem will be it doesn't save money. Unless ... the CBO evaluates their inclusion assuming the drug prices are directly negotiated by Medicare. Nothing bars Medicare from negotiating Part B drugs directly with pharmaceutical companies. And that approach might end up saving money, even while expanding access and improving care.
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