See what's new for drug payment, PET coverage, and HSCT trials. Summer may be winding down, but CMS is still churning out announcements left and right. Here are a few you'll want to be sure you don't miss. Expect Final Rule Nixing Payment for Overfill If you've been charging Medicare for the drug amount that manufacturers include as overfill, watch out. Medicare has proposed 2011 revisions to Part B payment policies and these include a planned update to the "Average Sales Price as the Basis for Payment" section, says Kelly Loya, CPC-I, CPhT, of Sinaiko Healthcare Consulting. In the proposed rule, CMS states that they have become aware that drug manufacturers often "overfill packages in excess of the amount noted on the label to account for the wasted drug volumes that can occur during medication administration to the patient," Loya says. CMS's position is that the overfill does not represent a cost to the purchasing provider, so "in accordance with our policy, providers may not bill Medicare for overfill harvested from containers, including overfill amounts pooled from more than one container," the proposed rule states. Bottom line: CMS drives this home by stating, "claims for drugs and biological that do not represent a cost to the provider are not reimbursable, and providers who submit such claims may be subject to scrutiny and follow up action by CMS, its contractors, and OIG." You can read the proposed rule at http://www.federalregister.gov/articles/2010/07/13/2010-15900/medicare-program-payment-policies-under-the-physician-fee-schedule-and-other-revisions-to-part-b-for#p-3. Look to Local Carrier for PET Rules CMS will be changing the national coverage determination (NCD) for solid tumor and myeloma PET imaging to give local contractors more control over how many PET scans to cover for each patient. Specifically, section 220.6.17, "Positron Emission Tomography (PET) (FDG) for Oncologic Conditions," will no longer have the absolute limit of "only one FDG PET study for beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing." The decision summary states the following changes will be made: removal of the current coverage limit of "only one" FDG PET scan used to determine the location or extent of the tumor for initial treatment strategy local MACs will decide whether to cover any additional FDG PET scan beyond that one for the initial treatment strategy. You can read the decision memo online at http://www.cms.gov/mcd/viewdecisionmemo.asp?id=237. Require Trial Participation for HSCT CMS also posted a decision memo stating that "evidence does not demonstrate that the use of allogeneic hematopoietic stem cell transplantation (HSCT) improves health outcomes in Medicare beneficiaries with myelodysplastic syndrome (MDS)." But CMS did find allogeneic HSCT reasonable and necessary through Coverage with Evidence Development. Result: