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Welcome to this first edition of Oplinc’s Best Practices Quarterly, as the business of oncology becomes increasingly complicated the need to facilitate networking, communication and education becomes paramount. Future editions of this electronic newsletter will include in-depth analysis of issues facing oncologists from Medicare rules and regulations to private payer initiatives as well as offering best practice resources and interactive benchmarking tools. COMPETITIVE ACQUISITION PROGRAM FOR MEDICARE CAP Mandated By MMA Under The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), CMS must implement a Competitive Acquisition Program (CAP) for certain Medicare Part B drugs and biologicals. Beginning January 1, 2006 physicians will have the choice of continuing to purchase the drugs administered in the office and to bill Medicare for these drugs under the current ASP (Average Sales Price) methodology or to participate in the CAP. There must be at least two vendors per competitive acquisition area defined as “an appropriate geographic region established by the Secretary.” Under the CAP physicians would choose a CAP vendor through which to receive the Medicare patient’s drugs, the physician would administer the drugs in the office and bill Medicare for the administration of those drugs; the CAP vendor would then bill Medicare directly for the drugs administered and collect the deductible and coinsurance from the patient. CMS identifies the CAP as an opportunity to realize Federal savings through lower prices on drugs and as an option for physicians who wish to opt-out of the business of drug acquisition and the risk associated with carrying the debt on drugs that may not be reimbursed under the Medicare program or through the physician’s inability to collect the coinsurance from the patient. Physicians electing to participate in the CAP will have from October 1st to November 15th of each year to sign up for the program. Enrollment in the CAP would require the physician to stay in the program for at least one calendar year. Therefore a physician who enrolls in the CAP during the 2005 enrollment period would be obligated to participate in the CAP from January 1, 2006 – December 31, 2006. Group practices must elect the CAP as a group and not individually. However, if a group physician also has a solo practice that physician may elect to participate in CAP or not individually when billing under his/her own provider number. New physicians will have ninety days to decide between CAP and ASP. Section 1847B (a) (1)(D) of the Social Security Act (the ACT) requires the Secretary of Health and Human Services (the Secretary) to establish the categories of drugs that will be included in the CAP and to determine how the program will be phased in. One option explored in the proposed rule is to implement the CAP with those drugs administered by oncologists. The rationale for starting this program in oncology is the fact that the drugs furnished in the oncology office represent the largest portion of Medicare Part B drugs. If the decision is made to begin the phase-in with drugs administered in the oncology office the potential CAP vendors would be required to bid on all the drugs administered by oncologists and the physicians electing to participate in the CAP would be required to obtain all those drugs from the CAP vendor. While vendors would be required to submit a bid on every HCPC typically used in oncology, they do not have to bid on every brand of the drug. The ACT only requires that the vendor include “at least one competitively biddable drug and biological within each billing and payment code…” Therefore, a vendor would be able to choose which brand of drug they will include in their bid. For instance, if carboplatin is available through four manufacturers the CAP vendor need only include one manufacturer’s product in the bid. Since vendors will have the option of choosing which brand of drug they include in their bid it stands to reason that manufacturers will be more willing to offer lower pricing to the CAP vendor in order to have their drug included. The vendors would be required to inform CMS and physicians of the specific brand of drug (by NDC number) that will be available through the vendor before the physician elects to participate in CAP and chooses a vendor. Potential Issues with CAP Administrative Burden/Cost In the proposed rule, CMS states that there is no provision for compensating physicians for the administrative burdens of participating in CAP as they don’t believe the clerical and inventory resources associated with participation in the CAP exceed those of the ASP system. However, under the CAP physicians would be responsible for providing the following written information to the vendor for each drug/treatment order:
Under certain circumstances a physician could use drugs from their own inventory to be replaced by the vendor; however the physician must be able to demonstrate all of the following:
Additionally, the physician would be required to:
Physicians now have the ability to take the financial risk of using drugs off’-label when they feel that drug is the most appropriate therapy for the patient. Under the CAP vendors will assume the financial risk of the drugs and the proposed rule states that physicians are responsible for knowing if the use of the drug is consistent with any local coverage determination policies (LCD’s). Under the proposed CAP rule if a claim is denied for medical necessity, only the physician has appeal rights. If a physician orders a drug that is not consistent with the LCD does the CAP vendor have the right to refuse shipment of that drug? If the drug is shipped and administered and subsequently denied by Medicare what is the physician’s responsibility in assisting the vendor to receive payment on the drug? Would off-label use violate the “clean claims” requirement of the proposed rule? Non-payment of Coinsurance Presently, physicians have the flexibility to offer patients’ payment plans when they can’t pay their coinsurance in full. Under the CAP if a Medicare patient can’t pay their coinsurance do the vendors have the right to deny shipment of the patients drugs? If so, when and how will the physician and patient be informed? If the patient does not have a secondary insurance can the vendor refuse
to take the financial risk associated with billing the patient for the
twenty percent coinsurance? What if there are no other facilities at which
the patient can receive the necessary treatment? Patient Assistance Programs Will vendors participate with patient assistance, drug replacement programs? Grievance Appeals Process Drug Delivery Will drugs be delivered in the vial size/sizes that most closely relate to the dose or will drugs be delivered pre-mixed for the patient? Who is responsible for the cost associated with waste disposal for drugs that are not administered? Comment on the Competitive Acquisition Program Proposed Rule The Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals under Part B; Proposed Rule was published in the Friday, March 4, 2005 Federal Register. This proposed rule outlines the approaches that could be used to implement the Competitive Acquisition Program as well as the rules and requirements for both participating physicians and vendors. The proposed CAP rule is open for public comments until 5 p.m. April 26, 2005. The public comment period allows for us to influence and participate in the CMS rulemaking process. I urge you to read the twenty-nine page document and to comment to CMS on this proposal and to carefully outline any issues/concerns you might have. Click here to read the proposed CAP rule When commenting, refer to file code CMS-1325-P To Comment Electronically: By Mail:
"incident to" services CMS Clarifies Reporting of Supervising Physician for "Incident To" Services
CMS Transmittal 148 dated April 23, 2004 describes how practices are to identify the supervising physician when a service is performed "incident to" another physician in the same group. The Medicare Claims Processing Manual Pub. 100-04 has been updated to clarify where the physician's Provider Information Numbers are to be reported when the ordering physician is not the supervising physician, and further clarifies the definition of "ordering physician." The definition of the ordering physician has been changed to include non-physician practitioners who order non-physician services for the patient. Examples of these services include diagnostic lab tests, clinical lab tests, pharmaceutical services, durable medical equipment, and services incident to that physician's or non-physician practitioner’s service. When the ordering physician is also the performing physician, the ordering physician's UPIN appears in items 17 and 17A. When a service is incident to the service of a physician or non-physician practitioner, the name and assigned UPIN (the NPI when implemented) of the physician or non-physician practitioner who performed the initial service and ordered the non-physician service must appear in items 17 and 17A. If a service is provided incident to the service of a physician or non-physician practitioner, and the practitioner who ordered the services is not the supervising practitioner, enter the PIN (NPI when implemented) of the supervising practitioner in item 24K. To bill incident to there must first be a service provided by the ordering physician, an initial office visit for new patients would establish the physician patient relationship and allow for incident to billing for follow-up visits. For infusion services the patient would first have to be seen by the ordering physician who would establish the treatment plan. When administering the drugs per the treatment order the nurses’ services in the infusion room can be billed as incident to. The services would be billed as incident to the practitioner providing direct supervision (on site) that day. Services meeting the incident to rules and provided by non-physician providers are paid at 100 percent of the Medicare fee schedule when billed incident to the supervising physician. The instructions for Item 31 of the CMS 1500 have been revised to read: "In the case of a service that is provided incident to the service of a physician or non-physician practitioner, when the ordering physician or non-physician practitioner is directly supervising the service as in 42 CFR 410.32, the signature of the ordering physician or non-physician shall be entered in item 31. When the ordering physician or non-physician practitioner is not supervising the service, then enter the signature of the physician or non-physician practitioner providing the direct supervision in item 31." CMS has received many inquiries regarding the correct method of reporting the ordering and supervising providers and Transmittal 148 CR # 3138 has been published to clarify and standardize the method of indicating both the ordering and supervising provider. Additional Incident To Information: The CMS Manuals Index can be found at the following CMS web site: The Medicare Claims Processing Manual (Pub 100-4) which has been
revised to include the “Incident To” clarification: The official instruction from CMS to your carrier regarding this
change: From that web page, look for CR3138 in the CR NUM column on the right,
click on the file for that CR. If you have any questions contact your
carrier/intermediary at their toll free number which may be found at: The Medlearn Matters Articles on “Incident To” MM3242 &
SE0441 can be found at:
PATIENT ASSISTANCE PROGRAMS With the continued trend of increasing patient coinsurance and decreasing reimbursements from both Medicare and private payers there is an ever-increasing need for patient assistance and advocacy programs to help cancer patients financially and legislatively. The following is a list of programs for cancer patient advocacy. Oplinc will also provide direct links to an exhaustive list of patient assistance sites and resources on the Oplinc website at: www.Oplinc.com Financial Assistance for Cancer Care Community Support Organizations for Breast Cancer Corporate Angel Network Patient Advocacy Phone Numbers Anderson Information Network Cancer Care Inc. Cancerdirectory Advocates: Cancer Research Foundation of America (CRFA) Health Care Policy and Advocacy from Cancer Care, Inc. Helping Patients Needy Meds
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BILLING FOR DISCARDED DRUGS
Medicare Rules for Billing Wasted Drug The Centers for Medicare and Medicaid Services (CMS) will pay for a "reasonable" amount of wasted drug. While the term "reasonable" is not defined we are given some guidance by CMS in the Medicare Claims Processing Manual Chapter 17 - Drugs and Biologicals: "The CMS encourages physicians to schedule patients in such a way that they can use drugs most efficiently. However, if a physician must discard the remainder of a vial or other package after administering it to a Medicare patient, the program covers the amount of drug discarded along with the amount administered. The coverage of discarded drugs applies only to single use vials. Multi-use vials are not subject to payment for discarded amounts of drug." CMS does not specify how to document the wasted/discarded drug but most Medicare carriers do specify that the discarded drug must be documented in the patient's medical record, Trailblazer Health Enterprises, LLC Medicare Contractor for Texas, Delaware, Maryland and Virginia states: "Any amount wasted must be clearly documented in the chart with the time, amount of medication wasted, and the reason for the wastage." Regardless of your local Medicare carrier's rules on documentation of wasted/discarded drugs it is never allowable to bill for the entire contents of a vial more than once. Recent Medicare audits of wasted/discarded drug have been reported; in one case the Medicare carrier recouped payment for the wasted/discarded drug because the provider did not document the amount of drug discarded in the patient's medical record. Noridian Administrative Services, LLC Medicare carrier for Alaska, Arizona, Colorado, Hawaii, Nevada, Iowa, North Dakota, Oregon, South Dakota, Washington and Wyoming gives the following instruction regarding documentation of wasted/discarded drug: "Documentation must show in the patient's medical record the exact dosage of the drug given and the exact amount of the discarded portion of the drug." Medicare does not cover wasted/discarded drug when the waste is due to using an inappropriate vial size. For example, if a drug were available in both 100mg and 200mg single-dose vials and the patient requires 100mgs it would be inappropriate to use the 200mg single dose vial and waste 100mgs. It is the responsibility of the physician to order the most appropriate vial sizes in order to reduce wastage. Drug inventory cabinets such as the Pyxis have the capability of tracking drug wastage. When a drug is removed from the cabinet the user would simply record the drug amount removed and then enter the drug amount wasted. This can be tied back to the individual patient for whom the wasted/discarded drug will be charged. However, if your Medicare carrier stipulates that the amount of wasted drug must be documented in the patient's medical record this may not suffice. If you are unsure whether or not your documentation and record keeping would support your billing for wasted drugs contact your Medicare carrier for a formal determination.
UPDATE ON NEW DRUG ADMINISTRATION CODES The new G-codes for drug administration and the Chemotherapy Demonstration Project became effective January 1. 2005. The new drug administration codes allow for more accurate representation and billing of services provided in the infusion room, and the Demonstration Project codes will provide some additional revenues to those physicians who choose to participate in this project. The implementation of the new drug administration and demonstration project codes was a bit bumpy as there were many denials due to both Medicare carrier claims processing errors and billing errors on the practice side. These errors were due in large part to the lack of necessary information on how to properly use the codes and the fact that many carriers were unprepared to properly process the claims. As of this week it is reported that most of the improperly denied and delayed claims are being processed and that by and large most claims are now being paid correctly. On Thursday February 3, 2005 the Centers for Medicare and Medicaid Services (CMS) held a Medicare Carrier Training Conference Call: 2005 Drug Administration Coding Revisions (CR 3631) and Chemotherapy Demonstration Project (CR 3670) During this teleconference CMS representatives presented a PowerPoint training session followed by a Q and A session for Medicare Part B Carriers on the new drug administration and demonstration project G-codes. During the Q and A session CMS provided some clarification to the Medicare carriers’ regarding the billing of the demonstration project codes. In particular, the question of billing for the demonstration project when patients receive IV chemotherapy multiple days in a row. CMS responded that the only limitation on billing is that it can only be billed once per day, so for those chemotherapy regimens where patients come for chemotherapy more frequently than once per week, the assessment is to be based on the patient’s symptoms since the last visit. There were many questions that were not answered but were deferred to either CMS clinical staff or to the CPT (Current Procedural Terminology) Editorial Board. You can view the PowerPoint presentation, read the transcript and/or listen to the audio transcript of this session on the CMS website at: http://www.cms.hhs.gov/ As of the print date of this newsletter we are still awaiting clarification from CMS on the following issues: Intravenous infusions of thirty minutes or less - Medlearn Matters MM3631 defines an IV push as “…an injection/infusion of short duration (i.e., thirty minutes or less) in which the healthcare professional who administers the substance/drug is continuously present to administer the injection and observe the patient.” Based on this CMS article many Medicare carriers are now requiring that intravenous infusion of thirty minutes or less be billed as an IV push (G0353, G0354, G0357, or G0358). This is inconsistent with the definition of the service provided; providers and oncology organizations are asking that this be reviewed by CMS and CPT. CMS could decide to change the definition of the IV push code to include short infusions of a defined length, or they could determine that short infusions are to be billed with the appropriate infusion code and a modifier that would identify it as a “short-infusion.” Concurrent infusions – There are inconsistencies amongst Medicare carriers as to their interpretation of when to use the concurrent codes. Some Medicare carriers are saying that you can bill an administration code for each drug administered and are therefore paying for the administration of each concurrent drug. Other Medicare carriers are limiting the use of the concurrent codes to once per bag; if you hang a bag containing three therapeutic drugs running sequentially to your initial chemotherapy service you would bill one sequential therapeutic code and one concurrent therapeutic code. When the new drug administration G-codes were developed the intent was to adequately pay for all services and to recognize the additional work and practice expense involved with the provision of multiple drugs. With this in mind it would appear that we should be able to bill a concurrent infusion code for each drug administered, however until CMS clarifies this issue there will likely remain inconsistencies in how these codes are reimbursed. Chemotherapy drug
Medicare carriers have asked CMS to provide more guidance on drugs such as calcium leucovorin, interleukin and IVIG. Just In! On the CMS Open Door Forum today, March 11, 2005 Steve Phillips, Director Division of Practitioner Services CMS stated that CMS is now developing instructions to change the previous directions on billing for drug administrations. Mr. Phillips declined to go into any detail on any particular changes that are forthcoming as he pointed out they are not final until published. However, Mr. Phillips did state that CMS would like a seamless transition from the G-codes to the new 2006 CPT codes and that they are developing their instructions with that in mind. A seamless transition from G-codes to CPT codes in 2006 would entail
that CMS follow the AMA CPT Editorial Panel guidelines. Although we will
have to wait until CMS publishes the new instructions before we know if
CMS does follow the AMA CPT Editorial Panel guidelines here are a few
clarifications and guidelines that were determined by the Panel in February: • The definition of a push has been redefined as: • When reporting codes for which infusion time is a factor, the actual time over which the infusion is administered should be used for code selection. * Again, these rules are not official for Medicare until and unless CMS publishes them. Mr. Phillips declined to answer the question as to whether the changes
in coding rules for drug administrations will be effective from the date
of publication forward or if the changes will be retroactive to January
1, 2005. Instead he stated that once published the effective date will
be announced. Updated News between Issues As this publication is quarterly and important news, changes and clarifications can occur at any time Oplinc will provide updates on the Oplinc website at: www.Oplinc.com as these issues arise.
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Off-label
Use
Correct
reporting of “incident to” services continues to be an issue
of concern and some confusion, this article looks at the current and updated
information available on “incident to” services.
CMS
stated that they would not develop a national list of approved chemotherapy
drugs but would instead allow each Medicare carrier to develop their own
list. As a result some Medicare carriers are allowing providers to bill
calcium leucovorin as chemotherapy when given in conjunction with 5-FU
and other Medicare carriers are instructing providers to use the therapeutic
drug administration code.