Erythropoiesis stimulating agents (ESAs) are anti-anemia biologics, marketed as Epogen®, Procrit®, and Aranesp®.
On March 9, 2007 the FDA issued a public health advisory outlining new safety information and updated product labeling for ESAs. The FDA cited recent studies with ESAs that have shown a higher chance of serious and life-threatening side effects and a greater number of deaths in patients treated with ESAs.
The March 9, FDA news release reminds us, “The three drugs are approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Epogen and Procrit are approved for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients. ESAs are not approved to treat the symptoms of anemia – including fatigue – in cancer patients, surgical patients, or those with HIV.”
The FDA stated that since all ESAs have the same mechanism of action the new concerns apply to all ESAs. They reported that while they are re-evaluating how to safely use ESAs, Amgen, the manufacturer of Aranesp, Epogen and Procrit, has changed the full prescribing information for these drugs.
The new product labeling includes a new boxed warning, updated warnings, and a change to the dosage and administration sections for all ESAs. The new boxed warning advises physicians to monitor red blood cell levels (hemoglobin) and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions.
On March 14, 2007 CMS initiated a National Coverage Analysis (NCA) on administration of erythropoiesis stimulating agents (ESAs) for non-renal disease applications. The analysis is the first step toward issuing a National Coverage Determination (NCD). The open comment period for the NCA ran from March 14 – April 13, 2007. CMS reported that they received 69 timely comments. You can view the public comments on the ESAs NCA on the CMS website.
CMS also stated that they are reviewing their erythropoietin monitoring policy for end-stage renal disease patients. In a March 14th CMS press release Barry Straube, M.D., CMS’ Chief Medical Officer said, “We will review the scientific evidence to determine the appropriate use of ESAs for multiple clinical indications. It is important to provide the correct coverage of ESAs for each specific clinical indication.”
On May 10, 2007 the Oncology Drugs Advisory Committee (ODAC) meet and according to the May 15, 2007 edition of the NCI (National Cancer Institute) Bulletin ODAC advised the FDA to continue evaluating all available and forthcoming data to determine if the use of ESAs should be limited in patients with certain tumor types; whether a specific hemoglobin level to trigger the drugs' use in asymptomatic patients should be established; and whether limits should be placed on their use within a certain time frame after chemotherapy is completed.
On May 14, 2007 CMS posted the “Proposed Decision Memo for the Use of Erythropoiesis Stimulating Agents [ESAs] for Non-Renal Disease Indications (CAG-00383N).” This Proposed Decision Memorandum (PDM) outlines the coverage policy that CMS is proposing to adopt for ESAs when used in cancer and related neoplastic conditions.
The issuance of this PDM commenced another 30-day public comment period during which interested stakeholders were invited to submit comments, which CMS will consider. In order to be considered, comments on this PDM had to be received by June 13, 2007. After considering those public comments and any additional evidence, CMS will make a final determination and issue a final decision memorandum outlining a National Coverage Determination (NCD).
In the ESA PDM CMS states, “In light of the issues discussed in our review of the evidence and serious safety concerns voiced in the May 10, 2007 FDA Oncologic Drugs Advisory Committee (ODAC) meeting we are also interested in public comment on whether coverage for ESA therapy for Medicare beneficiaries with cancer should occur only within appropriately designed clinical research studies where informed consent and safety monitoring can be assured. After considering the public comments and any additional evidence, we will make a final determination and issue a final decision memorandum.”
In the PDM CMS proposed non-coverage of ESAs for:
CMS proposes that ESA treatment is reasonable and necessary under specified conditions for the treatment of anemia in those types of cancer in which the presence of erythropoietin receptors on either normal tissue/cell lines or malignant tissue/cell lines has been reported in the literature. These cancer types include but are not necessarily limited to:
For patients undergoing treatment for these cancers, CMS stipulates that ESAs are reasonable and necessary with the following limitations:
On June 14, 2007 Representatives Anna Eshoo (D-CA) and Mike Rogers (R-MI) released a Dear Colleague letter asking members of Congress to sign on to a letter to CMS Administrator, Leslie Norwalk expressing concern with CMS' Proposal to drastically limit coverage for Erythropoietin Stimulating Agents (ESAs) for cancer patients.
The Eshoo-Rogers letter expresses their concern over a broad range of unintended public health consequences of the policy including the adverse impact the policy may have on the national blood supply. If you are concerned about the impact of the proposed NCD contact your representatives today and ask them to sign on to this letter.
The National Coverage Analysis that was initiated March 14, 2007 is expected to be completed by August 12, 2007 and the Proposed Decision Memo Due Date is September 14, 2007.You can view the public comments made in response to the initial NCA and the Proposed Decision Memo at: http://www.cms.hhs.gov/mcd/viewpubliccomments.asp?nca_id=203
The National Provider Identifier (NPI), a 10-digit unique identifier, is an Administrative Simplification Standard mandated by the Health Insurance Portability and Accountability Act (HIPAA). The purpose of the NPI is to improve the efficiency and effectiveness of the electronic transmission of health information. The effective date for use of the NPI is May 23, 2007 (small health plans have until May 23, 2008).
Although the compliance date for use of the NPI remains May 23, 2007 CMS states that for a 12 month period after the compliance date they will not impose penalties for noncompliance if the entity has deployed a contingency plan and has made good faith efforts to comply.
CMS is very clear that the compliance contingency guidance does not mean that providers have until May 23, 2008 to obtain and use their NPI. CMS states that failure by a provider to obtain an NPI may be viewed as a violation of the good faith provisions of CMS’ contingency guidance.
The following statement is posted on the NPI Contingency Webpage, “The CMS guidance and resultant contingency plans that may be implemented by covered entities does not remove the requirement and expectation for health care providers to acquire an NPI.”
The NPI contingency plan provision will be used primarily by payers and clearinghouses. This means that over the next twelve months (until May 23, 2008) providers can expect to be required to report different provider identifiers, legacy identifiers, NPIs or a combination of identifiers based on the payer’s or clearinghouse’s contingency plan.
Medicare Fee For Service Contingency Plan
Transmittal 1227, Change Request 5595 dated April 24, 2007 states that as a health plan Medicare fee for service (FFS) is establishing a contingency plan as follows:
What Do You Need To Do?
Finding & Sharing NPIs
The National Plan and Provider Enumeration System (NPPES) is the system used to enumerate health care providers and to house the information provided on health care providers’ NPI applications & updates. Through the NPI application and assignment process the NPPES creates a record for each health care provider assigned an NPI. This record is updated when providers furnish updates to the NPPES. HIPAA regulations require covered health care providers to update their NPPES data within 30 days of any change.
The NPI final rule requires covered health care providers to disclose their NPIs to any entity that needs them for use in standard transactions. In their recently published National Plan and Provider Enumeration System (NPPES) Data Dissemination Notice, CMS describes how providers and others in the health care industry can obtain a physician's National Provider Identifiers (NPIs) without asking physicians directly.
The NPI and other health care provider data that may be disclosed under the Freedom of Information Act (FOIA) will be updated monthly, posted on the internet and publicly available in downloadable files and in a query-only database (the NPI Registry).
In the NPPES Data Dissemination Notice CMS stated that the FOIA-disclosable NPPES data would be publicly available on June 28, 2007. However, CMS has delayed the dissemination of this data until August 1, 2007 in order to allow health care providers adequate time to review their data for accuracy.
CMS strongly urges health care providers to review their NPPES data for any necessary updates or corrections as soon as possible and to submit the changes promptly so that they will be reflected in the initial downloadable file. According to CMS, to ensure the inclusion of updates, changes, and deletions in the initial downloadable file, July 16 is the last date on which they may be submitted via the web-based process, and is the last date by which the NPI Enumerator can receive them on the paper NPI Application/Update form (CMS-10114).
CMS has published a document, “National Plan and Provider Enumeration System (NPPES) Data Elements – Data Dissemination – Information for Providers” to assist providers in making updates, changes, and deletions to the FOIA-disclosable NPPES provider data.
PRIT Identifies NPI Denial Issue
On May 25, 2007 the Physician Regulatory Issues Team (PRIT) reported improper denials due to an error on the NPI crosswalk file. PRIT detailed the issue on the CMS PRIT Webpage:
May 25: We were informed by the American Osteopathic Association that one of their members was experiencing a 100 percent claim denial for reasons that were unclear. We found that the NPI crosswalk had been automatically populated with his current NPI, crosswalked to an old inactive Medicare number. CMS is working to fix the crosswalk problem, but meanwhile we are concerned that other physicians may be having the same problem. If you are having all of your claims denied with reason code PR-B7 or a denial stating you are not certified/eligible to be paid for this procedure/service, you should contact your carrier so that they can determine the cause of the rejections. If it is a crosswalk problem we would like to hear from you.
If after contacting your carrier it is determined that the denials are due to a problem with the NPI Crosswalk File contact the PRIT at email@example.com.
Fox Systems, Inc. is the CMS contracted NPI Enumerator. The NPI Enumerator is responsible for dealing with providers and health plans on issues relating to unique identification.
The NPI Enumerator can assist with the following questions and issues:
Contact the NPI Enumerator:
New Medicare Drug Codes
CMS has created product specific codes for liquid immune globulin. The new temporary HCPCS codes were created for each brand of liquid IVIG. The codes become effective for Medicare as of July 1, 2007.
In order to ensure proper reimbursement providers must accurately report the HCPCs code for the specific products they administer to patients. While all brands of IVIG will be reimbursed at Average Sales Price (ASP) plus 6% the actual reimbursement amount may vary per brand as each manufacturer will report its IVIG product ASP to CMS. This is a change from the previously used weighted aggregate number used to determine the Medicare allowable for these products.
Medicare contractors will continue to pay for pre-administration related services (G0332) associated with intravenous immune globulin administration when Q4087, Q4088, Q4091, or Q4092 is billed in lieu of J1567. Continue to use J1566 for IVIG lyophilized (e.g. powder), 500 mg.
Sources: MLN Matters Number MM5635
New CMS Form Deadline
The National Uniform Claim Committee (NUCC) chaired by the American Medical Association (AMA) develops and maintains the CMS 1500 form. NUCC has revised the CMS 1500 form to accommodate the reporting of the NPI. The new CMS 1500 Claim Form version 08/05 replaces version 12/90. As shown below, the fields added to the CMS 1500 Claim Form to accommodate the NPI are:
Instructions 17b: Enter the NPI number of the referring, ordering, or supervising provider in Item Number 17b.
Instructions 24J: Enter the NPI number of the rendering provider in the unshaded area of the field. The Rendering Provider is the person or company (laboratory or other facility) who rendered or supervised the care.
*In the case where a substitute provider (locum tenens) was used, enter that provider’s information here. Report the identification number in Items 24I and 24J only when different from data recorded in items 33a and 33b.
If the provider does not have an NPI number, enter the appropriate qualifier and identifying number in the shaded area.
Instructions 32a: Enter the NPI number of the service facility location in 32a.
Instructions 33a: Enter the NPI number of the billing provider in 33a.
*Remember, these instructions are from the NUCC your Medicare carrier’s instructions may differ.
Additionally, each of the six service lines in box 24 were split length-wise and shading was added to the top portion of each line. The shaded area is to be used for the reporting of supplemental information.
The 1500 Health Insurance Claim Form Reference Instruction Manual version 2.1 3/07 includes examples using the supplemental information field. The example below illustrates how to enter the NDC supplemental information according to this manual.
Supplemental information can only be entered with a corresponding, completed service line.
In the example below the completed service line contains the IVIG drug code J1563 and the National Drug Code (NDC) number is the supplemental information provided in the shaded area of that service line.
When reporting the NDC as supplemental information, begin at 24A by entering the qualifier N4 and then the NDC number. Do not enter a space between the qualifier and the number. Do not enter hyphens or spaces within the number/code.
More than one supplemental item can be reported in the shaded lines of Item Number 24. Enter the first qualifier and number/code/information at 24A. After the first item, enter three blank spaces and then the next qualifier and number/code/information.
The following qualifiers are to be used when reporting NDC units:
Formatting errors on some of the revised CMS 1500 Claim Forms (version 08/05) resulted in a delay of the implementation deadline for use of the new form originally scheduled for April 01, 2007.
On May 25, 2007 CMS announced in Change Request 5616, that Medicare contractors will no longer accept CMS-1500 Claim Form version (12/90) after July 1, 2007. The only acceptable claim form will be the CMS-1500 Claim Form version (08/05). The new version must be used for all paper claims generated on or after July 2, 2007 regardless of the original date of service on the claim.
Complete information is available on the National Uniform Claim Committee Website including instructions for filling out the revised 1500 form, FAQs and a sample of the new 1500 08/05 form.
The HHS Office of E-Health Standards and Services (OESS) is responsible for all HIPAA Administrative Simplification enforcement with the exception of Privacy, which is enforced by the Office for Civil Rights.
The OESS is an office within The Centers for Medicare and Medicaid Services (CMS). For purposes related to HIPAA enforcement the OESS operates independently from CMS and its activities. The OESS develops and implements the enforcement program for HIPAA Administrative Simplification provisions.
Through the OESS Administrative Simplification Enforcement Tool (ASET) healthcare providers, payers, clearinghouses and others can submit complaints regarding all enforceable Administrative Simplification provisions, except for Privacy.
Complaints about covered entities’ non-compliance with the HIPAA transaction standards can be submitted online with the ASET or by the paper form HIPAA Non-Privacy Complaint Form available on the CMS Website.
Once a valid complaint is received OESS will notify the entity involved in the dispute of the complaint filed against them. The OESS will facilitate resolution of the dispute allowing the entity that the complaint is filed against the opportunity to:
Imaging Bills Seek
The Access to Medical Imaging Coalition (AMIC) was organized in early 2006, in response to the provision in the Deficit Reduction Act of 2005 (DRA), which significantly reduced the level of funding for medical imaging services provided in independent imaging facilities and physician offices. Coalition members include medical specialty societies and patient advocacy groups.
Section 5102 of the DRA includes a mandate for drastic reductions in payments for many imaging services under the Medicare Physician Fee Schedule (MPFS). Under this mandate that became effective January 1, 2007, the payment for the technical component of an imaging service will be set at the Hospital Outpatient Department (HOPD) payment rate, if the MPFS payment rate is higher.
The AMIC is seeking a two-year moratorium on future reductions to diagnostic magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET), and nuclear cardiology procedures.
On February 28, 2007 AMIC released a study from the Moran Company, Assessing the Deficit Reduction Act Limits on Imaging Reimbursement: Cross-Site Comparisons of Cost and Reimbursement, Pre and Post DRA, concluding that the DRA imaging reductions would cause total reimbursement for imaging services in physician offices and free-standing imaging centers to fall an estimated 18-19% below total reimbursement for similar services provided in hospital outpatient departments.
The AMIC engaged the Moran Company to help answer the following questions:
To answer these questions the Moran Company used 2005 volume data, the 2007 transitional and the 2010 fully implemented Medicare Physician Fee Schedule (MPFS) rates and the 2007 Ambulatory Payment Classification (APC) rates taking into consideration the differences in payment policy between the two systems, such as the multiple imaging procedure reduction policy in the MPFS and outlier payments in the OPPS.
In response to the first question the Moran report states,” current (2007) payment policy, prior to the application of the DRA caps, does not exhibit a bias toward higher payments in one setting versus another.” The report goes on to say that once the DRA caps are implemented, aggregate level imaging reimbursement in the office setting will be 18-19% less than in the outpatient setting.
The Moran report also states that a large majority of imaging procedures affected by the DRA caps will be paid below the estimated costs of performing the service:
On May 1, 2007 H.R. 1293 the Access to Medicare Imaging Act of 2007 was introduced in the House by Representative Carolyn McCarthy (D-NY), Representative Joseph Pitts (R-PA) and Representative Gene Green (D-TX). The bill currently has 121 co-sponsors.
On May 8, 2007 Senators Jay Rockefeller (D-WV) and Gordon H. Smith (R-OR) introduced the Access to Medicare Imaging Act of 2007 (S. 1338) as a companion bill to H.R. 1293. This bipartisan legislation calls for a two year moratorium on the imaging cuts of the Deficit Reduction Act of 2005 (DRA). If passed the legislation would delay the cuts by two years while requiring the Government Accountability Office (GAO) to conduct a comprehensive study on the effects of the cuts on Medicare beneficiaries. As of June 18th the bill had 17 co-sponsors.
The AMIC invites all interested parties to participate in this effort. They recommend that you use your own words and experiences when writing your letter. They have provided the following to help you formulate your own letter:
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