Medicare Update

CMS to Host End Stage Renal Disease Open Door Forum

The Centers for Medicare & Medicaid Services (CMS) will hold the first End Stage Renal Disease (ESRD) Open Door Forum of 2008 at 2:00 p.m. (EDT) on April 17, 2008.  The focus of the Open Door Forum will be the ESRD conditions for coverage Final Rule that CMS released on April 3, 2008.

There are 2 ways to participate in the Open Door Forum. To participate by telephone, one must dial 1-800-837-1935 and reference conference ID 30068679.  To participate in person, one must RSVP by 2:00 p.m. (EDT) on April 15, 2008 to ESRDODF-L@cms.hhs.gov, and include your name, organization, phone number, and “ESRD” in the subject line.  The Open Door Forum will take place at the Hubert H. Humphrey Building, 200 Independence Avenue S.W., Washington, D.C. 

Beginning on April 21, 2008, CMS will also make an audio recording available.  To access the audio recording, one must dial 1-800-642-1687 and enter the conference ID.  The recording will expire after 3 business days.

CMS Releases Final Rule for ESRD Facilities

On April 3, 2008, the Centers for Medicare & Medicaid Services (CMS) issued a Press Release announcing that it has released a display copy of a Final Rule, which establishes new conditions for coverage that dialysis facilities must satisfy to be certified under the Medicare program. According to CMS, the Final Rule reflects advances in dialysis technology and standard care practices since the existing conditions for coverage were issued in 1976.  CMS has posted a Fact Sheet on the CMS website.  The Final Rule is expected to appear in the Federal Register  during April 2008.

CMS Releases Coverage Policy for Continuous Positive Airway Pressure Therapy and Sleep Apnea

On March 13, 2008, the Centers for Medicare & Medicaid Services (CMS) announced in a Press Release that it has expanded Medicare coverage for continuous positive airway pressure (CPAP) devices to include beneficiaries who have been diagnosed with obstructive sleep apnea (OSA). According to the Press Release, the expansion of coverage is the result of a March 13, 2008 final Decision Memo, which adds coverage for CPAP following a positive at-home sleep test.  Prior to CMS issuing the final Decision Memo, Medicare policy provided for CPAP coverage only for beneficiaries who had OSA diagnosed using a sleep test (called polysomnography) in an attended sleep laboratory setting.

CMS Releases Decision Memo on Cardiac CT Scans

On March 12, 2008, the Centers for Medicare & Medicaid Services (CMS) released a final decision memorandum indicating that no national coverage determination on the use of cardiac computed tomography angiography (CTA) for coronary artery disease is appropriate at this time. According to the final decision memorandum, coverage should continue to be determined by local Medicare contractors through the local coverage determination process or case-by-case adjudication.

On July 13, 2007, CMS opened a national coverage analysis for CTA.  On December 13, 2007, CMS released a proposed decision memorandum and invited public comment.  In the proposed decision memorandum, CMS proposed adding language to Section 220.1 of the National Coverage Determination Manual indicating that evidence is inadequate to conclude that CTA is reasonable and necessary for the diagnosis of coronary artery disease (CAD).  However, under certain conditions and standards, the proposed decision memorandum would have provided for coverage with evidence development for symptomatic patients with:

• chronic stable angina at intermediate risk of CAD; or
• unstable angina at low risk of short-term death and intermediate risk of CAD.

CMS Publishes Final Rule on Prior Determinations of Coverage

On February 22, 2008, the Centers for Medicare & Medicaid Services (CMS) published a Final Rule establishing a process for Medicare contractors to provide physicians and beneficiaries with a determination of coverage (related to medical necessity) before physicians' services are furnished.   

In the Final Rule, CMS establishes limits on the physicians' services for which a prior determination of coverage may be requested. In fact, the Final Rule outlines the services that will be subject to a prior determination of coverage request by providing for a national list of:

• the most expensive physicians' services in the Medicare Physician Fee Schedule (MPFS) that are performed at least 50 times annually.
• plastic and dental surgeries that may be covered and have an amount of at least $1,000 on the MPFS (not including the adjustment for location by the geographic practice cost index).

The Final Rule also allows a Medicare contractor to send a copy of a local coverage determination (LCD) or national coverage determination (NCD) to a requester, with an explanation that the LCD or NCD serves as the prior determination, if the LCD or NCD has sufficiently specific reasonable and necessary criteria addressing the clinical indication for the procedure for which the prior determination is requested.  Medicare contractors will determine whether a LCD or NCD has "sufficiently specific reasonable and necessary criteria."

Among the limitations, the Final Rule also discusses CMS' plan for establishing procedures for obtaining a determination. Further, CMS reports that it intends to issue detailed instructions on the determination of coverage process to Medicare contractors through the CMS manuals.

The effective date of the Final Rule is March 24, 2008.  The Final Rule implements provisions of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 and is intended to provide physicians and beneficiaries with an opportunity to know the financial liability for a service before expenses are incurred.  On August 30, 2005, CMS published a Proposed Rule for public comment.  CMS responds to the public comments in the Final Rule.

CMS Extends Timeline for ESRD Facility Final Rule

On February 4, 2008, the Centers for Medicare & Medicaid Services (CMS) published a Notice in the Federal Register extending the timeline for publishing the "Medicare and Medicaid Programs; Conditions of Coverage for End Stage Renal Disease Facilities" final rule.   

On February 4, 2005, CMS published a Proposed Rule in the Federal Register that would establish new certification requirements for Medicare coverage of dialysis facilities. According to CMS, the proposed revisions would reflect advances in dialysis technology and standard care practices that have been developed since the requirements were last revised in 1976. 

In October 2007, CMS reported that a final rule had been drafted, was in the approval process, and would be published by February 4, 2008.  However, CMS now reports that an extension of the publication timeline is necessary and appropriate to ensure that it is able to address all comments and issues raised in response to the Proposed Rule.  According to the Notice, CMS has extended the timeline for the publication of the final rule until February 4, 2009.

Medicare Proposes Coverage for Artificial Hearts

On February 1, 2008, the Centers for Medicare & Medicaid Services (CMS) announced in a Press Release that it proposes coverage (with evidence development) for artificial heart devices in Medicare beneficiaries who are enrolled in Food and Drug Administration (FDA) approved studies. 

In conjunction with the Press Release, CMS released a Proposed Decision Memo for Artificial Hearts (CAG-00322N), which outlines the background and conditions for such coverage.  CMS invites comments on the Proposed Decision Memo and directs the public to the instructions for submitting comments.

Since 1986, the Medicare program has not covered artificial hearts as a permanent replacement for a human heart or as a temporary life support system until a human heart becomes available for transplant.  According to the Press Release, CMS now believes that there is sufficient scientific evidence on the use of artificial hearts to allow coverage for Medicare beneficiaries in FDA approved studies.

On August 1, 2007, CMS began a national coverage determination process for artificial hearts.  CMS reports that it plans to issue a final national coverage determination in early May 2008.  National coverage determinations are determinations regarding whether or not a particular item or service is covered nationally under the Medicare program.

Senator Baucus to Introduce Resolution on Erythropoiesis Stimulating Agents

On October 19, 2007, Senate Finance Committee Chairman, Max Baucus, announced in a News Release that he intends to introduce a resolution addressing the Medicare national coverage determination on Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications (NCD).  According to the News Release, the resolution would nullify the NCD, and compel the Centers for Medicare & Medicaid Services (CMS) to issue new coverage rules.   

On July 30, 2007, CMS announced in a Press Release that it had adopted a final NCD for the use of ESAs in cancer and related neoplastic conditions.  CMS reports that the NCD was opened in response to the Food and Drug Administration's (FDA) recent advisories regarding the use of ESAs. However, critics of the final NCD claim that CMS's decision on ESAs lacks a scientific basis, limits the use of ESAs to levels below amounts approved by the FDA, and will prevent vulnerable cancer patients from getting the care that they need.

In August 2007, Senator Arlen Specter introduced a similar resolution (S. Res. 305), directing CMS to reconsider the final NCD, consult with the clinical oncology community regarding revisions, and to implement revisions.  The Senate passed S. Res. 305 on September 4, 2007. More recently, Representative Anna Eshoo introduced a joint resolution (H.J. Res. 54) in September 2007, which disapproves of the final NCD and would cause the final NCD to have no force and effect. Following introduction, H.J. Res. 54 was referred to the House Ways and Means and Energy and Commerce Committees.

ESAs are marketed in the United States as Epogen, Aranesp and Procrit.  They are man-made versions of erythropoietin, a hormone produced in the kidney and that stimulates the bone marrow to make more red blood cells.

CMS Reviewing Medicare Policies on Erythropoiesis Stimulating Agents

On March 14, 2007, the Centers for Medicare & Medicaid Services (CMS) issued a Press Release announcing that it is reviewing all Medicare policies related to Erythropoiesis Stimulating Agents (ESAs).  This CMS announcement follows a Press Release that was issued by the Food and Drug Administration (FDA) on March 9, 2007, announcing that the FDA issued a public health advisory outlining new safety information and revised product labeling for ESAs.

In the Press Release, CMS reports that it is opening a National Coverage Analysis on the use of ESAs for conditions other than end-stage renal disease (ESRD), which is the first step toward issuing a National Coverage Determination.  CMS also reports that it is reviewing its Erythropoietin (EPO) monitoring policy for patients with ESRD, and who are dialyzed in renal facilities.

According to the Press Release, ESAs are anti-anemia biologics, distributed as Epogen, Procrit and Aranesp.  CMS reports that they are man-made versions of EPO, a hormone that is produced in the kidney and stimulates bone marrow to make more red blood cells.

In the Press Release, CMS Acting Administrator, Leslie V. Norwalk states that CMS pays "close attention to FDA block box warnings because the safety of our Medicare beneficiaries is paramount."

CMS Recharters the Medicare Coverage Advisory Committee

On December 13, 2006, the Centers for Medicare & Medicaid Services (CMS) announced that the Medicare Coverage Advisory Committee (MCAC) has been rechartered through autumn 2008.

Since 1998, CMS has relied on MCAC to develop recommendations about Medicare coverage issues and to comment on proposed and existing Medicare coverage policies.  The new charter renames MCAC as the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) and updates the Committee's role in the Medicare national coverage process. 

In particular, MedCAC now has explicit responsibility for advising CMS as part of CMS' coverage with evidence development (CED) activities.  The CED initiative involves the issuance of national coverage determinations (NCDs) that include, as a condition of payment, requirements for developing additional clinical data on a particular medical technology.   The new charter also formalizes the role of patient advocates on the Committee.

As part of this announcement, CMS has released MedCAC's Charter and issued a Guidance Document on the factors that CMS considers in referring topics to MedCAC.