October 25, 2006

HEADLINE

EPA Issues Final Rule on PM Pollution

The Environmental Protection Agency (EPA) released the much anticipated final rule on fine (PM2.5) and coarse (PM10-2.5) particulate matter pollution.   The new PM2.5 standard, which updates standards set in 1997, left unchanged the average annual standard of 15 micrograms per cubic meter, but decreased the maximum particle pollution considered safe during a 24-hour period from 60 micrograms per cubic meter to 35.

After reviewing the latest scientific studies, the American Thoracic Society and other medical associations supported both a tighter annual standard for PM2.5—12 micrograms per cubic meter—and more stringent 24-hour standard—25 micrograms per cubic meter.

“By failing to issue a more stringent standard,” said Dr. Heffner, “the EPA is ignoring compelling research, the advice of experts and the Clean Air Act, which requires the agency to regularly review the scientific data and set standards that protect the public’s health. This is particularly egregious, given that its own experts recommended a tighter standard.”

In issuing the coarse particle rule, EPA retained the current daily PM10 standard of 150 micrograms and eliminated the annual PM10 standard.  It appears that EPA has retracted its earlier proposal to exempt agricultural and mining emissions from the PM10 standard.  However, several key components of the rule, including the PM10 monitoring component, have not yet been released by EPA.  Under court order, the rule must be completed by September 27^th.

RESEARCH

NIHReauthorizationBillPassesCommittee

The House Energy and Commerce Committee recently passed legislation to reauthorize the National Institutes of Health.  The committee action marks the first time in 13 years a Congressional committee has successfully passed NIH reauthorization legislation. In general, the legislation would increase the funding and managerial authority of the NIH Director and diminish somewhat the funding authority of the Institute Directors.

The authorization legislation features several key features including:

NIH Director’s Common Fund

The bill establishes an NIH Director’s Common Fund to allow the NIH Director to fund cross cutting research.  Under the legislation, the common fund will receive 50% of future NIH budget increases, until the common fund reaches 5% of the total NIH budget.

Funding Levels

The legislation sets a maximum level of increase for the total NIH budget at 5% through 2009.  The bill further encourages, but does not require, the Appropriations Committee to provide one overall budget number for the NIH, thus allowing the NIH Director to allocate funds to the various NIH Institutes.  Currently the Congressional Appropriations Committees sets specific funding levels for NIH Institutes.

NIH Structure

The bill caps the number of NIH Institutes and Centers to the current 27.  The bill further clarifies and enhances the authority of the NIH Director to eliminate, consolidate or reorganize current Institutes, Centers and Offices without Congressional approval.  While the NIH Director currently has authority to reorganize NIH, the legislation clarifies and enhances that authority.

The legislation passed the committee with broad bipartisan support.  While the full House may see this legislation this session, it is unlikely the Senate will consider parallel legislation this year.

PHYSICIAN PRACTICE

Inhaled Insulin and Pulmonary Function Tests

In January 2006, the Food and Drug Administration (FDA) approved the first inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. 

In clinical trials up to two years duration, it was demonstrated that treated patient’s had a greater decline in pulmonary function, specifically the forced expiratory volume in one second (FEV1) and the carbon monoxide diffusing capacity (DL_CO), than comparator-treated patients. The mean treatment group difference in pulmonary function favoring the comparator group, was small, noted within the first several weeks of treatment with inhaled insulin, and did not change over the two year treatment period.

Because of the effect of inhaled insulin on pulmonary function, all patients should have spirometry (FEV1) assessed prior to initiating therapy. Assessment of DL_CO should be considered. Assessment of pulmonary function (eg, spirometry) is recommended after the first 6 months of therapy, and annually thereafter, even in the absence of pulmonary symptoms.

With the assistance of experts in ICD-9-CM diagnostic coding, it has been determined that the appropriate diagnosis code for a baseline PFT prior to initiation of therapy is V72.85, Other specified examination.  The underlying condition being treated (diabetes) would be listed as an additional diagnosis. 

The appropriate ICD-9-CM diagnosis code for the assessment of pulmonary function after the first 6 months oftherapy and annually thereafter is V58.83, Encounter for therapeutic drug monitoring.  In addition, V58.67 Long-term (current) use of insulin and the underlying condition being treated (diabetes) would be listed as an additional diagnoses.

The appropriate CPT code for spirometry prior to the initiation of therapy, after the first 6 months of therapy, and annually thereafter is:

 94010 Spirometry, including graphic record, total and timed vital capacity, expiratory flow rate measurement(s), with or without maximal voluntary ventilation. 

If the assessment of DL_CO is performed, the appropriate CPT code is:

 94720 Carbon monoxide diffusing capacity (eg, single breath, steady state). 

Additional clinical information including the full package insert and a medication guide for patients is available at www.exubera.com.

Medicare Holds Fiscal Year End Payments

Physicians should be aware that Medicare will hold payments to physician and hospitals for the last 9 days for the fiscal year (September 22-30).  Medicare payments held during those 9 days will be made on first business day of the new fiscal year, October 2, 2006. 

The delay in payment is mandated by the Deficit Reduction Act passed in 2005.  The payment delay was one of the budget mechanism used to avert the proposed cuts in Medicare physician update factor and provide the payment freeze in 2006.  No interest or late fees will be paid by Medicare on the delayed payments.

OXYGEN

ATS Submits Joint Comments on Oxygen Rule

The American Thoracic Society, the AmericanCollegeof Chest Physicians and the National Association for the Medical Direction of Respiratory Care issued joint comments on the proposed Centers for Medicare and Medicaid Services (CMS) rule on Medicare reimbursement for home oxygen.  The propose CMS rule provides regulatory guidance on the implementation of the recently passed Deficit Reduction Act. 

Under current policy, CMS pays for oxygen on a rental basis, paying about $200/month for oxygen plus an additional $32/month for patients using portable systems.  These payments are made as long as the Medicare beneficiary needs oxygen.

The Deficit Reduction Act (DRA) changed Medicare reimbursements for oxygen from an open-ended rental item to a capped rental item.  After 36 months, rental payment for the oxygen equipment stops.  The DRA further mandated that after 36 months, the ownership of the oxygen equipment would transfer to the Medicare beneficiary.  The DRA did allow for payments beyond the 36 month to refill oxygen and for maintenance and repair.

CMS’s proposed rule implements the provisions of the DRA.  As required by the law, the proposed rule implements the 36 month capped rental and title transfer provision as defined in the DRA.  The rule further clarifies that all equipment transfers to the beneficiary, including tubing, masks, cylinders and replacement cylinders.  This provisions impact on oxygen cylinders may problematic for oxygen providers.

However CMS's proposed rule goes even farther and proposes to change from a modality neutral to a modality specific oxygen payment system.  These changes were not part of the DRA.  CMS has proposed to change its reimbursement policy from a $200/month payment (+$32/ month for portable systems) to a 6-tier system. 

The joint comments are generally supportive of the categories of equipment that CMS is proposing.  The key points include:

- Support for a modality specific payment system

- Expressing concern on maintaining access to portable/ambulatory systems

- Support for adding a requirement for re-testing of patients

- Opposition to the title transfer provision of the Deficit Reduction Act

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