Introduced Wednesday in the House of Representatives, the Medicare Home Oxygen Therapy Act of 2009 (H.R. 3220) is a budget-neutral bill that would reform the way Medicare pays for home oxygen items and services.

Following is a summary of the bill's provisions courtesy Cara Bachenheimer, senior vice president of government relations for Invacare Corp., Elyria, Ohio.

1. Elimination of Oxygen Cap - The bill would eliminate the oxygen cap. Payments would be made throughout the period the beneficiary's medical need.

2. Elimination of Competitive Bidding for Oxygen - The bill would eliminate oxygen from competitive bidding.

3. Covered Services - The term "home oxygen therapy services" would be defined to include services and supplies furnished by a qualified home oxygen therapy provider. The services and supplies furnished must be linked to specific patient need and include at a minimum:
a) Conducting an initial evaluation of patients using a uniform Oxygen Patient Evaluation Form;
b) Providing written and verbal patient and caregiver education about home oxygen therapy, stationary and portable oxygen therapy options and oxygen safety (e.g., evaluating the home environment for safety risks or hazards, including home fire and fall prevention);
c) Providing appropriate delivery, set-up and coordination of services (e.g., delivery of oxygen technology to hospital prior to discharge, delivery and set-up of equipment in the home), as needed, in a timely manner as agreed upon by the beneficiary, and/or caregiver, provider, and prescribing physician;
d) Evaluating beneficiaries' ability to operate the equipment safely and effectively;
e) Educating and, when necessary, providing assistance with infection control, focusing on keeping equipment from leading to infection;
f) Providing equipment-related services consistent with the manufacturer specifications and in accordance with all federal, state, and local laws and regulations. These may include but are not limited to: checking oxygen system purity levels and flow rates, changing and cleaning filters, and assuring the integrity of equipment alarms and back-up systems;
g) Monitoring visits by appropriately trained personnel to evaluate all aspects of the oxygen therapy services being provided to the patient by the home oxygen provider, including ensuring that beneficiaries follow their prescribed plan of care;
h) Documenting exception reporting by the home oxygen therapy provider when changes occur in a patient's compliance with his/her plan of care to the prescribing physician;
i) Providing, as needed, continued education regarding appropriate home oxygen equipment maintenance practices and performance by the patient and caregivers;
j) Implementing all home oxygen therapy services that are prescribed by the physician's plan of care;
k) Providing as needed appropriate home oxygen equipment, supplies (including but not limited to supplemental supplies and emergency oxygen back-ups as appropriate);
l) Providing 24-hour on-call coverage to respond to patient needs with home oxygen therapy; and
m) Assisting the beneficiary with the coordination of oxygen equipment, services, and providers if the beneficiary travels outside of the provider's service area. If the beneficiary relocates permanently, the new oxygen provider caring for him/her would assume responsibility for billing the Medicare program directly.


4. Patient Classification System - The following system would be used to classify, document, and reclassify oxygen patients. Prescribing physicians would be responsible for performing an assessment of each beneficiary requiring home oxygen therapy and assigning him/her to the appropriate category. Beneficiaries could move from category to category over time, as their conditions change.
a) Patients would be classified into one of three patient categories:
- Category 1 - Patient who lacks mobility or is prescribed oxygen for nocturnal use only;
- Category 2 - Patient with standard portability needs;
- Category 3 - Patient with high portability needs.
b) "Portability needs" would be defined as:
- Standard - use of portable oxygen estimated at less than or equal to 40 "liter hours" per week; - High - use of portable oxygen estimated at more than 40 "liter hours" per week.
- "Liter hours" is defined as prescribed LPM multiplied by estimated number of hours of use per week.
c) An Expanded CMN would be developed:
- Physician would indicate the "patient category" on the CMN.
- For Category 2, the physician would check off a box indicating "standard portability needed."
- For Category 3, the provider would supply the estimated hours of weekly portable use based on information from the Oxygen Patient Evaluation Form. The physician would enter the estimated weekly hours as supplied and the prescribed LPM to arrive at the required liter hours per week
- The provider would be able to enter testing results on CMN.
- Provider and physician committee to work jointly on proposing CMN to CMS.
d) Patient classification would be changed upon the physician's determination of a change in the patient's medical condition and/or need (such change would be documented with updated CMN).

5. Payment, Including Services and Supplies - Payments for these would be included (bundled) in the monthly allowable. Payment to the oxygen provider would be based jupon the provider's monthly census of patients who are each classified into one of three patient categories described in section 4. Overall, the payment per patient would be a single bundled payment amount.

6. Patient Retesting - The HHS Secretary would establish a retesting process that allows:
a) Home oxygen providers to facilitate re-testing of patients between 60 and 120 days when those patients had an acute diagnosis for whom home oxygen therapy was prescribed for the first time.
b) The re-testing policy would not apply to patients whose diagnosis includes chronic respiratory disease, including, but not limited to, Chronic Obstructive Pulmonary Disease, Emphysema, Obstructive Chronic Bronchitis, Bronchiectasis, Congestive Heart Failure, Pulmonary Fibrosis, Obstructive Sleep Apnea and Alpha-1 Antitrypsin Deficiency (A1AD), since these chronic conditions typically require oxygen therapy for an extended period of time.
c) Oxygen retesting would be performed in accordance with current standards of practice and CMS regulations.

7. Establishment of Allowable Charges - The bill would provide for defined allowable charges for first two years and related budget neutral assumptions.

8. Updates to Allowable Charges - Annual updates would be made to the allowable amounts based on the Consumer Price Index for Urban Consumers (CPI-U).


9. Establishment of Advisory Committee - The HHS Secretary must establish and convene a meeting of a Home Oxygen Therapy Advisory Committee (HOTAC) pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a) within 6 months of enactment of this legislation.
a) The Advisory Committee would be comprised of members of the home oxygen therapy community, including, but not limited to, qualified home oxygen providers representing urban/rural markets and members that represent the diverse provider community, patients, nurses, respiratory therapists, pulmonary and primary care physicians, providers, public health organizations, patient advocates, and manufacturers. A public health organization is a private entity and the term does not include public health agencies.
b) The Committee will provide a forum for expert discussion and deliberation and the formulation of advice and recommendations to the Secretary regarding Medicare coverage for beneficiaries in need of home oxygen therapy, including:
- Designing an Oxygen Patient Evaluation Form to be developed with consensus from the Advisory Committee;
- Selecting, modifying, and updating quality measures;
- Developing the objective, evidence-based clinical criteria used to define each of the ambulatory payment categories;
- Refining the patient services provided under this benefit;
- Establishing a quality improvement program;
- Establishing appropriate case mix adjustment factors for home oxygen therapy services; and
- Evaluating a comparative effectiveness program that also would also include chronic care management.

10. Cost Reporting - Home oxygen providers would submit an annual cost report to CMS, no earlier than January 2012. The bill specifies that:
a) CMS could require a maximum of one cost report per year;
b) Cost report elements would be developed by the HOTAC;
c) Small providers (defined as $1 million or less in Medicare oxygen revenue) would be subject to shorter or streamlined report; and
d) Cost reporting would be delayed until at least 2 years after the new oxygen payment system is in place.

11. Anti Fraud and Abuse - The bill includes recommendations developed by the American Association for Homecare to improve the process for issuing Medicare supplier numbers and increased scrutiny of new providers.

12. Beneficiary Protections - The HHS Secretary would establish via regulations procedures to ensure that beneficiaries maintain their choice of oxygen provider, receive clear and understandable communications from their oxygen provider, are assured of privacy and confidentiality of their treatment and personal health information consistent with state and federal laws, are informed and able to participate in decisions about their home oxygen therapy services, and are informed about their right to refuse or discontinue treatment. In addition, the bill would provide the beneficiary the following rights, most of which are already required under existing law and regulation:

-To be informed by the home oxygen therapy provider of policies and expectations of the provider regarding patient conduct and responsibilities.
-To be informed by the home oxygen therapy provider about the individual's right to execute advance directives.
-To be informed by the home oxygen therapy provider about treatment modalities and categories of equipment relating to home oxygen therapy services for use by the individual and offered by the provider.
-To be informed of the home oxygen therapy provider's policies regarding 24-hour on-call coverage.
-To be informed by the home oxygen therapy provider of the individual's financial responsibilities with regard to such services.
-To be provided with the clinically appropriate oxygen equipment and services as agreed upon by the individual (or the individual's representative), the provider, and the prescribing physician.
-To be informed by the home oxygen therapy provider of any potential changes to the individual's equipment or services regarding home oxygen therapy services and the right to consult with individual's physician regarding such changes to ensure they are appropriate and necessary and the exceptions as specified by the Secretary when a home oxygen therapy provider may change an individual's oxygen equipment.
-To be informed by the home oxygen therapy provider of the provider's internal and external grievance processes (as well as how to contact Medicare through the hotline or Beneficiary Ombudsman), including the individual's right to file internal or external grievances or both without retaliation or denial of services and the right to file them personally or through a representative of the individual's choosing.
-To receive from the home oxygen therapy provider written notice 30 days in advance of an involuntary termination, after the home oxygen therapy provider follows established involuntary discharge procedures; however, in the case of immediate threats to the health and safety of others, the Secretary may permit the home oxygen therapy provider to use an abbreviated termination procedure.
-To be assisted by the home oxygen therapy provider in obtaining the equipment and supplies for home oxygen therapy services prescribed by individual's treating physician when the individual is traveling.
-To receive from the home oxygen therapy provider oxygen supplies, refills, and emergency back-up equipment and refills as appropriate.


13. Provider Status - The reform proposal would establish provider status for the home oxygen benefit.

14. No Federal Requirement to Retain Respiratory Therapists - The bill would not establish a federal requirement that a qualified home oxygen therapy provider employ or otherwise retain a licensed respiratory therapist to provide services for which state law does not require a licensed respiratory therapist.

15. No Separate NPI, Surety Bond or Mandatory Assignment - The bill would prohibit CMS from requiring a separate National Provider Identifier if the oxygen provider also provides DME, nor would it require a separate surety bond for the oxygen provider, nor would it allow CMS to require mandatory assignment or participation status.

16. Effective Date - If passed into law, the bill would be effective for oxygen services and items provided on or after Jan. 1, 2010.