‘(hhh)(1) In General- The term ‘home oxygen therapy services’ means services and supplies furnished by a qualified home oxygen therapy provider and includes, with respect to an individual, the following furnished by home oxygen therapy provider (as defined in paragraph (2)).
‘(A) Conducting an initial evaluation of the individual using a uniform Oxygen Patient Evaluation Form developed, in consultation with the Home Oxygen Therapy Advisory Committee, by the Secretary.
‘(B) Providing written and verbal individual and caregiver education about home oxygen therapy, stationary and portable oxygen therapy options, and oxygen safety (such as evaluating the home environment for safety risks or hazards, including home fire and fall prevention).
‘(C) Providing appropriate delivery, set-up, and coordination of oxygen (such as 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 individual or caregiver (or both), the home oxygen therapy provider, and the physician.
‘(D) Evaluating the individual’s ability to operate the oxygen equipment safely and effectively.
‘(E) Educating and, when necessary, providing assistance with infection control, focusing on keeping oxygen 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, which may include checking oxygen system purity levels and flow rates, changing and cleaning filters, and assuring the integrity of alarms and back-up systems.
‘(G) Monitoring visits by appropriately trained personnel to evaluate all aspects of the services being provided to the individual by the home oxygen therapy provider, including ensuring that individual is following the prescribed plan of care.
‘(H) Documenting exception reporting by the home oxygen therapy provider when changes occur in the individual’s compliance with the plan of care to the prescribing physician.
‘(I) Providing, as needed, continued education regarding appropriate home oxygen equipment maintenance practices and performance by the individual 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 supplemental supplies and emergency oxygen back-ups as appropriate.
‘(L) Providing 24-hour on-call coverage to respond to individual’s needs with home oxygen therapy.
‘(M) Assisting the individual with the coordination of oxygen equipment, services, and providers if the individual travels outside of the provider’s service area.
If an individual relocates permanently, the new home oxygen therapy provider for the individual shall assume responsibility for billing the Medicare program directly. The Secretary is directed to determine which of these covered services must be performed in person.
‘(A) The term ‘qualified home oxygen therapy provider’ means an entity that provides home oxygen therapy services and home oxygen equipment--
‘(i) furnishes home oxygen therapy services in compliance with applicable laws, rules, and regulations to individuals in their homes, pursuant to a physician’s order;
‘(ii) is accredited by an accreditation organization (including organizations deemed as of November 2006 by the Secretary to accredit durable medical equipment suppliers) that offers home medical equipment or respiratory service accreditation services;
‘(iii) complies with the Durable Medical Equipment, Prosthetics, Orthotics and Supplies Quality Standards adopted by the Secretary in October 2008; and
‘(iv) complies with the Durable Medical Equipment, Prosthetics, Orthotics and Supplies Supplier Standards as set forth at section 424.57(c) of title 42, Code of Federal Regulations).
‘(B) A qualified home oxygen therapy provider may determine which oxygen delivery system meets the requirements of the prescribing physician’s order and is appropriate for an individual based upon the physician’s classification of the individual in a patient category.
‘(C) Nothing in this subsection shall be construed to establish a Federal requirement that a qualified home oxygen therapy provider employ or otherwise retain a licensed respiratory therapist to furnish services for which State law does not require them to be furnished by such a licensed respiratory therapist.
‘(D) Nothing in this title shall be construed as authorizing the Secretary to require an entity that is a qualified home oxygen therapy provider--
‘(i) to obtain more than one National Provider Identifier for each location in which the provider operates, notwithstanding that the provider also furnishes durable medical equipment under this title;
‘(ii) to obtain a surety bond if the entity has already posted a surety bond for purposes of meeting such a bond requirement as a supplier of durable medical equipment or other lines of business; or
‘(iii) to accept assignment on claims for home oxygen therapy services or to be a participating supplier with respect to such services.
(b) Payment- Section 1834 of such Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:
‘(1) ESTABLISHMENT OF SINGLE BUNDLED PAYMENT SYSTEM- Payment for home oxygen therapy services under this part shall be based on a single bundled payment rate for home oxygen therapy services (including equipment and supplies) determined under this subsection. Such a rate shall--
‘(A) be applied separately for each patient category established under paragraph (2);
‘(B) be paid on a per-patient-per-month basis;
‘(C) be initially computed under paragraph (3) in a budget neutral manner based on allowed payments for providing such services (including equipment and supplies);
‘(D) be annually updated in accordance with paragraph (4); and
‘(E) be adjusted for its patient services component for geographic factors under paragraph (5).
‘(2) PATIENT CATEGORIES-
‘(A) IN GENERAL- Under the single bundled payment system, individuals receiving home oxygen therapy services shall be classified into one of three patient categories, as follows:
‘(i) CATEGORY 1- A first category of individuals (in this subsection referred to as ‘category 1’) who lack mobility or are prescribed oxygen for nocturnal use only.
‘(ii) CATEGORY 2- A second category of individuals (in this subsection referred to as ‘category 2’) who have standard portability needs for oxygen therapy.
‘(iii) CATEGORY 3- A third category of individuals (in this subsection referred to as ‘category 3’) who have high portability needs for oxygen therapy.
‘(B) DEFINITIONS- In this paragraph:
‘(i) The term ‘standard portability’ means the use of portable oxygen is estimated at less than or equal to 40 liter hours per week.
‘(ii) The term ‘high portability’ means the use of portable oxygen is estimated at more than 40 liter hours per week.
‘(iii) The term ‘liter hours per week’ means the total liters of oxygen used during a month divided by 4.3 (weeks per month) divided by liters per minute prescribed divided by 60 minutes.
‘(C) REQUIREMENT FOR ASSESSMENT-
‘(i) IN GENERAL- Subject to clause (ii), on and after January 1, 2010, an individual may not be furnished home oxygen therapy services under this part unless a physician has assigned an individual into a patient category and indicated such assignment on a certificate of medical need that is given to the home oxygen therapy provider.
‘(ii) GRANDFATHER- In the case of an individual who is receiving home oxygen therapy as of January 1, 2010, for which payment is being made under this title, clause (i) shall not apply until January 1, 2011, and until the date a physician assigns the individual into a patient category. Before such date, the individual shall be classified based on the individual’s prescription as in effect on December 31, 2009.
‘(3) INITIAL PAYMENT RATE-
‘(A) IN GENERAL-
‘(i) The single bundled payment rate for 2010, 2011, and 2012 shall be computed annually by the Secretary in a budget neutral manner consistent with subparagraph (D) using the distributions for each category in clause (ii). The Secretary shall not make any prospective adjustments to the payment rates under this reimbursement methodology for such years. The base year shall be the latest available calendar year adjusted data.
‘(ii) For 2010, 2011, and 2012, the Secretary shall establish the single bundled payment rate by assuming the following distribution of individuals among the categories:
‘(I) In category 1, 30 percent.
‘(II) In category 2, 50 percent.
‘(III) In category 3, 20 percent.
The Secretary shall base the allowed payments for categories 1 and 3 upon a percentage relationship to the allowed payment for category 2. Category 3 allowed payment rate should be greater than category 2 allowed payment rate and category 2 allowed payment rate should be greater than category 1.
‘(B) PAYMENTS FOR YEARS 2013 AND 2014- The single bundled payment rates for 2013 and 2014 shall be computed by the Secretary in a budget neutral manner consistent with subparagraph (D) using data obtained through the cost reports required under this section.
‘(C) PAYMENTS FOR YEARS 2015 AND BEYOND- The single bundled payment rates for 2015 and subsequent years shall be computed by the Secretary using data obtained through the cost reports required under this section.
‘(D) BUDGET NEUTRALITY- The Secretary shall calculate the single bundled payment rates established under this section for 2010, 2011, 2012, 2013, and 2014 such that the total spending for each year is equivalent in the aggregate to the spending that would have been made for home oxygen therapy during such year if the amendments made by the Medicare Home Oxygen Therapy Services Act of 2009 had not been enacted.
‘(4) ANNUAL UPDATE BY CPI-U- The payment rates established under this subsection shall be adjusted for each year (beginning with 2011) in a prospective manner by the Secretary and be published by October 1 of the previous year based on the percentage increase in the consumer price index for all urban consumers (all items; U.S. city average) applicable to the year involved.
‘(5) APPLICATION OF GEOGRAPHIC ADJUSTMENT- The payment rates established under this subsection shall be adjusted, in a budget neutral manner, to take into account differences among areas in labor and transportation costs.
‘(6) INCLUDING PATIENT CATEGORY AND RELATED INFORMATION ON CERTIFICATE OF MEDICAL NEED- The Secretary shall modify the certificate of medical need used under this part for home oxygen therapy services so that an individual’s physician would indicate on the form the appropriate patient category for the individual. Any change in an individual’s category would be made by the physician submitting an updated certificate of medical need form indicating the change in the individual’s category.
‘(7) RESPONSIBILITIES OF QUALIFIED HOME OXYGEN THERAPY PROVIDERS AND PHYSICIANS-
‘(A) PROVIDERS- A qualified home oxygen therapy provider is responsible for monitoring and periodically re-evaluating, using the Oxygen Patient Evaluation Form, each individual to whom the provider is furnishing home oxygen therapy services under this part and notifying the prescribing physician when the results of such an re-evaluation indicate that a re-assignment in a category under this subsection may be warranted due to a change in the individual’s clinical condition or ambulatory status.
‘(B) PHYSICIANS- Such an individual’s physician is responsible for making any change in such an individual’s category placement and for documenting such change in the individual’s medical record and providing an updated certificate of medical need to the home oxygen therapy provider.
‘(8) COST REPORTS-
‘(A) IN GENERAL- The Secretary in consultation with the Home Oxygen Therapy Advisory Committee established under paragraph (9) shall develop an annual cost report for qualified home oxygen therapy providers with respect to the costs incurred for equipment, supplies, and services furnished to individuals. Qualified home oxygen therapy providers shall submit such report annually to the Secretary and the Secretary shall not require the submission of more than one such cost report for such a provider for each year.
‘(B) STREAMLINED REPORT FOR SMALL SUPPLIERS- Qualified home oxygen therapy providers with not more than $1,000,000 in revenue from the provision of home oxygen therapy services under this part shall be permitted to submit a shorter or streamlined report under this paragraph.
‘(C) IMPLEMENTATION- The Secretary shall not require the submission of a cost report under this paragraph earlier than January 1, 2012.
‘(9) HOME OXYGEN THERAPY ADVISORY COMMITTEE-
‘(A) IN GENERAL- The Secretary shall establish and convene an independent, multidisciplinary, nonpartisan Home Oxygen Therapy Advisory Committee (in this paragraph referred to as the ‘Advisory Committee’) (pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a)) not later than 6 months after the date of the enactment of this subsection.
‘(B) COMPOSITION- The Advisory Committee shall consist of such members as the Secretary may appoint and who shall serve for such term as the Secretary may specify. In appointing members, the Secretary shall consult with the home oxygen therapy community. The Advisory Committee shall be comprised of members of the home oxygen therapy community, including patients, nurses, respiratory therapists, physicians, qualified home oxygen therapy providers representing urban and rural markets and the diverse provider community, public health organizations, patient advocates, and manufacturers. In this subparagraph, the term ‘public health organization’ means a private entity and does not include a public health agency.
‘(C) FUNCTIONS- The Committee shall provide a forum for expert discussion and deliberation and the formulation of advice and recommendations to the Secretary regarding coverage and payment for home oxygen therapy services under this part, including--
‘(i) selecting, modifying, and updating quality measures;
‘(ii) developing the objective, evidence-based clinical criteria used to define each of the patient categories;
‘(iii) designing a consensus-based oxygen patient evaluation form;
‘(iv) refining the services included in home oxygen therapy services;
‘(v) establishing a quality improvement program;
‘(vi) evaluating a comparative effectiveness program that also would also include chronic care management; and
‘(vii) strengthening anti-fraud, abuse, and waste provisions by--
‘(I) mandating site inspections for all new home oxygen therapy providers;
‘(II) requiring site inspections for all home oxygen therapy provider renewals;
‘(III) improving validation of new home oxygen therapy providers by improving the application process for obtaining a National Provider Identifier;
‘(IV) requiring two additional random, unannounced site visits for all new home oxygen therapy providers during the first year of operation;
‘(V) requiring a 6-month trial period for new home oxygen therapy providers during which time the provider would receive a preliminary National Provider Identifier;
‘(VI) establishing an anti-fraud office within the Centers for Medicare & Medicaid Services to coordinate detection and deterrence of fraud and improper payments across the Medicare and Medicaid programs by accepting and responding to reports of alleged fraud and abuse from physicians and providers;
‘(VII) considering the proper Federal funding levels needed for improving fraud prevention;
‘(VIII) requiring post-payment audit reviews for all new home oxygen therapy providers relying upon 6 months’ worth of claims submissions;
‘(IX) requiring the Centers for Medicare & Medicaid Services to conduct real-time claims analysis analyzing home oxygen therapy provider claims to identify aberrant billing patterns more quickly;
‘(X) ensuring that all providers are qualified to offer the services for which they submit claims by mandating cross-checking Medicare and other relevant databases to ensure that home oxygen therapy providers are qualified and accredited for providing home oxygen therapy services;
‘(XI) establishing written due process procedures for home oxygen therapy providers applying for a National Provider Identifier, including establishing an administrative appeals process and clear timelines;
‘(XII) increasing penalties and fines and fraud for activities such as buying or stealing beneficiaries’ Medicare numbers or physician’s provider numbers; and
‘(XIII) establishing more rigorous quality standards.
‘(D) REPORT- The Committee shall provide the Secretary with periodic reports that summarize the Committee’s activities and its recommendations for such legislation and administrative action as it considers appropriate.
‘(E) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated such sums as may be necessary to carry out the purposes of this paragraph.
‘(10) CLAIMS PROCESSING- The Secretary shall provide for processing of claims for home oxygen therapy services from home oxygen therapy providers to be conducted through the administrative contractors under this title for durable medical equipment.
‘(11) BENEFICIARY RIGHTS- The Secretary shall establish through regulation the following protections for individuals receiving home oxygen therapy services under this part:
‘(A) To choose the individual’s local provider of such services from among qualified home oxygen therapy service providers and to change such provider.
‘(B) To receive communications from the home oxygen therapy provider in a clear and understandable manner.
‘(C) To privacy and confidentiality in all aspects of treatment and their personal health information consistent with Federal and State laws.
‘(D) To be informed by the home oxygen therapy provider about and participate, if desired, in all aspects of the oxygen therapy services being furnished to the individual by the provider, and be informed by such provider of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research.
‘(E) To be informed by the home oxygen therapy provider of policies and expectations of the provider regarding patient conduct and responsibilities.
‘(F) To be informed by the home oxygen therapy provider about the individual’s right to execute advance directives.
‘(G) 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.
‘(H) To be informed of the home oxygen therapy provider’s policies regarding 24-hour on-call coverage.
‘(I) To be informed by the home oxygen therapy provider of the individual’s financial responsibilities with regard to such services.
‘(J) 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.
‘(K) 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.
‘(L) 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.
‘(M) 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.
‘(N) 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.
‘(O) To receive from the home oxygen therapy provider oxygen supplies, refills, and emergency back-up equipment and refills as appropriate.’.