ATTACHMENT B: SCOPE OF WORK

Article 1

DEFINITIONS

1.1 Definitions. In this contract, the following definitions apply:

“Associated Equipment” means equipment and maintenance services ordered by a Practitioner that addresses an individual’s medical disability, illness, or injury including gauges, humidifiers, oxygen tank racks, oxygen tank carts, and other items necessary for the use and function of Concentrators.

“Associated Supplies” means consumable or disposable items ordered by a Practitioner which are necessary for the use and function of the Concentrator.

“Caregiver” means a person who has taken a position to assist a Member with medical needs that the individual cannot meet by themselves including a family member, nursing facility staff, or some other person who regularly assists a Member in meeting their medical needs.

“Concentrator” means an oxygen concentrator including all valves, gauges, humidifiers, accessories, backup tank(s), reusable equipment and accessories associated with the regular use of an oxygen concentrator in a residential or facility-based setting as ordered from a Practitioner.

“CRTT” means a Certified Respiratory Therapy Technician, licensed to practice in Utah by the Department of Commerce, Division of Professional Licensing (“DOPL”).

“EPSDT” means Early Periodic Screening Diagnosis and Treatment Program which is the program to correct or ameliorate any defects and chronic conditions discovered among children ages birth through 20 years of age who qualify for Medicaid.

“Liquidated Damages” means a predetermined amount of money agreed upon by both parties in a contract to be paid as compensation if the Contractor fails to meet the performance standards.

“MCE” means Managed Care Entity which is a health care delivery system organized to manage cost, utilization, and quality. Medicaid managed care provides for the delivery of Medicaid benefits through contract arrangements between DHHS and MCEs.

“Medicaid” means the Utah administered medical assistance program authorized under Title XIX of the Social Security Act.

“Medically Necessary” means a service:(1) that is reasonably calculated to prevent, diagnose, or cure conditions in the recipient that endanger life, cause suffering or pain, cause physical deformity or malfunction, or threaten to cause a handicap and (2) for which there is no other equally effective course of treatment available or suitable for the recipient requesting the service that is more conservative or substantially less costly. Utah Administrative Code R414-1-2(18).

“Member” means an individual who is eligible and enrolled with Utah Medicaid on the date(s) the service is or will be provided including Fee-for-Service Members and those MCE Members in one of the 16 non-mandatory enrollment counties (not including an individual enrolled in an MCE in the 13 mandatory MCE enrollment counties) as designated by DHHS (by exception) in the All Providers Section I General Information of the Utah Medicaid Provider Manual found at https://medicaid.utah.gov/utah-medicaid-official-publications/.

“Practitioner” means a DOPL licensed physician (as defined in section 1861(r)(1) and 1861(aa)(5) of the Social Security Act), nurse practitioner, clinical nurse specialist, or physician assistant acting within their scope of practice and involved in providing the services of that discipline to Members.

“Reimbursement” means an established amount of money paid to a provider in exchange for a specifically defined and coded service provided to a Medicaid Member.

“RRT” means a DOPL licensed Registered Respiratory Therapist.

Article 2

PRICE GUARANTEE PERIOD

2.1 Reimbursement Rate. The Reimbursement rate will be $_______ per Concentrator unit. This rate is all-inclusive and DHHS will not provide separate Reimbursement for Associated Equipment, Associated Supplies, labor, delivery, Member education, or routine maintenance.

2.2 Rate Guarantee. The Contractor shall guarantee rates for one year from the contract effective date.

2.3 Requested Rate Adjustment. Following the guaranteed period:

(1) the Contractor may request a rate adjustment once per year for the remainder of the contract term;

(2) rate adjustment requests must be submitted in writing at least 180 calendar days prior to the proposed effective date;

(3) any request for price increase must include comprehensive documentation including market analysis, CPI adjustments, or manufacturer price lists justifying the change;

(4) no rate adjustment will be effective until the contract amendment is fully executed;

(5) any approved rate adjustment must be guaranteed for a minimum of one year from its effective date;

(6) DHHS shall receive the immediate benefit of any market-driven price decrease or allowable discounts; and

(7) DHHS reserves the right to review the contract regularly regarding performance and cost and may renegotiate price during the contract term.

Article 3

SERVICE AREA, CONCENTRATOR, EQUIPMENT AND SUPPLIES

3.1 Provisions. The Contractor shall provide Concentrators, Associated Equipment, and Associated Supplies for all Members statewide in accordance with orders received from a Practitioner.

3.2 Concentrators. Concentrators provided by the Contractor must meet the Member's medical needs and the following minimum requirements:

(1) deliver oxygen flow rates at 1-10 liters per minute;

(2) alarms for high system pressure, low system pressure, power failure, and low oxygen concentration;

(3) electrical requirements of 120v / 60 Hz (+/-10%);

(4) hour meter and oxygen concentration indicator on all equipment;

(5) mounted on wheels for easy movement by Member/Caregiver;

(6) must meet U.S. Food and Drug Administration Quality System Regulation standards;

(7) a sound level of 60 decibel or less;

(8) not exceed 600-watt power usage;

(9) weigh 60 pounds or less; and

(10) must be double insulated.

3.3 Included Items and Services. Associated Equipment, Associated Supplies, maintenance and services include:

(1) humidifiers and water traps;

(2) disposable oxygen cannulas;

(3) disposable masks;

(4) 25-50 feet of oxygen connecting tubing;

(5) trach collar and accessories including tubing and aerosol jars;

(6) cart for storing backup tanks;

(7) cylinder rack for backup tanks; and

(8) other items, maintenance and services, Medically Necessary for the Member for the proper use and function of Concentrators.

3.4 Backup Oxygen. The Contractor shall provide each Member with a backup oxygen supply sufficient to meet their medical needs. This supply must be maintained at a level capable of sustaining the Member for a minimum of three times the Contractor's anticipated response time to reach the Member’s place of residence to address the medical concerns.

3.5 Additional Equipment. The Contractor shall provide any additional equipment, such as extra stationary units, needed to maintain the minimum level of backup oxygen.

Article 4

MEMBER ELIGIBILITY FOR SERVICES

4.1 Eligibility Verification. The Contractor shall verify Medicaid eligibility as described in Chapter 6, Member Eligibility, of the All Providers Section I General Information of the Utah Medicaid Provider Manual, found at https://medicaid.utah.gov/utah-medicaid-official-publications/. DHHS shall provide the Contractor with access to eligibility data via the Medicaid website or customer service line. The Contractor shall only provide services to Members who are currently or who become eligible and enrolled as a Member for the specific dates service was provided.

Article 5

COMPLIANCE WITH MANUALS, RULES, AND REGULATIONS

5.1 Compliance. The Contractor shall comply with all provisions of the Medical Supplies and Durable Medical Equipment Provider Manual found at ttps://medicaid.utah.gov/utah-medicaid-official-publications/, pertaining to oxygen and Concentrators.

Article 6

SERVICING CONCENTRATOR AND ASSOCIATED EQUIPMENT

6.1 Service and Maintenance. The Contractor shall:

(1) perform scheduled preventative maintenance including testing, cleaning, regulating, and calibrating on each Member's Concentrator and Associated Equipment;

(2) perform preventative maintenance per the manufacturer's specifications or as necessary to maintain proper functionality;

(3) be responsible for tracking, documenting, and archiving all maintenance and repair logs; and

(4) provide maintenance records to DHHS upon request.

Article 7

CLAIMS AND BILLING

7.1 Claims Submission. The Contractor shall submit all claims in accordance with the policy outlined in Chapter 11-6, Submitting Claims, of the All Providers Section I General Information of the Utah Medicaid Provider Manual, found at https://medicaid.utah.gov/utah-medicaid-official-publications/, for Concentrators and equipment placed and in use for the month. The date of service listed on each claim must be the first service date of the month the Concentrator is installed and then the first day of each month thereafter.

Article 8

COMPLIANCE AND ANTI-FRAUD POLICIES

8.1 Written Policies. The Contractor shall establish, maintain, and distribute written policies and procedures for all its employees, including management and its agents and provide detailed information regarding federal and State anti-fraud measures, specifically including:

(1) the False Claims Act, 31 U.S.C §§ 3729-3733, administrative remedies for false claims and statements found at 31 U.S.C. Chapter 38;

(2) applicable Utah State laws establishing civil or criminal penalties for false claims, fraudulent statements, and whistleblower protections under such laws;

(3) clear educational guidance regarding the role of such laws in preventing, detecting, and mitigating fraud, waste, and abuse within federal health care programs, as defined 42 U.S.C. § 1320a-7b(f).

Article 9

PRACTITIONER ORDER

9.1 Written Order. The Contractor shall ensure there is a written Practitioner order for the placement of the Concentrator. If placing a Concentrator upon a Practitioner's telephone order, the Contractor must obtain the finalized, signed written order within 30 calendar days of equipment delivery and before submitting the claim to Medicaid. Medicaid will not reimburse for any services provided if a valid written order is not secured within this 30-day window.

9.2 Order Renewals. For continued service, the Practitioner must renew their order in writing every 12 months or on the expiration of the original order, whichever occurs first. Reimbursement shall not be made for the Concentrator for periods when a current, valid Practitioner's order is expired, missing, or invalid. In the event of an order expiration, the Contractor shall notify the Member and Utah Medicaid in writing at least 15 days before disrupting service or removing equipment.

Article 10

DOCUMENTATION OF PROOF OF DELIVERY

10.1 Proof of Delivery (“POD”) Documentation. The Contractor shall document delivery and receipt of the Concentrator. Claims submitted without a compliant POD that matches the date of service on the claim may be subject to immediate recoupment by Medicaid.

10.2 Required Documentation. POD documentation must include all the following elements:

(1) Member’s full name;

(2) Member’s Medicaid ID number;

(3) delivery address;

(4) a detailed description of the item(s) being delivered including make, model, and serial number of the Concentrator;

(5) quantity delivered;

(6) date delivered;

(7) the printed name, signature, and signature date from, the Member, the Member's legally authorized representative, an authorized Caregiver, or if delivered to a hospital, long-term care, or assisted living facility, the printed name, title, and signature of the facility employee accepting the equipment; and

(8) if an electronic POD system is used to capture an electronic signature, it must utilize secure software that logs a tamper-evident date and time stamp linked directly to the signature.

Article 11

TRAINING, INFORMATION, AND DOCUMENTATION RESPONSIBILITIES

11.1 Responsibilities. The Contractor shall:

(1) provide education to each Member at the time of Concentrator placement and each home visit (training must be delivered verbally and physically, reinforced via demonstration, and supplemented with written material left with the Member or Caregiver);

(2) utilize only educational materials that have been submitted to, reviewed by, and approved in writing by DHHS;

(3) submit an electronic copy of all baseline educational documents to DHHS for written approval within 30 calendar days of the contract effective date;

(4) request written DHHS approval prior to implementing any future changes, modifications, additions, or deletions to approved educational materials (review and respond to such requests within 30 calendar days of receipt);

(6) obtain a signed and dated acknowledgment from the Member or Caregiver verifying receipt of all required written documents and the successful completion of the verbal and physical training; and

(7) maintain all educational logs, signed acknowledgments, and device-related documentation on file for a minimum of seven years from the date of service, making them available to DHHS immediately upon request for audit purposes.

Article 12

SECONDARY STATIONARY CONCENTRATORS AND PORTABLE OXYGEN SYSTEMS

Article 13

CONTRACTOR QUALIFICATIONS TO DO BUSINESS

13.1 Contractor Qualifications. The Contractor shall:

(1) maintain stable financial operations to ensure timely payments to employees, subcontractors, and creditors;

(2) maintain active registration and good standing with the Utah Department of Commerce Division of Corporations and Commercial Code and hold all required licenses to conduct business within the State; and

(3) maintain active enrollment as a qualified provider for Utah Medicaid.

13.2 Contractor Compliance. The Contractor’s failure to maintain the qualifications set forth in section 13.1 constitutes grounds for contract termination.

Article 14

BILLING FOR SUBCONTRACTORS

14.1 Subcontractor Enrollment Requirements. The Contractor may utilize Subcontractors to perform services, provided that all such Subcontractors are actively enrolled as Utah Medicaid providers and possess an active National Provider Identifier at the time any service is rendered.

Article 15

MEDICAID REIMBURSEMENT AS PAYMENT IN FULL

15.1 Payment in Full. The Contractor shall accept Medicaid Reimbursement as payment in full for all covered services and equipment provided and shall not bill a Member for any amount.

Article 16

REPRESENTATION AT ADMINISTRATIVE HEARINGS AND JUDICIAL PROCEEDINGS

16.1 Participation Requirements. The Contractor shall:

(1) assist in administrative hearings concerning placement, retrieval, servicing, and other associated events related to this contract including, providing all documentation necessary for hearings and other judicial proceedings; and

(2) provide a representative at these hearings and other judicial proceedings at no additional cost to DHHS.

Article 17

ASSOCIATED RESPIRATORY EQUIPMENT AND SUPPLIES

17.1 Provision of Associated Equipment. In addition to standard Concentrators, the Contractor shall provide other Associated Equipment and Associated Supplies when Medically Necessary, covered by Medicaid, and meets Medicaid criteria.

17.2 Separately Billable Respiratory Devices. The Contractor may provide and separately bill for advanced respiratory devices in accordance with the Utah Medicaid Fee Schedule, subject to DHHS criteria and applicable Prior Authorization guidelines, including Positive Airway Pressure systems, mechanical ventilators (invasive and non-invasive), pulse oximeters and related monitoring supplies, and portable oxygen.

Article 18

LOST, STOLEN, OR DAMAGED EQUIPMENT

18.1 Replacement. If a Concentrator is lost, stolen, or damaged beyond repair, the Contractor shall ensure the Member’s health and safety are protected without interruption by:

(1) maintaining services and refraining from withholding or delaying Medically Necessary respiratory services from the Member;

(2) replacing the lost, stolen, or damaged equipment within six hours of Member’s notification, or sooner if required to prevent a life-threatening gap in the Member’s oxygen therapy; and

(3) absorbing the immediate operational cost without holding the Member or Caregiver financially responsible.

18.2 DHHS Notification and Reimbursement. Reimbursement for lost, stolen, or damaged equipment will be evaluated on a case-by-case basis following the policy found in the Medical Supplies and Durable Medical Equipment Policy Manual, Chapter 8-15, Equipment Service Requirements, found at https://medicaid.utah.gov/utah-medicaid-official-publications/. The Contractor shall submit all required documentation, including police reports for stolen equipment or fire and disaster logs for destroyed equipment to DHHS within 30 calendar days of the replacement to be evaluated for emergency Reimbursement.

Article 19

SERVICE CONTINUATION AFTER CONTRACT TERMINATION

19.1 Service Continuation. In the event of contract expiration or termination for any reason, the Contractor shall continue providing all covered equipment and services to active Medicaid Members under the exact terms, conditions, and Reimbursement rates in force at the time of termination or expiration.

19.2 Transition Phase Obligations. The service continuation period shall remain active until DHHS confirms in writing that all affected Members have been successfully transitioned to a successor Contractor and the Contractor shall:

(1) cooperate fully and in good faith with DHHS and the successor Contractor to facilitate an orderly transfer of Member clinical files, delivery schedules, and equipment logs;

(2) maintain uninterrupted delivery, tracking, emergency backup checks, and maintenance of all in-home equipment until the successor Contractor's equipment is fully operational in the Member's residence; and

(3) refrain from retrieving or decommissioning any active in-home Concentrator until the successor Contractor has placed a replacement unit and verified seamless operation.

Article 20

VENDOR AVAILABILITY TO THE STATE

20.1 Authorized Representative. The Contractor shall assign a project director, operations manager, or other authorized representative to serve as the contact liaison to DHHS. The authorized representative shall:

(1) remain available and responsible to DHHS for consultation and assistance;

(2) attend, upon request, all scheduled meetings, work groups, and hearings convened by Utah legislative committees, governmental bodies, or DHHS staff; and

(3) agencies, and officers and shall also provide timely and informed responses to operational and administrative inquiries arising in the Utah Medicaid program that pertain to the contract. In addition, the representative shall meet with the State designee and other DHHS staff, as required by DHHS.

20.2 Designation of Deputy Representative. The Contractor shall designate at least one qualified deputy representative fully authorized and prepared to assume all duties and responsibilities of the authorized representative during any period of unavailability.

20.3 Contact Information. The Contractor shall provide DHHS with updated contact information for both positions.

Article 21

TELEPHONE INQUIRIES

21.1 Telephone Service Availability. The Contractor shall maintain telephone services available 24 hours per day, seven days a week, including holidays and weekends, to address Member, Caregiver, and DHHS inquiries.

21.2 Answering and Callback Standards. The Contractor shall ensure the telephone service complies with the following mandatory operational standards:

(1) the phone line must be answered by live Contractor personnel during regular business hours and by live answering service personnel during non-business hours;

(2) answering service staff must inform the Member that the Contractor will return their call within 15 minutes;

(3) clinical or technical staff must return Member calls within 15 minutes; and

(4) an escalation protocol must be maintained ensuring that if the primary clinician fails to respond within 15 minutes, a secondary clinician, technician, or supervisor is available to contact the Member.

21.3 Telephone Response Time. The Contractor shall not use an answering machine or voice mail in lieu of an answering service.

Article 22

LICENSURE

22.1 Contractor Licensure. The Contractor shall possess and maintain all valid State and federal licenses and certifications required to distribute medical gases and Durable Medical Equipment in the State, and all required credentials must be active and on file with DHHS prior to the operational start date.

22.2 Mandatory Notification of Sanctions. The Contractor shall notify DHHS in writing within two business days if the Contractor, any corporate officer, or any utilized Subcontractor experiences any of the following regulatory events:

(1) a suspension, revocation, expiration, or non-renewal of any professional license or permit;

(2) the initiation of an administrative disciplinary action by a state licensing board, such as DOPL; or

(3) the exclusion or suspension from participation in any federal or State health care program, including Medicare or Medicaid.

Article 23

SATELLITE OFFICES

23.1 Locations. The Contractor shall provide DHHS quarterly written updates detailing all satellite location changes, including information on newly added, recently closed, or relocated locations, or changes to contact information. These updates must be submitted by the 15th day following the end of each calendar quarter.

Article 24

BACKGROUND CHECKS

24.1 DHHS Background Checks. DHHS reserves the right to conduct independent background checks on any person or entity that may assist in providing services under this contract to determine the person's fitness and qualifications to fulfill the contract requirements.

24.2 Contractor Background Checks. Upon request by DHHS, the Contractor shall obtain an official criminal background check from the Utah Department of Public Safety, Bureau of Criminal Investigation. These checks will be completed at the Contractor’s sole expense.

24.3 Delivery and Compliance. The Contractor shall deliver the results of requested background checks to DHHS within five business days of the request. The Contractor shall ensure that no employee or subcontractor with a disqualifying criminal history is permitted to perform in-home as outlined in Utah Administrative Code R501-14.

Article 25

REPORTS

25.1 Performance Reports. Using secure electronic means, the Contractor shall submit quarterly performance reports that aggregate data on a month-by-month basis. These reports must demonstrate compliance with the performance standards outlined in Article 26, Performance Standards and Penalties.

Article 26

PERFORMANCE STANDARDS AND PENALTIES

26.1 Assessment of Liquidated Damages. Should the Contractor fail to meet the performance standards detailed below, DHHS may, at its sole discretion, assess the associated monthly Liquidated Damages.

26.2 Reset Performance Standards. Performance standards subject to increasing Liquidated Damages will reset to baseline levels only after the Contractor demonstrates sustained compliance with the specific standard for three consecutive months.

26.3 Performance Standards Liquidated Damages:

a. Provision of Services. The Contractor shall provide services within the time frames established in Article 18.

Non-compliance with the six-hour service provision window must not exceed two episodes per calendar month or Liquidated Damages compensation will be assessed per the table below:

Liquidated Damages:

b. Telephone Service. The Contractor shall maintain a telephone service and response times as outlined in Article 21.2.

If the monthly average call response time exceeds 15 minutes, then Liquidated Damages will be assessed as stated below:

Liquidated Damages: $500.00 per month in which the monthly average response time for return calls exceeds 15 minutes, increasing to $1,000.00 per month if this performance standard is not met for three or more consecutive months.

c. Backup Oxygen. The Contractor shall provide and maintain appropriate backup oxygen systems consisting of an oxygen source and regulator with stand, humidifiers, cannulas or masks, for use during a power failure or mechanical malfunction for all Members as outlined in Article 3.4.

If there is a failure to provide and maintain appropriate backup oxygen systems, then Liquidated Damages will be assessed per the table below:

Liquidated Damages:

d. Incident Reporting System. The Contractor shall maintain a documented incident reporting system that tracks all never events and all sentinel events, as defined by CMS, including a detailed clinical and operational description related to each event.

If the number of sentinel events and never events exceed one per calendar month then Liquidated Damages will be assessed per the table below:

Liquidated Damages:

26.4 Liquidated Damages Maximum: The total maximum amount of Liquidated Damages payable by the Contractor in any single calendar month will not exceed $10,000.00. DHHS may elect to recover the Liquidated Damages described above or pursue actual damages, losses, or costs under the indemnity clause found in Attachment A. If DHHS elects to recover actual losses or damages through its right of indemnity, the underlying incident or event will not also be included or counted toward the monthly Liquidated Damages assessment defined above.

Article 27

OUTCOMES

(2) Enhanced Member Safety: Member safety risks are minimized through the maintenance of backup oxygen systems, prompt mitigation of equipment malfunctions, and the tracking and prevention of sentinel or never events.

(3) Effective Member and Caregiver Literacy: Members and Caregivers demonstrate competency in operating Concentrators and executing emergency safety protocols through standardized, low-literacy verbal and physical training.

(2) Telephone Service Responsiveness: The average monthly response and callback times for Member, Caregiver, and DHHS inquiries, measured against the strict 15-minute callback standard.

(3) Backup Oxygen Sufficiency: Verification that 100% of Members with Concentrators in use possess a functional emergency backup oxygen supply capable of sustaining their clinically prescribed flow rate for at least three times the Contractor’s anticipated response time.

(2) utilize secure electronic means to submit quarterly performance reports that aggregate data on a month-by-month basis, mapping directly to each outcome measure outlined in Article 27 and performance standard outlined in Article 26;

(3) maintain, track, and archive comprehensive logs of all preventative maintenance, calibration, and equipment repairs, and shall deliver these records to DHHS immediately upon request;

(4) maintain a documented incident reporting system for all sentinel and never events as defined by CMS, including detailed clinical and operational descriptions, available for immediate DHHS review; and

(5) retain all educational logs and signed Member or Caregiver training acknowledgments on file for a minimum of seven years from the date of service for audit and verification purposes.

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