Movement to Integrated Care Model
AMARILLO, TX – Health care is evolving from the traditional “fee-for-service” (“FFS”) model to an “integrated care” model. Under the FFS model, health care providers operate in separate “silos.” Each provider is paid for the services/products it delivers…regardless of whether such services/products result in a positive patient outcome. Plus, in the FFS model, the providers engage in very little coordination with each other. This approach is expensive and inefficient. Third party payors (“TPPs”) are pushing providers into the integrated care model. Under this model, providers are expected to coordinate with each other so that they work as a “team” to heal the patient…and then keep the patient healthy.

Further, reimbursement is tied to patient outcome. While commercial insurers are on the forefront in pushing the integrated care model, government health care programs are also going down this path. As providers engage in the integrated care model, they will desire to furnish products and value-added services to patients intended to “promote access to care.” Over the past several years, there has been an easing of restrictions against providing products and value-added services designed to promote access to care. Such easing of restrictions can be found in the Affordable Care Act (“ACA”), OIG regulations, and in recent OIG Advisory Opinions.

Affordable Care Act and OIG Regulations
Notwithstanding the prohibition contained in the beneficiary inducement statute, the ACA provides exceptions to what might constitute “remuneration” under the statute, including an exception for remuneration that “that poses a low risk of harm and promotes access to care.” Further, in December 2016 the OIG issued final regulations regarding patient incentive arrangements. The OIG defines “care” (in the context of “access to care”) as “access to items and services that are payable by Medicare or a state health care program for the beneficiaries who receive them.” The OIG interprets “promoting access to care” as “improving a particular beneficiary’s, or a defined beneficiary population’s, ability to obtain items and services payable by Medicare or a state health care program.” Promoting access to care includes the removal of “socioeconomic, educational, geographic, mobility or other barriers that could prevent patients from seeking care (including preventive care) or following through with a treatment plan.”

As an example, the OIG makes a distinction between free child care and movie tickets: “[P]roviding free child care during appointments also could promote access to care and help a patient comply with a treatment regimen. In contrast, offering movie tickets to a patient whenever the patient attends an appointment would not fit in the exception; such remuneration would be a reward for receiving care and does not help the patient access care, or remove a barrier that would prevent the patient from accessing care.” The OIG set out different factors and analysis tests for the “low risk of harm” component. The OIG stated that remuneration would pose a low risk of harm to Medicare and Medicaid beneficiaries and federal health care programs by (i) being unlikely to interfere with, or skew, clinical decision making, (ii) being unlikely to increase costs to federal health care programs or beneficiaries through overutilization or inappropriate utilization, and (iii) not raising patient safety or quality of care concerns.

OIG Advisory Opinion 17-01
In conjunction with its regulations, the OIG released Advisory Opinion 17-01 which expanded on its “low risk of harm” analysis by including additional factors to examine when assessing patient benefits. In addressing “skewing clinical decision making,” providers should look at whether (i) eligibility to receive the remuneration is conditioned on receipt of a particular service from the supplier and/or (ii) the physician receives remuneration that encourages referring eligible patients to the supplier. In addressing “increased costs to federal health care programs,” the provider should look at whether the patient incentive arrangement will shift the remuneration cost to federal health care programs and whether the arrangement is likely to lead to overutilization of covered items and services.

In addressing “overutilization,” the provider should look at whether (i) it is actively marketing the program to attract patients, (ii) the program is being offered before the patient decides to use the provider, and (iii) the offered remuneration is encouraging patients to seek out unnecessary or poor quality of care. If the answer is “yes” to one or more of these factors, then it is likely that the patient incentive arrangement does not result in a “low risk of harm.” When discussing activities that facilitate access to care, the OIG says that “promoting access to care” constitutes “improving a particular beneficiary’s, or a defined beneficiary population’s, ability to obtain items and services….”

This includes removing “socioeconomic, educational, geographic, mobility or other barriers that could prevent patients from seeking care…or following through with a treatment plan.” However, the OIG is careful to distinguish activities that directly provide access to care from activities that are not directly related. For instance, “providing free child care during appointments…could promote access to care…[while] offering movie tickets to a patient whenever the patient attends an appointment…would be a reward for receiving care and does not help the patient access care….”

Examples of services that promote access to care:

• A physician practice purchases a subscription to an internet based food and activity tracker that offers information on healthy lifestyles for diabetic patients. This helps the patient understand and manage interaction between disease state and lifestyle and creates a record that facilitates interactions with the physician for future care planning.
• A hospital sends patients home with inexpensive devices that record data that is then transmitted to the hospital or the patient’s physician. This facilitates follow up care and compliance efforts.
• A provider furnishes patients with an item that dispenses medications at a certain time with the correct dosage. This assists with a patient’s medication adherence.

OIG Advisory Opinion 19-03
Patients who meet all eligibility criteria and who choose to participate receive two visits from a community paramedic each week to for approximately 30 days following enrollment.  Each visit takes place in the patient’s home or ALF and lasts approximately 60 minutes. Services offered include:

• Medication review/reconciliation;
• Patient assessment and identify need for follow-up;
• Monitor compliance with the discharge plan of care or the patient’s disease management;
• Perform a home safety inspection;
• Perform a physical assessment of the patient.

With one exception, the services are not covered or reimbursed by federal health care programs when performed by a community paramedic. One Medicaid program reimburses for community paramedic services that the requestor represents are similar to the services, but the medical center stated that it does not, and would not, bill this Medicaid program for the services. Neither patients nor any payors are, or would be, billed for the services, and the medical center does not, and would not, shift any costs related to the arrangements to Medicare, Medicaid, other payors, or individuals.

The OIG stated that the identified arrangements implicate both the beneficiary inducement statute and the AKS. However, the OIG concluded that it would not impose sanctions on the medical center for the identified arrangements. The OIG stated that the services provide a significant benefit to patients (in the form of free health care services and care management) and thus would be considered remuneration which could influence a patient to select medical center for items and services that are covered by federal health care programs (“FHCPs”). But the OIG stated that any such risk is outweighed by the benefits of the programs.  Further reducing risk: (1) the patient already selected the medical center as his/her follow-up provider; (2) patients are given provider choice with respect to all other services; (3) the arrangements foster integrated care delivery.

The OIG stated that the identified arrangements promote access to care in that the arrangements:

• Provide continuity of care for patients at risk of readmissions;
• Appear “appropriately tailored” to achieve the medical center’s goals of improving adherence, reducing readmissions, and improving patient health;
• May also foster patient safety and improve quality of care.

The OIG also stated that the arrangements presented a low risk of harm to the program because (i) they are unlikely to lead to increased costs to federal health care programs or patients through overutilization or inappropriate utilization; (ii) the services, with one exception, are not covered by FHCPs and will therefore not be billed to any programs and the medical center stated it would not bill the one Medicaid program that covered the services; and (iii) if the arrangements work, they would likely result in overall savings to federal health care programs through reduced readmissions and improved patient health and adherence.

Any increase in utilization would likely represent an appropriate increase in the proper utilization of items and services. The risk that the arrangements will interfere with or skew clinical decision making is low (providers would not be compensated to refer patients to the programs). The arrangements would not be marketed or publicized.

Relaxation of Stark Law and Kickback Statute
The coordination of care model is premised, in part, on providers working together and sharing reimbursement. However, CMS and the OIG correctly determined that the AKS and Stark restricted the ability of providers to coordinate with each other. Recognizing this dilemma, the OIG published the aforesaid Advisory Opinion 17-01 and Advisory Opinion 19-03. These opinions approved free services by providers to patients in which such services were designed to break down socio-economic barriers to health care.

Further, on November 20, 2020, (i) the OIG published modifications to the safe harbors to the AKS and (ii) CMS published modifications to Stark. A White Paper, summarizing the modifications, can be found on the AAHomecare website. The goals of the modifications are to promote coordination of care and break down socio-economic barriers to health care. The message for providers is that CMS and the OIG are acknowledging the importance of providers coordinating with each other…even if such coordination would have historically implicated the AKS, Stark and the beneficiary inducement statute.

Applicability to Providers
Pharmacies, DME suppliers, HHAs and other providers are in a unique position to actively participate in the integrated model of health care. These providers (i) have visited patients’ homes, (ii) communicate on a regular basis with patients and their caregivers, and (iii) communicate on a regular basis with patients’ treating physicians. Providers can enter into Preferred Provider Agreements (“PPA”) with hospitals that are designed to reduce the hospitals’ exposure under the Hospital Readmissions Reduction Program. According to this program, if a patient is readmitted after discharge within a certain period of time, for a particular disease, then the hospital can be subjected to future payment reductions from Medicare.

Pursuant to a PPA, when a patient is about to be discharged from the hospital, and when the physician orders products/services for the patient to use in the home, then the hospital will give patient choice as to which provider will provide the product/service. If the patient does not express a preference for a provider, then the hospital will recommend the provider that has the PPA with the hospital. If the patient chooses the provider (that has the PPA with the hospital), then in addition to providing the products/services for home use, the provider will provide value-added services designed to improve the patient’s health … and keep him from being readmitted to the hospital.

These value-added services can include (i) reminding the patient and his caregiver that the patient needs to take his prescription medication; (ii) reminding the patient and his caregiver about the patient’s upcoming physician appointments; (iii) reminding the patient and his caregiver about the importance of hydration and healthy foods; and (iv) notifying the treating physician if the patient is not adhering to his treatment plan. In addition to providing “value-added” services, the provider can collect patient outcome data reflecting the patient’s progress … or lack thereof. The provider can provide this data to the hospital, the treating physician, and to the TPP. In providing the data to the hospital, the provider can show the benefits of the hospital entering into the preferred provider relationship with the provider. In providing the data to the physician, the provider can show the benefit of the physician referring patients to the provider. And by providing the data to the TPP, the supplier can show the benefit of the TPP maintaining the provider on the TPP’s provider panel.

In conjunction with, or separate and apart from, a PPA with a hospital, the provider can provide products and value-added services designed to promote access to care … while avoiding problems under the beneficiary inducement statute. In doing so, the supplier needs to follow the guidance contained in AO 17-01 and AO 19-03. For example:

• The provider can direct a nurse, respiratory therapist, occupational therapist, paramedic, or other type of clinician to drive to patients’ homes to check on their health and determine if they are adhering to the prescribed treatment plan.
• The provider can place equipment in the patient’s home that is designed to monitor whether the patient is using the provider’s equipment or adhering to the provider’s services, as prescribed.
• The provider can place equipment in the patient’s home that allows the provider to have real time visual/audio communications with the patient and his caregiver.
• The provider can direct a dietician/nutritionist to work with the patient and his caregiver on eating healthy.
• The provider can give the patient access to intent-based education programs relevant to the patient’s medical condition.

AAHOMECARE’S EDUCATIONAL WEBINAR

Legal Guidelines for Growing Your Retail Business

Presented by:

Jeffrey S. Baird, Esq., Brown & Fortunato
Tuesday, May 18, 2021

1:30-2:30 p.m. CENTRAL TIME

“Leave it to Beaver” has been replaced by “Modern Family.” The old way of running a DME business no longer works. With stringent documentation requirements, lower reimbursement, and post-payment audits, Medicare fee-for-service should only be a component of the supplier’s total income stream. There are 78 million Baby Boomers retiring at the rate of 10,000 per day. Boomers are accustomed to paying for things out-of-pocket. And most Boomers want the “Cadillac” product – not the “Cavalier” product – so they can have an active lifestyle well into their 80s. The successful DME supplier will be focused on selling upgrades, utilizing ABNs, and selling “Cadillac” items for cash. These retail sales may take place in a store setting, through a kiosk, or over the Internet.

When selling products for cash, there are a number of requirements that the DME supplier must meet. This program will discuss these requirements, including the following:

1. state licensure;
2. selling Medicare-covered items at a discount off the Medicare allowable;
3. obtaining a physician prescription; and
4. collection and payment of sales and/or use tax;
5. qualification as a “foreign” corporation;
6. required notification to a Medicare beneficiary even thoughthe supplier does not have a PTAN;
7. complying with federal and state telemarketing rules.

Lastly, this program will discuss the benefits of setting up a separate legal entity through which the retail business will be operated.

Register for Legal Guidelines for Growing Your Retail Business on Tuesday, May 18, 2021, 1:30-2:30 p.m. CT, with Jeffrey S. Baird, Esq. of  Brown & Fortunato.

Members:  $99
Non-Members:  $129 

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers and other health care providers throughout the United States. Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or [email protected].