Oklahoma Charitable Clinic Association Issues Comment on Medicare Program: Modernizing, Clarifying Physician Self-Referral Regulations

WASHINGTON, Dec. 30 -- Jeanean Yanish, chair of Oklahoma Charitable Clinic Association, Oklahoma City, has issued a public comment on the Medicare and Medicaid Services's proposed rule entitled "Medicare Program: Modernizing and Clarifying the Physician Self-Referral Regulations". The comment was written on Dec. 19, 2019, and posted on Dec. 27, 2019:

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On behalf of the Oklahoma Charitable Clinic Association, I appreciate the opportunity to comment on the proposed rule [CMS-1720-P] RIN 0938-AT64 Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations.

In these comments, the following topics will be addressed:

I. Oklahoma Charitable Clinic Association Organizational Background OCCA Purpose

To create an effective statewide network of charitable clinics.

To network within the membership and the broader health care community.

To educate members by providing information, training, technical assistance, new clinic support, and professional development opportunities.

To advocate for the needs of patients and charitable clinics with policymakers, funders, stakeholders, and the general public.

To support improvements in the quality, availability, and timeliness of appropriate and culturally competent services by charitable clinics.

OCCA Membership

Full membership is open to any charitable clinic operating in the State of Oklahoma that meets the following criteria:

The clinic provides some type of medical, dental, pharmacy, and/or behavioral health services to economically disadvantaged individuals who are predominantly uninsured.

The clinic is a community-based or faith-based organization.

The clinic has applied for or been approved as a 501(c)(3) nonprofit organization.

The clinic does not deny services based on patient's ability to contribute financially.

Member organizations may make tangible medical products (e.g. eye glasses, test strips) available at or below cost to patients.

Federally Qualified Health Centers (FQHCs) and FQHC look-a-likes are not eligible for OCCA full membership.

Mission Statement

The Oklahoma Charitable Clinic Association develops and strengthens charitable clinics and collaborates to improve the health of vulnerable Oklahomans

I. Provisions of the Proposed Regulations

a. Facilitating the Transition to Value-Based Care and Fostering Care Coordination

b. Proposed Definitions and Exceptions Sec.411.351

II. Exception for Physician Recruitment(Sec.411.357(e))

a. Relying on our authority under section 1877(b)(4) of the Act, we expanded the exception at Sec.411.357(e)(4)

III. Electronic Health Records Items and Services(Sec.411.357(w))

a. Cybersecurity Technology and Related Services Sec.411.357(bb)

b. The Sunset Provision Sec.411.357(w)(13)

c. 15-Percent Recipient Contribution Sec.411.357(w)

d. Replacement Technology

IV. Exception for Assistance to Compensate a Nonphysician Practitioner(Sec.411.357(x))

V. Closing Statement

I. Oklahoma Charitable Clinic Association Background

OCCA Purpose

To create an effective statewide network of charitable clinics.

To network within the membership and the broader health care community.

To educate members by providing information, training, technical assistance, new clinic support, and professional development opportunities.

To advocate for the needs of patients and charitable clinics with policymakers, funders, stakeholders, and the general public.

To support improvements in the quality, availability, and timeliness of appropriate and culturally competent services by charitable clinics.

OCCA Membership

Full membership is open to any charitable clinic operating in the State of Oklahoma that meets the following criteria:

The clinic provides some type of medical, dental, pharmacy, and/or behavioral health services to economically disadvantaged individuals who are predominantly uninsured.

The clinic is a community-based or faith-based organization.

The clinic has applied for or been approved as a 501(c)(3) nonprofit organization.

The clinic does not deny services based on patient's ability to contribute financially.

Member organizations may make tangible medical products (e.g. eye glasses, test strips) available at or below cost to patients.

Federally Qualified Health Centers (FQHCs) and FQHC look-a-likes are not eligible for OCCA full membership.

Mission Statement

The Oklahoma Charitable Clinic Association develops and strengthens charitable clinics and collaborates to improve the health of vulnerable Oklahomans

II. Provisions of the Proposed Regulations

a) Facilitating the Transition to Value-Based Care and Fostering Care Coordination

b) Proposed Definitions and Exceptions Sec.411.351

As CMS moves towards Value-Based Arrangements, we ask you to recognize that in order to have a healthy America, coordinated care value-based arrangements need to be considered not only for those patients with health insurance coverage through Medicare, Medicaid and private insurance but also those patients who are uninsured.

According to the Kaiser Family Foundation in their Key Facts about the Uninsured Population Issue Brief December 13, 2019, "People without insurance coverage have worse access to care than people who are insured. One in five uninsured adults in 2018 went without needed medical care due to cost. Studies repeatedly demonstrate that uninsured people are less likely than those with insurance to receive preventive care and services for major health conditions and chronic diseases."

By establishing value-based arrangement definitions that specifically list the words Free Clinic, Charitable Clinic and Charitable Pharmacies rather than "community partners or social service organizations", there will be less ambiguity when it comes to establishing partnerships at the local level.

Unfortunately, because there is such limited information about how the Stark Law and Anti-Kickback provisions impact uninsured patients and those who serve them, many hospitals are very risk averse when establishing or continuing programs with Free Clinics, Charitable Clinics and Charitable Pharmacies. As seen above, elimination of care programs has meant the discontinuation of donated imaging, laboratory, financial and electronic heath records which has led to less health care being provided to uninsured patients who need it the most. This, in turn, leads to patients either forgoing care altogether or utilizing the emergency department as a doctor's office, driving up the cost of health care.

Therefore, we respectfully request that CMS insert the words Free Clinic, Charitable Clinic and Charitable Pharmacy in sections Sec.411.357(aa) Sec.411.354(c)).

III. Exception for Physician Recruitment(Sec.411.357(e))

Free and Charitable Clinics and Charitable Pharmacies work with extremely dedicated physicians who provide access to health care and coordinate care for the uninsured and the medically underserved. The majority of these physicians are volunteers from the community in which they live. Therefore, the care they provide and the referrals they make should not be considered a violation of the Stark Law or Anti-Kickback Law.

However, as noted above, given that there is such limited information about how the Stark Law and Anti-Kickback provisions apply or do not apply to uninsured patients and those who serve them, many hospitals are very risk averse to establishing or continuing programs with Free Clinics, Charitable Clinics and Charitable Pharmacies.

For those physicians who are employed by Free Clinics, Charitable Clinics and Charitable Pharmacies, we again maintain that there is not a Stark or Anti-Kickback violation because they are seeing uninsured patients. However, some hospital legal counsels do not agree and as seen from the examples of challenges listed above, this has led to a cancellation of health care programs.

Therefore, we are asking that CMS rely on your authority under section 1877(b)(4) of the Act, to expand the exception in Sec.411.357(e)(4) by including the following words, Free Clinic, Charitable Clinic, and Charitable Pharmacy.

Given that CMS has expanded this provision previously to include Rural Health Centers in addition to Federally Qualified Health Centers, we believe that adding the categories of Free Clinic, Charitable Clinic and Charitable Pharmacies will provide the clarity and understanding our partners are seeking and allow for continued access to health care.

V. Electronic Health Records Items and Services(Sec.411.357(w))

a) Cybersecurity Technology and Related Services Sec.411.357(bb)

b) The Sunset Provision Sec.411.357(w)(13)

c) 15-Percent Recipient Contribution Sec.411.357(w)

d) Replacement Technology

Cybersecurity Technology and Related Services Sec.411.357(bb)

In the rapidly shifting landscape of health care and the high cost of cybersecurity protection of patient identifiable records and electronic communications, the Oklahoma Charitable Clinic Association supports a safe harbor for the donation of cybersecurity software and services. Additionally, we support the text in section Sec.411.357(bb) that donors do not directly take into account the volume or value of referrals or other business between the parties when determining the eligibility of a potential recipient for the technology or services, or the amount or nature of the technology or services to be donated.

We support any program that allows hospital partners to donate cybersecurity software and services to Free and Charitable Clinics and Pharmacies who provide access to care to the uninsured and underserved. We also support the ability for hospital partners to donate hardware to Free and Charitable Clinics and Pharmacies, which in conjunction with the software will protect patient information from cyber-attacks.

The Sunset Provision Sec.411.357(w)(13)

The Oklahoma Charitable Clinic Association supports the elimination of the Sunset Provision at Sec.411.357(w)(13). CMS is correct when it acknowledges the growth of those utilizing Electronic Health Records in this country. However, more adoption of electronic health records is still needed especially among those who are serving the uninsured in rural areas.

15-Percent Recipient Contribution Sec.411.357(w)

With respect to the 15-Percent Recipient Contribution, the Oklahoma Charitable Clinic Association supports the elimination of this requirement in Sec.411.357(w)). The requirement has proven to be cost-prohibitive to the adoption of electronic health records among Free and Charitable Clinics and Charitable Pharmacies nationwide. The 15% requirement restricts our clinics' ability to enhance and expand access to health care because the funds must be allocated to pay for interoperable software that is donated by a hospital system. The result is often that clinics do not adopt electronic health records, or they incorporate an electronic health record that does not communicate with the hospital's system. The 15% fee for updates and/or reporting makes the adoption of the records cumbersome and makes hospital risk averse to the donation. Finally, and perhaps most importantly, this 15% contribution does not serve the patient population because it sets up a barrier to efficient and effective information sharing for their care.

If CMS determines that utilizing the definition of small and rural practices is the best avenue for modifications to the 15-perfect recipient continuation rule, we ask that the words Free Clinic, Charitable Clinic, and Charitable Pharmacies are specifically listed as those eligible to receive donations of electronic health records from hospital partners.

Replacement Technology (Sec.411.357(w))

We support removing the restriction of donated replacement technology in section (Sec.411.357(w)). It is imperative the Clinics and Pharmacies have access to new technologies that allow for interoperability with hospital partners, and this restriction has severely limited the coordination of care in communities.

VI. Exception for Assistance to Compensate a Nonphysician Practitioner (Sec.411.357(x))

Consistent with our comments regarding an Exception for Physician Recruitment (Sec.411.357(e)), Free and Charitable Clinics and Charitable Pharmacies work with extremely dedicated Nonphysician Practitioners who help provide access to health care and coordinate care for uninsured and the medically underserved. These Physician and Nonphysician Practitioners are volunteers from the community in which they live. Therefore, the care they provide and the referrals they make should not be considered a violation of the Stark Law or Anti-Kickback Law.

For those Nonphysician Practitioners who are employed by Free Clinics, Charitable Clinics and Charitable Pharmacies, we again maintain that Stark or Anti-kickback violations should not apply because they are seeing uninsured patients. However, some hospital legal counsels do not agree and as seen from the examples of challenges listed above, this has led to a cancellation of health care programs.

Therefore, we are asking that CMS rely on your authority, to expand the exception at (Sec.411.357(x)) by including the following words, Free Clinic, Charitable Clinic, and Charitable Pharmacy.

Given that CMS expanded this provision previously to include Rural Health Centers in addition to Federally Qualified Health Centers, we believe that adding the categories of Free Clinic, Charitable Clinic and Charitable Pharmacies will provide the clarity and understanding our partners are seeking and allow for continued access to health care.

VII. Closing Statement

Currently, Free and Charitable Clinics and Charitable Pharmacies do not qualify for a safe harbor exemption like our Federally Qualified Health Center partners because our 501c3 clinics who serve the medically underserved do not receive 330 grants. We respectfully ask the Centers for Medicare and Medicaid Services (CMS) to provide a safe harbor exemption for America's 1,400 Free and Charitable Clinics and Charitable Pharmacies similar to the exemption that currently exists for 330 grantees.

Additionally, as CMS is reviewing the Stark Law and how it will apply to Value-Based Care, we respectfully ask that the uninsured in our country and those who serve them, including Free and Charitable Clinics and Charitable Pharmacies, are taken into account. By only focusing on insured patients and their providers who bill private insurance, Medicaid and Medicare, you are leaving out an important part of the population and a key factor that needs to be considered to better address high health care costs and eliminate high emergency department utilization.

Providing clarification and removing ambiguity for our hospital partners with respect to donations of technology, laboratory, diagnostic and financial support will allow America's Free and Charitable Clinics and Charitable Pharmacies to better coordinate care and to better serve our communities. I appreciate the opportunity to offer our comments on [CMS-1720-P]RIN 0938-AT64 Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations. Please do not hesitate to reach out to Nicole Lamoureux, President and Chief Executive Officer of the National Association of Free and Charitable Clinics (NAFC) at 703-647-7427 or via email [email protected] with any comments or questions and she will be happy to assist you.

Sincerely,

Jeanean Yanish, PhD(c), MA, CFRE

Oklahoma Charitable Clinic Association, Chair

HEALTH ALLIANCE FOR THE UNINSURED EXECUTIVE DIRECTOR

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The proposed rule can be viewed at: https://beta.regulations.gov/document/CMS-2018-0082-0394

TARGETED NEWS SERVICE, Harwood Place, Springfield, Virginia, USA: Myron Struck, editor; 703/304-1897; [email protected]; https://targetednews.com