Tennessee Updates

East Tennessee Communities Fight to Keep Rural Hospitals

A 2024 study by the Tennessee Health Care Campaign shows between 2010 and 2021, Tennessee experienced 22 hospitals closing, the majority of them in rural counties. DME providers rooftops in Tennessee have also declined. Access to care is an issue! WVLT8 did a story yesterday – Click on button below for the video.

OIG: Expanded FAQs

Beginning in March, 2023, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) has expanded the topics it considers for new FAQs submitted by providers as follows:

1. General questions about the federal Anti-Kickback Statute (AKS), prohibitions on remuneration to Medicare and beneficiaries of state healthcare programs, and the OIG’s enforcement of these statutes

2. Questions about the general application of the AKS and prohibitions on inducements to beneficiaries to arrangements that may implicate these statutes

3. Questions about compliance considerations

4. OIG’s Health Care Fraud Self-Disclosure Protocol

5. General questions about topics covered by existing FAQs; including advisory opinions, exclusions, and the OIG’s whistleblower protection coordinator function.

Providers should submit their questions to OIGComplianceSuggestions@oig.hhs.gov.

The OIG’s expansion of consideration of providers’ questions in FAQs is important because providers may be able to obtain the necessary guidance without expending time and money to obtain an OIG Advisory Opinion.

In addition, the OIG has provided several FAQs that may be especially important to providers. Two of these FAQs are detailed below.

“How does OIG differentiate between ‘cash,’ ‘cash equivalents,’ and ‘in-kind’ gift cards? How would OIG categorize a gift card to a big-box store? How would OIG categorize a gift card to a big-box store, the terms of which expressly limit the scope of items the consumer could purchase with such gift card (e.g., the gift card could only be used to purchase fresh food items)?

‘Cash’ refers to monetary payments in the form of currency. (Note that cash could be transmitted electronically, too, such as through a peer-to-peer application.) ‘Cash equivalents’ include items convertible to cash (such as a check) or items that can be used like cash, such as a general-purpose prepaid card such as a Visa or Mastercard gift card. Gift cards offered by large retailers or online vendors that sell a wide variety of items (e.g., big-box stores) could easily be diverted from their intended purpose of converted to cash. Consequently, OIG considers such gift cards to be cash equivalents. (We note that the regulatory text of the Preventive Care Exception, found at 42 CFR Section 1003.110, uses the term ‘instruments convertible to cash’ not ‘cash equivalents.’ The phrase ‘instruments convertible to cash’ refers to a subset of ‘cash equivalents,’ which includes a broader range of remuneration. For example, OIG would consider a preloaded prepaid card to be a ‘cash equivalent’ but not an ‘instrument convertible to cash.’)”

“Does remuneration exchanged between entities with common ownership implicate the Federal anti-kickback statute?

The Federal anti-kickback statute is an intent-based, criminal statute that, as a general matter, prohibits payments in exchange for referrals or other Federal health care program business. Congress did not exempt from the statute’s prohibitions remuneration exchanged between entities with common ownership. Consequently, such remuneration could implicate the Federal anti-kickback statute. Furthermore, OIG has previously declined to provide safe harbor protection for remuneration exchanged between wholly-owned entities, including parent entities and their wholly owned subsidiaries, indicating that common ownership does not eliminate the risk of improper referrals under the statute:

‘…we are concerned…that integrated delivery systems, including arrangements involving wholly-owned subsidiaries [emphasis added], may present opportunities for the payment of improper financial incentives that result in overutilization of services and increased program costs and that may adversely affect quality of care and patient freedom of choice among providers…” See 64 Fed. Reg. 63,518, 63,520 (Nov. 19, 1999).

However, we recognize that as the health care industry move away from a fee-for-service payment model toward value-based care, providers may need additional flexibility to support legitimate, collaborative arrangements. Through our final rule at 85 Fed. Reg. 77,684 (Dec. 2, 2020) we finalized safe harbors that provide additional flexibility to providers and suppliers pursuing value-based arrangements. Illustratively, providers and suppliers with common ownership may be able to establish a ‘value-based enterprise’ and utilize the safe harbors that are available to those entities [See e.e., 42 CFR Section 1001.952(ee)-(gg).]

We note that compliance with a safe harbor is voluntary and that the advisory opinion process remains available for those who wish to obtain OIG review of a particular arrangements involving common ownership.”

The OIG certainly seems to “beg the question” in this FAQ. Questions about remuneration exchanged between entities with common ownership often occur outside of value-based arrangements. And, yet, if such remuneration is impermissible, what are the practical effects on the ability of multi-provider systems to operate?

FAQs from the OIG are another way for providers to gain knowledge and insight into important fraud and abuse compliance issues. Definitely worth reading!

©2023 Elizabeth E. Hogue, Esq. All rights reserved.


AAHomecare Updates

CMS Proposes New Intermittent Catheter HCPCS Codes

Last week, CMS released the 2024 Bi-Annual HCPCS Public Meeting Agenda for May 28-30 (scroll to find). The first topic listed in the May 28th Agenda is CMS’ proposal to expand the HCPCS codes list for intermittent catheters (ICs). The request was submitted by AAHomecare based on the analysis and review by the Intermittent Catheter Coding Reform Coalition (ICCRC), a coalition of IC manufacturers.

CMS proposes to modify the current three IC HCPCS codes to six HCPCS codes—establishing five new IC codes to distinguish the coating types and discontinuing existing codes that do not distinguish coating types, A4351 and A4352. CMS will maintain A4353 as is. CMS also plans to maintain pricing continuity as per regulatory requirements when implementing the new codes. This would entail mapping previous fee schedule amounts for discontinued codes to the new ones to ensure consistent pricing.

Pending further feedback and final determination, CMS anticipates the proposed changes to take effect on January 1, 2026. ICCRC is pleased that CMS has established new HCPCS codes for intermittent catheters, recognizing hydrophilic features separately from other catchers. AAHomecare, in collaboration with ICCRC, will be commenting on the proposed changes.

You can find the proposal on pages 3-8 of the May 28th HCPCS Public Meeting Agenda.

HHS Surveying CGM Suppliers on Acquisition Costs & Prices

Last week, the HHS Office of Inspector General (OIG) began sending emails and letters to a select group of continuous glucose monitor (CGM) suppliers as part of an evaluation for their study "Medicare Payments Compared to the Prices Available to Consumers and Suppliers for Continuous Glucose Monitors and Sensors." This study aims to determine the cost-effectiveness of Medicare payments in comparison to the supplier’s acquisition costs and other prices available to consumers.

The OIG's request for information on acquisition costs by suppliers will identify potential areas where Medicare can optimize savings. In the announcement of the report originally posted in the OIG’s Work Plan in November 2023, the OIG noted CMS allowed more than $1.1 billion in Medicare Part B payments for CGMs and sensors in 2022. If the OIG identifies opportunities for Medicare to realize cost savings, CMS has the authority to either introduce CGMs into the competitive bidding program or exercise their authority of inherent reasonableness to adjust Medicare payments accordingly.

CGM suppliers who are recipients of the OIG requests have likely been notified via email. AAHomecare recommends suppliers to diligently monitor their email and mail correspondence for any communication from the OIG. It is imperative for suppliers who have received such requests to promptly respond within the specified timeframe to facilitate the OIG's analysis.

AAHomecare is actively monitoring the development of the study. To ensure comprehensive coverage and timely updates, we encourage CGM suppliers who have received communication from the OIG to connect with Mina Uehara, Senior Director of Regulatory Affairs at minau@aahomecare.org.

VGM Government Relations Updates

Provider Enrollment Contractor Issue Collection

A 570-page final rule released by the FTC on April 23 will effectively put an end to the use of noncompete agreements between employers and employees. The final rule is scheduled for publication in the Federal Register on May 7, 2024, and will go into effect 120 days from publication (September 4, 2024), barring the results of any legal challenges to the rule.



NCART Updates

Power Seat Elevation Update!

NCART and the ITEM Coalition met with CMS to discuss the pricing methodology and data utilized in the gap-filling method (legislatively approved), which was used to develop the fee schedule of $2,003 for seat elevation. To ensure access for all consumers, NCART and the ITEM Coalition shared their concerns we had that this low fee schedule could have on consumer access. We want to thank CMS for giving us the opportunity to discuss our concerns as well as allowing us to provide them with our data so they can review the information. Stay tuned…


NCART In Action

  • NCART and the ITEM Coalition held a call with CMS to discuss seat elevation- please see above.
  • NCART had a meeting with Massachusetts Healthcare Finance Committee Chairman Lawn, and Leader O’Day along with consumers to discuss the warranty bill. NCART has concerns that the language could extend the repair process. We discussed the bill's issues and how we would like to work with consumers and legislators to develop a bill to speed up consumer repairs.
  • NCART met with Rhode Island Senator Mark McKenney, the sponsor of a right-to-repair bill, to discuss the need for repair and service reform.
  • NCART participated in the Secure Ride Coalition with United Spinal, General Motors (Friend of NCART), and other stakeholders.
  • NCART worked with Connecticut legislators to finalize a repair reform bill introduced and passed in the Connecticut Senate. The bill has now been sent to the House of Representatives for debate and a vote. NCART Executive Director Wayne Grau was interviewed by several Connecticut media organizations about the bill.
  • NCART provided a legislative update on the monthly NRRTS Board of Directors call.

Julie Piriano, CRT industry veteran, to lead Payer Relations & Regulatory Affairs!

NCART has named Complex Rehab Technology (CRT) industry veteran Julie Piriano, PT, ATP/ SMS to the newly created position of Senior Director of Payer Relations & Regulatory Affairs.

Piriano, who has worked in the seating and mobility industry for 40 years, most recently served as Vice President, Clinical Education, Rehab Industry Affairs and Compliance Officer for Pride Mobility and Quantum. She is a member of the Board of Directors for the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) and serves on numerous other CRT industry-related boards and committees.

“NCART and our members are excited to have Julie join in this important new role,” said Wayne Grau, NCART Executive Director. “Her experience working with a variety of stakeholders, including government agencies, regulators, payers and consumers, will strengthen our team and provide leadership on issues that are critical to our members.”

NCART Launches New YouTube Channel




The Association for Tennessee Home Oxygen & Medical Equipment Services (ATHOMES) is an active, member-driven trade association exclusively focused on serving the needs of all types of home medical equipment suppliers in Tennessee, the customers and family caregivers they serve, and homecare vendors who provide quality products and resources. 


Ph: 919-387-1221

Fax: 919-249-1394

Email: beth@athomes.org

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Cary, NC 27519-4411

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