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• Preparing for a Meaningful Use Audit
• Competitive Bidding of Diabetic Testing Supplies Effective July 1, 2013

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Preparing for a Meaningful Use Audit

The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act (ARRA), established Medicare and Medicaid EHR incentive programs to promote adoption of electronic health records (EHRs).

State Medicaid agencies administer their own Medicaid EHR incentive programs and are responsible for overseeing program integrity. States make incentive payments directly to health care practitioners and hospitals. The Centers for Medicare and Medicaid Services (CMS) provides enhanced Federal financial participation to States for their EHR incentive programs. States are required to have an oversight plan to combat fraud, waste, and abuse, which includes checking that health practitioners and hospitals are eligible for the incentive payments.

CMS, OIG, GAO: A Multi-Agency Approach to Auditing and Oversight

The Centers for Medicare and Medicaid (CMS), the Office of the Inspector General (OIG), and the General Accounting Administration (GAO) all have a stake in the Meaningful Use (MU) program, including the audit processes.

The program represents more than $30 billion that will be given to providers to develop and enhance patient care through use of electronic health record systems. In September, 2012, CMS extended the proposed meaningful use program timeline through 2021.

CMS and the Office of the National Coordinator (ONC) implemented the EHR incentive program by adopting a self-certification strategy whereby providers certify their meaningful use of certified EHR technology as part of an attestation process required to claim incentive payments. The goal of CMS is to verify the accuracy of the claims made by providers. CMS shared their priorities regarding the program early on in the process:

• All providers receiving incentive funds are subject to audit.
• A single deficiency in meeting a required Meaningful Use measure will result in a finding of non-compliance, and CMS will move to recoup the entire incentive payment.
• Providers will be selected for audits based on a risk factor approach developed by CMS.
• CMS will evaluate the effectiveness of the audit strategy on an ongoing basis and modify the program as warranted.
• Federal and State audits have a different focus with State Medicaid agencies administering state audits of meaningful use funds, primarily through eligibility checking, although State programs may vary; Federal audits emphasize performance and compliance with the MU criteria.

CMS will recoup an EHR incentive payment if an entity fails to comply with an audit request to produce documents or data needed to audit the validity of an EHR incentive payment. If the results of an audit indicate that the provider is not eligible for an EHR incentive payment because it does not meet one or more of the criteria, CMS will recoup the incentive payment.

The OIG’s Work Plan for 2013 includes meaningful use. “We will review Medicare incentive payments to eligible health care professionals and hospitals for adopting electronic health records (EHR) and the Centers for Medicare & Medicaid Services (CMS) safeguards to prevent erroneous incentive payments." The OIG will also assess CMS’s plans to oversee incentive payments for the duration of the program and actions taken to remedy erroneous incentive payments.

The focus is on auditing, improved auditing through an iterative and changing process, discovery of potential fraud, and recoupment of payments where appropriate. The incentives program lacks a thorough accounting to ensure that the funds go to those who actually achieve meaningful use of electronic health records.

The OIG has consistently warned providers of documentation pitfalls in the use of EHRs that can lead to False Claims Act violations. Two common problems include cloning, which occurs when a clinician copies and pastes the same notes for several patients or for several visits for one patient into the record; and over-documentation, which can occur when an electronic system automatically copies information and includes it with documentation for each visit. The OIG recommends that providers audit these areas to ensure that documentation is accurate and that billing for services is appropriate.

Attesting to completing a security risk assessment, if one has not been done, is also a potential false claim. The OIG may use the False Claims Act as an instrument for whistleblower or other lawsuits, based on the assumption that some providers will file false attestations.

The Attestation Process: Auditing Pitfalls

In order to receive Medicare EHR incentive payments, providers must attest to CMS that they meet Meaningful Use criteria using certified EHR technology. Attestation is required at each stage of the Meaningful Use Program.

Audit Documentation Requirements

The audit program is one of the government’s tools to enhance compliance with the regulations, uncover fraudulent use of public funds, and recoup monies that have been inappropriately received.

All information submitted during registration, attestation, and any subsequent validation and audit procedures must be backed up by auditable data sources or documentation. Providers are required to retain documentation to support all attestations for no less than six years after each payment year.

Evidence of documentation may include computer screen shots showing required EHR technology functions were enabled during the reporting period, documents verifying a security risk assessment was conducted and mitigation plans put in place, documentation of patient volume, including those with paper records, for percentage-based measures with all patient denominators.

CMS initiated audits of the attestation materials in 2012, through a contract with Figliozzi and Company, acting as CMS’s auditor for the Program. While CMS has not stated this explicitly, it may be assumed that the results of these audits will be used to develop more substantial audits with additional initiatives as the Program progresses.

Preparing for an Audit

While the auditing processes of the various agencies will change over the term of the program, we can recommend a number of practices that providers should take into consideration to be “audit-ready” and prepared.

1. Assure that the risk analysis, required by the Security Rule, is revised and updated on a regular basis, and that risk mitigation plans are put in place, tracked, and updated as appropriate.

2. Don’t attest for EHR incentive monies until you have conducted the risk analysis (or re-assessment) and developed a risk mitigation plan to correct any deficiencies identified during the process. You must implement the plan.

3. Document changes in your security program.

4. Update security policies as appropriate to reflect changes and improvements in your security program.

5. Communicate security policies, changes, and priorities to the workforce on a regular basis.

6. Review your EHR vendor’s security policies to ensure that the vendor is meeting the Security Rule requirements as your business associate.

7. Work with your vendor to make sure that security updates of the software are implemented and that documentation for software and modules is updated and maintained.

8. If you used a contractor for any aspects of the attestation process or relied on the contractor’s assurances, request and review this documentation on a regular basis. Ask your contractor questions when information is not clear or you need more information.

9. Develop a coordinated, systematic approach to maintaining all documentation for the meaningful use process. Put someone in charge of this process and make sure information is current.

10. Keep all records including proof of possession of certified EHR technology, copy of the ONC certification for the system (and updates as they become available), licensing agreements with the vendor, invoices from time of purchase, documentation to support the method your organization selected to report emergency department admissions, calculations, and other information required. Keep supporting documentation used to complete the attestation module responses, e.g., screenshots from the EHR system) for both the core set objectives/measures and the menu set objectives/measures.

11. Verify that incentive payments were accurate.

12. Prepare the organization’s annual financial statements to ensure that incentive monies are disclosed and appropriately documented.

13. Maintain all documentation for at least 6 years.

14. Review all documentation for attestations, clinical quality measures reported, payment verification, etc. BEFORE any audit request is completed.

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Competitive Bidding of Diabetic Testing Supplies Effective July 1, 2013

This article is intended to inform Diabetes Educators about upcoming changes in how Medicare beneficiaries will get diabetic testing supplies as of July 1, 2013.

Under the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program, beneficiaries with fee for service Medicare who reside in competitive bidding areas (CBAs) are required to obtain competitive bidding items from a contract supplier, unless an exception applies. A national mail-order competitive bidding program for diabetic testing suppliers is scheduled to go into effect on July 1, 2013. The national mail-order program for diabetic testing supplies will include all 50 states.

The term “mail-order” means items shipped or delivered to the beneficiary’s residence regardless of the method of delivery. Only contract suppliers will be reimbursed by Medicare for diabetic testing supplies delivered to beneficiaries’ residences. Contract suppliers are required to use the KL modifier on each claim for diabetic testing supplies furnished on a mail-order basis. Effective July 1, 2013, beneficiaries with fee for service Medicare will have two options to purchase their diabetic testing supplies:

• Beneficiaries can have their diabetic testing supplies delivered directly to their home by a national mail-order contract supplier (mail-order), or
• Beneficiaries can pick up their supplies in person from any Medicare-enrolled supplier of diabetic testing supplies (non-mail-order).

The Medicare-approved payment amount for diabetic testing supplies will be the same regardless of where the supplies are furnished. Medicare contract suppliers must always accept assignment on these items. This means contract suppliers must accept the Medicare-approved amount as payment in full and cannot charge beneficiaries more than the 20 percent coinsurance and any unmet deductible.

Beneficiaries may also choose to purchase diabetic testing supplies in person at any Medicare-enrolled supplier storefront accredited to furnish these items. However, these retail locations may or may not accept assignment. Beneficiaries who use suppliers that do not accept assignment may pay more than the 20 percent coinsurance and any unmet deductible.

Contract suppliers for the national mail-order program are prohibited from influencing or incentivizing beneficiaries to switch their current glucose monitor and testing supplies brand to another brand. This is called the anti-switching rule. The anti-switching rule requires contract suppliers to furnish the brand of testing supplies that works with the beneficiary’s monitor. If the contract supplier does not carry the beneficiary’s brand of testing supplies, the beneficiary can ask the contract supplier about alternative brands and the supplier can then describe what brands it offers. However, the supplier cannot initiate the conversation. Contract suppliers will be required to make available the same range of products to Medicare beneficiaries that they make available to non-Medicare customers. In addition, the Program allows a physician (including a podiatric physician) or treating practitioner (i.e., a physician assistant, clinical nurse specialist, or nurse practitioner) to prescribe a specific brand or mode of delivery to avoid an adverse medical outcome.

The physician or treating practitioner must document in the beneficiary’s medical record the reason why the specific brand or mode of delivery is necessary to avoid an adverse medical outcome. This documentation should include the following:

• The product’s brand name or mode of delivery;
• The features that this product or mode of delivery has versus other brand name products or modes of delivery; and
• An explanation of how these features are necessary to avoid an adverse medical outcome.

If a physician or treating practitioner prescribes a particular brand or mode of delivery for a beneficiary to avoid an adverse medical outcome, the contract supplier must, as a term of its contract, ensure that the beneficiary receives the needed item. The contract supplier has three possible options:

• The contract supplier could furnish the specific brand or mode of delivery as prescribed;
• The contract supplier could consult with the physician or treating practitioner to find another appropriate brand of item or mode of delivery for the beneficiary and obtain a revised written prescription; or
• The contract supplier could assist the beneficiary in locating a contract supplier that will furnish the particular brand of item or mode of delivery prescribed by the physician or treating practitioner.

If the contract supplier does not ordinarily furnish the specific brand or mode of delivery and cannot obtain a revised prescription or locate another contract supplier that will furnish the needed item, the contract supplier must furnish the item as prescribed.

This will be a significant change for Medicare beneficiaries with diabetes. It will be important that diabetes educators and providers are aware of these changes in order to help their patients navigate the process; ensuring patients have uninterrupted access to their diabetic testing supplies.

Reference: CMS Medicare Learning Network (MLN), March 2013

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