Medicare

Published on: December 3, 2024

HHS Continues to Struggle with Skin Substitutes, OIG Increases Scrutiny

The HHS Office of Inspector General (OIG) recently issued several new work plan items aimed at Medicare Part B payments for skin substitutes. Part B reimbursement for skin substitutes products has long been a thorn in the side of Medicare. Medicare is generally required by federal law to reimburse certain skin substitute products covered under Part B using an Average Sales Price (ASP) methodology established by Congress. However, as the use of these products has grown and the pricing has increased exponentially, HHS has looked for ways to address rising costs to the Medicare program.

OIG updated its work plan in November 2024 to include several new initiatives that OIG intends to undertake in the area of skin substitutes and ASP pricing. First, OIG intends to update its prior conclusions regarding ASP pricing. ASP pricing requires manufacturers to report pricing data. In March 2023, OIG issued a report that found that manufacturer noncompliance with new ASP reporting requirements for skin substitutes led to millions in excessive Part B payments. OIG noted that, since then, Part B expenditures for skin substitute products have continued to rise significantly. OIG therefore intends to provide an update on these manufacturer reporting issues, as well as highlight billing trends and identify potential solutions to any challenges in using the ASP methodology for skin substitutes.

Second, OIG intends to investigate alternative pricing under ASP. The ASP methodology established by Congress mandates that OIG compare ASPs with average manufacturer prices (AMPs) and the widely available market price, if any. If OIG finds that the ASP exceeded the AMP by 5 percent in the two previous quarters or in three of the previous four quarters, then HHS may substitute the reimbursement amount with a lower calculated rate. OIG intends to perform this comparison for various time periods and believes that it may offer recommendations for Medicare to achieve additional savings.

Published on: November 25, 2024

HRSA and HHS Refuse to Budge on PRF Repayment Demands

by Wachler & Associates, P.C.

Shortly after the COVID-19 Public Health Emergency (PHE) began, Congress passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which established the Provider Relief Fund (PRF). The goal of the PRF program was to provide financial support to healthcare providers across the nation in response to the unprecedented challenges presented by the PHE. Despite this noble goal, the federal agencies responsible for carrying out the PRF program have focused their efforts recently on clawing back PRF payments made to providers who the agencies assert did not strictly comply with the Program’s reporting requirements, among others. These PRF repayment demands seek to collect money distributed to providers that was intended to promote patient safety and preserve access to healthcare services. In many instances, providers relied on these funds to simply keep the lights on and stay in business. Now, the government’s demands for return of these monies again threatens the stability of many providers who received PRF funds, and providers are consistently left with little to no information as to why or how these repayment demands are being made in the first place.

Originally tasked with administering the $178 billion authorized under the PRF program, the Health Resources & Services Administration (HRSA), a subagency of the Department of Health and Human Services (HHS) distributed hundreds of thousands of PRF payments to providers of all types over the last several years. Notably, not all providers that received PRF funds needed to request those funds in order to receive payment, or affirmatively agreed to be bound by a set of associated terms and conditions. Recipients of the first batch of disbursements in Period 1 typically received the funds as an automatic deposit, with no notice or solicitation, and with no specific request for the funds required. If Period 1 recipients retained the PRF funds for 90 days or longer, then those providers were deemed to have accepted the PRF program’s terms and conditions, even if providers never read the terms or signed anything and despite the fact that HRSA would not publish the full details of the terms and conditions until months later. Providers who received PRF disbursements in Period 2 or later generally submitted a specific application to receive the funds, along with an attestation agreeing to comply with the terms and conditions.

Regardless of the Period in which a provider may have received funds, one of the most critical requirements attached to the receipt of PRF disbursements was the requirement to submit a report to HRSA on the use of the funds. As the terms and conditions would come to explain, failure to timely submit the necessary reporting would be considered grounds for recoupment of the funds. If a provider did not submit the report on time, HRSA should have notified the provider of its perceived non-compliance with the PRF terms and conditions, and allowed 60 days for the provider to submit the report or otherwise come back into compliance to justify retention of the funds.

Published on: November 20, 2024

Who is Liable for a Medicare Overpayment?

by Wachler & Associates, P.C.

When a Medicare-enrolled provider or supplier receives a demand to repay an alleged overpayment, especially a massive and statistically extrapolated overpayment that dwarfs the company’s revenue and which the company can never hope to pay back, it often raises the question: who is liable for this alleged debt if the company cannot pay it back? While every company and set of circumstances are different, this question can have a significant impact on how to defend an alleged Medicare overpayment.

Whether the owner, members, or shareholders of the entity that received the alleged overpayment are personally liable generally turns on the corporate nature of the entity. Individually enrolled providers, sole proprietors, and partners in a partnership may generally share liability with the entity that received the overpayment, or may actually be the entity in the case of some individuals. Corporations, LLCs, and other corporate entities may offer more protection for their owners, members, or shareholders, who are generally not liable for the debts of the entity under the principle of “limited liability.” There are exceptions to limited liability which CMS (and other creditors) can attempt to use to collect from owners, but CMS rarely attempts to use these exceptions.

However, owners, members, and shareholders of entities with an alleged Medicare debt should be aware that there may be other impacts. CMS may refer the owner of an entity with an alleged Medicare debt to the OIG for placement on the OIG Exclusion List. CMS may also revoke the current enrollment or deny future enrollment applications of entities affiliated with the owner of an entity with outstanding Medicare debt. Perhaps most importantly, the owner or controller of an entity that knowingly causes the entity to fail to return a Medicare overpayment may create individual liability for themselves under the 60-Day Rule, Civil Monetary Penalties, and – importantly – the False Claims Act. CMS will generally also refer a debt to the US Department of Treasury for collections efforts.

Published on: November 18, 2024

CMS Issues Changes to the 60-Day Rule

by Wachler & Associates, P.C.

In the recently released 2025 Physician Fee Schedule (“PFS”) Final Rule, the Centers for Medicare & Medicaid Services (“CMS”) implemented changes to the 60 Day Rule regarding the return of identified Medicare and Medicaid overpayments. Initially created by the 2010 Affordable Care Act, the 60 Day Rule requires healthcare providers to report and return Medicare and Medicaid overpayments within 60 days of identifying such overpayments. Failing to comply with the 60 Day rule may result in the imposition of a civil monetary penalty or an alleged violation of the Federal False Claims Act.

CMS made two significant changes to the 60 Day Rule in the 2025 PFS Final Rule. First, CMS formalized a six-month period for a good faith investigation before the 60-day clock begins to run. CMS had previously posited in guidance that it believed a provider should generally have up to six months to perform a good faith investigation before the provider is deemed to have “identified” the overpayment. In the 2025 Rule, CMS incorporated this position into the regulation itself, providing that the deadline for reporting and returning an overpayment will be suspended until either the provider completes the investigation or 180 days after the date the overpayment is initially identified, whichever is earlier.

Second, the 2025 Rule dropped the “reasonable diligence” standard and adopted the “knowingly” standard of the False Claims Act. Previously, the provider was deemed to have identified the overpayment if it had or should have determined through reasonable diligence that it had received a quantified overpayment. With the change, the provider will now be deemed to have identified an overpayment when it knowingly receives or retains an overpayment. “Knowingly” is defined by direct reference to the False Claims Act, thus aligning the two standards. Many observers had noted that it was inconsistent for CMS to claim providers would have False Claims Act liability for violating the 60 Day Rule, when the two had different standards. That inconsistency no longer exists.

Published on: November 15, 2024

CMS Extends Direct Supervision by Telemedicine, Hints at Future Plans

by Wachler & Associates, P.C.

Telemedicine has become an increasingly important part of the healthcare delivery landscape. Since the early stages of the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (“CMS”) have repeatedly issued regulatory flexibilities to allow Medicare to cover certain services provided in whole or in part by telemedicine. One of the most important of these regulatory flexibilities is the expansion of the definition of “direct supervision” to include direct supervision by telemedicine. CMS recently extended the effective period of this expansion through the end of 2025 and hinted at how it may handle direct supervision after that.

CMS has created three levels of supervision: personal, direct, and general supervision. Various services may require one of these levels of supervision in order to be covered by Medicare. Direct supervision is particularly important because it applies to several circumstances, including services provided and billed “incident to” a physician’s service. Click here for an explanation of “incident to” billing. Historically, direct supervision in the office setting has meant that the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.

However, during the COVID-19 public health emergency (“PHE”), CMS expanded this definition of direct supervision to provide that the presence of the physician (or other practitioner) includes virtual presence through audio/video real-time communications technology. Audio-only communication is not included. This expansion was intended to be temporary and expires at the end of the PHE. However, it has proved so useful and integral to the delivery of services to Medicare beneficiaries that it has been repeatedly extended, including past the official end of the PHE.

Published on: October 14, 2024

That Medicare Audit Appeal May Be Worth More Than You Think

by Wachler & Associates, P.C.

When a Medicare provider or supplier receives claims denials or an overpayment demand as a result of a Medicare audit, the decision whether and how to appeal the decision, or to simply repay the amount demanded by the Medicare contractor, is usually a business decision. In some cases, it may initially appear that the value of the demand simply does not justify the effort and cost of pursuing an appeal. However, a Medicare provider in this position should be aware that forgoing an appeal may have consequences far above and beyond paying back the amount demanded by Medicare.

In many cases, choosing to forego an appeal is not simply a matter of repaying funds to the Medicare program, but the Centers for Medicare & Medicaid Services (CMS) and its contractors will generally take a decision not to appeal as an admission by the provider that the audit results are correct and that the claims were properly denied. CMS and its contractors may use this perceived admission of ‘guilt’ against a provider later, long after it is far too late for the provider to appeal the audit findings.

For example, a provider may receive a Medicare probe audit. The contractor conducting the probe audit reviews medical records for 10 claims and denies all 10, claiming that the provider did not meet Medicare requirements for coverage. The repayment demand is ‘only’ $3,000. The provider strongly disagrees with the contractor’s allegation, but decides it is not worth it to appeal and simply pays the $3,000. A few months later, the provider receives another probe audit. The contractor reviews 12 claims and denies all 12 for the same reasons as in the first probe audit. Again, the repayment demand is ‘only’ $4,000, so even though the provider strongly believes their claims meet Medicare requirements, the provider chooses to repay the $4,000 rather than expend the time and resources to pursue the lengthy and complex Medicare claims appeal process.

Published on: October 9, 2024

OIG Scrutiny of Remote Monitoring Services

by Wachler & Associates, P.C.

In September 2024, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report detailing its recent review of remote patient monitoring (RPM) services furnished to Medicare beneficiaries and recommending additional oversight of RPM services. The OIG’s call for heightened scrutiny in this area is likely an indicator of increased audit activity of providers of these services.

By way of background, remote patient monitoring services typically use digital technologies to collect medical and other forms of health data from a patient in one location and electronically transmit that data to the patient’s healthcare provider in a different location for evaluation and treatment management. In many instances, the data collected is automatically electronically transmitted to providers for review and allows for efficient patient management. In some cases, these technologies can either trigger direct patient engagement or facilitate communication between the patient and provider.

In 2019, the Centers for Medicare & Medicaid Services (CMS) expanded payment for remote patient monitoring services. Shortly thereafter, the availability of Medicare reimbursement for remote monitoring services led to a substantial increase of providers furnishing RPM services. OIG’s report specifically highlights the increase in utilization of RPM services between 2019 and 2022, with Medicare payments for RPM services totaling more than $300 million in 2022, compared to $15 million in 2019.

Published on: October 7, 2024

Medicare Audits: What a Provider Can Expect

by Wachler & Associates, P.C.

Medicare claims audits can be a complex and frustrating experience for healthcare providers who choose to accept Medicare. If claims are denied during the audit – and they nearly always are – the appeal process can itself take months or years and contains many strategic decisions for a provider to make.

A Medicare audit generally begins when a Medicare contractor requests medical records from a provider. At this stage, it is important to note which type of contractor is making the request (is it a MAC, UPIC, RAC, SMRC, etc.?), which type of review the contractor is performing (pre-payment, post-payment, TPE, PPEO, CERT, is it likely to be statistically extrapolated, etc.?), and any special circumstances of the provider (Has it received similar audits or requests recently? Did it have a recent change of ownership? Does a separate entity possess relevant documentation? Etc.). Depending on the circumstances of the review, the provider may take additional steps to increase the likelihood that the claims reviewed by the contractor are found payable in the first instance. A provider may choose to submit additional records, retain a clinical expert, engage in additional communication with the contractor, or submit some form of legal brief or position paper. On the other hand, in some cases, it may be more appropriate to simply submit the records and await a response.

If claims are denied during the review, such claims are generally eligible for the Medicare claims appeal process, a complex, 5-step administrative appeals process. First is Redetermination, usually with the same contractor that issued the denials initially. Second is Reconsideration, before a different Medicare contractor. Third is review by an Administrative Law Judge (ALJ), where the provider has the opportunity to conduct a hearing and present witnesses. Fourth is review by the Medicare Appeals Council, the highest level of appeal within the Department of Health and Human Services. Fifth is appeal to federal court, which is usually limited in scope and not appropriate in many cases.

Published on: October 1, 2024

Medicare Payment Suspensions: Shortcut to Revocation

by Wachler & Associates, P.C.

The number of Medicare payment suspensions issued by the Centers for Medicare & Medicaid Services (CMS) has grown in recent years. Although generally framed as a temporary and less severe sanction than an outright revocation of Medicare billing privileges, a suspension of Medicare payments can be just as devastating to a Medicare provider or supplier and can in many cases put the provider out of business, leading to significant procedural and due process concerns regarding CMS’ frequent use of payment suspensions.

A Medicare payment suspension is a suspension of a Medicare-enrolled provider or supplier’s ability to receive payment from the Medicare program. Suspensions are usually scheduled to last for 180 days, but they can be extended essentially indefinitely. While a provider may technically continue to treat Medicare patients and submit Medicare claims for payment – the claims simply will not get paid until the suspension ends – for a provider with a high percentage of Medicare patients, a sudden, unforeseen, and indefinite interruption of all Medicare payments can wreak havoc on cash flow and destroy a practice or business as quickly and effectively as any enrollment or licensing sanction. Payment suspensions are also often issued without notice, meaning that a provider’s Medicare payments may abruptly stop, often days before the provider receives a letter informing them of the suspension.

Given the devastating effects of a suspension of Medicare payments, one may think there may be significant procedural, due process, or appeal protections in place for providers. That is not the case. Although federal law only explicitly authorizes CMS to issue payment suspensions where there is a “credible allegation of fraud,” CMS has implemented regulations that also give it the authority to suspend payments any time CMS believes it has “reliable information that an overpayment exists” and that broadly expand the definition of what constitutes a “credible allegation of fraud.” These regulations also give CMS extremely broad authority to issue suspensions without first notifying the provider, while giving the provider very limited appeal rights.

Published on: September 24, 2024

Recent Updates to the OIG Work Plan

by Wachler & Associates, P.C.

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently updated its Work Plan, adding several new audits and reviews. The OIG Work Plan forecasts the projects that the OIG plans to implement over the foreseeable future. These new initiatives are a signal of which areas the OIG views as warranting heightened scrutiny, and providers in these areas should take note of the OIG’s actions.

One of the most notable projects on the OIG Work Plan focuses on auditing Medicare claim lines for which the payment exceeds the actual charge. CMS contracts with various Medicare Administrative Contractors (MACs) to, among other things, process and pay claims submitted by providers for items and services covered under Medicare Part B. Generally, Part B payments are based on a fee schedule, prospective payment system, or some other method, rather than a cost or charge basis. In most cases, a healthcare provider’s billed charges exceed the amount that Medicare pays for Part B items and services. Under this Work Plan item, the OIG is focused on Medicare payments that exceed the billed charges, which can be overpayments. Providers should keep a close watch on their Medicare remittance advices or explanation of benefits to be aware of any payments that exceed the corresponding billed charge.

In terms of specific healthcare services, the OIG is turning its attention to hyaluronic acid injections, commonly used to treat knee osteoarthritis. While these injections are widely used for joint pain, there are ongoing questions about whether they are worth the cost and being used appropriately. The OIG’s audit will review Medicare reimbursements for these treatments and whether providers are following proper billing procedures.