Articles Posted in Medicare

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In November 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its General Compliance Program Guidance (GCPG). This guidance was released as part of OIG’s Modernization Initiative, which seeks to make compliance program guidance more user friendly and accessible. The document does not include new information but instead summarizes existing guidance regarding fraud and abuse risk, serving as an up-to-date comprehensive reference guide for the general healthcare community and industry stakeholders. OIG also noted that in 2024 it will begin publishing industry segment-specific CPGs (ICPGs) which will address compliance measures for industry subsectors.

The GCPG is not legally binding on any individual or entity, but contains valuable information regarding compliance with federal fraud and abuse statutes and regulations. The OIG guidance includes information regarding key fraud and abuse laws, the primary elements of an effective compliance program, program adaptations for small and large entities, other compliance considerations, and OIG resources and processes.

The GCPG begins with an overview of the principal federal fraud and abuse laws including the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (PSL; also known as the “Stark law”), the False Claims Act (FCA), and the Civil Monetary Penalty law (CMP). Their stated goal in summarizing these laws is to “create awareness and provide tools and resources to aid compliance efforts in both preventing violations and identifying potential red flags early with respect to these laws and regulations.”

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On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final rule outlining the 2024 Medicare payment rates and policy updates for hospital outpatient and Ambulatory Surgical Center (ASC) services. The CMS final rule represents an annual update to the Medicare payment system and includes updates to the Outpatient Prospective Payment System (OPPS) and ASC payment rates, implementation of regulations aimed to improve hospital price transparency, and expansion of behavioral health services through the establishment of new payments and policies.

For calendar year (CY) 2024, CMS finalized an increased payment rate of 3.1% for OPPS and ASC services. This update reflects a projected hospital market basket increase of 3.3%, reduced by 0.2% for the productivity adjustment. This rate has been criticized by many leaders in the healthcare industry as inadequate to meet the financial burdens faced by hospitals and ASCs. American Hospital Association (AHA) Executive Vice President Stacey Hughes released the following statement in response to the final rule: “The AHA is concerned that CMS has again finalized an inadequate update to hospital payments…  Most hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging day to day. Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, which is why the AHA is urging Congress for additional support by the end of the year.”

The final rule also made changes to the CMS hospital price transparency requirements. All hospitals will now be required to display standard charge information through the use of a CMS template. The template is offered in various formats and requires hospitals to encode its standard charge information into the template. The rule also requires hospitals to place a “footer” at the bottom of their homepage linking users to the Hospital Price Transparency machine readable file (MRF). There will also be an affirmation statement requirement in which hospitals affirm they have made a good faith effort to ensure the MRF data is true, accurate, and complete.

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In light of the rapid technological advancements and increasing utilizations of artificial intelligence (AI), the World Health Organization (WHO) issued a publication outlining key regulatory considerations on AI for healthcare. The publication highlights emerging best practices for the development and use of AI in healthcare and aims to lay out an overview of regulatory considerations on AI for healthcare covering six general topic areas discussed below.

As the publication explains in greater detail, the WHO recommends that stakeholders take into account the following considerations as they continue to develop frameworks and best practices for the use of AI in healthcare:

  1. Documentation and transparency: Pre-specifying and documenting the intended medical purpose and development process should be considered in a manner that allows for the tracing of the development steps as appropriate. A risk-based approach should also be considered for the level of documentation and record-keeping utilized for the development and validation of AI systems.
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In November 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule expanding their ability to revoke Medicare billing privileges of providers and suppliers. This rule went into effect January 1, 2022, and has significantly increased the importance of a diligent and careful response when faced with a CMS audit.

Prior regulations required CMS to consider the following three factors when determining whether a provider or supplier was engaged in the type of billing practices which could support a revocation: (1) the reason for any claim denials, (2) the length of time over which any pattern or practice of submitting claims that fail to meet Medicare requirements occurred, and (3) how long the provider or supplier had been enrolled in Medicare.

CMS asserted that these three considerations inhibited their ability to “target brief periods involving a significant percentage of denied claims” and therefore proposed revisions to this framework which it believed would strengthen CMS’ overall program integrity efforts. The new framework now considers the following four factors:

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced several new changes in its Work Plan update for October 2023. The OIG Work Plan forecasts the projects that OIG plans to implement over the foreseeable future. These projects usually include OIG audits and evaluations. Below are the highlights from the Work Plan update of which providers and suppliers should take notice.

First, OIG will perform an audit of the Morehouse School of Medicine’s National Infrastructure for Mitigating the Impact of COVID-19 (NIMIC) initiative. The NIMIC initiative is a 3-year, $40 million cooperative agreement between HHS’s Office of Minority Health and the Morehouse School of Medicine to fight COVID-19 in racial and ethnic minority, rural, and socially vulnerable communities. The Morehouse School of Medicine is leading the initiative to coordinate a strategic network to deliver COVID-19 related information to communicates hit hardest by the pandemic.

Second, OIG will audit the accuracy of the Child Care and Development Fund (CCDF) attendance records at Minnesota child care centers. The CCDF is the primary federal funding source devoted to subsidizing the child care expenditures of low-income families. OIG has stated that it identified issues with the completeness and accuracy of child care attendance records and with related billings for child care services. Minnesota, as well as possibly additional states, have been selected by OIG for a review to determine whether the state(s) complied with federal and state requirements related to attendance records and whether payments for services at child care centers were allowable.

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On October 10, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an advisory opinion reinforcing the broad protection of physician employees under the safe harbor provision of the Anti-Kickback Statute (AKS). The AKS is a federal criminal law which prohibits payment for the inducement or reward of patient referrals or generation of business where any item or service payable by a federal healthcare program is involved.  Remuneration under the law has been interpreted to mean “the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.” Violation of the AKS can result in severe penalties, including imprisonment of up to 10 years, a maximum fine of $100,000, and exclusions from Medicare and Medicaid reimbursement.

There are several statutory and regulatory exceptions to the AKS, which allow for specific remuneration arrangements when certain criteria are met. One statutory exception protects payments made by employers to employees who are in bona fide employment relationships for providing covered items and services under the employment agreement. Similarly, safe harbor regulations have been promulgated by HHS which clarify that “remuneration” under the AKS does not include payments under the bona fide employer-employee relationship described above.

In the recent advisory opinion, the OIG considered whether employer payment of bonuses based on net profits to employed physicians in a multi-specialty ambulatory surgery center (ASC) would constitute a violation of the AKS. The employer practice operated two separate ASCs – noted to be divisions and not subsidiaries – and planned to compensate physician employees via a bonus structure where employed physicians who performed procedures at the ASCs would receive 30% of the practice’s net profits in addition to base employment compensation. The OIG concluded that this type of arrangement would not violate the terms set forth in the AKS.

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In August 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced its strategic plan to investigate the life cycle of Medicare and Medicaid managed care contracts. OIG’s plan will scrutinize these contracts from inception through enrollment, reimbursement, services, and renewal. In order to address fraud, waste, and abuse risks, the goal of OIG’s plan is to hold accountable Medicare Advantage organizations (MAOs) and Medicaid managed care organizations (MCOs).

Currently, more than half of Medicare enrollees and more than 80% of Medicaid enrollees are covered by managed care programs. In order to oversee the approximate $700 billion that the federal government spent on managed care programs in 2022, OIG has set out four phases of managed care that it intends to investigate: (1) plan establishment and contracting, (2) enrollment, (3) payment, and (4) provision of services.

In the first phase, OIG intends to review activities that occur when the Centers for Medicare & Medicaid Services (CMS) or states initially establish or renew managed care contracts. In this contract review phase, OIG will evaluate whether MAOs and MCOs are providing the government with accurate information, including in their bids, and abiding by the contract terms for their plan design, service offerings, and coverage area. In the second phase, OIG will review enrollment processes. Specifically, OIG will focus on potentially aggressive marketing campaigns and inaccurate information collection.

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As part of the Biden Administration’s initiative to improve quality and safety in nursing home care, the Centers for Medicare & Medicaid Services (CMS) issued a notice of proposed rulemaking on September 1, 2023, entitled “Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting.” This initiative resulted in part from a 2022 Nursing Home Staffing Study, which sought to establish “the level and type of staffing needed to promote acceptable quality and safety.” Notably, the study projected that the cost of implementing such new minimum staffing requirements could range from $1.5-6.8 billion, increasing the burden on an industry already struggling with personnel shortages and demanding regulatory requirements.

The proposed rule is comprised of three core staffing proposals, including establishing new minimum staffing standards for RNs and NAs, requiring an RN to always be onsite, and enhancing facility assessment requirements. There are staggered implementation protocols and possible hardship exemptions for qualifying facilities included in the proposed rule. CMS also announced a collaboration with the Health Resources and Services Administration (HRSA) to assist in training and growing the nursing workforce, by investing over $75 million in scholarships and tuition reimbursement.

The first core staffing proposal establishes a minimum staffing standard of 0.55 hours per resident day (HPRD) for RNs and 2.45 HPRD for NAs. Practically speaking, this translates to a facility with 100 residents having two RNs for each 8-hour shift and a third RN for one shift during the day, as well as ten NAs per 8-hour shift. As these are minimums, CMS noted that they expect facilities to increase staffing above this baseline pursuant to the individual facility assessment and acuity levels.

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The Centers for Medicare & Medicaid Services (CMS) recently announced that it intends to increase scrutiny on hospice providers as a result of increased reports and CMS findings suggesting potential hospice services fraud. CMS stated that it is strengthening its hospice program integrity strategy through actions such as site visits and proposed regulations to minimize impacts to Medicare beneficiaries.

As part of this revitalized focus on hospice integrity, CMS has highlighted several observed situations that it views with heightened scrutiny. Certain reports cited by CMS have supposedly identified instances of hospices certifying patients for hospice care when they were not terminally ill and providing little to no services to patients. CMS has also indicated that the listed address for some hospices appears to be non-operational. One particular alleged trend CMS has focused on is known as “churn and burn,” where a new hospice opens and starts billing, but once that hospice is audited or reaches its statutory yearly payment limit, it shuts down, keeps the money, buys a new Medicare billing number, transfers its patients over to the new Medicare billing number, and starts billing again.

In response to these purported findings, CMS embarked on a nationwide hospice site visit program, making unannounced site visits to every Medicare-enrolled hospice. As of mid-August 2023, CMS has visited over 7,000 hospices, and indicated that nearly 400 hospices are being considered for potential administrative action as a result. While many of these hospices may very well be able to demonstrate compliance with Medicare requirements, if CMS finds grounds to conclude that a hospice is allegedly non-compliant, this may result in significant consequences such as suspension or revocation. Further, CMS has noted that rapid hospice growth trends in four states – Arizona, California, Nevada, and Texas – has led the Centers to implement a provisional period of enhanced oversight in these states. During this provisional period, CMS plans to conduct medical reviews before making payments on claims submitted by newly enrolling hospices.

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The Centers for Medicare & Medicaid Services (CMS) recently announced the Making Care Primary (MCP) Model, a new voluntary primary care model that will be tested in eight states. The new model aims to improve care management and care coordination, equip primary care clinicians with tools to form partnerships with healthcare specialists, and leverage community-based connections to address patients’ health needs as well as their health-related social needs, such as housing and nutrition. CMS plans to work with eight state Medicaid agencies to engage in full care transformation across payers, with plans to engage private payers in the future. The MCP Model is slated to launch July 1, 2024 in eight participating states – Colorado, North Carolina, New Jersey, New Mexico, New York, Minnesota, Massachusetts, and Washington.

The MCP Model is a 10.5-year multi-payer model with three participation tracks that build upon previous primary care models. MCP’s overarching goal is to improve care for beneficiaries by supporting the delivery of advanced primary care services, which are foundation for a high-performing health system. To achieve this goal, the Model will provide a pathway for primary care clinicians with varying levels of experience in value-based care to gradually adopt prospective, population-based payments while building infrastructure to improve behavioral health and specialty integration and drive equitable access to care. The Model also attempts to strengthen coordination between patients’ primary clinicians, specialists, social service providers, and behavioral health clinicians, ultimately leading to chronic disease prevention, fewer emergency room visits, and better health outcomes.

Three domains define the MCP Model’s care delivery approach:

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