backOIG Releases Compliance Program Guidance Applicable to All Providers and Suppliers– On November 6, 2023, OIG released new General Compliance Program Guidance (General CPG). The General CPG applies to all individuals and entities involved in the healthcare industry. The release of the General CPG was not unexpected, as OIG previously announced its plans in April 2023 to update existing Compliance Program Guidance (CPG) and issue new provider-specific CPGs. As described in more detail below, the General CPG builds on expectations OIG has historically articulated for individuals and organizations but provides additional detail and illustrates OIG’s increased expectations for compliance program development and effectiveness.
Background
OIG previously developed voluntary CPGs to support specific healthcare industry stakeholders, such as guidance directed towards hospitals, home health agencies, clinical laboratories, hospices, and other groups. The first CPG was issued in 1998 for hospitals. Most recently prior to the issuance of the General CPG, OIG had last issued a CPG in 2008. OIG has also provided compliance guidance through other issuances outside of CPGs, including Practical Guidance for Health Care Boards on Compliance Oversight and OIG’s toolkit on Measuring Compliance Program Effectiveness, and has continued to communicate its expectations through updates to its Corporate Integrity Agreement model.
In an effort to improve and update its guidance, OIG released the new General CPG and in 2024 plans to publish industry segment-specific CPGs (ICPGs) for different types of providers, suppliers, and other participants in healthcare industry subsectors or ancillary industry sectors relating to Federal healthcare programs.
Overview of the General CPG
The General CPG is non-binding, voluntary guidance document spanning 91 pages that applies to all entities and individuals involved in the healthcare industry. OIG cautions that the General CPG and forthcoming ICPGs do not constitute a model compliance program, nor are they intended to be comprehensive for every organization. Instead, they are designed to be used as an ongoing resource.
The General CPG addresses the following topics:
- Healthcare Fraud Enforcement and Other Standards: Overview of Certain Federal Laws: The General CPG begins with an overview of certain Federal authorities that may apply to entities in the healthcare industry, including primary Federal fraud and abuse authorities as well as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. Embedded in some sections of the key authority overview are: (1) key questions posed by OIG to help organizations and individuals evaluate compliance risk; (2) guidance if organizations or individuals identify a potential problem; and (3) practical tips.
- Compliance Program Infrastructure: The Seven Elements: In this section, OIG discusses the traditional seven elements of an effective compliance program. This section also includes practical tips and indicators of success. Notably, OIG has expanded its traditional “auditing and monitoring” element of an effective compliance program to now be described as “risk assessment, auditing and monitoring.” This change reflects OIG’s emphasis on risk-based compliance programs in recent years.
- Compliance Program Adaptations for Small and Large Entities: OIG recognizes that compliance programs may be structured differently based on an entity’s size. In this section, OIG offers guidance on how small entities can implement a compliance program that meets the seven elements even with limited resources. For large organizations, OIG discusses key compliance program elements and leadership efforts needed to meet the needs of a larger entity.
- Other Compliance Considerations: In this section, OIG outlines considerations related to several key risk areas: (1) Quality and Patient Safety; (2) New Entrants in the Health Care Industry; (3) Financial Incentives: Ownership and Payment – Follow the Money (this section includes a discussion of private equity); and (4) Financial Arrangements Tracking. These focus areas are important for healthcare organizations and individuals to consider as they reflect topics that the OIG is underscoring as key risk areas, and some of these areas (e.g., new entrants in the healthcare industry) are newer focus areas for OIG.
- OIG Resources and Processes: The final substantive section of the General CPG provides an overview of other OIG resources such as compliance resources, OIG reports, advisory opinions and other guidance, frequently asked questions, Corporate Integrity Agreements, enforcement and self-disclosure information and the OIG hotline.
In sum, OIG’s new General CPG builds on OIG’s historical guidance to reflect OIG’s expanded expectations for individuals and organizations operating in the healthcare space. This document also provides more detailed guidance and practical tips for organizations and individuals to consider. It is also consistent with issuances in recent years from DOJ that emphasize the importance of effective compliance programs. Accordingly, healthcare individuals and organizations may wish to review the General CPG and forthcoming ICPGs as they develop and assess compliance programs across the healthcare industry. OIG states that it expects to update the General CPG in accordance with future changes in legal requirements or compliance practices.
The General CPG is available here.
Reporter, Lauren S. Gennett, Atlanta, + 1 404 572 3592, lgennett@kslaw.com.
CMS Proposes Changes to the Medicare Advantage and Part D Programs Aimed at Improving Beneficiary Protections, Access to Care, and Addressing Agent and Broker Compensation – On November 6, 2023, CMS released a pre-publication version of a proposed rule (Proposed Rule) that is set to publish in the Federal Register on November 15, 2023, and that would amend the regulations governing Medicare Advantage (MA or Part C), the Medicare Prescription Drug Benefit (Part D), Medicare cost plans, and Programs of All-Inclusive Care for the Elderly (PACE). According to CMS, the Proposed Rule changes aim to increase beneficiary protections, promote healthy competition, improve access to care, and promote equity in coverage and care. Comments on the Proposed Rule are due by 5:00 p.m. on January 5, 2024.
Some of the proposed changes are highlighted below.
Redefining Agent and Broker Compensation
The Proposed Rule seeks to address CMS concerns that agent and broker compensation may incentivize agents and brokers to enroll individuals in certain MA plans that CMS alleges can result in steering beneficiaries to some MA plans over others rather than recommending plans based on the prospective enrollee’s best interests.
CMS proposes to: (1) broaden the scope of “compensation” so that it includes activities associated with the sales to and enrollment of a beneficiary into an MA plan or Part D plan; (2) set a national fixed compensation amount that agents and brokers receive from MA organizations for new MA enrollments at $642 (compared to the existing national compensation which is a cap of no more than $611); and (3) prohibit contract terms that result in volume-based bonuses for enrollment.
Improving Access to Behavioral Health Services
The Proposed Rule seeks to strengthen network adequacy requirements and improve access to behavioral health care services for MA enrollees by adding a range of behavioral health providers under one category called “Outpatient Behavioral Health” as a facility specialty for which CMS sets MA plan network adequacy standards. Specialists under this category include marriage and family therapists, mental health counselors, addiction medicine physicians, Opioid Treatment Program providers, Community Mental Health Centers, and other providers who provide addiction medicine and behavioral health counseling or therapy services.
CMS proposes adding this Outpatient Behavioral Health facility specialty to the list of the specialty types that will receive a 10% credit if the MA organization’s contracted network of providers includes one or more telehealth providers of that specialty type who provide additional telehealth benefits for covered services.
Notifying Enrollees of Available Supplemental Benefits
The Proposed Rule seeks to help make consumers aware of their plan benefits by proposing an annual “Mid-Year Enrollee Notification of Unused Supplemental Benefits,” personalized to each enrollee, that includes a list of any supplemental benefits the enrollee has not accessed during the first six months of the year. Supplemental benefits are extra benefits offered by MA plans that go beyond regular Medicare Parts A and B benefits. The notification would include the scope of the benefit, cost-sharing, instructions on accessing the benefit, any network application information, and a customer service number.
New Standards for Special Supplemental Benefits for the Chronically Ill
The Proposed Rule aims to help ensure a robust and competitive MA marketplace by requiring MA plans to demonstrate, by the time they submit bids, that special supplemental benefits for the chronically ill (SSBCI) items and services meet the legal threshold of having a reasonable expectation of improving the health or overall function of chronically ill enrollees and are supported by research. CMS proposes that MA plans establish and maintain bibliographies of relevant research studies or other data demonstrating that an SSBCI meets these requirements. CMS also proposes to update SSBCI marketing requirements to prevent misleading marketing related to these benefits that would make it appear that the SSBCI benefits are available to everyone.
Promoting Health Equity - Annual Health Equity Analysis of UM Policies and Procedures
The Proposed Rule seeks to create additional transparency and identify disproportionate impacts of Utilization Management (UM) policies and procedures on enrollees who receive the Part D low-income subsidy, are dually eligible, or have a disability by proposing updates to the composition of, and responsibilities for, the MA organization’s UM committee to require: (1) a member of the UM committee to have expertise in health equity; (2) the UM committee conduct an annual health equity analysis of prior authorization policies and procedures used by the MA organization; and (3) MA organizations to publish the results of the analysis on their website.
Expanding Enrollees’ Rights to Appeal MA Plan’s Decision to Terminate Coverage for Non-Hospital Services
CMS proposes to expand the rights of MA plan enrollees to access the Quality Improvement Organization (QIO) review of fast-track appeals available to beneficiaries in traditional Medicare. The Proposed Rule would: (1) require the QIO, rather than the MA plan, to review untimely fast-track appeals of an MA plan’s decision to terminate services in a skilled nursing facility, comprehensive outpatient rehabilitation facility, or by a home health agency; and (2) eliminate the provision requiring forfeiture of an enrollee’s right to appeal a termination decision when the enrollee leaves the facility.
Expanding Access to Integrated Medicare and Medicaid Services for Dually Eligible Enrollees
The Proposed Rule seeks to increase the percentage of dually eligible MA plan enrollees who are in plans that also cover Medicaid by offering more opportunities to enroll in plans that integrate Medicare and Medicaid and more opportunities to switch to traditional Medicare, as opposed to MA plans that differ from the enrollee’s Medicaid plan. The Proposed Rule would revise the current quarterly special enrollment period (SEP) for dually eligible and other Part D low-income subsidy (LIS) enrolled individuals to a once-per-month SEP to enroll in a standalone prescription drug plan and create a new integrated care SEP, to allow dually eligible individuals to elect an integrated dual eligible special needs plan (D-SNP) on a monthly basis.
Limiting Out-of-Network Cost Sharing for D-SNP PPOs
CMS proposes to limit out-of-network cost sharing for D-SNP preferred provider organizations (PPOs) for specific services, beginning in 2026. The Proposed Rule would decrease cost shifting to Medicaid, protect dually eligible enrollees from unaffordable costs, expand dually eligible enrollees’ access to providers, and increase payments to safety net providers.
Increasing Access to Lower Cost Biosimilar Biological Products
The Proposed Rule seeks to promote access to affordable biosimilar and generic products by permitting Part D sponsors to treat formulary substitutions of biosimilar biological products other than interchangeable biological products for their reference products as “maintenance changes” that would not require prior approval by CMS. CMS currently requires plans to obtain explicit approval from CMS before substituting with biosimilar biological products other than interchangeable biological products, and such substitutions apply only to enrollees who begin therapy after the effective date of the change, which would delay access to lower cost options. Treating such substitutions as maintenance changes would mean that any substitutions would apply to all enrollees following a 30-day notice, and enrollees would have earlier access to equally effective and potentially more affordable options.
Standardizing Appeals for MA Plan Risk Adjustment Data Validation (RADV)
The Proposed Rule aims to standardize the RADV appeals process and address operational constraints of the appeals process. Currently, if MA organizations appeal both medical record review determinations and payment error calculations resulting from RADV audits, both issues must be appealed and move through the appeals process concurrently, which could result in inconsistent appeal adjudications at different levels of appeal that impact recalculations of the payment error. CMS proposes that MA organizations must exhaust all three levels of appeal for medical record review determinations before requesting a payment error calculation appeal.
The Proposed Rule would clarify that a revised audit report containing a recalculated payment error calculation will be issued when a medical record review determination appeal or a payment error calculation appeal is final, as applicable, and will not be issued at each level of appeal. Moreover, the Proposed Rule would require that if the CMS Administrator does not decline to review or elect to review within 90 days of receiving the MA organization’s or CMS’s timely request for review, the hearing officer’s decision becomes final.
Lowering the D-SNP Look-Alike Threshold
The Proposed Rule aims to address the continued increase of MA plans that are serving high percentages of dually eligible individuals without meeting the requirements to be a D-SNP by proposing to lower the D-SNP look-alike threshold from 80% to 70% in 2025 and to 60% in 2026. A D-SNP look-alike is an MA plan that is not a SNP but in which dually eligible enrollees account for 80% or more of the total enrollment.
The CMS fact sheet on the Proposed Rule is available here. The Proposed Rule is available here.
Reporter, Jason A. de Jesus, Los Angeles, +1 213 443 4343, jdejesus@kslaw.com.