Health Headlines – July 15, 2024

CMS Issues CY 2025 Physician Fee Schedule Proposed Rule - On July 10, 2024, CMS issued a proposed rule that identifies and seeks public comments on a broad array of proposed changes to the Medicare Physician Fee Schedule (PFS) and Medicare Part B payments (the Proposed Rule) for Calendar Year (CY) 2025. If finalized, the proposed changes would take effect January 1, 2025. Comments are due by September 9, 2024.

The Proposed Rule includes many updates affecting a wide range of practitioners and providers.  Medicare makes payments for the services of physicians and other billing professionals under the Physician Fee Schedule. The PFS pays for physician services provided in a variety of settings, such as hospitals, physician offices, ambulatory surgical centers, and various post-acute care settings.  The PFS also includes payments to suppliers of technical services for situations where payment is not made to an institution.  Below is a summary of key proposed changes to the PFS under the Proposed Rule.

CY 2025 PFS Rate Setting and Conversion Factor

CMS proposes reducing the average payment rates under the PFS by 2.93% for CY 2025 compared to the average amount CMS paid for these services for CY 2024. This will result in a proposed estimated CY 2025 PFS conversion factor of $32.36, a decrease of $0.93 (or 2.80%) from the current CY 2024 conversion factor of $33.29.

Improving Ambulatory Specialty Care

CMS is soliciting feedback through a Request for Information on CMS’s design of a potential ambulatory specialty care model that would leverage the Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) to boost engagement of specialists in value-based care and expand incentives for primary and specialty care coordination.  Under CMS’s proposed design, participants would receive a payment adjustment based upon a set of clinically relevant MVP measures and how they performed relative to other specialists of their same specialty type and clinical profile (instead of the Merit-based Incentive Payment System adjustment).

Caregiver Training Services (CTS)

CMS proposes establishing new coding and payment for caregiver training for direct care services and supports such as for techniques to prevent decubitus ulcer formation, wound dressing changes, infection control, special diet preparation, and medication administration, among others.  CMS also proposes to allow the CTS to take place via telehealth. The proposal also includes new coding and payment for caregiver behavior management and modification training that could be furnished to the caregiver of an individual patient.

Office/Outpatient (O/O) Evaluation and Management (E/M) Visits

CMS proposes for CY 2025 to allow payment of the office/outpatient evaluation and management visit complexity add-on code G2211 when the base code is reported by the same practitioner on the same day as an annual wellness visit, vaccine administration, or any Medicare Part B preventive service furnished in the office or outpatient setting.

Telehealth Services under the PFS

CMS has several proposals under the PFS for CY 2025 related to telehealth payments.  First, CMS proposes adding several services to the Medicare Telehealth Services List (on a provisional basis) including caregiver training services (described above) and demonstration prior to initiation of home International Normalized Ratio monitoring.  Second, CMS proposes extending its current suspension of limitations on frequency for subsequent telehealth inpatient visits, nursing facility visits, and critical care consultations.  Third, CMS proposes including two-way, real-time audio-only communication technology in the category of “interactive telecommunications system” for any telehealth service furnished to a beneficiary in their home if the distant site physician or practitioner is technically capable of using an interactive telecommunications system but the patient is not capable of, or does not consent to, the use of video technology.  Fourth, CMS will continue to allow a distant site practitioner to use their enrolled practice address instead of their home address even when the practitioner provides telehealth services from their home.  Fifth, CMS proposes that for some telehealth services where there is a requirement that they are furnished under the direct supervision of a physician or other supervising practitioner to permanently adopt a definition of direct supervision that allows the physician or supervising practitioner to provide such supervision through real-time audio and visual interactive telecommunications.  Sixth, CMS will continue to allow, for billing purposes, teaching physicians as a virtual presence when the medical resident is providing medical services in a virtual setting (only in clinical instances when the service is furnished virtually such as a three-way telehealth visit with the physician/resident/patient in different locations) through December 31, 2025.

Advanced Primary Care Management Services (APCM)

CMS proposes for CY 2025 to establish coding and payment under the PFS for a new set of APCM services captured by three new HCPCS G-codes to better describe advanced primary care services and simplify billing and documentation requirements.

Strategies for Improving Global Surgery Payment Accuracy

For CY 2025, CMS proposes to expand the applicability of the transfer of care modifiers for global packages and require the use of the existing modifiers for all 90-day global surgical packages in any case when a practitioner expects to furnish only the pre-operative, procedure, or post operative portions of a global package. CMS seeks to learn how global package services are regularly furnished to improve the accuracy of Medicare payments.

Behavioral Health Services

CMS proposes to establish separate coding and payment under the PFS to capture efforts for safety planning interventions for patients in crisis, including those with suicidal ideation or otherwise at risk of suicide or overdose.  This proposal also includes the development of a monthly billing code that requires specific protocols in furnishing post-discharge follow-up contacts that take place in conjunction with a discharge from the emergency department for a behavioral health crisis encounter.  The proposal additionally includes Medicare payment for digital mental health treatment devices used in professional behavioral health services for ongoing treatment under a behavioral health plan of care.

Opioid Treatment Programs (OTPs)

CMS proposes payment increases for opioid use disorder treatment as well as telehealth flexibilities including making permanent the current flexibility for providing audio-only periodic assessments and allowing the OTP intake add-on code to be used for two-way audio-video communication when billed for the initiation of treatment with methadone (if the OTP determines that an adequate evaluation of the patient can be accomplished through this method of communication.)

Hospital Inpatient or Observation (I/O) Evaluation and Management (E/M) Add-on for Infectious Diseases

CMS proposes a new HCPCS add-on code to better capture the intensity and complexity that is present when a physician with specialized training in infectious diseases addresses, either via hospital inpatient or observation care, a case of a confirmed or suspected infectious disease.

Supervision Policy for Physical Therapists (PTs) and Occupational Therapists (OTs) in Private Practice

CMS seeks to increase flexibility for PTs and OTs by proposing to permit general supervision of physical therapist assistants and occupational therapy assistants by PTs in private practice and OTs in private practice for all applicable physical and occupational therapy services.  CMS states that its goal for this proposed change is to better enable these professionals to meet the needs of beneficiaries and increase access in underserved areas.

Dental and Oral Health Services

CMS proposes amending its regulations to increase the list of clinical scenarios related to ESRD where FFS Medicare payment is made for dental services that are inextricably linked to covered services.  The amendments would be added at 42 CFR § 411.15(i)(3).  CMS also proposes two policies related to dental services billing  linked to covered services including a modifier on claims for dental services that clinicians believe to be inextricably linked to covered medical services beginning in CY 2025 and a requirement to submit a diagnosis code on the 837D dental claims format beginning January 1, 2025.  CMS has a Request for Information regarding services associated with furnishing oral appliances used for the treatment of obstructive sleep apnea.

Drugs and Biological Products Paid Under Medicare Part B

• Refunds for Discarded Amounts of Certain Single-Dose Containers or Single Use-Package Drugs by Manufacturers - CMS proposes to clarify policies implemented in CY 2023 and CY 2024 to implement Section 9004 of the Infrastructure Investment and Jobs Act, which established a refund for discarded amounts of certain single-dose container or single-use package drugs under Part B by manufacturers, including identifying single-dose containers and excluding drugs that have been covered under Part B for fewer than 18 months.

• Approach to Payment Limit Calculations when Negative or Zero ASP Date is Reported to CMS -  CMS proposes to calculate payment limits when manufacturers report negative and zero average sales price  data to CMS by considering such date to be “not available” under section 1847A(c)(5)(B) of the Act and that positive average sales price data be considered available.

• Payment for Radiopharmaceuticals in the Physician Office - CMS is proposing that Medicare Administrative Contractor (MACs) shall determine payment limits for radiopharmaceuticals based on any methodology used to determine payment limits for radiopharmaceuticals in place on or prior to November 2003, including, but not limited to, the use of invoice-based pricing.

Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) 

• Care Coordination Services - CMS proposes several changes related to reporting care coordination services to better align payment to RHCs and FQHCs for these services with other entities furnishing this kind of care, including that RHCs and FQHCs would report the individual CPT and HCPCS codes that describe care coordination services instead of a single HCPCS code.

• Teleradiology Services - CMS is proposing to continue to allow direct supervision via telecommunication, including extending the definition of “immediate availability” to include telecommunication, and to allow payments on a temporary basis for non-behavioral health visits furnished via telecommunication technology.

• Payment for Radiopharmaceuticals in the Physician Office - CMS is proposing that MACs shall determine payment limits for radiopharmaceuticals based on any methodology used to determine payment limits for radiopharmaceuticals in place on or prior to November 2003, including, but not limited to, the use of invoice-based pricing.

• Inpatient Outpatient Program Services – CMS is proposing to provide a different payment rate only after four or more services per day rather than the different payment currently provided based only on three services per day, which would align with the four or more services per day payment rate for hospital outpatient services department.

Medicare Prescription Drug Inflation Rebate Program

CMS proposes codifying policies established in the revised guidance for the Medicare Drug Inflation Rebate Program and Medicare Part D Drug Inflation Rebate Program whereby drug companies must pay inflation rebates if they raise their prices for certain Part B and Part D drugs faster than the rate of inflation, including establishing the method and process for reconciliation of a rebate amount and clarifying rebate calculations for Part B and Part D rebatable drugs in specific circumstances.

Other topics addressed in the Proposed Rule include the following:

• CMS is issuing a Request for Information for additional policy refinements in future rulemakings concerning Community Health Integration services, Principal Illness Navigation services, and Social Determinants of Health Risk Assessment.
• CMS proposes coding and payment for an Atherosclerotic Cardiovascular Disease risk assessment service and risk management services.
• CMS proposes amendments to the certification and recertification regulations to decrease the current burden on therapists and physician/NPPS by not requiring a signature for a treatment plan during initial certification when there is already a written order or referral on file that was transmitted within thirty days of the initial evaluation.
• With respect to drugs and biological products paid under Medicare Part B, CMS proposes:
• to modify regulations to include certain compounded formulations of FDA-approved drugs for immunosuppressive drugs; and
• to update regulatory text to clarify existing CMS Policy to avoid double payment of administration fees by clarifying that blood clotting factors must be self-administered to be considered clotting factors for which the furnishing fee applies.
• With respect to RHCs and FQHCs, CMS proposes:
• allowing RHCs and FQHCs to bill and be paid for Part B preventative vaccines and their administration at time of service;
• clarifying that dental services furnished in the physician office that are inextricably linked to certain covered services furnished in RHCs and FQHCs would be considered to be RHC and FQHCs services and paid under the RHC All-Inclusive Rate (AIR) methodology and FQHC PPS, respectively.
• removing productivity standards that can impact the AIR methodology;
• rebasing and revising the FQHC market basket to reflect a 2022 base year, with a proposed CY 2025 FQHC productivity-adjusted market basket update of 3.5%; and
• proposing changes to the RHC and FQHC Conditions for Coverage to increase flexibility, decrease burden for the providers, and improve access to services for patients.

The Proposed Rule is available here. The fact sheet to the Proposed Rule is available here.

Reporters, Christopher C. Jew, Los Angeles, + 1 213 443 4336, cjew@kslaw.com, and Kasey Ashford, Washington D.C., +1 202 626 2906, kashford@kslaw.com.

Physician Fee Schedule Proposed Rule Proposes New Quality-Driven Payment Policies – Within its proposed CY 2025 Physician Fee Schedule (PFS) rule (the Proposed Rule), CMS is proposing to implement new payment policies intended to advance health equity and support whole-person care. CMS expects these new payment policies will strengthen primary care, expand access to various health care services, and maintain telehealth flexibilities. 

CMS is proposing new quality-driven payment policies in an effort to expand access to quality and affordable care. These policies are intended to improve “whole-person care” through various payment and coding initiatives. Dr. Seshamani, a Deputy CMS Administrator, explained that whole-person care is intended to recognize “each unique aspect of a person and their wellbeing, including physical health, behavioral health, oral health, social determinants of health, and caregiving supports.”

Strengthening Primary Care

Under the Proposed Rule, CMS is proposing to implement various new payment and coding initiatives designed to strengthen access to and utilization of comprehensive primary care. CMS is proposing a new, advanced primary care management bundle. This proposed payment bundle uses coding describing certain primary care services that would be provided by advanced primary care teams, with adjustments for patient medical and social complexity to promote health equity. These services would be tied to primary care quality measures to improve patient health outcomes.

CMS also proposes new payment and coding for cardiovascular-focused risk management and cardiovascular disease risk assessment furnished in conjunction with an evaluation and management visit. CMS proposes six new Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) centering around ophthalmology, dermatology, gastroenterology, pulmonology, urology, and surgical care. CMS is also proposing to update the MIPS scoring methodologies and measure inventories to give all clinicians the opportunity to achieve positive scores and continued improvement. 

CMS also issued proposals with respect to accountable care organizations (ACOs). Eligible ACOs with a history of success in the Medicare Shared Savings Program will be allowed advances on their earned shared savings, also knowns as prepaid shared savings, in order to encourage investment in staffing, health care infrastructure, and additional services related to nutrition support, transportation, dental, vision, hearing, and Part-B cost-sharing reductions. For ACOs that serve individuals within rural and underserved communities, CMS also proposes a health equity benchmark adjustment similar to the approach utilized by the Innovation Center’s ACO REACH Model for ACOs. CMS is also proposing a methodology to account for the impact of improper payments when reopening an ACO’s shared savings and shared losses calculation.

Expanding Access to Certain Health Care Services

In an effort to expand access to behavioral health, oral health, and caregiver training services, CMS is proposing new payments in the Proposed Rule for the following:

• Practitioners assisting people at high risk of suicide or overdoes, including separate payment for safety planning interventions and post-discharge follow-up contacts;
• Use of digital tools that support the delivery of specific behavioral health treatments;
• In connection with services furnished by Opioid Treatment Programs, FDA-approved medications for the treatment of Opioid Use Disorder (OUD) and known or suspected opioid overdose, increased telecommunication flexibilities for periodic assessments and methadone treatment initiation;
• Intake activities to provide more comprehensive services for the treatment of OUD;
• Certain dental services associated with dialysis treatments for end-stage renal disease; and
• Caregiver training services related to direct care services and supports and allowing caregiver training services to be provided virtually.

Expanding Preventive Services

In an effort to expand coverage of the hepatitis B vaccine, CMS is proposing to provide free hepatitis B vaccines to those individuals who have not received a vaccine or where the vaccination status of the individual is unknown. Under the Proposed Rule, these expanded coverage initiatives will allow individuals to receive hepatitis B vaccines from pharmacies. Pharmacies and mass immunizers will also be allowed to roster bill consistent with the current roster billing process for flu, pneumococcal, and COVID-19 vaccines.

In addition, CMS is proposing to institute a fee schedule for drugs covered as additional preventive service. These drugs are currently not covered by CMS under the benefit category of additional preventative services.

Maintaining Telehealth Flexibilities

Under the Proposed Rule, CMS will maintain certain flexibilities to telehealth services and payments that are otherwise set to expire at the end of the year. For example, CMS is proposing to continue allowing certain practitioners to provide virtual direct supervision to auxiliary personnel when required. CMS is also proposing to continue its current billing and payment policies allowing virtual supervision by teaching physicians for services furnished virtually by residents in all teaching settings (for example, a 3-way telehealth visit, with the patient, resident, and teaching physician in separate locations).

The fact sheet summarizing these new payment and coding rules is available here and the Proposed Rule containing these new policies is available here. Comments are due by September 9, 2024.

Reporter, Dennis Mkrtchian, Los Angeles, + 1 213 218 4046, dmkrtchian@kslaw.com.

CMS Issues CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule – On July 10, 2024, CMS issued a proposed rule with updates to the Medicare payment rates for the Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2025 (the Proposed Rule). The Proposed Rule revises payment rates for OPPS and the Medicare ASC payment systems and proposes policies that address health outcomes, expand access to behavioral health care, improve transparency in the health system, and promote safe patient care.

The proposed payment policies included in the Proposed Rule would affect around 3,500 hospitals and approximately 6,100 ASCs. Below is a summary of the updates and proposals set forth in the Proposed Rule.

Updates to the OPPS and ASC Payment Rates

The Proposed Rule updates the OPPS payment rates for hospitals by 2.6%, based on the projected hospital market basket percentage increase of 3.0%, reduced by a productivity adjustment of 0.4%. CMS also proposes to update ASC rates for ASCs by 2.6%, based on the proposed inpatient prospective payment system market basket percentage increase of 3.0%, reduced by a productivity adjustment of 0.4%. The Proposed Rule would also update the Medicare payment rates for intensive outpatient program (IOP) services furnished in hospital outpatient departments and Community Mental Health Centers (CMHCs). The IOP is a distinct outpatient program of psychiatric and behavioral health services paid on a per diem basis for a minimum of nine (9) hours of IOP services per week under the OPPS or another applicable payment system when furnished in hospital outpatient departments, CMHCs, Federally Qualified Health Centers, and Rural Health Clinics. Beginning in 2024, CMS established four separate per diem payment rates for IOPs: one for CMHCs for three-service days and another for CMHCs for four-service days, and one for hospital-based IOPs for three-service days and another for hospital-based IOPs for four-service days. The Proposed Rule would maintain the calculation of both hospital outpatient and CMHC IOP payment rates for three (3) services per day and four (4) or more services per day based on cost per day using OPPS data that includes partial hospital program and non-partial hospitalization program days.

Partial Hospitalization Program

The Proposed Rule would also update the Medicare payment rates for partial hospitalization program (PHP) services furnished in hospital outpatient departments and CMHCs. The PHP is an outpatient program alternative to psychiatric hospitalization and consists of mental health services paid on a per diem basis for at least twenty (20) hours of PHP services per week under the OPPS.

Access to Non-Opioid Treatments for Pain Relief

The Proposed Rule would implement Section 4135 of the Consolidated Appropriations Act (CAA). The CAA provides temporary additional payments from January 1, 2025 through December 31, 2027 for non-opioid treatments for pain relief in the hospital outpatient department and ASC settings. Seven drugs and one device are proposed by the Proposed Rule to qualify as non-opioid treatments for pain relief.

Hospital Inpatient Quality Reporting Program

The Hospital Inpatient Quality Reporting (IQR) Program is a quality program that reduces payments to hospitals that do not meet program requirements. Hospitals that fail to meet all IQR requirements are subject to a one-fourth reduction in their annual payment update under the IPPS. The Proposed Rule proposes to continue voluntary reporting of the core clinical data elements and linking variable for both the Hybrid Hospital-Wide Readmission and Hybrid Hospital-Wide Standardized Mortality measures for the performance period from July 1, 2023 through June 30, 2024.

Hospital Outpatient Qualify Reporting Program

The Hospital Outpatient Quality Reporting (OQR) Program is a quality program for hospital outpatient departments that requires hospitals to meet quality reporting requirements or receive a reduction of two percentage points in their annual payment update. The Proposed Rule would adopt the following quality measures with respect to the OQR:

• Hospital Commitment to Health Equity
• Screening for Social Drivers of Health
• Screen Positive Rate for Social Drivers of Health
• Patient Understanding of Key Information Related to Recover After a Facility-Based Performance

The Proposed Rule would remove the following quality measures with respect to the OQR:

• MRI Lumbar Spine for Low Back Pain
• Cardiac Imaging for Preoperative Risk Assessment for Non-Cardiac, Low-Risk Surgery

The Proposed Rule would also require that Electronic Health Record (EHR) technology be certified to all electronic clinical quality measures (eCQMs) available to report in the Hospital OQR Program measure set to ensure that hospitals can accurately capture and report data for all eCQMs in the measure set.

ASC Quality Reporting Program

The ASC Quality Reporting (ASCQR) Program is a quality reporting program under which ASCs must report data on certain quality measures required by CMS. If an ASC fails to report on such measures, the ASC will receive a two-percentage point payment penalty to its annual payment rate update. The Proposed Rule would adopt the following additional measures with respect to the ASCQR:

• Facility Commitment to Health Equity
• Screening for Social Drives of Health
• Screen Positive Rate for Social Drives of Health

Proposed Obstetrical Services Conditions of Participation

The Proposed Rule also proposes to adopt new Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) with respect to obstetrical services, including the following:

• Organization and Staffing. Under the Proposed Rule, hospitals and CAHs providing obstetrical services outside of an emergency department would be required to provide such obstetrical services in accordance with nationally recognized acceptable standards of practice for the health care of pregnant and postpartum patients. This would include ensuring adequate integration with other service departments of the hospital, such as the laboratory, surgical, and anesthesia departments. The Proposed Rule would also require that obstetrical patient care units be supervised by an individual with necessary education and training, such as an experienced registered nurse, certified midwife, nurse practitioner, physician assistant, or doctor of medicine.
• Delivery of Service. The Proposed Rule would require that obstetrical services be consistent with the needs and resources of the facility and that hospital policies ensure high standards of medical practice and patient care. The Proposed Rule would also require that labor and delivery rooms have certain basic resuscitation equipment, including a call-in system, cardiac monitor, and fetal doppler or monitor.
• Staff Training. The Proposed Rule would require that hospitals and CAHs providing obstetrical services to develop policies and procedures to ensure that staff are trained on certain topics to improve maternal care. Under the Proposed Rule, hospitals and CAHs would be required to identify which staff must complete the required trainings, document such training, and be able to demonstrate staff knowledge on the training topics.
• Quality Assessment and Performance Improvement (QAPI) Program. Under the Proposed Rule, hospitals and CAHs would be required to use its QAPI program to assess and improve health outcomes among obstetrical patients, including conducting at least one annual performance improvement project focused on improving health outcomes and disparities among the hospital’s obstetrical patients.
• Emergency Services Readiness. The Proposed Rule would revise the Emergency Services CoP to require hospitals and CAHs providing emergency services to have adequate provisions and protocols to meet the emergency needs of patients. The Proposed Rule would also require hospitals with emergency services to require staff to be trained annually on these protocols.
• Transfer Protocols. The Proposed Rule would also require hospitals to have written policies and procedures for transferring patients to the appropriate level of care as needed to meet the patients’ needs and to provide appropriate staff training on the transferring of patients.

A copy of the Proposed Rule can be downloaded here.  Comments on the Proposed Rule are due by September 9, 2024.

Reporter, Brittany Tandy, Austin, + 1 512 457 2071, btandy@kslaw.com.

 

OIG Updates Fraud and Abuse Authorities FAQs – On July 8, 2024, OIG updated the Frequently Asked Questions on its website, adding four new questions and answers to its General Questions Regarding Certain Fraud and Abuse Authorities.  The questions touch on (1) a hospital’s ability to waive cost-sharing charges to patients in connection with financial assistance and charity care policies, whether such waivers violate the federal anti-kickback statute (AKS) or the Civil Monetary Penalty Law (CMP Law) and whether a hospital can make Federal health care program enrollees aware of such waivers; (2) a hospital’s provision of free care to uninsured patients and whether advertising such care would violate the AKS or CMP Law; and (3) whether a hospital can disseminate on its website and in public areas, without violating the AKS or CMP Law, information about its financial assistance policy that requires an individual assessment of a patient’s financial need and offers of financial assistance to patients who have such a financial need.  The exact questions and a summary of OIG’s answers are below.

(13) Does the Federal anti-kickback statute or the Beneficiary Inducements CMP prohibit hospitals from waiving their patients’ cost-sharing amounts pursuant to hospitals’ financial assistance or charity care policies?

OIG states that, as a general matter, the AKS and CMP Law do not apply to cost-sharing waivers for those who are uninsured or who are insured by a commercial health insurance plan.  But for Federal health care program enrollees, the laws could be implicated: “[H]ospitals that routinely waive cost-sharing amounts—as part of a financial assistance policy or otherwise—for reasons unrelated to individualized, good-faith assessments of financial hardship may be held liable under the Federal anti-kickback statute, the Beneficiary Inducements CMP, or both.”

However, OIG states that it is possible to structure cost-sharing waivers for Federal health care program enrollees such that the waivers fall under an AKS safe harbor or an exception to the Beneficiary Inducements CMP.  For example, waivers based on an enrollee’s financial need are likely low-risk under the AKS, so long as the waivers are neither advertised nor routine and made based on a good-faith assessment of the individual enrollee’s financial need.  Similarly, waivers may satisfy an exception to the definition of “remuneration” under the Beneficiary Inducements CMP, provided the waivers are: (i) not offered as part of any advertisement or solicitation; (ii) not routine; and (iii) made following an individual determination of financial need.

(14) Can a hospital make patients aware of its financial assistance policy that permits lawful waivers of Federal health care program enrollees’ cost-sharing amounts without violating the Federal anti-kickback statute, the Beneficiary Inducements CMP, or both?

Yes, but only if the waiver “is not offered as part of any advertisement or solicitation.”  Whether a particular communication constitutes an “advertisement or solicitation” depends on the facts and circumstances of each situation.  OIG offers two general observations about what would and would not qualify as an advertisement or solicitation.  First, a hospital stating on its website that the hospital offers financial assistance to patients in financial need, and that patients in need should contact the hospital’s billing office for further information, would not be considered a noncompliant advertisement or solicitation.  Second, and on the other hand, a hospital announcing on its website that it offers “insurance only” billing to all patients (as an inducement to attract patients to the hospital, including Federal health care program enrollees) would be an advertisement or solicitation that presents risk under the Beneficiary Inducements CMP and the AKS.

(15) A hospital’s financial assistance policy establishes that the hospital furnishes free care to uninsured patients and patients insured solely by commercial health plans, including qualified health plans (“commercially insured patients”). Does the provision of free care to uninsured patients or commercially insured patients, pursuant to this policy, violate the Federal anti-kickback statute or the Beneficiary Inducements CMP? Would advertising the free care available to uninsured or commercially insured patients under the policy or otherwise communicating about the free care available to uninsured or commercially insured patients under the policy to patients or potential patients violate the Federal anti-kickback statute or the Beneficiary Inducements CMP?

No.  OIG states that neither the AKS nor the Beneficiary Inducements CMP prohibits hospitals from furnishing free or discounted services to uninsured or commercially insured patients.  And neither statute prohibits hospitals from advertising or communicating about the provision of such services.

(16) A hospital’s financial assistance policy provides that the hospital must conduct a good faith, individualized assessment of the financial need of any patient who requests financial assistance with their bill, and after making such an assessment, offer financial assistance to any patient who qualifies as having financial need. Under the policy, the hospital does not routinely waive any patient’s cost-sharing obligations. The hospital shares that it provides assistance to patients with financial need and suggests on its website, on posters in the hospital’s public areas, and on its mailed bills that patients may contact the hospital for additional information about potential financial assistance. Can the hospital disseminate this message on its website, its public areas, and its billing materials without violating the Federal anti-kickback statute or the Beneficiary Inducements CMP?

Yes, so long as the hospital’s policy prescribes lawful assistance to Federal health care program enrollees and the hospital follows that policy when providing the assistance, then the hospital can disseminate information about its financial assistance policy through its website, on posters in the hospital’s public areas, and on its mailed bills (and potentially through other mechanisms) in a manner that is sufficiently low risk to avoid sanctions under the AKS and other OIG authorities.

The new FAQs are available here.

Reporter, Doug Comin, Atlanta, +1 404 572 3525, dcomin@kslaw.com.

 

King & Spalding Client Alert - FTC Final Rule on Non-Competes: Texas District Court Stops Short of a Nationwide Injunction and Creates Uncertainty on the Implementation of the Final Rule - On July 3, 2024, the U.S. District Court for the Northern District of Texas in Ryan, LLC v. Federal Trade Commission granted a limited stay of the effective date for the Federal Trade Commission’s (FTC) final rule on non-competes (the Rule). Though the court held that the FTC likely does not have the authority to issue the Rule and that the Rule was arbitrary and capricious, the court’s order rejected a nationwide stay of the Rule’s effective date. Instead, the court stayed the Rule’s effective date only as to the plaintiff and the plaintiff-intervenors themselves. Thus, the effective date of the Rule is stayed, but only as the Ryan parties: Ryan LLC, the Chamber of Commerce of the United States of America; the Business Roundtable; the Texas Association of Business; and the Longview Chamber of Commerce. The full King & Spalding Client Alert with additional insight can be found here.