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Remote Patient Monitoring Enforcement Initiatives

Below is an excerpt of an article published in the American Bar Association Health Law Section’s March 2024 Health eSource issue.

In recent years, there has been a significant increase in the use of digital technologies and innovative solutions in healthcare, including the increased use of remote patient monitoring (RPM) services. Telehealth and other digital therapies proliferated during the COVID-19 pandemic, particularly as entities took advantage of the relaxation of telehealth rules and the need to provide patient care remotely. Rules have adapted and changed over the years to accommodate the growing field. In addition, the increased utilization of telehealth and digital technologies to treat patients has been followed by a robust government response.

This article discusses RPM topics and key takeaways RPM providers must know about the 2024 Physician Fee Schedule Final Rule, including various billing requirements, recent RPM Department of Justice (DOJ) enforcement actions, related Department of Health and Human Services (HHS) Office of Inspector General (OIG) consumer alerts, and guidance regarding how providers can avoid compliance issues when providing RPM services. In this time of continuous technological development, it is especially important for providers to stay up to date on the various legal requirements and guidance in this area in order to ensure adherence to the latest compliance standards. Read the full article.

Status of 340B Payment Remediation and Manufacturer Litigation

Below is an excerpt of an article published in American Health Law Association’s Regulation, Accreditation, and Payment Practice Group on March 21, 2024.

The 340B program, as established under Section 340B to the Public Health Service Act (PHSA), Pub. L. No. 78-410, 58 Stat. 682 (1944) (“340B Statute”), [1] has experienced significant legal challenges over the last few years propelled by certain Medicare underpayments and drug manufacturer litigation. The following is a brief summary of the current status of these developments.

1. 340B Payment Remediation

On November 2, 2023, the Department of Health and Human Services (HHS) issued a Final Rule to remediate certain underpayments to 340B hospitals for 340B drugs from CY2018 through September 27, 2022. [2] This Final Rule was issued following SCOTUS’ unanimous ruling that HHS’ reduced payment rate to certain 340B covered entity hospitals during this period constituted an unlawful payment cut. [3] On remand to the district court, the U.S. District Court for the District of Columbia vacated the differential payments to 340B covered entity hospitals prospectively as of the date of the ruling on September 28, 2022, and remanded to HHS to remediate the underpayments.[4] Following the Court’s decision, HHS found itself in the unfavorable position of trying to retrospectively untangle payments which were and continue to be subject to budget neutrality requirements. [5] Read the full article.

Staying on Top of Medical Necessity and Marketer Compliance

Below is an excerpt of an article published in G2 Intelligence on March 25, 2024

Recent enforcement actions have made clear that fraud, waste, and abuse is a continual concern of regulating agencies for the healthcare space, including for clinical laboratories. Reports by the U.S. Department of Health and Human and Services (HHS), the Office of Inspector General (OIG) and the U.S. Department of Justice (DOJ) in late 2023 highlighted their continued focus on clinical laboratories. Read the full article.

FOOTNOTES

[1] Public Health Service Act, § 340B (PHSA) (codified at 42 U.S.C. § 256b).

[2] See Dept. Health & Human Servs., Final Rule, Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018–2022, 88 Fed. Reg. 77150, 77186 (Nov. 8, 2023); CMS.gov, Fact Sheet, CY 2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS 1786-FC) (Nov. 2, 2023), https://www.cms.gov/newsroom/fact-sheets/cy-2024-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0.

[3] See Am. Hosp. Assn v. Becerra, 142 S. Ct. 1896 (2022).

[4] See Am. Hosp. Ass’n v. Becerra, No. 18-cv-2084, 2022 WL 4534617 (D.D.C. Sept. 28, 2022) (ruling on plaintiff’s first motion to vacate the 340B payment rate for the remainder of 2022); Am. Hosp. Assn. v. Becerra, No. 1:18-cv-02084-RC (D.D.C. Jan. 10, 2023) (ruling on plaintiff’s second motion to remand to HHS to establish remedial payments for CY2018 through CY2022).

[5] Id.; 88 Fed. Reg. 77150, 77151-52 (Nov. 8, 2023).