K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
CMS estimates that between 2017 and 2021, Medicare Part A improperly paid $23.9 billion for inpatient hospital stays, with $7.8 billion attributable to short stays that did not qualify for Medicare Part A. On June 13, 2024,...more
In the buffet of regs (and eggs) released a couple of weeks ago, the fried egg served up by the Centers for Medicare & Medicaid Services (CMS) was the 340B Remedy Final Reg. Unlike the other final regs that will affect...more
After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more
Sharpen your pencils and locate your reading glasses: the final Medicare payment regulations for calendar year (CY) 2024 will be released within the next week. In the last Regs & Eggs blog post, I discussed a major issue...more
The healthcare industry is no stranger to mergers and acquisitions (M&A). Over the years, consolidation has played a significant role in reshaping the healthcare landscape, driven by factors such as regulatory changes,...more
The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2024 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1786-P),...more
Valuations, and how a business reacts to them, directly impact a business’s ability to complete successful transactions. In the healthcare sector, compliance with federal and state laws against self-referral and kickbacks and...more
In this episode of Triage, Andrew Ruskin, Darlene Davis, and Gabriel Scott discuss key provisions associated with conversion to CMS’s new rural emergency hospital provider type. They review the purpose of the new provider...more
What You Need to Know- •The Hospital Price Transparency Rule requires hospitals to annually make public a comprehensive list of the hospital’s standard charges for provided items and services, including a display of charges...more
Rural emergency hospitals (REHs) are a new provider type that will allow Medicare to pay for emergency department and other outpatient hospital services in rural areas beginning on January 1, 2023, without requiring the...more
Beginning in 2023, Medicare will recognize a new provider type: the Rural Emergency Hospital (REH). The establishment of REHs is intended to preserve access to emergency departments and other outpatient services in rural...more
Rural emergency hospitals (REHs) are a new Medicare provider type that will allow Medicare to pay for emergency department and other outpatient hospital services in rural areas beginning on January 1, 2023, without requiring...more
I. Certificate of Need Program - A. AL2021-053, The Clubhouse Autism & Developmental Learning Center, LLC, Jackson, AL: Proposes to establish a multi-specialty outpatient pediatric rehabilitation facility providing speech...more
Report on Medicare Compliance 30, no. 32 (September 13, 2021) - Saint Francis Medical Center in Missouri agreed to pay $1.625 million in a civil settlement of allegations it violated the Controlled Substances Act, the...more
Compliance Today (March 2021) - The Centers for Medicare & Medicaid Services (CMS) has provided the following compliance notice: “In a recent report, the Office of Inspector General (OIG) determined that Medicare made...more
At long last, the Centers for Medicare and Medicaid Services (CMS) has issued decisions on provider applications for the mid-build exception. Nearly four years after the deadline for hospitals to apply for the mid-build...more
Buried within the latest issue of the Centers for Medicare and Medicaid Services’ (CMS) MLN Connects, dated January 14, 2021, is an announcement from the agency that hospitals with excepted hospital outpatient departments...more
Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more
The U.S. Court of Appeals for the D.C. Circuit recently reversed a district court ruling and upheld the Centers for Medicare & Medicaid Services site-neutrality payment cuts for off-campus outpatient hospital clinic visits....more
In case you missed it, the Connecticut Department of Public Health (DPH) issued two Orders last week affecting patients with disabilities and patients who are minors in certain health care facilities. Both Orders went into...more
In the Calendar Year 2020 Outpatient Prospective Payment System/Ambulatory Surgical Center Final Rule (2020 OPPS Final Rule), the Centers for Medicare and Medicaid Services (CMS) established a prior authorization process and...more
In recent years, there has been a trend towards the provision of cardiovascular procedures in the outpatient setting and particularly in ambulatory surgery centers (“ASCs”). This trend is in part motivated by the fact that...more
On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced additional blanket waivers and temporary rule changes designed to assist the health care system in coping with patient surges due to the novel...more
On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) released a Quality, Safety & Oversight Group (QSO) memorandum (QSO-20-22-ASC, CORF, CMHC, OPT, RHC/FQHCs) addressing standards for infection control and...more
UnitedHealthCare ("United") is instituting a new policy imposing a “Requirement to Use a Specialty Pharmacy Provider for Certain Medications” (“Specialty Pharmacy Policy”) that is scheduled to take effect on April 1, 2020. ...more