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
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
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
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
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
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 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) released a Quality, Safety & Oversight Group (QSO) memorandum (QSO-20-22-ASC, CORF, CMHC, OPT, RHC/FQHCs) addressing standards for infection control and...more
On February 20, 2020, CMS released a proposed rule that would extend the bundled-payment model for joint replacement surgery for an additional three years and broaden its scope to include outpatient procedures (the Proposed...more
CMI, CMMI, and Changing the Consumer Experience in the U.S. and China - Case Mix Index: Sitting in multiple hospital, payor and physician organization presentations at the J.P. Morgan healthcare conference this year, it is...more
The Big Cost; Cancer is the Answer; and SDOH Evolves - The Big Cost: You’re okay today, and then tomorrow you’re not. Life has changed and there’s a new reality. Whether it’s an acute event – an accident, a heart attack, a...more
The Centers for Medicare & Medicaid Services (CMS) on Nov. 18, 2019, published a proposed Medicaid Fiscal Accountability rule that would amend existing regulations related to 1) base and supplemental payments, 2)...more
On December 16, 2019, the U.S. District Court for the District of Columbia ruled that its 2019 decision invalidating the Center for Medicare and Medicaid Services’ (CMS) site-neutral payment cuts does not automatically vacate...more
On December 12, 2019, the Centers for Medicare and Medicaid Services (CMS) announced that it will automatically reprocess claims which had been reimbursed at a reduced rate in 2019 under the site-neutral payment policy and...more
On November 5, 2019, the United States District Court for the Eastern District of Pennsylvania ruled on a motion to dismiss a False Claims Act (FCA) qui tam suit filed by the United States Department of Justice, long after it...more
CMS’ 340B Rate Cut Continues to Dampen Hospital Outpatient Expansion Efforts - Hospitals hoping to benefit from favorable 340B drug pricing when acquiring independent physician practices for conversion to hospital...more
Report on Medicare Compliance 28, no. 40 (November 11, 2019) - CMS has given the green light to prior authorization for five types of procedures in an attempt to control “unnecessary increases” in these procedures as part...more
Despite a court ruling against its site-neutral policy in September 2019, in the Calendar Year (CY) 2020 Medicare Outpatient Prospective Payment System (OPPS) final rule, released on November 1, 2019, the Centers for Medicare...more