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Ensuring Fair Access: SB 269 Protects Affordable Medication for Low-Income Patients

Client Alert
May 29, 2024

Senate Bill 269 (SB 269), introduced on May 14, 2024, will ensure that 340B covered entities, including Federally Qualified Health Centers, Ryan White Clinics, disproportionate share hospitals, and Title X clinics, can acquire 340B drugs without facing undue restrictions or discriminatory practices from drug manufacturers and distributors. This protection is crucial for 340B covered entities to continue to provide affordable medications and comprehensive services to low-income patients.

What is the Federal 340B Drug Pricing Program?
Under the 340B Program, Federal law permits covered entities to buy outpatient prescription drugs from drug manufacturers at a discount. In exchange for committing to serve historically marginalized and underserved patients, payors reimburse covered entities at retail rates, allowing the covered entity to realize a savings. Covered entities reinvest that savings into their services and programs; the savings covered entities achieve through the 340B Program helps them stretch scarce federal resources. Without the 340B Program, covered entities will not be able to provide care to vulnerable populations.

What Does SB 269 Do?
Prohibits Restrictive Practices: SB 269 prohibits drug manufacturers, re-packagers, third-party logistics providers, and wholesale distributors (and their agents or affiliates) from denying, prohibiting, restricting, discriminating against, or otherwise limiting the acquisition or delivery of 340B drugs to covered entities, unless required by Federal law. The law would prohibit drug manufacturers and others from limiting covered entities’ use of contract pharmacies, a practice that interferes with the ability of patients who rely on covered entities to access needed health care services and affordable prescription drugs. Under the bill, these parties also cannot require 340B covered entities to submit claims or utilization data as a condition for acquiring or delivering 340B drugs, unless such data sharing is mandated by Federal law.

Enforcement and Penalties: Under the bill, violations of these provisions may result in a civil penalty of $50,000 per violation, as well as referral to the Ohio Board of Pharmacy for further action.

Please contact BMD Healthcare Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com with any questions about SB 269 or the 340B drug pricing program, or to weigh in with your lawmaker about the bill.

340BDrug Discount ProgramHealthcareHealth LawDaphne Kackloudisjordan burdick
Client Alert

Ohio’s Managed Care Overhaul Delayed – New Implementation Timeline

May 4, 2022At the direction of Governor Mike DeWine, the Ohio Department of Medicaid (ODM) launched the Medicaid Managed Care Procurement process in 2019. ODM’s stated vision for the procurement was to focus on people and not just the business of managed care. This is the first structural change to Ohio’s managed care system since the Centers for Medicare & Medicaid Services' (CMS) approval of Ohio’s Medicaid program in 2005. Initially, all of the new managed care programs were supposed to be implemented starting on July 1, 2022. However, ODM Director Maureen Corcoran recently confirmed that this date will be pushed back for several managed care-related programs.Client Alert

Laboratory Specimen Collection Arrangements with Contract Hospitals - OIG Advisory Opinion 22-09

May 3, 2022On April 28, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) published an Advisory Opinion[1] in which it evaluated a proposed arrangement where a network of clinical laboratories (the “Requestor”) would compensate hospitals (each a “Contract Hospital”) for specimen collection, processing, and handling services (“Collection Services”) for laboratory tests furnished by the Requestor (the “Proposed Arrangement”). The OIG concluded that the Proposed Arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) if the requisite intent were present. This is due to both the possibility that the proposed per-patient-encounter fee would be used to induce or reward referrals to Requestor and the associated risk of improperly steering patients to Requestor.Client Alert

Property Owner Protection from Tax Valuation Challenges

April 29, 2022New legislation provides significant new protections for commercial property owners against challenges to valuation primarily by local school boards and prohibiting side agreements to avoid tax valuation changes. The Ohio Legislature has approved House Bill 126 which will go into effect July 2022 but will effectively apply to the 2023 tax valuation year.Client Alert

No Surprises Act Update: The IDR Portal is Open

April 25, 2022The No Surprises Act (“NSA”) became effective January 1, 2022, and has been the subject of lawsuits and criticisms since its inception. The goals of the No Surprises Act are to shield patients from surprise medical bills, provide to uninsured and self-pay patients good faith estimates of charges, and create a process to resolve payment disputes over surprise bills, which arise most typically in emergency care settings. We have written about Part I and Part II of the NSA previously. This update concerns the Independent Dispute Resolution (“IDR”) procedure created by Part II but applicable to claims covered by Part I. The Centers for Medicare & Medicaid Services (“CMS”) finally opened the Portal for providers to submit disputes to the IDR process following some updated guidance regarding the arbitration process itself.Client Alert

Updated FAQs for the No Surprises Act - Good Faith Estimates

April 7, 2022The No Surprises Act (“NSA”) became effective January 1, 2022. Meant to protect consumers from surprise medical bills, the new law is good for consumers, but vexatious for health care providers and facilities. One particular source of frustration is the operationalization of the Good Faith Estimate (“GFE”) requirement, governed by Part II of the regulations that implement the NSA. The GFE requirements apply broadly to all healthcare providers and facilities that practice within the scope of their state-issued license.
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