In this episode of the Diagnosing Health Care Podcast: A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model.
How do these factors combine to create a roadmap for companies navigating the direct access testing industry?
In this episode of the Diagnosing Health Care Podcast: In the aftermath of the Dobbs v. Jackson Women’s Health Organization decision, important questions have emerged about the current legal and regulatory landscape surrounding patient access to drugs that have historically been used to induce abortions.
How can health care providers and pharmacies navigate these new restrictions?
On April 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued new guidance on the Independent Dispute Resolution (IDR) process, created under the No Surprises Act (NSA) to provide a mechanism for payers and providers to resolve disputes as to appropriate payment amounts for certain out-of-network claims. In addition, the Departments of Health and Human Services, Labor and the Treasury launched two online portals– one to host the IDR process for providers and payers and one to host the patient-provider dispute resolution process for self-pay and uninsured patients.
This new guidance replaces earlier instruction from the agency on how the IDR process would operate and what the independent arbitrator was required to consider. The prior guidance was withdrawn after a successful legal challenge to the interim final rule implementing the No Surprises Act provisions on the IDR process, specifically with respect to the weight to be given to the Qualifying Payment Amount (QPA). The QPA is essentially the payer’s median contracted rate for similar services. The QPA is used to calculate patient cost sharing and must be considered by the independent arbitrator in resolving a payment dispute between a payer and an out-of-network provider. Initially, regulators directed arbitrators to use the QPA as a baseline, and when choosing between the parties’ proposed payment offers to choose the amount closest to the QPA unless one of the parties submitted credible information demonstrating that the appropriate payment amount was materially different from QPA.
Continue Reading No Surprises Act Update – New IDR Guidance
On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued guidance terminating numerous blanket waivers applicable to skilled nursing facilities (SNFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end stage renal disease (ESRD) facilities. The amount of blanket waivers ending is notable; while there have been terminations of waivers previously, these were usually limited to a single waiver.
CMS expressed concern “about how residents’ health and safety has been impacted by the regulations that have been waived, and the length of time for which they have been waived.” CMS reported that findings from onsite surveys at these facilities “revealed significant concerns with resident care that are unrelated to infection control.” Accordingly, CMS is acting to remove certain operational flexibilities not directly related to infection control.
In this episode of the Diagnosing Health Care Podcast: This term, the Supreme Court of the United States is set to rule in a Medicare reimbursement case that has sparked a fresh look at the historical deference often granted to agencies and whether it should remain, be modified, or even be overruled.
Attorneys Stuart
On February 4, 2022, the Centers for Medicare and Medicaid Services (CMS) issued important updated guidance in a memo (QSO-21-08-NLTC) regarding how acute and continuing care facilities—including hospitals, ambulatory surgical centers, end-stage renal disease facilities, home health agencies, and hospices—manage infection control procedures in light of the COVID-19 public health emergency.
Continue Reading CMS Discontinues Prior Guidance on Visitation Restrictions and Rescinds COVID-19 Focus Infection Control Survey Procedures
On September 30, 2021, the federal Departments of Treasury, Labor, and Health and Human Services issued “Requirements Related to Surprise Billing; Part II,” the second in a series of interim final regulations (the “Second NSA Rules”) implementing the No Surprises Act (“NSA”). This new federal law became effective for services on or after January 1, 2022.
Continue Reading Challenged in Court: Dispute Resolution Rules in Second Federal No Surprises Act Interim Final Regulations
In this episode of the Diagnosing Health Care Podcast: The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and self-pay patients scheduling appointments for services or upon request.
Continue Reading Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 2) – Diagnosing Health Care
In this episode of the Diagnosing Health Care Podcast: The No Surprises Act (NSA) will go into effect on January 1, 2022. Since our last episode on the topic, the federal government has issued additional interim final rules and guidance to implement the NSA, including the second interim final rule. In addition to describing how the NSA interacts with the plan external review procedures, the second interim final rule describes the independent dispute resolution (IDR) process and how the IDR’s determination is made.
Attorneys Helaine Fingold, Lesley Yeung, and Alexis Boaz dive into how these changes impact entities subject to the NSA’s balance billing prohibitions.
From our Thought Leaders in Health Law video series: Is your organization ready for the No Surprises Act (NSA)? The law goes into effect January 1, 2022, and contains a new federal ban on surprise billing as well as new disclosure requirements.
The NSA applies to certain payors, providers, facilities, and ancillary service entities that support patients who receive emergency services or other non-emergency services at certain facilities, such as hospitals, hospital outpatient departments, and ambulatory surgical centers.
Continue Reading Video: Getting Ready for the No Surprises Act – Thought Leaders in Health Law