CMS

CMS Issues Final Rule Impacting Prior Authorization Process

Posted by Jacqueline Glennon on January 24, 2024
CMS / No Comments

Last week CMS issued its final rule “CMS Interoperability and Prior Authorization” (CMS-0057-F), unchanged from its proposed rule in 2022, which addresses prior authorizations. Prior authorization, a “utilization management” technique, requires a health insurer to consent to a doctor’s proposed course of treatment for a patient before the insurer agrees to pay for any medical services the physician wishes to provide. See July 2023 Health Law Informer Article.

On January 17, 2024, CMS issued the rule which requires certain health plans to decide prior authorization requests within 72 hours for expedited requests and seven days for non-urgent appeals. The rule applies to Medicare, Medicare Advantage (MA), Medicaid, and Children’s Health Insurance Plans (CHIP), as well as qualified health plans on the Federally-Facilitated Exchanges (collectively, “Covered Entities”). [cite] In addition to the decision timeframe requirements, the rule also requires payers to provide a specific reason for denied prior authorization requests, and allows such decisions to be communicated via portal, fax, email, mail or phone. [cite] The rule does not apply to prior authorization decisions for drugs. [cite

Continue reading…
About The Author

HHS Proposes $9 Billion Lump Sum Payment for Hospitals to Remedy Unlawful 340B Payment Reductions

Posted by Health Law Informer Author on July 10, 2023
CMS, HHS / No Comments

On Friday, July 7, 2023, the Centers for Medicare & Medicaid Services (CMS) published their long-awaited proposed remedy to the unlawful 340B drug payment reductions.

Background: In 2018, CMS significantly reduced the Average Sales Price (ASP) plus six-percent (6%) formula for calculating 340B drug payments to ASP minus 22.5%. After conflicting decisions from the District of Columbia’s federal District and Appeals Courts, on June 15, 2022, a unanimous U.S. Supreme Court concluded that the ASP minus 22.5% formula was “unlawful” and violated a clear statutory mandate to reimburse 340B drugs at ASP plus 6%. American Hospital Assn. v. Becerra, 142 S. Ct. 1896, 1906 (2022). However, the U.S. Supreme Court did not address remedies and remanded the case to the U.S. District Court for the District of Columbia. On September 28, 2022, the District Court vacated the payment reduction and ruled that CMS had to stop paying the unlawful rate. However, it did not address the damages from January 1, 2018 – September 27, 2022.[1]  On January 10, 2023, the District Court further remanded the case to CMS to provide a remedy for the underpayments dating back to January 1, 2018.[2]  

Continue reading…
About The Authors

Will The Standard of Liability Under The 60-Day Repayment Rule Change?

Posted by Aselle Kurmanova on February 21, 2023
CMS, Repayment Rule / No Comments

At the end of last year, the Centers for Medicare & Medicaid Services (CMS) proposed changes to the so-called 60-day repayment rule. The proposed changes include eliminating the current “reasonable diligence” standard that applies to providers in connection with potential liability for overpayments and replacing it with “actual knowledge” or “acting with reckless disregard.” The proposed changes can be located here.

Continue reading…
About The Author

CMS Releases Second Set of FAQs Regarding Good Faith Estimates to Uninsured and Self-pay Patients Under “No Surprises Act”

Posted by Chris Raphaely on April 06, 2022
CMS / No Comments

CMS continued to roll out guidance regarding the No Surprises Act. The latest guidance is the second set of FAQs regarding the Good Faith Estimate Requirement for uninsured and self-pay patients was issued on April 5, 2022. The FAQs address six questions regarding the requirement and can be found here.

About The Author

District Court grants TRO on Most Favored Nation Rule

Posted by Danielle E. Sapega on December 23, 2020
CMS / No Comments

On December 23, 2020, The District Court for the District of Maryland granted a temporary restraining order temporarily ceasing the implementation of the Centers for Medicare and Medicaid Services’ (“CMS”) Most Favored Nations Rule (the “Rule”) for fourteen (14) days. The Rule, published on November 27, seeks to lower the amount paid for 50 high-cost Medicare Part B drugs to the lowest price that drug manufacturers receive in similar countries. The Rule was set to take effect on January 1, 2021. Several suits have been filed challenging the Rule’s validity and CMS’ authority in issuing the Rule, particularly since the Rule was issued without the usual notice and comment procedures. In granting the TRO, the Court found that the plaintiffs demonstrated a likelihood of success on the merits of their claim under the Administrative Procedures Act, which requires an agency to publish a general notice of proposed rulemaking in the Federal Register and allow stakeholders to comment. We will continue to monitor developments on this case and the other pending cases closely.

About The Author

CMS Releases Final Stark Rules To Promote Value-Based Care

Posted by Chris Raphaely on November 23, 2020
CMS / No Comments

On Friday, November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released final regulations to remove certain barriers to the implementation of physician compensation arrangements under value-based payment arrangements posed by the “Stark” Physician Self-Referral law. The new regulations are the first substantive changes to the regulations in two years and the first attempt by CMS to update the regulations specifically to address value-based payment arrangements that have proliferated since the regulations were initially implemented in the early 2000s.

The new rules contain three new exceptions to the Stark law’s general prohibition on physician referrals for designated health services to entities with which the physician has a financial relationship that are specifically targeted at value-based arrangements; one for value-based arrangements involving full financial risk, one for value-based arrangements with meaningful downside risk for physicians, and one for value-based arrangements that involve neither full financial for physicians or meaningful downside risk.

Continue reading…
About The Authors

Hospital Price Transparency Requirements

Posted by Danielle E. Sapega on November 19, 2019
CMS / No Comments

CMS finalized the Outpatient Prospective Payment System hospital price transparency rules on November 15, 2019. As of January 1, 2021, hospitals will have to publicly post (and update annually) two sets of data: first, a comprehensive list of standard charges for items services offered by the hospital, and second, a consumer-friendly list of 300 “shoppable” services, including 70 selected by the Centers for Medicare and Medicaid Services (“CMS”).

The first transparency requirement states that each hospital operating within the United States must establish and make public a list of the hospital’s standard charges for items and services provided by the hospital, including diagnosis-related groups (DRGs). Standard charge is defined as “the regular rate established by the hospital for an item or service provided to a specific group of paying patients. This includes: (i) gross charge, (ii) payer-specific negotiated charge, (iii) de-identified minimum negotiated charge, (iv) de-identified maximum negotiated charge, and (v) discounted cash price.” Items and services is defined as “all items and services, including individual items and services and service packages, that could be provided by a hospital to a patient in connection with an inpatient admission or an outpatient department visit for which the hospital has established a standard charge.” Examples include supplies and procedures and room and board.

Continue reading…
About The Author

CMS Guidance on “Shared Space” – Comment Period Closing July 2, 2019

Posted by Danielle E. Sapega on June 24, 2019
CMS / No Comments

CMS recently issued long-awaited draft guidance on hospital co-location with other hospitals or healthcare facilities, providing some potential insight on the otherwise ambiguous prohibition on “shared space.” This prohibition loosely stems from the requirement that a Medicare participating hospital is evaluated “as a whole” for compliance with the Conditions of Participation (“CoP”), among other state and federal regulatory requirements. Previously, it was believed that the provider based regulations at 42 C.F.R. § 413.65 governed this prohibition (this section was cited in a 2016 memorandum from the Pennsylvania Department of Health), but the CMS guidance did not cite this particular section.

In recent years, CMS has started to crack down on provider based hospital departments that physically share space with non licensed or separately owned hospital facilities, generally prohibiting shared staff, waiting rooms, check-in desks, patient bathrooms, and other similar items and costs. Although the prohibition was not absolute (CMS had permitted certain things to be shared, such as staff lounges and shared main lobbies), hospitals that sought to attain and maintain compliance struggled with the lack of clear guidance from CMS, and had to rely largely on word of mouth, occasional information distributed by State Survey Agencies, or even citations received if the hospital was caught with prohibited shared space or staffing. This was especially troubling in light of the fact that remediation potentially involved large scale, expensive construction and a hiring and staffing model revamp, among other mandatory modifications.

Continue reading…
About The Author

CMS Releases Final ACO Regulations

Posted by Chris Raphaely on December 21, 2018
CMS / No Comments

This morning CMS released a final rule regarding its most popular program for accountable care organizations (ACOs), the Medicare Shared Savings Programs. The final rule is based on the proposed rule for the program that was published in August.  The final rule adopts the major structural overhaul contained in the proposed rule, the reduction of the program to two tracks, Basic and Enhanced, the 1 year limitation for most established (ACOs) to remain in an “upside only” risk model and the 2 year limitation for most new ACOs to remain in an “upside only” risk model. The final rule increased the percentage of savings that will be shared with an ACO in an “upside only” model from 25% as proposed to 40%.  The rule also gives approved ACOs the ability to operate patient incentive programs which include cash payments up to $20 from certain ACO professionals and federally qualified health centers for qualifying primary care services,  provides some ACOs with more flexibility with respect to reimbursement for telehealth services, and includes numerous other detailed changes to the program’s operations. Continue reading…

About The Author

Tags:

Medicare’s New Virtual Check-In Code: 7 Things You Need to Know

Posted by Health Law Informer Author on November 12, 2018
CMS / No Comments

On November 1, 2018, CMS issued a 2,379 page final rule titled “Revisions to Payment Policies under the Medicare Physician Fee Schedule, Quality Payment Program and Other Revisions to Part B for CY 2019.”  While there are some interesting changes related to remote patient monitoring for chronic kidney disease patients and loosening of originating site requirements for certain behavioral health services, most notable is the new “virtual check-in” code (HCPCS code G2012). Traditionally, CMS viewed brief telephone calls as non-billable, deeming the services rendered by providers to patients on such calls to be merely ancillary and included in an office visit. Conversely, the only way to bill for the exchange was to conduct the office visit.

The stated purpose of the “virtual check-in” code is for the billing provider herself (not her clinical staff) “to assess whether the patient’s condition necessitates an office visit.” To the extent the in-person visits are rendered unnecessary by the “virtual check-in,” both CMS and the patient save money. Continue reading…

About The Author

Tags: