Posted by Gregory M. Fliszar
on July 10, 2023
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. 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.
Posted by Aselle Kurmanova
on February 21, 2023
, Repayment Rule
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.
Posted by Chris Raphaely
on April 06, 2022
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.
Posted by Danielle Sapega
on December 23, 2020
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.
Posted by Chris Raphaely
on November 23, 2020
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.
Posted by Danielle Sapega
on November 19, 2019
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”).
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.
Posted by Danielle Sapega
on June 24, 2019
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.
Posted by Chris Raphaely
on December 21, 2018
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…
Posted by Marc Goldsand
on November 12, 2018
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…
Posted by Mark Gallant
on January 25, 2018
As a first in the history of the Medicaid program, the Centers for Medicare & Medicaid Services (CMS) approved, on January 12, 2018, Kentucky’s section 1115 waiver application that imposes on many beneficiaries a “community engagement” requirement as a condition of Medicaid eligibility. This is commonly referred to as a “work” requirement, given that it can be satisfied through employment. The prior administration had rejected similar work requirements proposed under an Arkansas waiver requirement as falling outside the boundaries of the Secretary’s statutory authority under Title XIX of the Social Security Act to provide “medical assistance” to designated indigent populations.
The following are some takeaways from the Kentucky HEALTH approved demonstration project.
What must affected beneficiaries do? Beneficiaries subject to the requirement must demonstrate completion of 80 hours (each month) of community engagement activities. Otherwise, they will lose Medicaid coverage. Beneficiaries can fulfill the requirement through a combination of employment, education, job skills training, or community service. Continue reading…