CMS

District Court grants TRO on Most Favored Nation Rule

Posted by Danielle 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.

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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.

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Hospital Price Transparency Requirements

Posted by Danielle 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.

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

Posted by Danielle 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.

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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…

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

Posted by Marc Goldsand 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…

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CMS Approves Medicaid Waiver Requiring “Community Engagement”

Posted by Mark Gallant on January 25, 2018
CMS, Medicaid / No Comments

Medicaid, health concept. Stethoscope, syringe and pills on grey backgroundAs 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…

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End of 2017 Marked by Scaling Back of Obama Era Nursing Home Financial Penalties under the Trump Administration

Posted by J. Nicole Martin on January 05, 2018
CMS / No Comments

CMS outlined changes to the nursing home survey process in a October 2017 memo to state survey agency directors, which scaled down the use and severity of civil monetary penalties (CMPs) for certain nursing home deficiencies. Shortly thereafter, CMS released a November 2017 memo that among other things, outlined an 18-month moratorium on the imposition of CMPs, discretionary denials of payment for new admissions and discretionary termination by surveyors for survey deficiencies identified by the following eight  “F” tags: Continue reading…

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Futures in Doubt of CMS’ New Mandatory Bundled Payment Models and Medicare Shared Savings Program Track 1+

Posted by Chris Raphaely on December 23, 2016
CMS / No Comments

medical-documentsWord spread quickly Monday (December 20, 2016) about CMS’ issuance of final regulations (to be published in the Federal Register on January 3, 2017) rolling out new mandatory bundled payments models for Acute Miocardial Infarction (AMI), Coronary Artery Bypass Graft (CABG), Surgical Hip and Fracture Treatment (SHFFT), a Cardiac Rehabilitation (CR) incentive model and Track 1+ Accountable Care Organizations. Speculation that President-elect Donald Trump’s nominee for HHS secretary, Rep. Tom Price, would move to roll the regulations back spread just as quickly.

The new regulations mandate bundled payment models (covering the period from admission to ninety days post-discharge) for AMI and CABG in 98 geographies covering 1,120 hospitals; for SHFFT in the 67 geographies where the Comprehensive Joint Replacement (CJR) has already been mandated covering 850 hospitals and for CR in 90 geographies covering 1,320 hospitals. CMS’ chart of geographies covered by each program is set forth here. The AMI, CABG and SHFFT programs give participant clinicians the opportunity to be excluded from Medicare and CHIP Reauthorization Act of 2015’s (MACRA) Medicare Incentive Payment System (MIPS) and to qualify under MACRA’s Advanced Alternative Payment Model (AAPM). Continue reading…

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Arbitration Agreements in Nursing Homes

Posted by J. Nicole Martin on October 04, 2016
CMS / No Comments

elderly man in wheelchairIn a final rule published today in the federal register (“Final Rule”), CMS announced numerous changes to the consolidated Medicare and Medicaid requirements for participation for long term care (LTC) facilities (42 CFR part 483, subpart B), which take effect on November 28, 2016 (see the March 7, 2016 blog for information about the July 16, 2015 proposed rule (“Proposed Rule”)). Much to the satisfaction of elder care advocates, the Final Rule provides that nursing homes may no longer require prospective nursing home residents to agree to binding arbitration. This strikes a blow at LTC facilities, which generally used arbitration as a tool to avoid incurring the onerous costs associated with litigation.

CMS’ position in the final rule isn’t shocking as it had expressed concern about the use of arbitration agreements in nursing homes in its Proposed Rule. Although no longer permissible for LTC facilities to use as a condition of admission, according to Andy Slavitt, CMS’ Acting Administrator, and Kate Goodrich, Director of the Center for Clinical Standards & Quality, “facilities and residents will still be able to use arbitration on a voluntary basis at the time a dispute arises.” However, such agreements will still need to be “clearly explained” to residents.

Nursing homes that have traditionally asked residents to sign binding arbitration agreements should revisit their admissions processes and implement revised policies and procedures to ensure compliance with the Final Rule, so that, beginning November 28, 2016, residents at such LTC facilities are no longer required to agree to binding arbitration. LTC facilities may also consider revising their policies and procedures to incorporate recommending the use of arbitration to residents following disputes that may arise, and to ensure that any such recommendations are clearly explained to their residents.

For more information regarding the voluntary use of arbitration agreements in the nursing home context, contact J. Nicole Martin, Dana Petrillo or any member of Cozen O’Connor’s health care law team.

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