On December 28, 2022, the Department of Health and Human Services’ Office of Inspector General (OIG) issued a favorable advisory opinion on a proposal by a drug manufacturer to enter into an arrangement with certain hospitals to provide up to a specified number of free samples of a long-acting antipsychotic drug for inpatient use.

The OIG indicated it would not impose administrative sanctions, despite the fact that there is no safe harbor available under the federal Anti-Kickback Statute (AKS) to protect the proposed arrangement.Continue Reading OIG approves arrangement involving free drug samples for inpatient hospital use

Just when the procedures thought they were out(patient), CMS pulls them back in(patient).

Last year, in the final CY 2021 Outpatient PPS rule, CMS announced its intention to eliminate the Inpatient Only (IPO) List by January 1, 2024. The IPO list featured more than 1,700 procedures that were surgically invasive or required more than 24 hours of post-operational recovery time. As a result, any procedure on the list would only be paid for by Medicare on an inpatient basis.

With the CY 2021 rule, those procedures would be released to outpatient providers in stages, allowing physicians to clinically determine whether inpatient admission was indicated for a particular procedure.

However, in the proposed CY 2022 Outpatient PPS rule, announced on July 19, 2021, CMS reversed that decision and announced that it will now keep the IPO List, reinstating the 298 procedures that were removed by the 2021 rule. CMS said it was responding to concerns from stakeholders about patient safety. In particular, CMS indicated that the 2021 rule removed the procedures on too steep of a timeline. The agency said it wanted to provide “greater consideration of the impact removing services from the list has on beneficiary safety and to allow providers impacted by the COVID-19 PHE additional time to prepare to furnish appropriate services safely and efficiently before continuing to remove large numbers of services from the list.”Continue Reading CMS Gives the IPO List the Godfather 3 Treatment

On May 3, 2021, the Centers for Medicare & Medicaid Services (CMS) published an 81-page final rule to both extend and change the Comprehensive Care for Joint Replacement (CJR) model. We previously reported on the proposed rule here. The CJR model was initially implemented by way of notice-and-comment rulemaking in April 2016; the recent

The Medicare Payment Advisory Commission (MedPAC) has issued its annual report to Congress with recommendations for updates to Medicare fee-for-service rates for 2020.

With regard to hospital services, MedPAC recommends that Congress update Medicare inpatient and outpatient prospective payment system (PPS) rates by 2% in 2020.  MedPAC also proposes a new hospital value incentive program (HVIP) to replace Medicare’s current inpatient hospital quality programs.[1]  In short, the HVIP would include a small set of population-based outcome, patient experience, and value measures; score all hospitals based on the same prospectively-set performance targets; and account for social risk factors by distributing payment adjustments through peer grouping.  MedPAC believes the HVIP “will be simpler and will produce more equitable results compared with existing quality payment programs.”

MedPAC recommends no change to Medicare physician fee schedule rates in 2020, in accordance with the Medicare Access and CHIP Reauthorization Act of 2015.  MedPAC reiterates its criticism of current Merit-based Incentive Payment System measures, stating that they “are neither effective in assessing true clinician quality nor appropriate for Medicare’s value-based purchasing programs.”

MedPAC continues to call for implementation of a unified PPS for post-acute care (PAC) providers, including skilled nursing facilities (SNFs), home health agencies (HHAs), inpatient rehabilitation facilities (IRFs), and long-term care hospitals (LTCHs).   Acknowledging that implementation of a unified PAC PPS “is on a longer timetable,” MedPAC recommends the following setting-specific interim payment updates for 2020:
Continue Reading MedPAC Recommends Medicare Payment Updates for 2020

On July 31, 2015, the Centers for Medicare & Medicaid Services (CMS) released a major final rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and the long-term care hospital prospective payment system (LTCH PPS) for fiscal year (FY) 2016. The official version of the rule will be published in the Federal Register on August 17, 2015, and generally applies to discharges occurring on or after October 1, 2015. With regard to the IPPS, CMS projects that the rate and policy changes in the final rule will increase IPPS operating payments by approximately 0.4%, or about $378 million in FY 2016. The rule provide a 0.9% operating payment rate update for hospitals that submit quality data and are meaningful users of Electronic Health Records (EHR). This update reflects a 2.4% market basket update, adjusted by a -0.5 percentage point multi-factor productivity (MFP) cut and an additional -0.2 percentage point cut (as mandated by the Affordable Care Act, or ACA), with an additional -0.8 percentage point documentation and coding recoupment adjustment required by the American Taxpayer Relief Act of 2012.
Continue Reading CMS Issues Final FY 2016 Medicare IPPS/LTCH Rule

On July 27, 2015, the Senate approved H.R. 876, the Notice of Observation Treatment and Implication for Care Eligibility Act, clearing the measure for the President. H.R. 876 would require hospitals to provide written and oral notification to Medicare beneficiaries receiving observation status for more than 24 hours, rather than admitted as inpatients.
Continue Reading Senate Approves Hospital Outpatient Observation Status “Notice” Act

Today President Obama signed into law H.R. 2, the “Medicare Access and CHIP Reauthorization Act of 2015” (MACRA), which reforms Medicare payment policy for physician services and adopts a series of policy changes affecting a wide range of providers and suppliers. Most notably, MACRA permanently repeals the statutory Sustainable Growth Rate (SGR) formula, achieving a goal that has eluded Congress for years. Now, after a period of stable payment updates, MACRA will link physician payment updates to quality, value measurements, and participation in alternative payment models.
Continue Reading President Obama Signs MACRA: Permanently Reforms Medicare Physician Reimbursement Framework, Includes Other Health Policy Provisions

CMS recently sent several major proposed rules to the White House Office of Management and Budget for regulatory clearance – the last step before publication in the Federal Register. OMB is reviewing proposed rules to update the skilled nursing facility, inpatient rehabilitation facility, and inpatient psychiatric facility prospective payment systems (PPS) for fiscal year (FY)

Late on April 30, 2014, CMS released the advance text of its proposed rule to update the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2015.

With regard to IPPS hospitals, the rule would provide for a 1.3% operating payment rate update

On April 1, 2014, President Obama signed into law H.R. 4302, the “Protecting Access to Medicare Act of 2014” (“the Act”). The Act includes a one-year Medicare physician fee schedule fix that averts a nearly 24 percent payment cut set for April 1, 2014, but which falls far short of earlier hopes for full repeal of the current sustainable growth rate (SGR) formula. The Act also includes numerous other Medicare payment and policy changes, including skilled nursing facility value-based purchasing provisions, reforms to the physician fee schedule relative valuation process, a new framework for clinical laboratory payments, a variety of changes impacting imaging services, changes in the exceptions for long term care hospitals, and extension of certain expiring provisions. In other areas, the bill includes a one-year delay in the transition to ICD-10, changes to the timetable for Medicaid disproportionate share hospital cuts, and “front-loading” of the 2024 Medicare sequestration reduction.
Continue Reading President Signs Medicare Physician Fee Schedule/SGR Patch with Numerous Health Policy Provisions

The Medicare Payment Advisory Commission (MedPAC) has released its annual report to Congress on Medicare payment policy, including payment update recommendations for all the major Medicare fee-for-service payment (FFS) systems, limited recommendations related to the Medicare Advantage (MA) program, and a status report on the Medicare Part D program. The following are highlights of the

CMS has announced that it is extending provider education activities related to its new Medicare inpatient hospital admission and medical review criteria (commonly known as the 2-Midnight Rule). Specifically, CMS is extending what it refers to as the “Probe & Educate” review process for an additional six months, through September 30, 2014. Under this extension,

CMS continues to release subregulatory guidance on the inpatient hospital admission/medical review criteria that were adopted in the final FY 2014 Medicare inpatient prospective payment system/long-term care hospital final rule. In short, under this new policy, if the ordering practitioner expects a beneficiary’s surgical procedure, diagnostic test, or other treatment to require a stay in

A November 12, 2013 CMS call will focus on the physician order, physician certification, inpatient hospital admission, and medical review criteria that were adopted in the final FY 2014 Inpatient Prospective Payment System/Long-Term Care Hospital final rule. In short, under this new policy, if the ordering practitioner expects a beneficiary’s surgical procedure, diagnostic test or

On August 19, 2013, the Centers for Medicare & Medicaid Services (CMS) published a final rule updating FY 2014 Medicare payment policies and rates under the acute inpatient prospective payment system (IPPS) and the long-term care hospital (LTCH) prospective payment system (PPS). The following are highlights of the lengthy rule:
Continue Reading CMS Finalizes FY 2014 Medicare IPPS, LTCH Rates

As previously reported, CMS has issued a proposed rule and an Administrator’s Ruling that address the submission of Medicare Part B inpatient claims where a Medicare Part A claim for a hospital inpatient admission is denied by a Medicare review contractor on the grounds that the inpatient admission was not “reasonable and necessary.” A

MedPAC has released its annual report to Congress on Medicare Payment Policy, including payment update recommendations for all the major Medicare FFS payment systems and limited Medicare Advantage (MA) recommendations. The report also includes data on the status of the MA and Medicare Part D programs, including information about enrollment, plan options, and beneficiary cost-sharing. Note that while MedPAC’s recommendations are not binding, Congress and CMS often take into account MedPAC’s assessments when updating Medicare payment policies. Major recommendations include the following (many of which were included in previous reports):
Continue Reading MedPAC’s March 2013 Report to Congress