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CMS Announces Part D Senior Savings Model for Seniors Requiring Insulin

Citing the high cost of insulin as a common barrier to proper diabetes treatment, CMS has announced a new model to allow beneficiaries additional Part D plan options with lower out-of-pocket costs for insulin. Under the Part...more

CMS Finalizes CY 2020 Physician Fee Schedule

On November 1, 2019, CMS released the Calendar Year (CY) 2020 Physician Fee Schedule (PFS) final rule (the Final Rule). The Final Rule updated payment policies, payment rates, and quality provisions for services furnished...more

D.C. Circuit Issues Favorable Jurisdictional Decision in Medicare Clinical Laboratory Case

On July 30, 2019, the D.C. Circuit issued a favorable jurisdictional decision on behalf of King & Spalding client the American Clinical Laboratory Association (ACLA), reversing the district court. Accepting ACLA’s arguments,...more

CMS Issues FY 2020 Inpatient PPS and Long-Term Care Hospital PPS Final Rule

On August 2, 2019, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System Final Rule for FY 2020 (the Final Rule). Highlights include...more

CMS Increases CLIA Certification Fees By 20% Effective Immediately

CMS recently announced a 20 percent increase to the fees that laboratories must pay when certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This is the first such increase in the last 20 years and...more

CMS Announces Additional Guidance on State Empowerment and Relief Waiver Concepts

Following up on a Federal Register notice published October 24, 2018, CMS announced additional information relating to State Relief and Empowerment Waivers, also known as “Section 1332 Waivers” on November 29, 2018 (the...more

CMS Releases Final 2019 Outpatient Prospective Payment System Rulemaking, Finalizing Site Neutral Payment Policy for Off-Campus...

On November 2, 2018, CMS issued the 2018 Hospital Outpatient Prospective Payment System (“OPPS”) Final Rule (“Final Rule”) in which it finalized its proposal to pay the lower Physician Fee Schedule (“PFS”) rate rather than...more

D.C. District Court Issues Favorable Decision in Section 1115 Waiver DSH Case

On September 28, 2018, the United States District Court for the District of Columbia issued a favorable decision for hospitals appealing the CMS Administrator’s disallowance of certain Medicaid section 1115 waiver days from...more

Provider Reimbursement Review Board Announces Significant New Appeal Rules

On August 29, 2018, the Provider Reimbursement Review Board (PRRB) announced significant new changes to the rules governing its appeals, effective immediately. The rules apply to both newly filed and pending appeals, and...more

9/5/2018  /  Electronic Filing , MACs , PRRB

Secretary Must Again Explain His FY 2004 Outlier Turbo-Charging Rulemaking, D.C. District Court Orders

Following several lines of litigation, a federal court has again ordered the HHS Secretary to justify his FY 2004 outlier rulemaking in light of Administrative Procedure Act requirements. In District Hospital Partners v....more

D.C. Circuit Says CMS’s Predicate Fact Rule Does Not Apply to Administrative Appeals

Last week, the U.S. Court of Appeals for the District of Columbia Circuit invalidated CMS’s prohibition on appeals of so-called predicate facts. The appeal before the court, described in greater detail below, challenged the...more

Federal Court Enters $111 Million False Claims Judgment Against Individual Healthcare Defendants

On May 23, 2018, the U.S. District Court for the District of South Carolina entered a multi-million dollar judgment against Latonya Mallory, former CEO of Health Diagnostic Laboratory (HDL) and Floyd Calhoun Dent III and...more

Iowa Hospital Settles False Claims Act Case for Inpatient Claims Submitted Under the Two Midnight Rule

Genesis Medical Center in Davenport, Iowa has reached a settlement with the Department of Justice related to improper hospital admissions from January 1, 2013 to December 31, 2016. According to the DOJ, Genesis “improperly...more

Congressional Leaders Focusing Sights on Nonprofit Hospitals

On February 15, 2018, Senate Finance Committee Chairman Orrin Hatch and senior committee member Senator Charles Grassley sent a letter to David Kautter, acting commissioner of the Internal Revenue Service (IRS), requesting...more

Medical Records Production Company Sues to Prohibit Enforcement of HIPAA Medical Record Payment Policies

On January 8, 2018, CIOX Health, LLC filed a complaint challenging two HHS policies limiting whether and how much a HIPAA covered entity can charge for providing copies of medical records. According to the lawsuit filed in...more

Laboratory Group Challenges CMS’s Implementation of Clinical Laboratory Commercial Data Reporting Requirements

On December 11, 2017, the American Clinical Laboratory Association (ACLA) filed suit on behalf of its membership against the Secretary of HHS, challenging the Secretary’s implementation of the Protecting Access to Medicare...more

In Targeting Outlier Payment Reconciliation, OIG Calls for an Aggressive Reading of CMS Reopening Regulations

The HHS OIG recently published a report detailing CMS’s and Medicare Administrative Contractor’s (“MACs’”) ongoing issues in the outlier payment reconciliation process. A previous 2012 review identified 465 cost reports that...more

CMS Outpatient Advisory Panel Speaks Out Against Planned 340B Cuts

On August 21, 2017, a CMS advisory panel consisting of provider representatives recommended that CMS not finalize its proposed rule to reduce payments for outpatient drugs to hospitals under the 340B Drug Pricing Program....more

D.C. Circuit Decides Part C DSH Issue in Favor of Providers

On July 25, 2017, the United States Court of Appeals for the District of Columbia Circuit held that HHS violated the terms of the Medicare statute by failing to undertake notice-and-comment rulemaking in implementing its...more

CMS Issues Proposed Rule on Physician Quality Payment Models

In October 2016, CMS issued a Final Rule for the new physician payment system under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA replaced the Medicare Sustainable Growth Rate (SGR) with a new...more

OIG Faults CMS for its Medicare and Medicaid Improper Payment Rates

Under the Improper Payments Information Act of 2002, as amended, the Department of Health and Human Services (HHS) is required to annually report on improper payments and meet certain improvement metrics. In a report...more

D.C. District Court Allows Part C Plan to Continue with Challenge of Overpayment Rule

On March 31, 2017, Judge Rosemary Collyer of the United States District Court for the District of Columbia held that plaintiffs UnitedHealthcare Insurance Company et al. (“United”) had standing to challenge CMS’s overpayment...more

D.C. District Court Upholds CMS’s Predicate Fact Three-Year Reopening Limitation

On March 10, 2017, Judge John Bates of the U.S. District Court for the District of Columbia upheld CMS’s three-year cost report reopening limitation, as applied to “predicate fact” determinations. The regulation at issue is...more

White House “Regulatory Freeze” Delays Implementation of Bundled Payment Models

In the February 17, 2017 Federal Register, CMS announced that it will delay implementation of several bundled payment initiatives until March 21, 2017. The Advancing Care Coordination Through Episode Payment Models (EPMs),...more

MedPAC Votes on Medicare Payment Rate Sufficiency

On January 12, 2017, Medicare Payment Advisory Commission (MedPAC) members unanimously voted to maintain Medicare’s existing updates (i.e., maintain the increases Congress and the HHS Secretary have already established) to...more

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