Centers for Medicare & Medicaid Services

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Blog: FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop...more

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more

CMS Finalizes Testing of New Episode Payment Models and MSSP Track 1+ ACO

On January 3, 2017, CMS published a final rule addressing three care coordination models: - Cardiac care: CMS added two new cardiac care episode payment models (“EPMs”) for items and services furnished to patients...more

Urban hospitals that established GME caps after 1996: Be careful with this compliance issue

If a teaching hospital meets certain regulatory requirements, the hospital is generally permitted to loan its cap slots to other hospitals through a Medicare GME affiliated group agreement. (See Sharing FTE Caps: Threshold...more

CMS Finalizes Mandatory Cardiac and Joint Bundles … But Their Future is Uncertain

When Tom Price assumes the top post at the U.S. Department of Health and Human Services (HHS) later this month (subject to Senate confirmation), the ink will barely be dry on a final rule issued by the Centers for Medicare &...more

Joint Commission Confirms Ban on Texting of Patient Care Orders

After briefly considering a reversal of its prohibition on texting orders, The Joint Commission (TJC), in consultation with the Centers for Medicare & Medicaid Services (CMS), announced last month that its ban would continue...more

CMS Clarifies the Application Processes for the Mid-Build Exception under the 21st Century Cures Act and for Relocation Exception...

CMS has issued guidance documents addressing how hospitals can (1) qualify an off-campus provider-based department (PBD) for the “mid-build” exception set forth in the 21st Century Cures Act and (2) request from their CMS...more

CMS to Host Call on Transitioning Physician Quality Reporting to MIPS (Jan. 24)

On January 24, 2017, CMS is hosting a call to discuss how to complete the final reporting period for the “legacy” Medicare physician quality reporting programs (Physician Quality Reporting System, Medicare Electronic Health...more

CMS Again Extends HHA/Ambulance Enrollment Moratoria in Selected States

The Centers for Medicare & Medicaid Services (CMS) is extending for six months its current moratoria on the Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollment of new nonemergency ground ambulance...more

CMS Corrects Final 2017 OPPS/ASC Rule, Results in Slight Payment Increase

CMS has published a notice correcting technical errors in its November 14, 2016 final rule with comment period updating the Medicare hospital outpatient prospective payment system (OPPS) and ambulatory surgical center payment...more

Manatt on Health Reform: Weekly Highlights - January 2017

Physician groups and American Enterprise Institute authors come out against ACA repeal without a replacement; Hawaii’s 1332 waiver is the first to receive federal approval; and North Carolina’s Governor moves to expand...more

New billing modifier required for services furnished at certain off-campus provider-based departments on or after January 1, 2017

Changes to Medicare billing and payment rules for services furnished at certain off-campus provider-based departments (PBDs) went into effect on January 1, 2017. Pursuant to the statutory “site-neutral” payment policy enacted...more

Capitol Hill Healthcare Update

A growing number of moderate and conservative Republicans in Congress are voicing concerns about the party’s strategy to repeal the Affordable Care Act (Act) in February but then wait months – and possibly even into 2018 –...more

The New “Price” of U.S. Health Care: The Future of Value-based Reimbursement Under President-elect Trump and Tom Price

The total U.S. health care expenditure was $3.2 trillion in 2015, and is projected to grow to nearly $5.6 trillion by 2025. As our nation’s cost of care rises, both Democrats and Republicans recognize the overwhelming need to...more

CMS Issues Time-Sensitive Instructions for Provider-Based Clinics That Have Relocated

Hospitals that have relocated a provider-based clinic after the enactment of the Bipartisan Budget Act must take action now. Centers for Medicare & Medicaid Services (CMS) recently released guidance on extraordinary...more

“Bundles of Bundles”: CMS Announces New Mandatory Bundled Payment Programs for Heart Attack, Heart Surgery, and Hip and Femur...

The Centers for Medicare and Medicaid Services (“CMS”) is forging ahead with the implementation of innovative and value-based payment programs, despite Donald Trump’s win in the presidential election and Republican...more

Manatt on Medicaid: Monthly Expansion Recap - January 2017

Arkansas - Task Force Report Highlights Expected Cost Savings From Medicaid Expansion - The Arkansas Health Reform Legislative Task Force met for the last time to approve its final report, which includes findings...more

A Condition of Participation for Medicare Providers in 2017

This year, Medicare providers and suppliers — including hospitals, ambulatory surgical centers (ASCs) and end-stage renal disease (ESRD) facilities — will need to develop emergency preparedness plans for both natural and...more

2016 in Arbitration Law: Fleeting Victories for Consumer Advocates?

If I had drafted this annual summary post on November 7, 2016, it would have looked different. At that point, the year had produced numerous (final or proposed) federal regulations that significantly restricted the use of...more

CMS and OIG Issue Notice of Amended Waivers for Next Generation ACO Model

On December 29, 2016, CMS and OIG issued a Notice of Amended Waivers of Certain Fraud and Abuse Laws in Connection with the Next Generation ACO Model (the 2016 Notice). The 2016 Notice does not change or limit arrangements...more

Medicaid Demonstration Waivers: A Shorter Path to Increasing State Control Over Healthcare Policy?

Seema Verma’s nomination to head the Centers for Medicare and Medicaid Services (CMS) places Section 1115 Medicaid demonstration waivers into increasing spotlight. This article explores some of the current applications of...more

HHS OIG Issues Report on Medicare’s 2-Midnight Rule

On December 19, 2016, the HHS OIG issued a report on Medicare’s 2-midnight rule titled “Vulnerabilities Remain Under Medicare 2-Midnight Hospital Policy.” The report reviews data from 2013 and 2014 and reaches several...more

“Should Auld Acquaintance Be Forgot” - Performant to Initiate Home Health, Hospice, and DME Audits in 2017

The final quarter of 2016 ended with the Centers for Medicare & Medicaid Services (CMS) announcing Performant Recovery, Inc. (Performant) as the new national Recovery Audit Contractor (RAC) to focus solely on Home Health,...more

New Initiatives for the New Year: Highlights of the OIG’s 2017 Work Plan

On November 10, 2016, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued its 2017 Work Plan. The 2017 Work Plan outlines the areas of special concern to the OIG and...more

CMS Finalizes Mandatory Cardiac Care Bundled Payment Model and More

On December 20, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (the Final Rule) which includes three new mandatory episode-based payment programs for cardiac care, as well as the expansion of the...more

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