Centers for Medicare & Medicaid Services

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FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more

Energy Newsletter - January 2017

LNG in Europe 2016/2017: An Overview of LNG Import Terminals in Europe - The increase in the supply of LNG to Europe in 2015 and the first half of 2016 was led by the UK and Italy, with other significant increases in...more

Health Care E-Note - January 2017

On October 4, 2016, The Centers for Medicare and Medicaid Services ("CMS") released the final rules regarding the requirements of participation for skilled nursing facilities. One of the most significant changes to the...more

CMS Finalizes Revamped Home Health Agency Conditions of Participation

CMS recently issued revamped home health agency (HHA) conditions of participation (CoPs), strengthening patient confidentiality, patient rights, quality assessment, care and performance standards. The final rule was published...more

Manatt on Health Reform: Weekly Highlights - January 2017 #2

CBO estimates 27 million would lose coverage under partial ACA repeal in the first year after elimination of Marketplace subsidies and Medicaid expansion; a federal judge orders delay in submission of North Carolina’s...more

Obama Administration Finalizes Changes to Home Health Conditions of Participation

CMS has finalized extensive changes to the conditions of participation (CoPs) that home health agencies (HHAs) must meet to participate in the Medicare and Medicaid programs. The rule is intended to provide HHAs with enhanced...more

Burr Alert: New Requirements of Participation for Skilled Nursing Facilities

On October 4, 2016, The Centers for Medicare and Medicaid Services (“CMS”) released the final rules regarding the requirements of participation for skilled nursing facilities. One of the most significant changes to the...more

Reimbursement Changes for Hospital Off-Campus Provider-Based Departments

Off-campus provider-based departments (PBDs) of hospitals face changes in reimbursement beginning Jan. 1, 2017, the effective date of the Centers for Medicare & Medicaid Services (CMS) outpatient prospective payment system...more

Qualifications for Artificial Limb Suppliers, After Only 16 Years

Bill Clinton was President when Congress enacted a law requiring CMS to come up with qualifications for those who make or supply artificial limbs to Medicare patients. It was January 11, 2017, when CMS finally unveiled the...more

CMS Guidance on Off-Campus Provider-Based Department Policy Changes

CMS recently released guidance on how hospitals can request from their CMS Regional Office a relocation exception from site-neutral payment rates for an excepted off-campus department of a provider due to an extraordinary...more

The MACRA Final Rule: In Search of the “Goldilocks” Model

The Medicare Access and CHIP Reauthorization Act (“MACRA”) Final Rule published late last year implements CMS’ new payment approach for physicians and other Medicare Part B eligible clinicians under the Merit-Based Incentive...more

Notes on Day 4 of the JPMorgan Healthcare Conference

Some interesting presentations on the last day of the JPMorgan Healthcare Conference that concentrated on common themes – the increasing importance of ancillary business line to bolster core business revenue and of filling in...more

FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal

On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is...more

CMS Appeals the Injunction Halting the Nursing Home Arbitration Ban—Where Will it Go From Here?

Few things have had the post-acute care industry on the edge of their seats like the ban on arbitration agreements and the subsequent injunction preventing its application. On January 5, 2017, CMS filed a Notice of Appeal...more

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

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