Mark Faccenda (US)

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CMS Publishes CY 2021 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule

On Tuesday, August 4, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published the calendar year (“CY”) 2021 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment System proposed rule. The proposed rule would increase hospital Medicare OPPS payment rates by 2.6 percent and ASC payment rates by 2.6 percent … Continue reading

CMS Publishes CY 2021 Proposed Policy, Payment, and Quality Provision Changes to Medicare Physician Fee Schedule

On Monday, August 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the CY 2021 Physician Fee Schedule (PFS) proposed rule. We describe certain material provisions from the proposed rule below. Telehealth CMS proposes to add services to the Medicare telehealth list on a Category 1 basis.  The additional services include group psychotherapy, … Continue reading

President Trump unveils executive orders on lowering drug prices

On Friday, July 24, 2020, President Trump issued three executive orders, and announced a potential fourth executive order, with the stated intention of lowering the cost of prescription drugs in the United States. The general consensus among legal commentators is that the executive orders are not self-executing and implementation of the policies therein will, therefore, … Continue reading

Court of Appeals Upholds HHS Site-Neutral Payment Cuts to Off-Campus Provider Based Departments

On Friday, July 17, 2020, the Court of Appeals for the District of Columbia found in favor of the U.S. Department of Health and Human Services (“HHS”) by holding that Medicare Part B payment cuts to certain services provided to Medicare beneficiaries in off-campus provider-based departments (“PBDs”) are within the agency’s statutory authority. More specifically, … Continue reading

CMS Issues Second Round of Regulatory Waivers and Rule Changes

Today, the Centers for Medicare & Medicaid Services (CMS) released an additional round of regulatory waivers and rule changes to support the healthcare system during the COVID-19 pandemic.  The changes include new rules to expand COVID-19 diagnostic testing, increase care capacity and the healthcare workforce, and further promote telehealth services. Medicare no longer requires an … Continue reading

CMS Pauses Accelerated and Advanced Payments Programs

CMS announced on Sunday, April 26, that it is suspending payments under the Advanced Payments Program to Part B suppliers immediately and reevaluating payment amounts under the Accelerated Payment Program.  The Accelerated and Advanced Payments Programs enable Medicare providers and suppliers to receive advance Medicare payments and address cash flow issues during a disruption in … Continue reading

HHS Releases Information on Remaining CARES Act Provider Relief Fund Payments

On April 21, 2020, the U.S. Department of Health and Human Service (“HHS”) announced how the remaining $70 billion of CARES Act funds in the Public Health and Social Services Emergency Fund (“Relief Fund”) will be distributed.  HHS explained that $50 billion of the Relief Fund is allocated for general distribution.  Between April 10 and … Continue reading

Healthcare and Coronavirus Testing Funding in the $484 Billion Relief Package

On Tuesday, April 21, the U.S. Senate approved a $484 billion coronavirus relief package aimed at reviving the depleted loan program for small businesses and providing funds for hospitals and coronavirus testing.  The House of Representatives is expected to vote on the legislation as soon as Thursday morning. On top of the $100 billion allotted … Continue reading

COVID-19 Update: Provider Relief Fund Attestation Portal Opens

On April 10, 2020, CMS made $30 billion in aggregate Public Health and Social Services Emergency Fund (“Relief Fund”) payments to providers, with each provider receiving a proportionate distribution based on how much that provider billed Medicare fee-for-service in 2019.  Providers receiving Relief Fund payments authorized by the CARES Act must submit an attestation to … Continue reading

COVID-19 Update: CMS Issues Additional Waivers to Assist Providers

The Centers for Medicare & Medicaid Services (CMS) temporarily suspended a number of rules to boost frontline medical staff at healthcare facilities during the COVID-19 pandemic.  The new waivers expand on the workforce flexibilities announced by CMS on March 30, 2020 (previously covered by the HL Pulse here).  The new waivers include: Physicians in Critical … Continue reading

COVID-19 Update: HHS Releases Details of CARES Act Provider Relief Fund

On Friday morning April 10, the U.S. Department of Health and Human Services (“HHS”) released details regarding the first $30 billion in payments under the CARES Act.  The CARES Act provides a total of $100 billion in relief funds to providers “to support healthcare-related expenses or lost revenue attributable to COVID-19 and to ensure uninsured … Continue reading

COVID-19 Update: CMS Issues Wide Ranging Blanket Waivers to Assist Providers

On Monday, March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued wide ranging blanket waivers and published an interim final rule intended to “equip the American healthcare system with maximum flexibility” to respond to COVID-19. The waivers will remain in effect until the end of the emergency declaration. CMS issued a summary … Continue reading

COVID-19 Update: Senate Unanimously Passes Emergency Stimulus Package

The United States Senate has passed a $2 trillion phase three emergency package, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).  The Senate approved the CARES Act on a unanimous vote of 96-0, with three Senators in self-quarantine and another returning home out of an abundance of caution.  The CARES Act, assuming it … Continue reading

Update to Prior CMS Action: CMS Approves 11 New Medicaid Section 1135 Waivers; 13 States Total

On March 13, 2020, following President Trump’s declaration of a national emergency in response to the COVID-19 pandemic, CMS announced its approval of the first Section 1135 Waiver aimed at addressing the spread of COVID-19 (Coronavirus) in Florida. On March 19, CMS granted a Section 1135 Waiver to deal with the COVID-19 outbreak in Washington … Continue reading

COVID-19 Update: FDA will use enforcement discretion for limited ventilator modifications

On March 22, 2020, the FDA released guidance describing an enforcement policy that will help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic.  FDA’s guidance would permit “limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to … Continue reading

FDA Final Rule Amends Definition of “Biological Product”

On February 20, 2020 the U.S. Food and Drug Administration (FDA) published a final rule, revising the regulatory definition of biological products to match the definition Congress agreed to in the Further Consolidated Appropriations Act, 2020.  The changes reflect the FDA’s efforts to remove regulatory hurdles in order to create cheaper versions of biological products, … Continue reading

CMS Publishes CY 2020 OPPS & ASC Price Transparency Requirements Final Rule and Transparency in Coverage Proposed Rule

On November 15, the Centers for Medicare & Medicaid Services (CMS) published the Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Changes Public final rule and the Transparency in Coverage proposed rule. CMS intends through this rulemaking to increase price transparency … Continue reading

CMS Releases Final Rule on CY 2020 Physician Fee Schedule Updates and Implements Opioid Use Disorder Treatment Programs

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates the Medicare Physician Fee Schedule (PFS) rates and policies for calendar year (CY) 2020 and expands Medicare coverage to opioid treatment programs (OTPs) that treat beneficiaries with opioid use disorder (OUD). In a fact sheet accompanying the … Continue reading

CY 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) published its CY 2020 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule.  The final rule implements a number of significant changes to payment policies and rates for services furnished to Medicare beneficiaries in hospital outpatient … Continue reading

U.S. District Court Upholds Ruling that CMS Exceeded Its Statutory Authority in Reducing Medicare Payments for Clinic Visit Evaluation and Management Services Furnished in Hospital Excepted Off-Campus Provider-Based Departments

On October 21, 2019, U.S. District Judge Rosemary M. Collyer denied the government’s request to modify the Court’s previous ruling on September 17, 2019, that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory authority when it reduced Medicare payment rates for clinic visit evaluation and management (E&M) services provided to Medicare patients … Continue reading

CMS releases FY 2020 IPPS and LTCH PPS final rule

On August 2, 2019, the Centers for Medicare & Medicaid Services (CMS) published its Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System (PPS) final rule (CMS-1716-F). The final rule is scheduled to be published in the Federal Register on August 16, 2019. … Continue reading

FDA publishes new 510(K) guidance

On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices.  A new “safety and performance-based pathway” for certain, well understood device types, may be used by manufacturers to demonstrate substantial equivalency to devices already on the market. Under the 510(k) process, … Continue reading
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