Mark Faccenda (US)

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HHS Issues Final Rule Requiring Retrospective Review of Regulations

On Friday, January 8, 2021, the Department of Health and Human Services (“HHS”) released a final rule that would provide HHS with five years to review existing regulations that are more than ten years old, subject to certain exceptions, to determine if each regulation is still necessary. HHS will be permitted to extend this deadline … Continue reading

COVID-19 Update: Healthcare provisions (Including Medicare GME Revisions) in the Consolidated Appropriations Act, 2021

On December 27, 2020, President Trump signed into law the fourth round of COVID-19 emergency relief that passed both the U.S. Senate and the U.S. House of Representatives. The Consolidated Appropriations Act, 2021 (“Act”) includes approximately $900 billion in pandemic relief and is reportedly the longest bill (5,593 pages) to be passed in Congress’s history. … Continue reading

D.C. Circuit Upholds CMS Price Transparency Rule

On December 29, 2020, three days before the implementation date, the U.S. Court of Appeals for the D.C. Circuit upheld the Centers for Medicare & Medicaid Services (“CMS”) price transparency final rule.  Beginning January 1, 2021, hospitals will be required to make public their standard charges for 300 shoppable services, including 70 services identified by … Continue reading

Congress Passes Surprise Medical Bill Legislation

After two years of negotiations Congress has enacted legislation to protect patients from certain surprise medical bills as part of Consolidated Appropriations Act, 2021.   The No Surprises Act (the “Act”) amends the Public Health Services Act and will take effect on January 1, 2022.  While several states have passed surprise billing protections in recent years … Continue reading

CMS releases special alert on monitoring hospital compliance with price transparency requirements

On Friday, December 18, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a special alert to remind hospitals that the Hospital Price Transparency final rule (“final rule”) requirements are effective starting January 1, 2021 and that CMS will monitor a “sample of hospitals” when the final rule goes into effect to determine compliance … Continue reading

CMS releases proposed interoperability rule to improve prior authorizations and the electronic exchange of healthcare data

On December 10, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to revise the prior authorization process and to add new requirements for state Medicaid and Children’s Health Insurance Program (“CHIP”) fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally-facilitated Exchanges … Continue reading

COVID-19 Update: CMS Releases Fourth COVID-19 Interim Final Rule with Comment Period

On Wednesday, October 28, 2020, the Centers for Medicare & Medicaid Services (“CMS”), with the Departments of Treasury and Labor, issued a fourth interim final rule (“IFR”) with comment period addressing the public health emergency (“PHE”). The policies in the IFR will become effective upon publication in the Federal Register. The IFR’s stated goal is … Continue reading

COVID-19 Update: HHS Renews COVID-19 Public Health Emergency Declaration

On October 2, 2020, Secretary Azar of the Department of Health and Human Services (“HHS”) renewed his public health emergency (“PHE”) declaration because of “the continued consequences” of the COVID-19 pandemic. This renewal will become effective on October 23, 2020 when the previous July 23 renewal was set to expire and will continue to January … Continue reading

CMS Publishes Proposed Rule on Medicare Coverage for Innovative Technologies 

On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would establish a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (“MCIT”), for medical devices that are designated by the Food and Drug Administration (“FDA”) as breakthrough devices. Under the proposed MCIT pathway, CMS would provide national … Continue reading

CMS Issues FY 2021 IPPS and LTCH PPS Final Rule

On Wednesday, September 2, the Centers for Medicare & Medicaid Services (CMS) issued the FY 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) final rule. The final rule is scheduled to be published in the Federal Register on September 18 and most of its provisions will be effective … Continue reading

COVID-19 Update: CMS Updates Conditions of Participation for Hospitals and CAHs to Require COVID-19 Reporting

On Tuesday, August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule that updates the Medicare Conditions of Participation to require all hospitals to which 42 CFR Part 482 applies, as well as critical access hospitals (“CAHs”), to electronically report information including the number of confirmed or suspected COVID-19 … Continue reading

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
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