Thomas Dowdell (US)

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HHS Issues Final Rule Requiring Retrospective Review of Regulations

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on January 11, 2021 Posted in General, Regulatory

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

By Mark Faccenda (US), Andrew Roth (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on January 4, 2021 Posted in Coronavirus, General, News from DC

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

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on December 29, 2020 Posted in General, News from DC

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

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on December 22, 2020 Posted in News from DC

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

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on December 21, 2020 Posted in General, News from DC, Regulatory

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

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on December 14, 2020 Posted in General, News from DC, Regulatory

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

CMS Publishes 2021 Hospital OPPS and ASC Final Rule

By Jeff Wurzburg (US) and Thomas Dowdell (US) on December 4, 2020 Posted in General, Regulatory

The Centers for Medicare & Medicaid Services (“CMS”) has published the Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgery Center (“ASC”) final rule for CY 2021. CMS finalized an annual increase OPPS and ASC rates of 2.4 percent for CY 2021, based on a 2.4 percent market basket update and without a cut for … Continue reading

CMS Announces New Acute Hospital Care At Home Program and Additional Flexibility in the Hospitals Without Walls Program

By Thomas Dowdell (US) on November 25, 2020 Posted in General, News from DC, Regulatory

On Wednesday, November 25, the Centers for Medicare & Medicaid Services (CMS) announced its new Acute Hospital at Home program and additional regulatory flexibility in its Hospitals Without Walls program. The Acute Hospital Care at Home program is for beneficiaries who require acute inpatient admission to a hospital and who require at a minimum daily … Continue reading

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

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on November 4, 2020 Posted in Coronavirus, General, News from DC, Regulatory

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

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on October 12, 2020 Posted in Coronavirus, General, News from DC

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 launches website intended to assist hospitals in complying with the price transparency requirements effective January 1, 2021

By Thomas Dowdell (US) on October 1, 2020 Posted in General, Regulatory

The Centers for Medicare & Medicaid Services in its 2020 outpatient prospective payment system final rule requires hospitals to publicly post standard charge information beginning January 1, 2021. On September 30, CMS launched a website intended to assist hospitals in complying with the price transparency requirements. The website is available at link here. The website … Continue reading

CMS Withdraws Proposed Medicaid Fiscal Accountability Rule

By Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on September 15, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On Monday, September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Seema Verma announced on Twitter that CMS was withdrawing the proposed Medicaid Fiscal Accountability Rule (“MFAR”) from its regulatory agenda. The MFAR, which was proposed in November of 2019, would have added new reporting requirements for state governments to receive state … Continue reading

CMS Publishes Proposed Rule on Medicare Coverage for Innovative Technologies

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on September 4, 2020 Posted in General, Regulatory

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

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on September 4, 2020 Posted in General, Regulatory

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

By Yvonne Puig (US), Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on August 28, 2020 Posted in Coronavirus, Enforcement, Regulatory

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

HHS Issues Proposed Rule on Good Guidance Practices

By Jeff Wurzburg (US), Thomas Dowdell (US) and Hayley White (US) on August 25, 2020 Posted in Coronavirus, General, Regulatory

On August 20, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would impose requirements regarding the issuance and reliance on HHS guidance documents. This proposed rule results from the 2019 U.S. Supreme Court decision in Azar v. Allina Health Services (139 S. Ct. 1804). In this case the … Continue reading

Supreme Court to Hold Oral Arguments on Certain Republican States’ Challenge to the ACA on November 10

By Thomas Dowdell (US) and Jeff Wurzburg (US) on August 19, 2020 Posted in General, News from DC, Regulatory

The U.S. Supreme Court will hear oral arguments on certain red states’ challenge to the Affordable Care Act on November 10, one week after the November 3 presidential election, according to the court’s online docket released on Wednesday, August 19. The central argument in the case is whether the entire ACA is invalid without a … Continue reading

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

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on August 7, 2020 Posted in Coronavirus, General, Regulatory

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

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Rachel Park (US) on August 5, 2020 Posted in Coronavirus, Enforcement, Regulatory

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

Court of Appeals upholds 340B Reductions

By Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on August 4, 2020 Posted in News from DC

On Friday July 31, 2020 the U.S. Circuit Court of Appeals for the District of Columbia Circuit reversed the federal district court and permitted reimbursement cuts for drugs purchased through the 340B Drug Discount Program.… Continue reading

CMS publishes FY 2021 Skilled Nursing Facility, Inpatient Psychiatric Hospital, and Hospice Medicare Payment final rules

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on August 4, 2020 Posted in Enforcement, News from DC, Regulatory

All three of these Medicare payment final rules will become effective on October 1, 2020.… Continue reading

President Trump unveils executive orders on lowering drug prices

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on July 30, 2020 Posted in Coronavirus, Enforcement, General, News from DC

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

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on July 20, 2020 Posted in Coronavirus, Enforcement, General

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 Administrator Publishes Blog Post on Expansion of Medicare Telehealth Services

By Thomas Dowdell (US), Jeff Wurzburg (US) and Rachel Park (US) on July 17, 2020 Posted in Coronavirus, General, Regulatory

On Wednesday, July 15, 2020, Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, published a blog post on the Health Affairs Blog discussing CMS’ efforts to expand telehealth for Medicare beneficiaries during the COVID-19 pandemic and reviewing the potential of adopting some flexibilities as permanent measures. Historically Medicare has covered telehealth … Continue reading