Topic: Regulatory

COVID-19: OSHA Updates and Reporting Requirements

The Occupational Safety and Health Administration (“OSHA”), part of the U.S. Department of Labor, continues to update guidance for employers regarding protection of employees from exposure to COVID-19. Despite their best intentions, many employers have struggled to adapt to the constantly changing safety and reporting requirements during the COVID-19 pandemic. OSHA recently updated its COVID-19 … 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

President Trump Signs Most Favored National Executive Order

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on September 15, 2020 Posted in General, News from DC, Regulatory

President Trump signed a controversial Executive Order on September 13, 2020 entitled Executive Order on Lowering Drug Prices by Putting America First with the intention of tying drug costs paid by the Medicare program to the costs borne by countries that have national health systems. The Executive Order provides that “[i]t is the policy of … 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

COVID-19 Update: CMS Announces Resumption of Survey Activities

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 19, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On August 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced it was resuming inspections of Medicare and Medicaid certified providers and suppliers, which had been suspended in late March in response to the COVID-19 public health emergency. More specifically, CMS will be resuming onsite revisit surveys for surveys with end dates on, … 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

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

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

COVID-19 Update: FDA Inspections Signal Resumption of Government Enforcement Efforts

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on July 14, 2020 Posted in Coronavirus, General, Regulatory

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced it would resume domestic on-site inspections beginning the week of July 20. Due to the COVID-19 pandemic, the FDA suspended inspections of facilities in March “to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.” To … Continue reading

COVID-19 Update: CMS releases guide encouraging patients to seek in-person healthcare

By Thomas Dowdell (US) and Hayley White (US) on June 11, 2020 Posted in Coronavirus, Regulatory

On Tuesday, June 9, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a guide for patients who are considering their in-person care options following certain healthcare facilities re-opening for all medical services. As COVID-19 cases decline in some areas of the country, CMS created this guide to give patients recommendations, and to help … Continue reading

COVID-19 Update: The Joint Commission to Resume Hospital Surveys

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 10, 2020 Posted in Coronavirus, General, Regulatory

The Joint Commission (TJC) is resuming regular surveys and reviews after suspending them at the outset of the COVID-19 pandemic. Safety will be “the first and foremost priority” as surveys and reviews are resumed and the survey’s will “assess the impact that the coronavirus pandemic had on their operations and their current state.” The surveys … Continue reading

FTC Submits Comment Supporting Telehealth Provisions in CMS Interim Final Rule

By Amanda Wait (US), Jeff Wurzburg (US) and Rachel Park (US) on June 8, 2020 Posted in Coronavirus, General, Regulatory

On June 2, 2020, the staffs of the Federal Trade Commission’s (FTC) Office of Policy Planning, Bureau of Economics, Bureau of Competition and Office of the General Counsel submitted a comment to the Centers for Medicare & Medicaid Services (CMS) on its Interim Final Rule regarding policy and regulatory revisions in response to the COVID-19 … Continue reading

COVID-19 Update: CDC Publishes Additional Guidance on Reopening

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 21, 2020 Posted in Coronavirus, General, Regulatory

The U.S. Centers for Disease Control and Prevention (“CDC”) has quietly released more expansive guidance regarding the reopening of different types of organizations. The document, entitled CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again, builds upon the decision tools issued by the CDC last week. The … Continue reading

CMS Proposed Rule Includes Significant Changes to Medicare GME Funding

By Andrew Roth (US) and Thomas Dowdell (US) on May 20, 2020 Posted in General, News from DC, Regulatory

On May 11, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its Fiscal Year (FY) 2021 hospital inpatient prospective payment system (IPPS) and long term care hospital (LTCH) prospective payment system (PPS) proposed rule. We previously reported on the hospital IPPS and LTCH PPS proposed changes. See link here . In this rulemaking, … Continue reading

CMS Issues FY 2021 Hospital IPPS and LTCH PPS Proposed Rule

By Thomas Dowdell (US) on May 13, 2020 Posted in Coronavirus, General, Regulatory

On May 11, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its Fiscal Year (FY) 2021 hospital inpatient prospective payment system (IPPS) and long term care hospital (LTCH) prospective payment system (PPS) proposed rule. Under the proposed rule Medicare IPPS payment rates would increase an estimated net 3.1 percent for hospitals that successfully … Continue reading

CMS Issues Second Round of Regulatory Waivers and Rule Changes

By Thomas Dowdell (US), Mark Faccenda (US), Rachel Park (US) and Jeff Wurzburg (US) on April 30, 2020 Posted in Coronavirus, General, Regulatory

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

By Thomas Dowdell (US), Mark Faccenda (US), Rachel Park (US) and Jeff Wurzburg (US) on April 27, 2020 Posted in Coronavirus, General, Regulatory

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

COVID-19 Update: HHS Issues Omnibus Advisory Opinion Regarding PREP Immunity

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 23, 2020 Posted in Coronavirus, General, News from DC, Regulatory

The HHS Office of the General Counsel has released an important Advisory Opinion that provides insight regarding the interpretation and application of the Secretary’s March 17, 2020 Declaration, which is retroactively effective beginning February 4, 2020. (HL Pulse discussion here). The Declaration provides immunity to certain individuals and entities for liability against “all claims for … Continue reading