Author Info for Morgan Lewis - Health Law Scan

Bernard Archbold

FTC Votes to Rescind Vertical Merger Guidelines, No Replacement Announced

The US Federal Trade Commission (FTC) recently voted to withdraw its approval of the Vertical Merger Guidelines (the 2020 VMGs), which, as we covered in the past, the FTC and Department of Justice (DOJ) issued over a year ago on…more

Antitrust Provisions, Competition, Department of Justice (DOJ), Federal Trade Commission (FTC), Merger Controls

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Meredith Auten

CMS Publishes Final Rule for Minimum Staffing Standards for Long-Term Care Facilities

The Centers for Medicare & Medicaid Services (CMS) published its Final Rule today to implement a minimum staffing “floor” for nursing homes in the United States, as first announced on April 22. The Final Rule, which as proposed…more

Centers for Medicare & Medicaid Services (CMS), Final Rules, Health Care Providers, Long Term Care Facilities, Long-Term Care

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David Brenneman

Antitrust Enforcers Rachet Up Scrutiny of Private Equity and Labor Issues in Healthcare – Health Law Scan

Federal antitrust enforcers at the US Department of Justice (DOJ) and Federal Trade Commission (FTC) continue to take an aggressive stance in healthcare. Two recent developments underscore the trend…more

Antitrust Division, Antitrust Provisions, Department of Justice (DOJ), Federal Trade Commission (FTC), Hart-Scott-Rodino Act

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Laurie Burlingame

Get Ready, Set, and Go to the JPM Healthcare Conference

As Prescribed and Health Law Scan subscribers know that the end of the holidays means the annual J.P. Morgan (JPM) Healthcare Conference is only days away. To make the most of the 2024 conference and conference-adjacent…more

Biotechnology, Investors, Life Sciences, Pharmaceutical Industry, Research and Development

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Giovanna Cinelli

CFIUS Issues Final Regulations Under FIRRMA: Healthcare Industry

On January 13, the Committee on Foreign Investment in the United States (CFIUS) published the final rules implementing the Foreign Investment Risk Review Modernization Act (FIRRMA)…more

CFIUS, Covered Transactions, Critical Infrastructure Sectors, Cross-Border Transactions, Final Rules

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Beverly Dale

US Government Cracks Down on Alleged Misuse of US Funded Research by Chinese Scholars, Students

US government–funded academic medical centers and other research institutions are caught between traditional values of academic freedom, collaboration, and nondiscrimination and their obligations to comply with US law and…more

China, Health Care Providers, Medical Research, Research Funding

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Tinos Diamantatos

DOJ and OIG Warn Against Fraud Schemes Related to COVID-19 Pandemic

In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources…more

Coronavirus/COVID-19, Fraud, Medical Supplies, Personal Protective Equipment, Risk Mitigation

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John Dodds

DOJ and OIG Warn Against Fraud Schemes Related to COVID-19 Pandemic

In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources…more

Coronavirus/COVID-19, Fraud, Medical Supplies, Personal Protective Equipment, Risk Mitigation

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Roshni Edalur

HHS and FBI Release Joint Cybersecurity Advisory Statement for Healthcare Providers

Shortly after our prior blog post discussing the need for healthcare entities to shore up protections against phishing attacks, the Department of Health and Human Services (HHS) and the Federal Bureau of Investigation (FBI)…more

Cyber Attacks, Cyber Threats, Cybersecurity, Department of Health and Human Services (HHS), FBI

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Gregory Etzel

Don’t Wait to Review CMS’s Proposal to Implement Minimum Managed Care Appointment Wait Times

The Centers for Medicare & Medicaid Services (CMS) proposed on April 23, 2023 two rules that would affect Medicaid managed care: Ensuring Access to Medicaid Services (CMS 2442-P) and Medicaid and Children’s Health Insurance…more

Centers for Medicare & Medicaid Services (CMS), Fee-for-Service, Health Care Providers, Managed Care Contracts, MCOs

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Allison Fepelstein

CMS Advances Price Transparency with Rules for Hospitals and Insurers

CMS has released a pair of rules “that take historic steps to increase price transparency to empower patients and increase competition among all hospitals, group health plans and health insurance issuers in the individual and…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Healthcare Reform, Hospitals, Price Transparency

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Suzanne Filippi

Get Ready, Set, and Go to the JPM Healthcare Conference

As Prescribed and Health Law Scan subscribers know that the end of the holidays means the annual J.P. Morgan (JPM) Healthcare Conference is only days away. To make the most of the 2024 conference and conference-adjacent…more

Biotechnology, Investors, Life Sciences, Pharmaceutical Industry, Research and Development

See all updates »

Stephen Forster

The Ins and Outs of Medicare’s Prescription Payment Plan

Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government. Included…more

Centers for Medicare & Medicaid Services (CMS), Inflation Reduction Act (IRA), Medicare, Medicare Part D, Prescription Drugs

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Gregory Fouts

Beware of Biometrics: Complying with Illinois’ Biometric Information Privacy Act

Biometrics are physical or behavioral human characteristics that can be used to digitally identify a person to grant access to systems, devices, or data. Examples of biometric identifiers are fingerprints, facial geometry scans,…more

Biometric Information, Biometric Information Privacy Act, Cybersecurity, Data Collection, Data Privacy

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Kirstin Gibbs

How Does Climate Change Affect the Healthcare Industry?

The US Department of Health and Human Services recently announced the establishment of the Office of Climate Change and Health Equity (OCCHE). Noting that the OCCHE is “the first office of its kind at the national level to…more

Air Pollution, Climate Change, Department of Health and Human Services (HHS), Greenhouse Gas Emissions, Hospitals

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Jacob Harper

CMS Publishes Final Rule for Minimum Staffing Standards for Long-Term Care Facilities

The Centers for Medicare & Medicaid Services (CMS) published its Final Rule today to implement a minimum staffing “floor” for nursing homes in the United States, as first announced on April 22. The Final Rule, which as proposed…more

Centers for Medicare & Medicaid Services (CMS), Final Rules, Health Care Providers, Long Term Care Facilities, Long-Term Care

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Alborz Hassani

Illinois Supreme Court Holds Healthcare Employee Fingerprint Data Exempt from BIPA

In the first win for defendants facing Illinois Biometric Information Privacy Act (BIPA) litigation before the Illinois Supreme Court, the Court in Mosby v. Ingalls Memorial Hospital held that BIPA excludes from its protections…more

Biometric Information, Biometric Information Privacy Act, Data Collection, Data Privacy, Fingerprints

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Douglas Hastings

How Does Climate Change Affect the Healthcare Industry?

The US Department of Health and Human Services recently announced the establishment of the Office of Climate Change and Health Equity (OCCHE). Noting that the OCCHE is “the first office of its kind at the national level to…more

Air Pollution, Climate Change, Department of Health and Human Services (HHS), Greenhouse Gas Emissions, Hospitals

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Elizabeth Herrington

Illinois Supreme Court Holds Healthcare Employee Fingerprint Data Exempt from BIPA

In the first win for defendants facing Illinois Biometric Information Privacy Act (BIPA) litigation before the Illinois Supreme Court, the Court in Mosby v. Ingalls Memorial Hospital held that BIPA excludes from its protections…more

Biometric Information, Biometric Information Privacy Act, Data Collection, Data Privacy, Fingerprints

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W. Reece Hirsch

OCR Announces Settlement Agreement in PHI Breach

The US Department of Health and Human Services, Office for Civil Rights (OCR), announced a settlement agreement on June 15, 2023 with not-for-profit community hospital Yakima Valley Memorial Hospital (Yakima) related to Yakima…more

Business Associates, Covered Entities, Department of Health and Human Services (HHS), Health Care Providers, Health Insurance Portability and Accountability Act (HIPAA)

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Yunica Jiang

OIG Issues Telehealth Special Fraud Alert on the Heels of DOJ Takedown

The recent increase in use of telehealth as a care modality has been important to patients and providers alike, with significant benefits for public health. However, with the growing mainstream acceptance of virtual care, the US…more

Department of Justice (DOJ), Enforcement Actions, Health Care Providers, Healthcare Fraud, OIG

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Zachary Johns

Antitrust Enforcers Rachet Up Scrutiny of Private Equity and Labor Issues in Healthcare – Health Law Scan

Federal antitrust enforcers at the US Department of Justice (DOJ) and Federal Trade Commission (FTC) continue to take an aggressive stance in healthcare. Two recent developments underscore the trend…more

Antitrust Division, Antitrust Provisions, Department of Justice (DOJ), Federal Trade Commission (FTC), Hart-Scott-Rodino Act

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Daniel Kadish

September Fast Break Recap: Vaccine Mandates – Latest Developments and Best Practices

In our latest Fast Break session and on the heels of recent announcements from the Biden-Harris administration and the US Food and Drug Administration’s (FDA’s) granting of full authorization for the Pfizer vaccine in August, we…more

Americans with Disabilities Act (ADA), Biden Administration, Centers for Disease Control and Prevention (CDC), Employer Mandates, Federal Employees

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Ryan Kantor

Antitrust Enforcers Rachet Up Scrutiny of Private Equity and Labor Issues in Healthcare – Health Law Scan

Federal antitrust enforcers at the US Department of Justice (DOJ) and Federal Trade Commission (FTC) continue to take an aggressive stance in healthcare. Two recent developments underscore the trend…more

Antitrust Division, Antitrust Provisions, Department of Justice (DOJ), Federal Trade Commission (FTC), Hart-Scott-Rodino Act

See all updates »

Kayla Stachniak Kaplan

CMS Publishes Final Rule for Minimum Staffing Standards for Long-Term Care Facilities

The Centers for Medicare & Medicaid Services (CMS) published its Final Rule today to implement a minimum staffing “floor” for nursing homes in the United States, as first announced on April 22. The Final Rule, which as proposed…more

Centers for Medicare & Medicaid Services (CMS), Final Rules, Health Care Providers, Long Term Care Facilities, Long-Term Care

See all updates »

Bryan Killian

How Does Climate Change Affect the Healthcare Industry?

The US Department of Health and Human Services recently announced the establishment of the Office of Climate Change and Health Equity (OCCHE). Noting that the OCCHE is “the first office of its kind at the national level to…more

Air Pollution, Climate Change, Department of Health and Human Services (HHS), Greenhouse Gas Emissions, Hospitals

See all updates »

Rachel Lamparelli

The Ins and Outs of Medicare’s Prescription Payment Plan

Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government. Included…more

Centers for Medicare & Medicaid Services (CMS), Inflation Reduction Act (IRA), Medicare, Medicare Part D, Prescription Drugs

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John Lavelle, Jr.

Additional PREP Act Amendments Accommodate Vaccination Administration Needs

Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit additional personnel to administer vaccinations, the secretary of the US Department of…more

ACIP, Coronavirus/COVID-19, Department of Health and Human Services (HHS), Health Care Providers, Healthcare Workers

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Mark Lazaroff

How Does Climate Change Affect the Healthcare Industry?

The US Department of Health and Human Services recently announced the establishment of the Office of Climate Change and Health Equity (OCCHE). Noting that the OCCHE is “the first office of its kind at the national level to…more

Air Pollution, Climate Change, Department of Health and Human Services (HHS), Greenhouse Gas Emissions, Hospitals

See all updates »

Michael Madderra

HHS and FBI Release Joint Cybersecurity Advisory Statement for Healthcare Providers

Shortly after our prior blog post discussing the need for healthcare entities to shore up protections against phishing attacks, the Department of Health and Human Services (HHS) and the Federal Bureau of Investigation (FBI)…more

Cyber Attacks, Cyber Threats, Cybersecurity, Department of Health and Human Services (HHS), FBI

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Amy Magnano

HHS and FBI Release Joint Cybersecurity Advisory Statement for Healthcare Providers

Shortly after our prior blog post discussing the need for healthcare entities to shore up protections against phishing attacks, the Department of Health and Human Services (HHS) and the Federal Bureau of Investigation (FBI)…more

Cyber Attacks, Cyber Threats, Cybersecurity, Department of Health and Human Services (HHS), FBI

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B. Scott McBride

OIG Approves Consultant’s Provision of Gift Cards to Physician Practices

The US Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion No. 23-15 on January 3, which concluded that a consultant’s proposal to provide gift cards to existing…more

Anti-Kickback Statute, Client Referrals, Department of Health and Human Services (HHS), Gift-Cards, Health Care Providers

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Ryan McCarthy

OIG Issues Telehealth Special Fraud Alert on the Heels of DOJ Takedown

The recent increase in use of telehealth as a care modality has been important to patients and providers alike, with significant benefits for public health. However, with the growing mainstream acceptance of virtual care, the US…more

Department of Justice (DOJ), Enforcement Actions, Health Care Providers, Healthcare Fraud, OIG

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Zane David Memeger

Tele-Tuesday: DOJ National Healthcare Fraud Takedown Targets Telehealth – But Should DOJ’s Focus Be Elsewhere?

DOJ recently announced a massive coordinated effort with other federal agencies to charge 345 defendants allegedly responsible for over $6 billion in fraud. DOJ, OIG, FBI, DEA, and various US Attorneys’ Offices in 51 federal…more

Department of Justice (DOJ), Enforcement Actions, Health Care Providers, Healthcare Fraud, Telemedicine

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Scott Memmott

Manufacturers Should Carefully Evaluate OIG’s Approval of Medicare Cost Sharing Subsidies in Clinical Trials

At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device…more

Clinical Trials, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Life Sciences, Medical Devices

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Kenneth Nunnenkamp

CFIUS Issues Final Regulations Under FIRRMA: Healthcare Industry

On January 13, the Committee on Foreign Investment in the United States (CFIUS) published the final rules implementing the Foreign Investment Risk Review Modernization Act (FIRRMA)…more

CFIUS, Covered Transactions, Critical Infrastructure Sectors, Cross-Border Transactions, Final Rules

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Vincent Papa

FTC Votes to Rescind Vertical Merger Guidelines, No Replacement Announced

The US Federal Trade Commission (FTC) recently voted to withdraw its approval of the Vertical Merger Guidelines (the 2020 VMGs), which, as we covered in the past, the FTC and Department of Justice (DOJ) issued over a year ago on…more

Antitrust Provisions, Competition, Department of Justice (DOJ), Federal Trade Commission (FTC), Merger Controls

See all updates »

Eleanor Pelta

Federal Court Temporarily Blocks Health Insurance Requirement for Immigrant Visa Applicants

The US District Court for the District of Oregon on November 2 issued a temporary restraining order (TRO) to block the new health insurance requirement for immigrant visa applicants from taking effect on November 3, 2019. As…more

Foreign Nationals, Health Insurance, Immigration Procedures, Restraining Orders, Visa Applications

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Ulises Pin

CFIUS Issues Final Regulations Under FIRRMA: Healthcare Industry

On January 13, the Committee on Foreign Investment in the United States (CFIUS) published the final rules implementing the Foreign Investment Risk Review Modernization Act (FIRRMA)…more

CFIUS, Covered Transactions, Critical Infrastructure Sectors, Cross-Border Transactions, Final Rules

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Jeffrey Raskin

Consider Enhancing Cyberliability Insurance Policies to Align with CCPA: Part 2

Our prior post discussed three potential enhancements to cyber-related liability insurance policies designed to maximize their potential responsiveness to actions initiated by consumers or the state attorney general under the…more

California Consumer Privacy Act (CCPA), Cyber Attacks, Cyber Insurance, Cybersecurity, Personally Identifiable Information

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Sydney Reed

CARES Act Distribution of $35 Billion for Safety Net/Medicaid and CHIP Providers – HHS Attempt to Level the Playing Field

Congressional stimulus packages appropriated $175 billion in relief funds under the CARES Act and the Paycheck Protection Program and Health Care Enhancement Acts for the benefit of hospitals and other healthcare providers in…more

Children's Health Insurance Program (CHIP), Coronavirus/COVID-19, Department of Health and Human Services (HHS), Health Care Providers, Healthcare Facilities

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Amanda Robinson

DOJ and OIG Warn Against Fraud Schemes Related to COVID-19 Pandemic

In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources…more

Coronavirus/COVID-19, Fraud, Medical Supplies, Personal Protective Equipment, Risk Mitigation

See all updates »

Albert Shay

OIG Approves Consultant’s Provision of Gift Cards to Physician Practices

The US Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion No. 23-15 on January 3, which concluded that a consultant’s proposal to provide gift cards to existing…more

Anti-Kickback Statute, Client Referrals, Department of Health and Human Services (HHS), Gift-Cards, Health Care Providers

See all updates »

Angela Silva

OIG Lauds UPIC Program and Recommends Expansion, Additional Targeting of Medicaid Providers

On October 3, the Office of Inspector General (OIG) of the US Department of Health and Human Services issued a report titled “UPICs Hold Promise to Enhance Program Integrity Across Medicare and Medicaid, But Challenges Remain.”…more

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Health Care Providers, Medicaid, Medicare

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Eric Sitarchuk

DOJ and OIG Warn Against Fraud Schemes Related to COVID-19 Pandemic

In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources…more

Coronavirus/COVID-19, Fraud, Medical Supplies, Personal Protective Equipment, Risk Mitigation

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Sydney Swanson

OIG Advisory Opinion: Free Hearing Aids from Cochlear Implant Maker Could Violate Fraud and Abuse Laws

The US Department of Health and Human Services Office of Inspector General (OIG) posted on October 25, 2023 Advisory Opinion No. 23-08, in which OIG rejected a proposed arrangement from a cochlear implant device manufacturer…more

Ambulatory Surgery Centers, Anti-Kickback Statute, Health Care Providers, Healthcare Facilities, Hospitals

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Daniel Tehrani

DOJ and OIG Warn Against Fraud Schemes Related to COVID-19 Pandemic

In managing the quickly evolving healthcare landscape during this current crisis, healthcare companies should be wary of fraudsters who attempt to divert critical resources…more

Coronavirus/COVID-19, Fraud, Medical Supplies, Personal Protective Equipment, Risk Mitigation

See all updates »

Carl Valenstein

CFIUS Issues Final Regulations Under FIRRMA: Healthcare Industry

On January 13, the Committee on Foreign Investment in the United States (CFIUS) published the final rules implementing the Foreign Investment Risk Review Modernization Act (FIRRMA)…more

CFIUS, Covered Transactions, Critical Infrastructure Sectors, Cross-Border Transactions, Final Rules

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Catherine Wang

Tele-Tuesday: Updates to the FCC’s Rural Health Care Program Focus on Telehealth Development

Coming on the heels of the FCC’s recently proposed $100 million Connected Care Program to fund telehealth-based connections between healthcare providers and patients, and continuing its recognition of the critical role…more

Digital Health, FCC, Health Care Providers, Rural Health Care Program, Rural Health Care Providers

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Tesch Leigh West

Medicare Advantage: Managed Care Compliance in 2024

The Medicare program is broken down into four parts. Part A covers the cost of healthcare items and services provided during inpatient hospital stays as well as skilled nursing facility, hospice, and some home health care. Part…more

Centers for Medicare & Medicaid Services (CMS), Fee-for-Service, Health Care Providers, Medicare, Medicare Advantage

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Jonathan York

Manufacturers Should Carefully Evaluate OIG’s Approval of Medicare Cost Sharing Subsidies in Clinical Trials

At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device…more

Clinical Trials, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Life Sciences, Medical Devices

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Howard Young

Hospice Update: March Goes Out Like a Lion

The old adage—March comes in like a lion and goes out like a lamb—didn’t quite hold true for the hospice sector, which experienced a late-month flurry of activity. The government gave the hospice sector a lot to consider, from…more

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Health Care Providers, Hospice, Medicare

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Morgan Lewis - Health Law Scan

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