Alissa Smith on Medicare

U.S. Supreme Court Lifts Injunction Against CMS’ Health Care Facility Vaccine Mandate: What Does This Mean for Your Health Care...

Health care employers are not alone in feeling overwhelmed by the constantly changing legal status of the various federal vaccine mandates. On Thursday afternoon, the Supreme Court made its rulings on two preliminary...more

1/18/2022 / Biden Administration , Biden v Missouri , Centers for Medicare & Medicaid Services (CMS) , Constitutional Challenges , Coronavirus/COVID-19 , Employer Mandates , Health Care Providers , Healthcare Facilities , Interim Final Rules (IFR) , Medicaid , Medicare , National Federation of Independent Business v Department of Labor and OSHA , OSHA , SCOTUS , Stays , Vaccinations , Virus Testing

CMS’ COVID-19 Vaccine Mandate: What Health Care Providers Need to Know

Last week, the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety and Health Administration (OSHA) published their much-anticipated rules mandating COVID-19 vaccinations. ...more

Regulatory Sprint to Coordinated Care

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary...more

11/23/2020 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Healthcare , Hospitals , Medicaid , Medicare , Physicians

Stark Law Blanket Waivers Related to “COVID-19 Purposes” Announced

The COVID-19 pandemic has led to rapid and drastic changes to health care delivery in the United States, including as it relates to arrangements between health care providers and physicians that may implicate the federal...more

4/2/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Health Care Providers , Hospitals , Medicare , Physicians , Stark Law , Waivers

COVID-19 and Provider Enrollment: CMS issues FAQs About the Broad 1135 Waiver

On Monday, March 23, 2020, the Center for Medicare and Medicaid Services (“CMS”) released Frequently Asked Questions on Medicare Provider Enrollment Relief related to COVID-19 (“FAQs”), available here. The recent Public...more

3/27/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Enrollment , Health Care Providers , Licensing Rules , Medicare , Public Health Emergency , Relief Measures , Waivers

CMS Announces Relief for Participants in Quality Reporting Programs in Response to COVID-19

On March 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced in a press release that it is granting exceptions from reporting requirements and extensions for upcoming data submission and measure reporting...more

3/26/2020 / Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Health Care Providers , Hospitals , Medicare , Public Health Emergency , Relief Measures

CMS Finalizes Changes to the Stark Advisory Opinion Regulations; 2020 DHS Code List and CPI-U Updates

In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the...more

11/21/2019 / Advisory Opinions , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Medicare , OIG , Physician Fee Schedule , Physicians , Regulatory Standards , Request For Information , Stark Law

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more

9/10/2019 / Anti-Kickback Statute , Department of Health and Human Services (HHS) , Managed Care Contracts , Medicaid , Medicare , Medicare Part D , OIG , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Proposed Regulation , Safe Harbors

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May...more

7/10/2019 / Advertising , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Lack of Authority , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs , Public Health , Rulemaking Process , Social Security Act , Trump Administration

At Long Last, CMS Issues Proposed Guidance on Hospital Co-Locations

For years, CMS has informally applied restrictions for hospitals which share space, equipment, staff or services in the same physical location (i.e., “co-locate”) with other hospitals or health care entities. Although these...more

5/8/2019 / Centers for Medicare & Medicaid Services (CMS) , Draft Guidance , Health Care Providers , Healthcare Facilities , Hospitals , Medicare

CMS’s New “Primary Cares Initiative” Places Primary Care at the Center of the Shift to Value-Based Care

On April 22, 2019, the Centers for Medicare and Medicaid Services (CMS) announced two sweeping new payment innovation models under the Primary Cares Initiatives. The models will seek to incentivize primary care and other...more

4/26/2019 / ACOs , Alternative Payment Models (APM) , Cardiac Episode Payment Program , Centers for Medicare & Medicaid Services (CMS) , CMMI , Episode Payment Models (EPM) , Fee-for-Service , Health Care Providers , Medicaid , Medicare , Physicians , Request For Information , Value-Based Care

President Trump Gives Speech on Prescription Drug Prices and Releases Blueprint to Lower Drug Prices and Reduce Out-of-Pocket...

On May 11, 2018, President Trump gave his long-awaited speech on his administration’s plan to lower prescription drug prices. In addition, the administration published its Blueprint to Lower Drug Prices and Reduce...more

5/14/2018 / Anti-Kickback Statute , Drug Pricing , Generic Drugs , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Section 340B , Trump Administration

Applying Escobar’s Materiality Standard, Florida Federal Court Reverses $350 Million False Claims Act Verdict against a Nursing...

If the government does not take action and continues to pay for Medicare/Medicaid claims after it learns of non-compliance related to the claims, is the non-compliance material to the government’s decision to pay? This is a...more

1/24/2018 / Conditions of Payment , False Claims Act (FCA) , False Implied Certification Theory , Federal Contractors , Health Care Providers , Implied Certification , Materiality , Medicaid , Medicare , SCOTUS , Universal Health Services Inc v United States ex rel Escobar

CMS To Expand Use of TPE Audits Nationwide by End of 2017

Perhaps lost amid the healthcare news coverage of competing proposals regarding “Medicare for All” and the repeal of Obamacare, the Centers for Medicare & Medicaid Services (“CMS”) last month announced the expansion of its...more

9/19/2017 / Audits , Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , MACs , Medicare , Recovery Audit Contractors (RACs)

OIG issues Advisory Opinion on a Retail Pharmacy’s Paid Membership Program Which Includes Federal Health Care Program...

On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes...more

9/13/2017 / Advisory Opinions , Discounts , Incentive Awards , Medicaid , Medicare , OIG , Pharmacies , Prescription Drugs , Rebates , Retailers

CMS’s 2018 Medicare Physician Fee Schedule Proposed Rule Would Slash Non-Excepted Provider-Based Department Payments

The Centers for Medicare & Medicaid Services (CMS) released its 2018 Medicare Physician Fee Schedule proposed rule on July 13, 2017. The proposed rule, among other things, proposes to cut Medicare payments for services...more

7/21/2017 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Health Care Providers , Medicare , Outpatient Prospective Payment System (OPPS) , Physician Fee Schedule , Physicians , Proposed Rules

Medicare Proposes Continued Relief for Critical Access and Rural Hospitals Through 2-Year Moratorium on Direct Supervision...

On July 13, 2017, CMS released a proposed rule as part of its 2018 Outpatient Prospective Payment System proposals that is aimed at helping to reduce some of the burdens rural hospitals experience in recruiting physicians....more

7/19/2017 / Centers for Medicare & Medicaid Services (CMS) , Hospitals , Medicare , Moratorium , Outpatient Prospective Payment System (OPPS) , Physicians , Proposed Rules , Recruitment Incentives , Rural Health Care Providers , Supervision

Alissa Smith

Dorsey & Whitney LLP

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