Sheree Kanner at Hogan Lovells

Expanded access to telehealth services during the COVID-19 pandemic

In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state Medicaid programs, and private payers have implemented significant changes to...more

4/2/2020 / Coronavirus/COVID-19 , Health Care Providers , Relief Measures , Telehealth , Telemedicine

CMS Radiation Oncology Model proposed rule – summary and early insights

Last week, the Centers for Medicare & Medicaid Services (CMS) announced new details of a proposed bundled payment model for radiation oncology services (RO Model), which would make fundamental (but temporary) changes to the...more

7/19/2019 / Bundled Payments , Cancer , Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Health Insurance , Life Sciences , Medicare , Physician Medicare Reimbursements , Proposed Rules , Rulemaking Process

U.S. Supreme Court ruling expands scope of Medicare notice-and-comment requirement

On 3 June 2019 the U.S. Supreme Court held in Azar v. Allina Health Services that Medicare interpretive guidance must go through notice-and-comment if it establishes or changes a substantive legal standard governing payment,...more

6/10/2019 / Administrative Procedure Act , Azar v Allina Health Services , Department of Health and Human Services (HHS) , Hospitals , Low-Income Issues , Medicare , Medicare Advantage , Medicare Part A , Medicare Part C , Notice and Comment , Pay Reductions , Provider Payments , Reaffirmation , Retroactive Application , SCOTUS , Substantive Rule , Vacated

CMS proposes long-awaited draft guidance on co-located hospitals

On May 3, 2019, the Centers for Medicare & Medicaid Services (CMS) issued draft manual guidance for surveyors evaluating whether hospitals that are co-located with other hospitals (or with other health care entities) meet the...more

5/17/2019 / Centers for Medicare & Medicaid Services (CMS) , Draft Guidance , Healthcare Facilities , Hospitals , Life Sciences , Rulemaking Process

CMS proposes changes to new-technology add-on payment amounts and criteria in the inpatient prospective payment system proposed...

On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020...more

4/29/2019 / Add-ons , Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Life Sciences , Long Term Care Facilities , Medical Devices , Payment Systems , Regulatory Agenda , Request For Information , Rulemaking Process

Medicare further expands payment for and coverage of telehealth and similar services

Through several recently published rules, the Centers for Medicare & Medicaid Services (CMS) is making it possible for Medicare beneficiaries to have greater access to health care services provided remotely through telehealth...more

11/8/2018 / Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Health Information Technologies , Medical Reimbursement , Medicare , Medicare Advantage , Physician Fee Schedule , Telehealth , Telemedicine

HHS watchdog eyes anti kickback safe harbors for care coordination beneficiary incentives and cost sharing

On Monday, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a wide-ranging request for information (RFI) seeking ideas on how it might add or modify safe harbors to the...more

8/29/2018 / Anti-Kickback Statute , Civil Monetary Penalty , CMMI , Comment Period , Cost-Sharing , Department of Health and Human Services (HHS) , Fraud and Abuse , Health Care Providers , Medicare Shared Savings Program , OIG , Request For Information , Safe Harbors , Stark Law

Administration presents plans to lower drug prices

On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. ...more

5/15/2018 / Biosimilars , Comment Period , Competition , Drug Pricing , Life Sciences , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Section 340B , Trump Administration

CMS releases Medicare Advantage/Part D final rule

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released a final rule to revise regulations and clarify program requirements within the Medicare Advantage (MA) and the Prescription Drug Benefit (Part D)...more

4/9/2018 / Biologics , Biosimilars , Cooperative Compliance Regime , Final Rules , Generic Drugs , Medicare Advantage , Medicare Part D , Pharmacies , Rebates , Regulatory Oversight , Star Ratings , Uniformity

Expanded coverage of telehealth

The recently enacted Bipartisan Budget Act of 2018 expands Medicare’s coverage for telehealth services in several ways. Inclusion of these provisions, which had been part of a Senate bill called the CHRONIC Care Act, is...more

3/2/2018 / ACOs , Bipartisan Budget Act , Health Care Providers , Health Information Technologies , Home Health Care , Medicare Advantage , New Legislation , Telehealth , Telemedicine

Bundle Up: CMS Releases Request for Applications for New Version of Bundled Payments for Care Improvement Model

This week, the Centers for Medicare & Medicaid Services (CMS) released details on the much-anticipated new version of the Bundled Payments for Care Improvement (BPCI) payment model, which will be known as BPCI Advanced. Like...more

1/12/2018 / BPCI , Bundled Payments , Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Provider Payments

CMS Proposes Key Changes to the Medicare Advantage Program

On November 16, 2017, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would revise regulations and clarify requirements for the Medicare Advantage (MA) and Medicare Prescription Drug Benefit...more

11/28/2017 / Centers for Medicare & Medicaid Services (CMS) , Cost-Sharing , Medicare , Medicare Advantage , Medicare Part D , Pharmaceutical Industry , Prescription Drug Coverage , Prescription Drugs , Star Ratings

CMS Releases Major MA/Part D Proposed Rule

CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more

11/27/2017 / Biologics , Centers for Medicare & Medicaid Services (CMS) , Generic Drugs , Health Insurance , Medicare , Medicare Part D , Pharmacies , Prescription Drug Coverage , Prescription Drugs

A Path Forward: Corporate Integrity Agreement Sheds Light on Manufacturer Interactions With Independent Charitable Foundations

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more

10/2/2017 / Anti-Kickback Statute , Biologics , Charitable Organizations , Corporate Integrity Agreement , False Claims Act (FCA) , Health Care Providers , Manufacturers , Patient Assistance Programs , Pharmaceutical Industry

Slow but Steady: CMS Proposes to Simplify and Slow Down the Quality Payment Program Rollout

On Tuesday, June 20, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to continue the rollout of the Quality Payment Program (QPP), an initiative to adjust Medicare payments to eligible clinicians...more

6/26/2017 / Alternative Payment Models (APM) , CEHRT , Centers for Medicare & Medicaid Services (CMS) , Electronic Health Record Incentives , Medicare Access and CHIP Reauthorization (MACRA) , MIPS , Quality Payment Program (QPP)

Draft Senate Health Bill Finally Revealed – Vote Could Take Place as Early as Next Week

On June 22, 2017, Republican Senators released a “discussion draft” of the Better Care Reconciliation Act (BCRA). The draft is the first public glimpse at the Senate version of the American Health Care Act bill, which...more

6/23/2017 / Abortion , Affordable Care Act , Employer Mandates , Health Insurance , Health Savings Accounts , Healthcare Reform , Individual Mandate , Medicaid , Proposed Legislation , Repeal , Tax Credits , Trump Administration

US: Governor Cuomo and NY Department of Financial Services Respond to Congressional Efforts to Repeal the Affordable Care Act with...

On 5 June 2017, in response to the Congressional efforts to “repeal and replace” the Affordable Care Act (the ACA), the New York Department of Financial Services (NYDFS) issued a press release entitled “Governor Cuomo...more

6/12/2017 / Affordable Care Act , Health Insurance , Healthcare Reform , Legislative Agendas , NYDFS , Popular , Proposed Legislation , Repeal , Trump Administration

Health Care Reform Bill Clears the House, but Could Hit a Wall in the Senate

On 4 May 2017, the American Health Care Act (AHCA), a bill that would repeal and replace key portions of the Affordable Care Act (ACA), narrowly passed the House of Representatives. The bill, however, faces an uncertain...more

5/8/2017 / Affordable Care Act , American Health Care Act (AHCA) , Cadillac Tax , CBO Report , Essential Health Benefits , Health Insurance , Medicaid , Proposed Legislation , Repeal , Trump Administration

CMS request for information presents rare opportunity for medicare stakeholder engagement

On 14 April 2017, the Centers for Medicare & Medicaid Services (CMS) published the fiscal year (FY) 2018 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective...more

4/24/2017 / Centers for Medicare & Medicaid Services (CMS) , Comment Period , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Long Term Care Facilities , Medicaid , Medicare , Request For Information , Stakeholder Engagement

Calling for Ideas—CMS Releases Final 2018 Medicare Advantage and Part D Rate Announcement and Call Letter

On 3 April 2017, the Centers for Medicare & Medicaid Services (CMS) released its final Medicare Advantage (MA) and Part D Rate Announcement and Call Letter (Call Letter) for calendar year 2018. The Call Letter is part of...more

4/7/2017 / Call Letter , Centers for Medicare & Medicaid Services (CMS) , Cost-Sharing , Health Care Providers , Medicare , Medicare Advantage , Medicare Part D , Opioid , Physician Medicare Reimbursements , Substance Abuse

Republicans Release Much Anticipated ACA "Repeal and Replace" Bill, But Will it Fly Under the Byrd Rule?

On March 6, 2017, House Republicans in the Committee on Ways and Means and the Committee on Energy and Commerce introduced the American Health Care Act (AHCA), a bill that would repeal and replace key portions of the...more

3/9/2017 / Affordable Care Act , Employer Mandates , Health Insurance , Health Savings Accounts , Healthcare Reform , Medicaid , Proposed Regulation , Repeal , Subsidiaries , Tax Credits , Tax Rates , Trump Administration

Trump administration issues proposed health insurance market stabilization rule: Will it be enough to stabilize exchange...

On 15 February 2017, the Centers for Medicare & Medicaid Services (CMS) took a step toward addressing concerns about the stability of the individual and small group health insurance markets by proposing a modicum of...more

2/21/2017 / Affordable Care Act , Centers for Medicare & Medicaid Services (CMS) , Certification Requirements , Comment Period , Employer Group Health Plans , Federal Register , Health Insurance , Health Insurance Exchanges , Insurance Industry , Open Enrollment , Trump Administration , Verification Requirements

Trump Administration Issues Proposed Health Insurance Market Stabilization Rule: Will It Be Enough to Stabilize Exchange...