On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The long-anticipated Final Notice on the TCET pathway...more
On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions. The bill generally revives many of the drug pricing provisions...more
Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms, providing companies that are new to the U.S. market, or looking to launch in the...more
This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more
Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1) emergency services provided by non-participating providers at participating...more
2/17/2021
/ Arbitration ,
Billing ,
Consolidated Appropriations Act (CAA) ,
Cost-Sharing ,
Employee Retirement Income Security Act (ERISA) ,
Health Care Providers ,
Healthcare Reform ,
Internal Revenue Code (IRC) ,
New Legislation ,
Out of Network Provider ,
Out-of-Pocket Expenses ,
PHSA ,
Regulatory Requirements ,
Surprise Medical Bills
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
In a late-night announcement on Friday, 1 November, the Center for Medicare and Medicaid Innovation (CMMI) gave cancer providers the first look at a possible sequel to the Oncology Care Model (OCM).
...more
11/8/2019
/ Bundled Services ,
Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Healthcare Reform ,
Life Sciences ,
Payment Methods ,
Regulatory Agenda ,
Regulatory Requirements ,
Request For Information ,
Rulemaking Process
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
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
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
On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more
10/30/2018
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
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
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
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