Meeting Cancer Reporting Requirements
Podcast - Counsel That Cares - The Value of Value-Based Cancer Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 136: Dr. Amy Curtis, Radiation Oncologist, Gibbs Cancer Center & Research Institute
The Rare Air of Elevation Oncology: Raising Nearly $200M in 2 Years, with CEO Shawn Leland
Federal Appeals Court Hears Arguments on CAR T-Cell Therapy Patent Dispute
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The Center for Medicare and Medicaid Innovation (CMMI) is launching a long awaited new oncology model, the Enhancing Oncology Model (EOM). EOM is a successor to the Oncology Care Model (OCM), which ended June 30, 2020 after a...more
On September 18, 2020, under the authority of the Center for Medicare and Medicaid Innovation, CMS finalized the new Radiation Oncology Alternative Payment Model (Model), with a new payment methodology for radiation therapy...more
On January 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a national coverage determination (“NCD”) that authorizes Medicare coverage of next-generation sequencing (“NGS”) as a diagnostic laboratory...more
On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (Innovation Center) released a Request for Information (RFI) on the Oncology Care First (OCF) model. The...more
On October 29, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed decision memo with a national coverage determination (“NCD”) that would allow for Medicare coverage of next-generation sequencing...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
The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...more
On July 10, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare & Medicaid Innovation (Innovation Center) released a much awaited proposal for a new bundled payment model for radiation...more
On July 10, 2019, CMS announced a new proposal for episode-based payment for radiation oncology services. The aim of this new proposal is to determine whether episode-based payment to hospitals, physician groups, and...more
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
Medicare recently released a new national coverage determination (NCD) that addresses certain diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer. NGS technology has made it...more
Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more
• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more
A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more
On Friday, March 16, Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination (NCD) for Next Generation Sequencing (NGS) tests for Medicare beneficiaries with advanced cancer. ...more
The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the...more
The Center for Medicare & Medicaid Innovation first introduced its Oncology Care Model (OCM) last year. OCM went into effect July 1, 2016, and will run through June 30, 2021. The new multi-payer model is the first CMS...more
A bill amending the “site neutrality” limitations brought by Section 603 of the Bipartisan Budget Act of 2015 was introduced in the House of Representatives last week and passed out of committee yesterday. H.R. 5273, the...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more
I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more
Martin Shkreli Not the Big Story on the Hill Last Week - Congress’s complex relationship with prescription drugs was on display last week in the House of Representatives. In the House Committee on Oversight and...more