Arizona passes new law requiring insurers to cover cancer biomarker tests
Arizona has enacted HB 2144 seen here which requires health care insurers, the Arizona Health Care Cost Containment System (AHCCCS) and its contractors to provide coverage for biomarker testing. Prescribes processes and requirements for the usage and coverage of biomarker testing.
Arizona has enacted HB 2144 seen here which requires health care insurers, the Arizona Health Care Cost Containment System (AHCCCS) and its contractors to provide coverage for biomarker testing. Prescribes processes and requirements for the usage and coverage of biomarker testing.
Bills like these are needed as they improve physicians’ abilities to target cancers more accurately which could lead to improved patient outcomes and less healthcare financial waste.
Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our healthcare practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your priorities.
Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.
CMS is Proposing to Delay the Radiation Oncology (RO) Model
Last week the Centers for Medicare & Medicaid Services (CMS) announced its proposal to delay the start of the Radiation Oncology Model. The announcement can be found here. No reason was given but the proposed reimbursement structure was undoubtedly the major reason behind this delay.
Last week the Centers for Medicare & Medicaid Services (CMS) announced its proposal to delay the start of the Radiation Oncology Model. The announcement can be found here. No reason was given but the proposed reimbursement structure was undoubtedly the major reason behind this delay.
So what is the RO Model? According to CMS “The Radiation Oncology (RO) Model aims to improve the quality of care for cancer patients receiving radiotherapy (RT) and move toward a simplified and predictable payment system. The RO Model tests whether prospective, site neutral, modality agnostic, episode-based payments to physician group practices (PGPs), hospital outpatient departments (HOPD), and freestanding radiation therapy centers for RT episodes of care reduces Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries.”
Below are some key elements of the RO Model:
Alternative Payment:
Episode Payments: CMS makes prospective, episode-based (i.e., bundled) payments, based on a patient's cancer diagnosis, that cover RT services furnished in a 90-day episode for the included cancer types meeting the included cancer type criteria described in the final rule;
Site-neutrality: The Model uses site-neutral payment by establishing a common, adjusted national base payment amount for the episode, regardless of the setting where it is furnished;
Professional and Technical Payment Components: Episode payments are split into professional and technical components to allow the current claims systems for the Physician Fee Schedule (PFS) and the Outpatient Prospective Payment System (OPPS) to be used to adjudicate RO Model claims and for consistency with existing business relationships.
Linking Payment to Quality: The Model links payment to quality using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to RO participants. The Model meets the requirements to qualify as an Advanced Alternative Payment Model (APM) and a Merit-Based Incentive Payment System (MIPS) APM under QPP starting in performance year (PY) 1.
RO Participants in a Mandatory Model: The RO Model requires participation from RT providers and RT suppliers that furnish RT services within randomly selected CBSAs.
If you are a radiation oncology stakeholder, this is something to continue to watch.
Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our healthcare practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your priorities.
Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.
Cancer Moonshot Initiative Returns
In 2017 we wrote an article that previewed the Cancer Moonshot Initiative (CMI). It was a widespread belief that with Joe Biden becoming President that the CMI would return in some capacity. Today, the White House issued a Fact Sheet that has reginited this policy effort.
In 2017 we wrote an article that previewed the Cancer Moonshot Initiative (CMI). It was a widespread belief that with Joe Biden becoming President that the CMI would return in some capacity. Today, the White House issued a Fact Sheet that has reignited this policy effort.
According to the White House’s announcement on the reignited CMI, here is what the Initiative is going to focus on:
Re-establish White House Leadership, with a White House Cancer Moonshot coordinator in the Executive Office of the President, to demonstrate the President and First Lady’s personal commitment to making progress and to leverage the whole-of-government approach and national response that the challenge of cancer demands.
Form a Cancer Cabinet, which will be convened by the White House, bringing together departments and agencies across government to address cancer on multiple fronts. These include the Department of Health and Human Services (HHS), Department of Veterans Affairs (VA), Department of Defense (DOD), Department of Energy (DOE), Department of Agriculture (USDA), Environmental Protection Agency (EPA), National Institutes of Health (NIH), National Cancer Institute (NCI), Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), Office of Science and Technology Policy (OSTP), Domestic Policy Council (DPC), Gender Policy Council (GPC), Office of the First Lady (OFL), Office of the Vice President (OVP), Office of Management and Budget (OMB), Office of Legislative Affairs (OLA), Office of Public Engagement (OPE), along with additional members, as needed, to help establish and make progress on Cancer Moonshot goals.
Issue a Call to Action on Cancer Screening and Early Detection:
Build on a White House Cancer Roundtable Conversation Series hosted over the last six months, with experts, including people living with cancer, caregivers, and survivors.
As the industry starts to refocus on initiatives prior to COVID-19, we fully expect issues like precision based medicine, gene therapy, biologics and other cutting edge policy solutions to return front and center as we continue our transition towards a world of value based payment models for improved patient outcomes. This means that many private market initiatives will be implemented in state and federal policies.
Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our life sciences practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
New Louisiana Law Bans White Bagging
The Governor has enacted Act No. 50 effective June 1, which seeks to ban “white bagging” in the state. White bagging is when a drug is delivered from an insurer’s preferred pharmacy to a physician’s office. This new law which is the first of its kind in the country provides that insurers cannot refuse to pay for physician-administered drugs to covered patients. Similar legislation has been seen in Massachusetts, New York and Texas.
The Governor has enacted Act No. 50 effective June 1, which seeks to ban “white bagging” in the state. White bagging is when a drug is delivered from an insurer’s preferred pharmacy to a physician’s office. This new law which is the first of its kind in the country provides that insurers cannot refuse to pay for physician-administered drugs to covered patients. Similar legislation has been seen in Massachusetts, New York and Texas.
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.
FTC Files Administrative Complaint Against Illumina on Market Competition Concerns
This week the Federal Trade Commission filed an administrative complaint to “block Illumina’s $7.1 billion proposed acquisition of Grail—a maker of a non-invasive, early detection liquid biopsy test that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing. Illumina is the only provider of DNA sequencing that is a viable option for these multi-cancer early detection, or MCED, tests in the United States.
This week the Federal Trade Commission filed an administrative complaint to “block Illumina’s $7.1 billion proposed acquisition of Grail—a maker of a non-invasive, early detection liquid biopsy test that can screen for multiple types of cancer in asymptomatic patients at very early stages using DNA sequencing. Illumina is the only provider of DNA sequencing that is a viable option for these multi-cancer early detection, or MCED, tests in the United States.
The complaint alleges the proposed acquisition will diminish innovation in the U.S. market for MCED tests. MCED tests could be used to detect up to 50 types of cancer, most of which are not screened for at all today, saving millions of lives around the world. Grail is one of several competitors racing to develop these liquid biopsy tests, which analyze a sample of a patient’s blood or other fluid through DNA sequencing.”
Furthermore the complaint addressed the effect on the marketplace. The FTC alleged “that even if a viable substitute to Illumina’s NGS platform entered the market, it would take years for MCED test developers to switch to a platform other than Illumina’s because they would have to reconfigure their tests to work with the new NGS platform, and in some situations, conduct new clinical trials.”
Lanton Law is a national boutique regulatory law and lobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.