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Government Relations

• Bipartisan Group Moves to Expand Access to Diagnostic Radiopharmaceuticals

  Jul 17, 2019 — On July 16, a bipartisan group introduced the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 (HR 3772). The bill would expand patient access to highly targeted, precision diagnostic radiopharmaceuticals that evaluate conditions such as Alzheimer’s disease, Parkinson’s disease, and some cancers—allowing patients to get the right treatment faster and saving taxpayers money.

• USP Publishes General Chapter <825> Effective December 1, 2019

  Jun 5, 2019 — On June 1, the U.S. Pharmacopeia (USP) published General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. This General Chapter provides uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and non-sterile radiopharmaceuticals for humans and animals that occur as part of state-licensed activities.

• NRC Proposes Reductions in Training and Experience Requirements for Administering Radiopharmaceuticals

  May 29, 2019 — The NRC has proposed changes that could reduce the training and experience currently required to administer radiopharmaceuticals for which a written directive is required. SNMMI believes these changes would compromise the safety of patients, their caregivers, and family members. Read more.

• SNMMI's Voice Heard in Medicare Local Coverage Decision

  May 15, 2019 — In the summer of 2018, SNMMI submitted comments to a Medicare Administrative Contractor offering support for SPECT imaging with DaTscan.

• SNMMI Member Hosts Policymakers at Georgetown Hospital

  Apr 30, 2019 — On Thursday April 25th, distinguished SNMMI member Giuseppe Esposito, MD, alongside staff from SNMMI, and MITA hosted congressional staffers at Georgetown Hospital in Washington, DC.

• Courtney Lawhn-Heath Awarded 2019 Henkin Fellowship

  Apr 23, 2019 — SNMMI is pleased to announce that Courtney Lawhn-Heath, MD, has been selected as the recipient of the 2019 Robert E. Henkin Government Relations Fellowship.

• NRC Advisory Committee on Medical Uses of Isotopes Spring Meeting Summary

  Apr 5, 2019 — The Nuclear Regulatory Commission (NRC) held its spring meeting of the Advisory Committee on Medical Uses of Isotopes (ACMUI) on April 3rd and 4th. It addressed several topics of importance to SNMMI, including Part 35, training and experience requirements, and Germanium-68/Gallium-68 Generator Licensing Guidance.

• SNMMI/ASNC Alert: Important Drug Safety Information for Rubidium 82 Generators

  Apr 4, 2019 — Recently, there has been a report of high-level radiation exposure with use of incorrect eluent in Rubidium 82 Rb82 generators after a failure to follow the eluate testing protocol. ASNC and SNMMI members are reminded to use only additive-free, 0.9 % Sodium Chloride Injection, USP (normal saline) to elute the Rubidium 82 Rb82 generator.

• SNMMI Members Host Congressman Loebsack at University of Iowa Hospitals and Clinics

  Mar 18, 2019 — Congressman Loebsack and staff visited the PET and nuclear medicine facilities at the University of Iowa.

• FDA Updates Bulk Drug Substances List with Amino Acid Solutions

  Mar 4, 2019 — On March 1, the U.S. Food and Drug Administration announced updates to the categories of bulk drug substances under its interim policy under section 503B of the Federal Food, Drug, and Cosmetic Act. SNMMI commends the FDA for their swift action to update the 503B Bulk Drugs list, which will ultimately make it easier for manufacturers to compound and make available an arginine/lysine only solution.

• SNMMI-ACNM Submit Comments to NRC on Training and Experience Requirements

  Jan 30, 2019 — SNMMI together with representatives from ACNM provided feedback to the NRC on the training and experience requirements for those who wish to be authorized users of unsealed byproduct material.

• SNMMI Submits Comments to USP on General Chapter <825>

  Dec 6, 2018 — SNMMI submitted comments on USP General Chapter <825> on Friday, November 30th.

• SNMMI Addresses Mo-99 Isotope Shortage

  Nov 19, 2018 — SNMMI, along with several other organizations, signed a letter to the U.S. Department of Energy and the Office of Management and Budget in regards to Mo-99 shortages.

• SNMMI Advocacy Post-Election

  Nov 7, 2018 — A brief summary of yesterday's election results, including milestones achieved, new faces, and how you can get involved.

• NRC Seeks Public Input on Training and Experience Requirements

  Nov 6, 2018 — The Nuclear Regulatory Commission will be holding public meetings to obtain input on training and experience requirements.

• CMS Issues Final 2019 Payment Rules

  Nov 2, 2018 — CMS has released the Physician Fee Schedule and Hospital Outpatient Prospective Payment System final rules.

• SNMMI Needs Your Help – RUC Survey

  Oct 25, 2018 — The American Medical Association (AMA) has an expert panel called the Relative Value Scale Update Committee (RUC), which advocates for accurate valuation of all physician services. If you receive a request from SNMMI to participate in an AMA RUC survey, it is imperative that you participate so your voice can be heard.

• NRC Advisory Committee on Medical Uses of Isotopes Fall Meeting Summary

  Sep 27, 2018 — The Nuclear Regulatory Commission (NRC) held its fall meeting of the Advisory Committee on Medical Uses of Isotopes (ACMUI) on September 20th and 21st. It addressed several topics of importance to SNMMI, including training and experience requirements, nursing mother guidelines, and compounding of sterile and non-sterile radiopharmaceuticals.

• Register today! USP to Host Open Mic Session on <825> Radiopharmaceuticals

  Sep 26, 2018 — USP is hosting an open microphone session Wednesday, October 10th, 2018 to discuss the Proposed General Chapter <825> on radiopharmaceuticals. Registration is currently open and there is no cost to participate.

• SNMMI Comments on 2019 Proposed Hospital Outpatient Rule

  Sep 25, 2018 — SNMMI raises concerns about radiopharmaceuticals being removed from pass-through status for 2019 and other matters.

• BlueCross BlueShield TN Expands Coverage for Cardiac PET

  Sep 24, 2018 — BlueCross BlueShield of Tennessee has expanded Medicare coverage for Cardiac PET.

• Availability of Mo-99

  Sep 11, 2018 — Nuclear reactors in both South Africa and Australia are off-line for unscheduled reasons. Efforts are being made to reduce the impact on patients.

• SNMMI Supports Proposed Coverage Expansion for Cardiac PET

  Sep 10, 2018 — SNMMI backed a proposal to expand coverage of Cardiac PET in Tennessee and suggested that the expansion go further.

• SNMMI Supports Proposed Medicare 2019 Payment Rule for Physicians

  Sep 10, 2018 — SNMMI backed CMS's plan not to reduce payments for two nuclear medicine procedures.

• Aetna Expands Coverage for Gallium-68 DOTATATE

  Aug 16, 2018 — Aetna has changed its policy to expand coverage for Gallium-68 DOTATATE.

• SNMMI Seeks Comments on BlueCross BlueShield of Tennessee's Proposed Changes to PET Coverage

  Aug 15, 2018 — A new BlueCross Blueshield draft coverage policy was released that includes changes to PET oncologic applications.

• SNMMI Encourages FDA to Alleviate Shortage of Gallium-68

  Aug 13, 2018 — SNMMI outlines the shortage of Gallium-68, its causes and suggests ways the FDA could help.

• USP Opens Call for Volunteers to Serve on Expert Committees

  Aug 6, 2018 — The United States Pharmacopeia is in need of qualified volunteers in the areas of chemical medicines, compounding, and other radiopharmaceutical-related fields.

• USP Releases Chapter 825 on Radiopharmaceuticals

  Jul 27, 2018 — A summary of this new chapter on radiopharmaceuticals is provided here. SNMMI had recommended that a new chapter be established and now looks forward to reviewing it and providing comments. Members are also encouraged to submit comments.

• CMS Proposes 2019 Outpatient Payment Rules

  Jul 26, 2018 — CMS's Proposed Hospital Outpatient Rule has been released. Fees are up slightly.

• The NRC Adopts Many of SNMMI's Recommendations in Final Rule on Medical Use of Byproduct Material

  Jul 25, 2018 — NRC releases amendments related to medical event reporting, training and experience, and measuring molybdenum concentration, among other provisions.

• SNMMI Supports Bill Funding Mo-99 Domestic Production

  Jul 19, 2018 — In a letter to the Senate and House subcommittees on Energy and Water Development, SNMMI President Satoshi Minoshima, MD, PhD, joined with leaders of other medical societies, patient groups, radiopharmaceutical manufacturers and distributors, and medical imaging companies to urge support of a provision in both the Senate and House bills that would provide $20 million in additional funding to continue establishing domestic production of Mo-99.

• CMS Proposes 2019 Payment Rule for Physicians

  Jul 13, 2018 — CMS issued its CY 2019 proposed payment policies and payment rates for services furnished under the Medicare Physician Fee Schedule.

• Availability of Mo-99

  Jul 12, 2018 — Nuclear reactors in both South Africa and Australia are off-line for unscheduled reasons. Efforts are being made to reduce the impact on patients.

• SNMMI-ACNM-ASTRO Submit Joint Comments to NRC on Training and Experience Requirements

  Jul 10, 2018 — SNMMI together with representatives from ACNM and ASTRO offered recommendations for potential updates to the Nuclear Regulatory Commission’s requirements for those who wish to be authorized users of unsealed byproduct material.

• SNMMI Opposes Florida Proposal

  Jul 3, 2018 — SNMMI responds to an attempt to withdraw Medicare coverage of DAT-SPECT with Iodine I-123 Ioflupane (DatScan).

• The AMA's RUC and Why It Is Important to You

  Jun 12, 2018 — The American Medical Association (AMA) has an expert panel called the Relative Value Scale Update Committee (RUC), which advocates for accurate valuation of all physician services. If you receive a request from SNMMI to participate in an AMA RUC survey, it is imperative that you participate so your voice can be heard.

• Comments Sent to FDA Regarding Amino Acids Needed During Lu-177 DOTATATE Therapy

  May 29, 2018 — SNMMI, the Mayo Clinic, Washington University School of Medicine in St. Louis, and Memorial Sloan Kettering Cancer Center have jointly filed comments with the FDA with recommendations for regulatory changes that would make it easier for patients with GEP-NETs to obtain arginine and lysine--amino acids that can mitigate side effects of Lu-177 DOTATATE therapy.

• SNMMI Advocates for Improved Reimbursement at CMS Public Meeting

  May 21, 2018 — SNMMI recently advocated on behalf of members and their patients at the Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) workgroup public meeting. Lu-177-dotatate, Ga-68-dotatate, and Fl-18-fluciclovine are all delivered by pharmacies in per-study doses, not per-unit doses; SNMMI requested that CMS modify the coding descriptors for payment accordingly.

• eviCore Adds Coverage for Thyroid Imaging, Cites SNMMI Guideline

  Apr 25, 2018 — eviCore has updated its coding recommendations for whole-body thyroid imaging.

• SNMMI Seeks to Change Aetna's PET Coverage Policy

  Apr 18, 2018 — On March 30, 2018, Aetna issued a revised PET coverage policy that failed to cover Dotatate and Fluciclovine. SNMMI requests that it change these policies.

• Aria Razmaria, MD, Awarded 2018 Henkin Fellowship

  Apr 11, 2018 — SNMMI and the Education and Research Foundation for Nuclear Medicine and Molecular Imaging are pleased to announce that Aria Razmaria, MD, has been selected as the recipient of the 2018 Robert E. Henkin Government Relations Fellowship.

• Medicare Jurisdiction J Transition from Cahaba to Palmetto GBA

  Mar 27, 2018 — On February 23, 2018, Palmetto GBA officially transitioned all Part A and Part B Jurisdiction J providers. SNMMI has concerns about the rate differences with the new policy.

• Partial Relief for High-Value Radiopharmaceuticals in Signed Budget Bill

  Mar 23, 2018 — Buried in the Budget Bill that was just signed into law is a provision that provides some high-value radiopharmaceuticals partial and temporary relief. It also mandates that the Government Accountability Office study the problems with reimbursement for these drugs and report back to Congress.

• SNMMI Seeks Expanded Coverage for NaF PET

  Mar 21, 2018 — SNMMI, the World Molecular Imaging Society (WMIS), and the American College of Radiology (ACR) are recommending that the Centers for Medicare and Medicaid Services (CMS) reconsider the current restrictive coverage policy for NaF PET imaging to identify bone metastases, which can inform treatment strategy.

• Patient Fly-In for Capitol Hill Advocacy: Bill to Reclassify Diagnostic Radiopharmaceuticals as Drugs

  Mar 15, 2018 — Patients advocates with a wide range of health conditions—including neuroendocrine tumors, lymphoma and cancers of the lung, breast, and prostate—flew into Washington, DC, for March 14 meetings on Capitol Hill to urge support for a bill that would require the Centers for Medicare & Medicaid Services (CMS) to reclassify diagnostic radiopharmaceuticals as drugs. Patients rely on the radiopharmaceuticals for diagnosing and monitoring their conditions, as well as guiding therapy.

• NRC Advisory Committee on Medical Uses of Isotopes Spring Meeting Summary

  Mar 13, 2018 — The Nuclear Regulatory Commission (NRC) held its spring meeting of the Advisory Committee on Medical Uses of Isotopes (ACMUI) on March 7 and 8, 2018. It addressed several topics of importance to SNMMI, including worldwide supply and domestic production of Mo-99 and training and experience requirements.

• USP Call for Candidates to Serve as Experts

  Mar 9, 2018 — USP (United States Pharmacopeia) is seeking technical and scientific experts and healthcare practitioners in the pharmaceutical, biologics, and food and dietary supplements industries, academia, regulatory and government sectors to volunteer for USP’s Council of Experts and Expert Committees.

• SNMMI Sends South Africa Letter of Concern About Mo-99 Production Stoppage

  Feb 5, 2018 — SNMMI has concerns that a prolonged shutdown of NTP could impact global availability of Mo-99 and has requested that South Africa prioritize its review and approval for NTP to resume operation.

• SNMMI-TS State Advocacy Update

  Jan 25, 2018 — SNMMI has been working with state Technologist Advocacy Group (TAG) representatives to promote licensure and the new Nuclear Medicine Technologist Scope of Practice and Performance Standards. Read about recent successes and current efforts.

• Nuclear Medicine Community Calls for Funding of Domestic Mo-99 Production

  Dec 11, 2017 — SNMMI and other societies and organizations in the nuclear medicine community have sent joint letters to the U.S. Senate and House chairs and ranking members of the respective Subcommittees on Energy and Water Development of the Committees on Appropriations, voicing support for $67.4 million to secure a sufficient domestic supply of the medical isotope molybdenum-99 (Mo-99).

• SNMMI Submits Comments to NRC on Naturally Occurring and Accelerator-Produced Radioactive Materials

  Nov 14, 2017 — SNMMI has submitted comments to the NRC on its open petition for rulemaking, asking that its regulations be revised to include radionuclides and their corresponding activities to the list of "Quantities of Licensed Material Requiring Labeling."

• SNMMI Commends FDA for Release of Microdose Guidance

  Nov 13, 2017 — SNMMI recently submitted comments to FDA on its draft guidance for microdose radiopharmaceutical diagnostic drugs.

• CMS Issues Final Rules for 2018

  Nov 3, 2017 — Final rules on Medicare for 2018 include the Physician Fee Schedule (PFS), Hospital Outpatient Prospective Payment System (OPPS) and Quality Payment Program (QPP). This is a preliminary summary of how the rules affect nuclear medicine and molecular imaging. There are some tweaks, but no major surprises or changes. For example, the mandate that referring physician consult Appropriate Use Criteria (AUCs) is pushed back from 2018 to 2020.

• Cardiac PET Coverage to be Expanded in Florida

  Nov 1, 2017 — Medicare's contractor in Florida has announced it will expand its coverage for cardiac PET in Florida. The change was requested by SNMMI, ASNC and ACC.

• NOPR Update: Closure of NOPR (NaF-PET) on December 14, 2017

  Oct 17, 2017 — The current NCD and Medicare coverage for NaF-PET (under CED) is due to expire on December 14, 2017 at midnight EST.

• NRC Advisory Committee on Medical Uses of Isotopes Fall Meeting Summary

  Sep 19, 2017 — The Nuclear Regulatory Commission (NRC) held their fall meeting of the Advisory Committee on Medical Uses of Isotopes (ACMUI) on September 11 and 12, 2017.

• SNMMI Sends CMS Comments on Proposed 2018 Hospital Outpatient Payment Regulation

  Sep 11, 2017 — SNMMI recommends improvements in the ways that CMS pays hospital outpatient departments for nuclear medicine and molecular imaging procedures.

• SNMMI Comments on CMS's Proposed Physician Fee Schedule for 2018

  Sep 11, 2017 — In its comment letter on the proposed 2018 Medicare Physician Fee Schedule, SNMMI recommends improvements to how CMS pays physicians for nuclear medicine and molecular imaging procedures.

• Expanded Coverage for Cardiac PET sought for Medicare in Florida

  Jul 21, 2017 — A joint letter from SNMMI, ASNC and ACC was sent to First Coast Service Options, Medicare's Contractor for Florida, Puerto Rico and the Virgin Islands. It recommended expanded coverage for cardiac PET consistent with our recent joint recommendations.

• CMS Proposes 2018 Payment Rules for Outpatient Hospital Procedures and Physicians

  Jul 17, 2017 — CMS's proposals and an initial assessment of them.

• Reducing the Regulatory Burden - SNMMI Comments to CMS

  Jul 13, 2017 — In response to the Administration’s request for recommendations on how to reduce the regulatory burden on physicians SNMMI summited the attached letter making several recommendations such as using specialty-specific quality measures and rewarding physicians with additional training and expertise for their work.

• SNMMI Comments on NRC Patient Release Program

  Jun 10, 2017 — SNMMI submitted comments to the U.S. Nuclear Regulatory Commission (NRC) on its patient release programs.

• USP Plans to Establish New Chapter for Radiopharmaceuticals and Calls for Candidates on Expert Panel

  Jun 2, 2017 — The USP plans to establish a new General Chapter <825> Compounding-Radiopharmaceuticals.

• SNMMI Supports NIH Funding for 2018

  Jun 1, 2017 — SNMMI submits written testimony in support of NIH Funding for 2018.

• 2017 Robert E. Henkin Government Relations Fellowship

  May 31, 2017 — The fellows spent a week in Washington, DC, and gained firsthand knowledge of Capitol Hill and inside federal agencies.

• SNMMI"s Congressional Testimony Supporting NIH Funding

  May 30, 2017 — The Society of Nuclear Medicine and Molecular Imaging has submitted testimony to the Senate Appropriations Committee’s Subcommittee on Labor, Health and Human Services supporting increased funding in 2018 for the National Institutes of Health (NIH). The subcommittee will meet June 9, 2017.

• NRC Advisory Committee on Medical Uses of Isotopes Spring Meeting Summary

  May 25, 2017 — The Nuclear Regulatory Commission (NRC) held their spring meeting of the Advisory Committee on Medical Uses of Isotopes (ACMUI) on April 26 and 27.

• SNMMI Supports NIH Funding

  May 19, 2017 — The President has proposed dramatic reductions in the NIH’s budget for the remainder of 2017 and for 2018. SNMMI joined with many other physician groups in a letter to House leaders supporting increases in NIH funding.

• NIH to Receive Additional $2 billion for 2017

  May 1, 2017 — Under a bipartisan Congressional spending deal reached April 30, 2017, the National Institutes of Health (NIH) will receive an additional $2 billion in funding over the next five months for a total of $34.1 billion. Thank you, SNMMI members who advocated for NIH with your representatives! Your voices made a difference.

• SNMMI Supports NIH Funding for NIH

  May 1, 2017 — SNMMI is working with numerous other groups encouraging Congress to expand NIH funding in 2018.

• Call to Action: Support Funding for the NIH

  Apr 26, 2017 — Dramatic proposed reductions in NIH funding could halt all new medical research. Please contact your Members of Congress and urge them to oppose these reductions and seek increases.

• NRC Seeks Comments on Patient Release Program

  Apr 20, 2017 — The U.S. Nuclear Regulatory Commission (NRC) is requesting comments from the general public on its patient release programs.

• SNMMI Supports NIH Funding

  Apr 17, 2017 — SNMMI joined with many other physician groups in a letter to House leaders supporting increases in NIH funding.

• SNMMI Supports NIH Funding

  Apr 15, 2017 — SNMMI supporting growing funding for NIH in the 2017 budget.

• SNMMI Begins Release of Appropriate Use Criteria for High-Value Nuclear Medicine Procedures

  Apr 6, 2017 — SNMMI has released a new appropriate use criteria (AUC) for bone scintigraphy in prostate and breast cancer, the two most common diagnoses for which bone scans are ordered in the adult population. This is the first in a series of new AUC developed by SNMMI in its role as a qualified provider-led entity (PLE) under the Medicare Appropriate Use Criteria Program for advanced diagnostic imaging.

• SNMMI Submits Comments to FDA on Compounding

  Mar 1, 2017 — SNMMI submitted comments to the FDA on radiopharmaceutical compounding.

• Fast Fact #1: The Joint Commission (TJC)

  Feb 23, 2017 — Did you know that The Joint Commission now requires a technologist to hold the credential of RT(R), RT(N) and/or CNMT in order to perform diagnostic computed tomography procedures?

• USP to Post Second Round of Public Comments for General Chapter <797>

  Feb 16, 2017 — The general chapter <797> on pharmaceutical compounding—sterile preparations will be posted for second round of public comments.

• Ashley Mishoe and Daniel Yokell Chosen as Recipients of the 2017 Henkin Fellowship

  Feb 6, 2017 — SNMMI and the Education and Research Foundation for Nuclear Medicine and Molecular Imaging are pleased to announce that Ashley Mishoe, B.S., Pharm.D., and Daniel L Yokell, Pharm.D., are the recipients of the 2017 Robert E. Henkin Government Relations Fellowship.

• SNMMI Responds to U.S. Travel Restrictions

  Feb 3, 2017 — SNMMI joins many other professional societies in the United States in asking President Trump to rescind his Executive Order restricting entry to America for individuals from certain countries. Read a message from SNMMI President Sally Schwarz, and see her letter to the President.

• SNMMI Submits Comments to NRC on Training and Experience Requirements

  Jan 25, 2017 — The society submitted comments to NRC on training and experience requirements in CFR 10 Part 35.

• FDA Issues Draft Guidances on Compounding and Repackaging Radiopharmaceuticals

  Jan 11, 2017 — The FDA issued two draft guidances that describe FDA’s proposed policies regarding the compounding and repackaging of radiopharmaceuticals for human use by state-licensed nuclear pharmacies or federal facilities, and outsourcing facilities.

• VA scales back proposal on nurses reading imaging studies

  Dec 14, 2016 — The U.S. Department of Veterans Affairs (VA) has scaled back a proposal that would have granted expanded duties to advanced-level nurses within the VA system by removing language that could have allowed nurses to perform and interpret medical imaging studies. SNMMI, as well as other organizations in the imaging community, submitted comments to the VA expressing concern about this potential expansion of nurses’ duties into areas for which they do not have the requisite training.

• SNMMI Develops USP Recommendations for Compounded Sterile Radiopharmaceuticals

  Dec 14, 2016 — SNMMI has developed USP Recommendations for Compounded Sterile Radiopharmaceuticals.

• Passage of the 21st Century Cures Act: What It Means

  Dec 8, 2016 — Both the House and Senate have passed the 21st Century Cures legislation, which President Obama has said he will sign into law.

• House Passes 21st Century Cures Bicameral Compromise

  Dec 1, 2016 — On Wednesday, November 30, the House passed the 21st Century Cures legislation 392-26, sending the sweeping FDA and CMS reform package to the Senate.

• “Pick your Pace” for MACRA Participation

  Nov 30, 2016 — The Centers for Medicare and Medicaid Services (CMS) is rolling out a “Pick Your Pace” system to help clinicians make the transition to a new payment system.

• A Look at the New Administration’s Healthcare Nominees

  Nov 29, 2016 — President-elect Donald Trump’s healthcare nominees are in keeping with his promise to repeal and replace the Affordable Care Act (ACA), as well as to work with Republicans to overhaul Medicare and Medicaid significantly. Trump has selected Republican Representative Tom Price, an orthopedic surgeon from Georgia, to lead the Department of Health and Human Services and Seema Verma—president, CEO and founder of SVC, Inc., a national health policy consulting company—to serve as CMS administrator.

• Updated NMT Scope of Practice and Performance Standards

  Nov 9, 2016 — Minimal changes were made to the NMT Scope of Practice and Performance Standards approved in September 2016.

• CMS Releases CY 2017 HOPPS & MPFS Final Rules - Effective January 1, 2017

  Nov 3, 2016 — CMS released the CY 2017 Final Rules for the Hospital Outpatient Prospective Payment System (HOPPS) and the Medicare Physician Fee Schedule.

• CMS Releases Final Rule for MACRA

  Oct 17, 2016 — The U.S. Centers for Medicare and Medicaid Services (CMS) has released its final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA ends the Sustainable Growth Rate formula for updates to the physician fee schedule, which threatened clinicians participating in Medicare with potential payment cliffs for 13 years. It replaces it with the Quality Payment Program, which rewards the delivery of high-quality patient care.

• Medicare Physician Compare Period Open Through November 11, 2016

  Oct 17, 2016 — Physician Compare allows clinicians and group practices to preview their performance scores for select 2015 Physician Quality Reporting System (PQRS) measures and Consumer Assessment of Healthcare Providers and Systems (CAHPS) for PQRS measures before they are publicly reported on Physician Compare later this year.

• SNMMI Submits Comments on FDA Compounding Draft Guidance

  Oct 13, 2016 — SNMMI has submitted comments to FDA regarding the Draft Guidance for Industry: Insanitary Conditions at Compounding Facilities.

• NRC Advisory Committee on Medical Uses of Isotopes Meeting Summary

  Oct 13, 2016 — The Nuclear Regulatory Commission (NRC) held their fall meeting of the Advisory Committee on Medical Uses of Isotopes (ACMUI) on October 6 and 7.

• FDA Approves New Generator and Elution System

  Oct 3, 2016 — On Friday, September 30, the U.S. Food and Drug Administration approved a New Drug Application for a generator and elution system to produce Rb-82 chloride.

• Nuclear Science Advisory Committee Holds Mo-99 Meeting

  Sep 30, 2016 — The Nuclear Science Advisory Committee (NSAC) is meeting this week to review the progress of the National Nuclear Security Administration’s (NNSA) Molybdenum-99 (Mo-99) program.

• SNMMI Submits Comments to CMS Regarding CY 2017 Proposed Rules for HOPPS and MPFS

  Sep 1, 2016 — The Society recently submitted comments to the Centers for Medicare and Medicaid Services on two proposed rules.

• Imaging Drug Development - FDA Regulatory Issues Presentation Available to Members

  Aug 1, 2016 — The society has been given permission by the Food and Drug Administration to share the "Imaging Drug Development - FDA Regulatory Issues" presentation from SNMMI's 2016 Annual Meeting.

• SNMMI Presents at NRC Stakeholders Meeting

  Jul 27, 2016 — The Society recently presented at a high-level stakeholders meeting on July 26, 2016.

• SNMMI Comments on VA Proposal to Allow Nurses to Perform Imaging Studies

  Jul 22, 2016 — SNMMI submits comments opposing the Department of Veterans Affairs’ (VA) proposed rule to grant advanced practice registered nurses the authority to, among other things, perform imaging services.

• SNMMI Comments on FDA Data Integrity and Compliance with CGMP

  Jul 21, 2016 — The Society of Nuclear Medicine and Molecular Imaging (SNMMI) provided comments on FDA’s draft Guidance Document on Data Integrity and Compliance with CGMP.

• Call to Action: Oppose VA Proposal to Allow Nurses to Perform Imaging Studies

  Jul 18, 2016 — On May 25, 2016, the Department of Veterans Affairs (VA) released a proposed rule to grant advanced practice registered nurses (APRNs) the authority to, among other things, perform advanced imaging services. SNMMI is strongly opposed to the implementation of this section and urges you to submit comments on this matter.

• IDEAS Study Webinar Available for Replay

  Jun 17, 2016 — If you were unable to join the IDEAS study webinar on Tuesday, May 24, it is available for replay. Denise Merlino, CPC, CNMT, reviewed the Medicare billing guidance for the IDEAS study, including the basics of the CPT and HCPCS codes as well as national payment rates based on the varying patient setting.

• NRC Advisory Committee on Medical Uses of Isotopes Meeting Summary

  Mar 31, 2016 — The Nuclear Regulatory Commission (NRC) held their Spring meeting of the Advisory Committee on Medical Uses of Isotopes (ACMUI) on March 17 and 18.

• Thomas Hope and Prashant Jolepalem Chosen as Recipients of the 2016 Henkin Fellowship

  Mar 1, 2016 — SNMMI and the Education and Research Foundation for Nuclear Medicine and Molecular Imaging are pleased to announce that Thomas Hope, MD, and Prashant Jolepalem, MD, CCD, are the recipients of the 2016 Robert E. Henkin Government Relations Fellowship.

• Cardiologist Nominated to Be Head of FDA

  Feb 25, 2016 — On Tuesday February 24, the Obama administration nominated Dr. Robert Califf, a cardiologist and clinical researcher long affiliated with Duke University, to be the commissioner of the Food and Drug Administration.

• SNMMI Comments on USP General Chapter 797 Pharmaceutical Compounding

  Feb 24, 2016 — On February 24, 2016, SNMMI submitted comments to USP on General Chapter 797 Pharmaceutical Compounding - Sterile Preparations.

• The Joint Commission Revises Standards for Diagnostic Imaging Services

  Feb 17, 2016 — On February 16, 2016, the Joint Commission (TJC) approved new Standards for Diagnostic Imaging Services for hospitals, critical access hospitals, and ambulatory care organizations. Effective September 1, 2016.

• SNMMI Submits Comments to NRC on I-131 Patient Release

  Feb 16, 2016 — On Tuesday, February 16, SNMMI submitted comments to the U.S. Nuclear Regulatory Commission (NRC) on a number of issues associated with medical treatment of patients with sodium iodide I–131.

• SNMMI Submits Comments to CMS Regarding CY 2016 Final Rules for HOPPS and MPFS

  Dec 16, 2015 — On Wednesday, December 16, SNMMI submitted comments to CMS on the CY 2016 Final Rules for the Hospital Outpatient Prospective Payment System (HOPPS) and the Medicare Physician Fee Schedule (MPFS).

• USP Call for Candidates: Radioactive Drugs Expert Panel

  Nov 30, 2015 — The US Pharmacopeia (USP) is currently in the process of forming a Radioactive Drugs Expert Panel. The call for members of this Panel is now open and the deadline to apply is December 20th.

• NRC Seeks Information Regarding I-131 Patient Release

  Nov 16, 2015 — The U.S. Nuclear Regulatory Commission is seeking information from the public regarding sodium iodine-131 patient release practices and standards.

• CMS Releases CY 2016 HOPPS & MPFS Final Rules - Effective January 1, 2016

  Nov 11, 2015 — On October 30, CMS released the CY 2015 Final Rules for the Hospital Outpatient Prospective Payment System (HOPPS) and the Medicare Physician Fee Schedule.

• CMS Creates Modifier to Enforce XR-29 Radiation Dose Penalties

  Nov 9, 2015 — The Protecting Access to Medicare Act (PAMA) established radiation dose requirements that will take effect on January 1, 2016.

• USP Seeking Comments on General Chapter Revisions: Deadline approaching!

  Nov 9, 2015 — The US Pharmacopeia (USP) is currently in the process of revising several general chapters that are important to the nuclear medicine community.

• Bipartisan Budget Agreement - Hospital Outpatient Payment Change Included

  Oct 30, 2015 — Lawmakers have negotiated an agreement on a two-year budget package which would lift federal spending caps for two years, increasing discretionary spending by $80 billion.

• SNMMI Submits Comments on CMS Proposed Decision Memo for NaF-18 PET

  Oct 16, 2015 — SNMMI submitted comments to CMS regarding the Proposed Decision Memo on Positron Emission Tomography (NaF-18) to identify bone metastasis of cancer.

• 2nd Call to Action: Nuclear Medicine Reimbursement

  Oct 6, 2015 — You still have time to email your members of Congress. Please urge them to sign the Congressional letters circulating in the House and the Senate regarding the Centers for Medicare and Medicaid Services Hospital 2016 proposed rule for the Outpatient Prospective Payment System (OPPS) no later than Wednesday, October 7. We need to act quickly to make a strong impact in favor of change.

• SNMMI's 2015 Patient Advocacy Hill Day

  Oct 1, 2015 — On Monday, September 28, 2015, SNMMI, patient advocates, and members of the Patient Advocacy Advisory Board, met with 42 Congressional offices for SNMMI's 2015 Patient Hill Day.

• CMS News: MACRA - New Opportunities

  Sep 29, 2015 — CMS released a Request for Information (RFI) to seek public comment related to new provisions in the Medicare Access and CHIP Reauthorization Act of 2015.

• Call to Action: Nuclear Medicine Reimbursement

  Sep 29, 2015 — The Centers for Medicare and Medicaid Services (CMS) has proposed changes to the nuclear medicine Ambulatory Payment Classifications (APCs) in its 2016 proposed rule for the Hospital Outpatient Prospective Payment System (OPPS). The Society of Nuclear Medicine and Molecular Imaging (SNMMI) believes the proposed rule will exacerbate an already existing nuclear medicine reimbursement problem that is impacting patient access and innovation.

• SNMMI Submits Comments to CMS Regarding CY 2016 Proposed Rules for HOPPS and MPFS

  Aug 26, 2015 — On Wednesday, August 26, SNMMI submitted comments to CMS on the CY 2016 Proposed Rules for the Hospital Outpatient Prospective Payment System (HOPPS) and the Medicare Physician Fee Schedule (MPFS).

• CMS & AMA Announce Efforts to Help Providers Prepare For ICD-10

  Jul 7, 2015 — On July 6, CMS and the AMA announced efforts to help providers prepare to transition from ICD-9 to ICD-10 coding.

• CMS Releases the CY 2016 HOPPS Proposed Rule

  Jul 2, 2015 — On July 1, 2015, CMS released the CY 2016 Hospital Outpatient Prospective Payment System proposed rule.

• TJC Seeks Input on Diagnostic Imaging Requirements

  Jun 1, 2015 — TJC seeks input on proposed new and revised diagnostic imaging requirements that address minimum qualifications for technologists who perform diagnostic CT exams in the Ambulatory Care, Critical Access Hospital, and Hospital programs.

• SNMMI Releases Executive Summary from FDA Stakeholder Meeting

  May 20, 2015 — SNMMI finalized its executive summary of the broad FDA Stakeholder meeting held in the fall of 2014.

• 2015 Robert E. Henkin Government Relations Fellowship

  May 6, 2015 — During the week of April 27, SNMMI and the ERF hosted the 2015 Robert E. Henkin Fellows, David Douglas, MD, from the Stanford University School of Medicine and Ben Franc, MD, from the University of California.

• SNMMI Holds 2015 Capitol Hill Day

  May 6, 2015 — On Monday, April 27, SNMMI held it's annual Capitol Hill Day. This year there were 45 participants who met with 62 congressional offices representing 20 states.

• MDP-Bracco™ Discontinued Effective June 1, 2015

  May 5, 2015 — On April 20, Bracco Diagnostics Inc. announced that MDP-Bracco™ will be discontinued, effective June 1, 2015.

• President Signs Legislation to Replace the SGR

  Apr 16, 2015 — On April 16, President Obama signed H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015. This legislation will replace Medicare's SGR formula before CMS begins processing a 21% cut to physician reimbursements.

• SNMMI Submits Comments on Ending Data Collection for NaF-18 PET

  Apr 8, 2015 — SNMMI submitted comments to CMS regarding NOPR's request to reconsider a national coverage policy for positron emission tomography (18F-NaF PET) to identify bone metastasis of cancer.

• Congress Adjourns for Spring Recess Without Passing SGR Legislation

  Mar 30, 2015 — Congress adjourned for their spring recess without passing legislation that would permanently repeal Medicare's sustainable growth rate (SGR) and provide incentives for doctors to focus on value-driven care.

• SNMMI Submits Comments on Compounding

  Mar 27, 2015 — On Tuesday March 24, SNMMI submitted comments to the FDA regarding the distinction between nuclear pharmacy and manufacturing.

• Congress Introduces New SGR Repeal Legislation

  Mar 19, 2015 — Congress has introduced bipartisan, bicameral legislation would permanently repeal Medicare's sustainable growth rate (SGR) and provide incentives for doctors to focus on value-driven care.

• CMS Requests Comments on Ending Data Collection for NaF-18 PET

  Mar 18, 2015 — CMS has solicited public comments regarding NOPR's request to end the prospective data collection requirements under CED for use of NaF-18 PET imaging in intended patient management.

• Deadline Looms for SGR Appeal

  Mar 11, 2015 — With the year-long patch set to expire on April 1, 2015, Congress must pass SGR legislation to prevent a 21 percent pay cut to Medicare physicians.

• Douglas and Franc Chosen as Recipients of the 2015 Henkin Fellowship

  Feb 26, 2015 — SNMMI and ERF are pleased to announce that David Douglas, MD and Benjamin Franc, MD are the recipients of the 2015 Robert E. Henkin Fellowship.

• NRU Reactor Extends Operations Until 2018

  Feb 9, 2015 — The Canadian government has announced that the NRU reactor will extend operations until March 31, 2018.

• SNMMI Comments Regarding DaTscan™

  Jan 30, 2015 — SNMMI submits comments to the DEA regarding their regulation to waive the registration requirements for persons licensed or permitted to administer DaTscan™.

• SNMMI Submits Comments to CMS for CY2015 HOPPS & MPFS Final Rules

  Jan 6, 2015 — SNMMI submitted comments to CMS regarding the CY15 Final Rules for HOPPS and MPFS. Both rules were due no later than 5pm ET on Wednesday, December 31, 2014.

• Election 2014: GOP Wins a Majority in the Senate

  Dec 8, 2014 — Following the November 4 midterm elections, Republicans have gained a majority in the Senate. This gives control of the Senate to the Republicans for the first time since 2006.

• CMS Releases CY 2015 HOPPS & MPFS Final Rules

  Oct 31, 2014 — On October 31, CMS released the CY 2015 Final Rules for the Hospital Outpatient Prospective Payment System (HOPPS) and the Medicare Physician Fee Schedule.

• Highlights of SNMMI’s FDA Stakeholder Meeting

  Oct 30, 2014 — On October 27, 2014, SNMMI hosted a broad stakeholder meeting in Linthicum Heights, Md. The society brought in more than 40 experts from the field of nuclear medicine and molecular imaging to discuss the current regulatory climate.

• SNMMI Submits Comments to TJC

  Oct 17, 2014 — On October 17, SNMMI submitted comments to The Joint Committee (TJC) regarding proposed revisions to diagnostic imaging services.

• Mallinckrodt to Increase Prices

  Oct 13, 2014 — Mallinckrodt informed customers that, due to some of the significant cost drivers that the nuclear medicine industry is experiencing, they will be increasing prices over the next several years.

• Upcoming Freeze on Claims for FDG PET for Solid Tumors

  Oct 6, 2014 — CMS has announced a temporary processing freeze on claims submitted for FDG PET for Solid Tumors between October 6 and November 10.

• CALL TO ACTION - Proposed Changes to TJC Imaging Standards

  Oct 3, 2014 — The Joint Commission has released Proposed Revisions to Diagnostic Imaging Services, which will change the standards that are essential to nuclear medicine and, if approved, could have a detrimental effect on the industry as a whole.

• Update on Kinevac Availability

  Sep 17, 2014 — Bracco Diagnostics Inc. announced that production is moving forward with targeted efforts for Kinevac commercial availability by the end of September.

• Upcoming Webinar: Oncologic PET Coding & Reimbursement

  Aug 20, 2014 — On September 23, 2014, Merlino Health Care Consulting Corp. will hold the webinar "Oncologic PET Coding & Reimbursement, Where Are We Today?"

• NTP to Resume Normal Operations

  Aug 13, 2014 — NTP Radioisotopes has received approval to resume normal operations.

• Scheduled NTP Shutdown Moved Up

  Jul 24, 2014 — Recently, NTP Radioisotopes experienced a minor operational incident at their manufacturing facility, and their Nuclear Regulator instructed them to not proceed with any operation until they had the opportunity to review the situation. NTP moved up their scheduled two week maintenance period to minimize the impact of the current situation.

• Technetium Tc99m Exametazime Injection (Ceretec Kit) Shortage

  Jul 15, 2014 — On July 14, 2014, FDA announced a shortage of Technetium Tc99m Exametazime Injection (Ceretec Kit).

• CMS Releases CY 2015 Medicare Physician Fee Schedule Proposed Rule

  Jul 3, 2014 — On July 3, 2014, CMS issued a proposed rule that would update payment policies and payment rates for services furnished under the MPFS on or after Jan. 1, 2015.

• CMS Releases CY 2015 Hospital Outpatient Prospective Payment System Proposed Rule

  Jul 3, 2014 — On July 3, 2014, CMS released the CY 2015 HOPPS proposed rule.

• CMS Releases Instructions Related to the NCD to End the Coverage with Evidence Development Requirement for FDG PET for Solid Tumors

  Jul 1, 2014 — CMS has released instructions to Medicare Administrative Contractors regarding the processing of claims pursuant to the June 11, 2013 final decision to end the coverage with evidence development (CED) requirement for certain FDG PET studies for solid tumors.

• SNMMI Receives 2014 Creating New Beginnings Award for Donations to Shelter House

  Jun 27, 2014 — On June 24, SNMMI received the 2014 Creating New Beginnings Awards for its donations and efforts to Shelter House, Inc. Representative Gerry Connolly (D-VA) recognized both Shelter House and SNMMI and entered their names into the Congressional Record of the 113th Congress.

• Bracco Provides a Summary on Kinevac Shortage

  May 23, 2014 — Kinevac is anticipated to be commercially available in the third quarter of 2014. Bracco has provided a summary of the most current information about the Kinevac shortage.

• The Joint Commission Postpones Release of New Hospital Requirements

  May 16, 2014 — CMS updated its interpretive guidelines and survey procedures for Medicare Condition of Participation in December 2013. The Joint Commission determined that two standards of performance for deemed status hospitals were needed. The changes will be postponed until July 2015.

• CMS Releases Final Rule Concerning Direct Supervision

  May 8, 2014 — On May 7, 2014, CMS released the Final Rule for Part II Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction. This new rule finalized the previously proposed change of removing the term “direct" from the current requirement at § 482.53(b)(1).

• Bracco Announces that All Remaining Kinevac Inventory has been Depleted

  Apr 29, 2014 — All remaining Kinevac inventory has been depleted, resulting in an “Out of Stock” situation by April 30. Bracco anticipates any remaining customer orders, where product has been allocated and held at their warehouse, may be shipped within the next few weeks. All unfulfilled orders will remain on the back order list.

• SNMMI Releases Q&A Regarding the Price Increase for Macroaggregated Albumin (MAA)

  Apr 23, 2014 — SNMMI has released a Coding Corner Q&A in response to the drastic price increase that went into effect on April 1, 2014 for macroaggregated albumin (MAA).

• Shine Medical Technologies to Supply Moly-99 to GE Healthcare

  Apr 4, 2014 — SHINE Medical Technologies, Inc. announced that it has entered into a strategic long-term supply agreement with GE Healthcare, a division of the General Electric Company, for supply of molybdenum-99 (moly-99).

• Bracco Diagnostics Inc. Launches New CardioGen-82® Website

  Apr 1, 2014 — On April 1, 2014, Bracco Diagnostics Inc. launched a new CardioGen-82® (Rubidium Rb 82 Generator) Website with Enhanced Resources.

• Congress Passes Legislation Linking Physician Payments to Appropriate Use Criteria

  Mar 31, 2014 — On March 31, 2014, the Senate voted to pass H.R. 4302 the Protecting Access to Medicare Act of 2014. This legislation makes permanent changes to how physicians are paid by connecting it to appropriate use criteria.

• Congress Continues Work on SGR Legislation As Deadline Approaches

  Mar 28, 2014 — On March 27, the House passed H.R. 4302, a year-long SGR patch, by voice vote.

• Bracco Releases Status Update on the Commercial Availability of Kinevac

  Mar 28, 2014 — Bracco has a limited supply of Kinevac in inventory. Bracco will continue to partially fulfill back orders aligned with the inventory on hand. An ‘Out of Stock’ situation is anticipated by the end of April.

• NRC Advisory Committee on Medical Uses of Isotopes Names SNMMI Members to Fill Open Seats

  Mar 28, 2014 — The Nuclear Regulatory Commission (NRC) selected two SNMMI members to fill open seats on the Advisory Committee on Medical Uses of Isotopes (ACMUI). They are Vasken Dilsizian, M.D., as Nuclear Cardiologist and Philip Alderson, M.D., as Health Care Administrator.

• Update on Mo-99 Availability

  Mar 27, 2014 — Standing customer orders for Technetium-99m generators should be met throughout April, despite the ongoing Molybdenum-99 (Mo-99) supply challenges faced by the nuclear medicine industry.

• A Limited Supply of Kinevac will be Available - March 21 Update

  Mar 21, 2014 — Bracco has a limited supply of Kinevac in inventory. Customer shipments are underway in an effort to meet patient needs. Bracco will continue to partially fulfill back orders aligned with the inventory on hand.

• A Limited Supply of Kinevac will be Available - March 14 Update

  Mar 14, 2014 — Bracco received a limited supply of Kinevac and has begun shipping product to customers this week. Kinevac inventory will continue to be rationed until such time manufacturing meets a ‘routine’ production schedule and Bracco inventory is replenished.

• A Limited Supply of Kinevac will be Available - March 7 Update

  Mar 7, 2014 — A limited supply of Kinevac will be commercially available and shipped to Bracco. Initially, all back orders will be partially fulfilled. Bracco inventory will continue to be rationed until inventory is replenished.

• JDI Determines a Price Adjustment on MAA and DTPA is Required

  Mar 7, 2014 — Jubilant DraxImage has determined that a onetime market price adjustment on MAA and DTPA is required. This market –wide pricing adjustment will take effect on March 1st 2014 to support ongoing sustainability and continuity of these critical products in the US.

• NRU Reactor Scheduled for Maintenance in April, Disrupting Mo-99 Supply

  Feb 28, 2014 — The NRU reactor is scheduled for one month of maintenance starting April 13. Mo-99 supply will be disrupted during this time.

• Bracco Releases Status Update on the Commercial Availability of Kinevac

  Feb 28, 2014 — On February 28, Bracco released an update on their work with manufacturers and governmental agencies regarding Kinevac commercial availability.

• Update on Mo-99 Availability

  Feb 25, 2014 — Standing customer orders for Technetium-99m generators should be met throughout March, despite the ongoing Molybdenum-99 (Mo-99) supply challenges faced by the nuclear medicine industry.

• CMS Releases Instructions on the NCD for Beta Amyloid PET in Dementia and Neurodegenerative Disease

  Feb 24, 2014 — CMS has released instructions to contractors related to its National Coverage Determination for Beta Amyloid PET in Dementia and Neurodegenerative Disease.

• DOE Releases Funding Opportunity Announcement for Nuclear Medicine Research

  Feb 12, 2014 — The Department of Energy released a funding opportunity announcement (FOA) for targeted radiochemistry and associated technology development for integrated nuclear medicine research and training with human application.

• PCORI’s $90 Million Call for Pragmatic Studies Proposals Focuses on Topics of Particular Interest to Specialties

  Feb 11, 2014 — The Patient-Centered Outcomes Research Institute (PCORI) is making up to $90 million available to support a series of large pragmatic clinical studies designed to advance patient-centered outcomes research under “real world” conditions. A webinar is scheduled for February 28 from 2:30pm-3:30pm. Applicants must submit letters of intent no later than 5 p.m. Friday, March 7 for the funding.

• Congress Introduces Legislation to Replace the SGR

  Feb 6, 2014 — House and Senate leaders have introduced bipartisan legislation to replace the SGR.

• SNMMI Submits Comments to CMS on CY 2014 HOPPS & MPFS Final Rules

  Jan 29, 2014 — On January 27, SNMMI submitted comments to CMS on the CY 2014 HOPPS & MPFS Final Rules.

• Update on Mo-99 Availability

  Jan 27, 2014 — The ongoing Molybdenum-99 (Mo-99) supply challenges faced by the nuclear medicine industry remain in effect.

• BRAIN Initiative Adds Imaging Funding

  Jan 23, 2014 — The BRAIN Initiative at NIH will now include funding for advanced imaging projects. The deadline is March 13, 2014.

• President Signs Omnibus; Includes $5 Million for Nuclear Medicine Research

  Jan 21, 2014 — President Obama has signed the $1 trillion omnibus spending bill, which includes $5 million for nuclear medicine research with human applications.

• Status Update on NTP’s Radiochemical Production Facility

  Jan 16, 2014 — NTP Radiochemical production facility expects to be at full production at the beginning of February 2014.

• Updated NMT Scope of Practice and Performance Standards

  — Minimal changes were made to the NMT Scope of Practice and Performance Standards approved in June 2017.