November 6, 2019
On November 5, the U.S. Food and Drug Administration (FDA) announced that the FDA's office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed as part of modernization plans approved in September 2019.
The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been reorganized and renamed the Office of Oncologic Diseases (OOD).
Richard Pazdur, M.D., who joined the FDA in 1999 as director for the Division of Drug Oncology Products and became the OHOP Director in 2005, is the acting director of OOD. Read FDA press release .
Posted 11/06/2019
November 5, 2019
On Nov. 5, Sandoz, a Novartis division, announced U.S. Food and Drug Administration (FDA) approval of the company's biosimilar Ziextenzo TM (pegfilgrastim-bmez).
Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Read company press release .
Posted 11/5/2019
November 4, 2019
Late Friday, Nov. 1, the Center for Medicare and Medicaid Innovation (the Innovation Center) released an informal Request for Information (RFI) , on value-based payment to support high-quality oncology care. In the Nov. 1 announcement the Innovation Center stated they hope to gather feedback during today's Public Listening Session that will outline a potential Oncology Care First (OCF) Model.
The Innovation Center stated Friday at the Nov. 4 Public Listening Session and in submitted written feedback, they hope to solicit stakeholder input on the following targeted topics:
We invite feedback on the interest of physician group practices (PGPs) and hospital outpatient departments (HOPDs) in participating in a potential OCF Model. We are particularly interested in hearing from PGPs and HOPDs about the conceptualized participation eligibility parameters (e.g., the grouping concept), and whether they think that meeting those parameters would be feasible. We also invite feedback from potential payer partners, including commercial payers and state Medicaid agencies. We welcome suggestions about the model concept that would better incentivize participation in the potential model.CMMI Public Listening Session on Potential Oncology Payment ModelMonday, Nov. 4, 20191:00 to 4:00 PMEST
Registration for the Public Listening Session is required. There are three ways to participate: in person, via livestream video, or via teleconference. REGISTER HERE .
Posted 11/04/19
November 1, 2019
On Friday, Nov. 1, the Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2020 Hospital Outpatient Prospective Payment System (OPPS) rule (CMS-1717-FC) and the final CY 2020 Physician Fee Schedule (PFS) and Quality Payment Rule (CMS 1715-F).
The CMS CY 2020 OPPS fact sheet states that: As finalized in last year’s rule, CMS is completing the two-year phase-in of the method to reduce unnecessary utilization in outpatient services by addressing payments for clinic visits furnished in the off-campus hospital outpatient setting.
And further states: We acknowledge that the United States District Court for the District of Columbia vacated the volume control policy for CY 2019 and we are working to ensure affected 2019 claims for clinic visits are paid consistent with the court’s order. We do not believe it is appropriate at this time to make a change to the second year of the two-year phase-in of the clinic visit policy. The government has appeal rights, and is still evaluating the rulings and considering, at the time of this writing, whether to appeal from the final judgment.340B Drug Pricing Program
The CMS 2020 OPPS final rule fact sheet states that: For CY 2020, CMS is finalizing its proposal to continue to pay an adjusted amount of ASP minus 22.5 percent for separately payable drugs or biologicals that are acquired through the 340B Program. In the proposed rule, CMS acknowledged that the CY 2018 and 2019 OPPS payment policies for 340B-acquired drugs are the subject of ongoing litigation, and the agency is currently appealing the decision in the United States Court of Appeals for the District of Columbia Circuit.Access full CMS Fact Sheet on the CY 2020 OPPS final rule . Access the CY 2020 OPPS final rule here . CY 2020 Physician Fee Schedule (PFS) and Quality Payment Rule
The CMS fact sheet on the final CY 2020 PFS and Quality Payment rule states that: . . . we are aligning our E/M coding with changes adopted by the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel for office/outpatient E/M visits. The CPT coding changes retain 5 levels of coding for established patients, reduce the number of levels to 4 for office/outpatient E/M visits for new patients, and revise the code definitions. The CPT code changes also revise the times and medical decision making process for all of the codes, and requires performance of history and exam only as medically appropriate. The CPT code changes also allow clinicians to choose the E/M visit level based on either medical decision making or time.Physician Supervision Requirements for Physician Assistants
In its 2020 PFS file rule fact sheet, the agency states: We are updating our regulation on physician supervision of PAs to give PAs greater flexibility to practice more broadly in the current health care system in accordance with state law and state scope of practice. In the absence of any state rules, CMS is finalizing a revision to the current supervision requirement to clarify that physician supervision is a process in which a PA has a working relationship with one or more physicians to supervise the delivery of their health care services. Such physician supervision is evidenced by documenting the PA’s scope of practice and indicating the working relationship(s) the PA has with the supervising physician(s) when furnishing professional services.Access the CMS 2020 PFS final rule fact sheet . Access the 2020 QPP Final Rule Fact SheetAccess the CMS 2020 PFS final rule here .
ACCC's policy team is analyzing these final rules and will provide more in-depth information to members soon.
Posted 11/01/2019
October 24, 2019
On October 23, 2019, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.
The FDA also approved the Myriad myChoice CDx test for determination of tumor HRD status to select patients for niraparib. Read the FDA announcement . Access information on FDA-approved test for detection of deleterious or suspected deleterious BRCA mutation and/or genomic instability for this indication.
Posted 10/24/2019
October 24, 2019
Congressional bipartisan legislation to address surprise medical billing (H.R. 3502) has received 102 cosponsors . The bill, Protecting People From Surprise Medical Bills Act was introduced Raul Ruiz, MD, (D-Calif.) and Phil Roe, MD, (R-Tenn.). The legislation would end the practice of unexpected healthcare bills by implementing independent dispute resolution. This process would require neutral arbitrated resolution on the billing cost between insurers and providers.
Posted: 10/25/2019
October 23, 2019
According to a new study from The Leukemia & Lymphoma Society (LLS), 59 percent of blood cancer patients enrolled in traditional Medicare do not start active treatment within three months of their diagnosis. While there are multiple reasons for delayed treatment starts or the decision to forego treatment, the study shows that patients receiving treatment for blood cancers may face the burden of high out-of-pocket costs.
The study from Milliman, conducted on behalf of LLS, examines factors driving healthcare system costs and affecting patients. LLS released the study on Oct. 21.
Read The Cost Burden of Blood Cancer in Medicare .
Posted: 10/23/2019
October 23, 2019
The National Academy of Medicine (NAM) has released a consensus study, Taking Action Against Clinician Burnout: A Systems Approach to Supporting Professional Well-Being , that is a call to action for healthcare organizations and educational institutions training health professionals, government, and industry to significantly improve clinical work and educational environments for all disciplines "to prevent and mitigate clinician burnout and foster professional well-being for the overall health of clinicians, patients, and the nation."
The report sets out six goals and recommended system-wide actions to speed progress on burnout prevention and mitigation:
1. Create positive work environments work that prevent and reduce burnout, foster professional well-being, and support quality care.
2. Create positive learning environments that prevent and reduce burnout, foster professional well-being, and support quality care.
3. Reduce administrative burden on clinicians that stem from a host of sources including legislation, policy, and an increasing requirements of accrediting and standard-setting entities.
4. Optimize the use of technology to support clinicians in providing high-quality care.
5. Provide support to clinicians and learners to alleviate symptoms of burnout.
6. Invest in research on clinician professional well-being. Read the report recommendations . Read report highlights . Access the full report .
Posted 10/23/2019
October 17, 2019
The Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) has announced a Public Listening Session on Potential Future Oncology Payment Model . Through the session CMMI seeks to gather feedback on value-based payment to support high-quality oncology care. According to the announcement, CMMI plans to release additional materials before the Nov. 4, 2019, Public Listening Session, and will announce when additional materials have been posted to the Innovation Center website .
CMMI Public Listening Session on Potential Oncology Payment ModelMonday, Nov. 4, 20191:00 to 4:00 pmEST
Hubert H. Humphrey Building (Great Hall)
200 Independence Avenue,
SW Washington, DC Registration for the Public Listening Session is required. There are three ways to participate: in person, via livestream video, or via teleconference.
Posted 10/17/2019
October 10, 2019
The Association of Cancer Care Centers together with the the Oncology Nursing Society, Friends of Cancer Research, the LUNGevity Foundation, and other oncology stakeholder organizations have joined in comments to the Centers for Medicare & Medicaid Services (CMS) regarding changes to the Laboratory Date of Service Policy (also known as the 14-day rule) included in the CY 2020 Hospital Outpatient Prospective Payment System proposed rule.
The letter urges the agency not to finalize policy proposals that would reinstate barriers for Medicare beneficiaries that effectively limit or eliminate access to advanced diagnostics in a timely manner. Read comment letter.
Posted 10/10/19
October 7, 2019
On Monday, the Nobel Assembly announced the Nobel Prize in Physiology or Medicine would be jointly awarded to William G. Kaelin Jr., of the Dana-Farber Cancer Institute and Harvard University; Peter J. Ratcliffe of Oxford University and the Francis Crick Institute; and Gregg L. Semenza , of Johns Hopkins University. The three scientists are being honored for their work in revealing how cells manage responses to changes in oxygen levels. The results of their work have implications for treating a number of diseases, including cancer, anemia, heart attacks, and stroke.
Posted 10/7/2019
September 30, 2019
On Friday, September 27, the Association of Community Cancer Centers (ACCC) provided comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed calendar year 2020 Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS) rules.
CMS is expected to release the final CY 2020 Medicare payment rules in early November.
Read ACCC's comments to the proposed CY 2020 OPPS rule .
Read ACCC's comments to the proposed CY 2020 PFS rule .
Posted 9/30/2019
September 26, 2019
On September 26, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT). Read FDA announcement .
Posted 9/26/2019
September 24, 2019
Exact Sciences Corp. announced September 23 that the U.S. Food and Drug Administration (FDA) has approved the company's non-invasive colorectal cancer (CRC) screening test, Cologuard, for eligible average-risk individuals ages 45 and older, expanding on its previous indication for ages 50 and older. Read corporate press release .
Posted 9/24/2019
September 23, 2019
On September 16, the Association of Cancer Care Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed Radiation Oncology (RO) Model rule .
In its comment letter, ACCC expresses committed support for the movement toward value-based care, noting that ACCC members have long been leaders in developing and participating in value-based payment systems.
As CMS looks to finalize a model for radiation oncology, ACCC urges the agency to:
Read ACCC's comment letter .
Posted 9/23/2019
September 19, 2019
On Sept.19, House Speaker Nancy Pelosi introduced her much-anticipated government price negotiation plan that would empower the U.S. Department of Health and Human Services (HHS) to negotiate drug prices that would apply to all payers. A summary of the revised bill includes one major change from a draft plan (leaked on Sept. 9): the final version instructs HHS to negotiate prices on drugs without generic or biosimilar competition. Price negotiation would apply to drugs with no competition that are among the top 250 most costly drugs to Medicare and the U.S. health system. Under Pelosi's plan, the negotiated prices would be available to all payers, including commercial payers, and HHS would be required to negotiate a minimum of 25 drugs per year. (The earlier draft plan included price negotiation on drugs with less than two competing two competing generics or biosimilars.)
Pelosi's plan also proposes a $2,000 out-of-pocket cap on prescription drugs for Medicare beneficiaries and disabled individuals.
The House Energy & Commerce Committee's Health Subcommittee is scheduled to hold a hearing on drug pricing legislation next week on Wednesday, Sept 25.
Sources: InsideHealth Policy; NPR Posted: 9/19/2019
September 18, 2019
On September 17, 2019, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada, Janssen Biotech, Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer. Read FDA announcement .
Posted 9/18/2019
September 13, 2019
The U.S. Food and Drug Administration (FDA) has announced new webpage on respiratory illnesses associated with use of vaping products.
Both FDA and the U.S. Centers for Disease Control (CDC) are working to investigate incidents of severe respiratory illness associated with use of vaping products.
While federal and state health officials work to identify more information about the products used, where they were obtained and what substances they contain is ongoing, the FDA has some information that consumers can use to help protect themselves. Access the FDA information .
Posted 9/13/2019
August 30, 2019
The Centers for Medicare & Medicaid Services (CMS) Aug. 30 announced efforts underway to support Florida in response to Hurricane Dorian. Health and Human Services Secretary Alex Azar declared a public health emergency in the state. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of Hurricane Dorian. CMS will be waiving certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare quickly; and taking steps to ensure dialysis patients obtain critical life-saving services.
Below are key administrative actions CMS will be taking in response to the public health emergency declared in Florida:
Waivers and Flexibilities for Hospitals and other Healthcare Facilities: CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. CMS will also issue a number of blanket waivers, listed on the website below, and the CMS Regional Office will grant other provider-specific requests for specific types of hospitals and other facilities in Florida. These waivers work to provide continued access to care for beneficiaries. More information is available here .
Special Enrollment Opportunities for Hurricane Victims: CMS will make available special enrollment periods for certain Medicare beneficiaries and individuals seeking health plans offered through the Federal Health Insurance Exchange. This gives people impacted by the hurricane the opportunity to change their Medicare health and prescription drug plans and gain access to health coverage on the Exchange if eligible for the special enrollment period. More information available here and here .
Disaster Preparedness Toolkit for State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. Access more information and the toolkit .
Dialysis Care: CMS is helping patients obtain access to critical life-saving services. The Kidney Community Emergency Response (KCER) program has been activated ahead of the storm and is working with the End Stage Renal Disease (ESRD) Network of Florida, ESRD NW7, to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility, the ESRD NW hotline number, and contact information of those with whom they may stay or for out-of-state contacts in a water proof bag. They have also been instructed to have on hand supplies to follow a three-day emergency diet. The ESRD NW7 toll-free hotline is 800-826-3773 and the KCER hotline is 866-901-3773. Additional information is available on the KCER website .
Medical equipment and supplies replacements: CMS will be temporarily suspending certain requirements necessary for Medicare beneficiaries who have lost or realized damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. This will help to make sure that beneficiaries can continue to access the needed medical equipment and supplies they rely on each day. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.
Suspension of Enforcement Activities: CMS will suspend current survey and enforcement activities for healthcare facilities in Florida, but will continue to investigate allegations of immediate threat to patient health and safety.
Ensuring Access to Care in Medicare Advantage and Part D: During a public health emergency, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.
Posted 8/30/2019
August 20, 2019
The U.S. Preventive Services Task Force has updated its Recommendation Statement on BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing . The full recommendation is published online in the Aug. 20 issue of JAMA .
The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with breast cancer susceptibility 1 and 2 ( BRCA1/2 ) gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing.
The USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations.
Read the Recommendation Statement on the USPSTF website .
Posted 8/20/2019
August 16, 2019
On August 16, 2019, the Food and Drug Administration approved fedratinib (Inrebic, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
The prescribing information for fedratinib includes a Boxed Warning to advise healthcare professionals and patients about the risk of serious and fatal encephalopathy, including Wernicke’s encephalopathy. Healthcare professionals are advised to assess thiamine levels in all patients prior to starting fedratinib, periodically during treatment, and as clinically indicated. If encephalopathy is suspected, fedratinib should be immediately discontinued and parenteral thiamine initiated. Read FDA announcement .
Posted 8/16/2019
August 16, 2019
Roche announced August 16 that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).
The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. Read corporate press release .
8/16/2019
August 7, 2019
On August 7, the Centers for Medicare & Medicaid Services (CMS) released the finalized National Coverage Determination for FDA-approved Chimeric Antigen Receptor T-cell (CAR T-cell) Therapy . FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.
Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia .
The NCD continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.
In announcing the NCD, CMS notes that outcomes data for CAR T-cell therapy in the Medicare population are "relatively limited," and states that "CMS will leverage information obtained from the FDA’s required post-approval safety studies for CAR T-cell therapies to the fullest extent possible." Read the CMS Decision Memo.Download CMS Decision Memo.
Posted 8/07/2019
August 1, 2019
On August 1, the National Comprehensive Cancer Network (NCCN) announced release of new NCCN Guidelines for Small Bowel Adenocarcinoma . These are the first clinical guidelines in the U.S. to address this rare but growing cancer type, which is sometimes associated with hereditary causes like Lynch syndrome.
NCCN also recently released Updated NCCN Guidelines for Genetic/Familial Risk Assessment: Colorectal Cancer and Colorectal Cancer Screening, which clarify how to use genetic testing and screening to detect cancer in high-risk individuals at an earlier stage. Read NCCN press release.
Posted 8/1/2019