ONCOLOGY NEWSFEED

On Dec. 18, 2019, President Trump, along with the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA), issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow states to import certain prescription drugs from Canada. In addition, the administration announced a new draft guidance for industry that allows drug manufacturers to important their own prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.

The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. ( FDA's Safe Importation Action Plan .)

Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register . Read the HHS press release . Read Importation of Prescription Drugs Proposed Rule . Read new draft guidance for industry .

On Dec. 16, 2019, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC).

FDA previously approved enzalutamide for patients with castration-resistant prostate cancer. Read the FDA announcement .

Posted 12/17/2019

On Dec. 16, 2019, a spokesperson for the Centers for Medicare & Medicaid Services (CMS) issued the following statement:

"In an abundance of caution, to accommodate consumers who attempted to enroll in coverage during the final hours of Open Enrollment but who may have experienced issues, starting at 3:00 PM EST today, December 16 we are extending the deadline to sign up for January 1 coverage until 3:00 AM EST December 18."

The website and the call center were open for business on Sunday, December 15, CMS says. However, due to the high volume of consumers (more than half a million) calling to enroll in health insurance on the exchange, some consumers were asked to leave their name at the call center. The agency states: "Those consumers who have already left their contact information at the call center do not need to come back and apply during this extension because a call center representative will follow up with them later this week.” Read CMS statement on Health Insurance Exchange Open Enrollment Extension .

Posted 12/16/2019

On Dec. 12, 2019, the U.S. Senate voted to confirm radiation oncology Stephen Hahn, MD, FASTRO, as the next Commissioner of the U.S. Food and Drug Administration (FDA).

Posted 12/12/2019

On Dec. 11, 2019, Inside Health Policy reported that the Centers for Medicare & Medicaid Services (CMS) "plans to repay hospitals that sued over 2019 pay cuts from the agency’s so-called site-neutral policy. The agency has also updated the 2019 pay rates for clinic visits at certain off-campus hospital facilities to remove the cut in light of a federal court decision that said the agency didn’t have the authority to implement it."

In September 2019, a Federal Washington, D.C., District Court judge found that CMS exceeded its authority in introducing these cuts in the 2019 Hospital Outpatient Prospective Payment System (HOPPS) rule. Several stakeholder organizations filed suit against CMS in response to the final 2019 (HOPPS) rule's provision that established a new reimbursement rate for off-campus hospital outpatient department clinic visits that aligned the payment rate with that under Medicare's Physician Fee Schedule. The 2019 HOPPS rule extended these payment cuts to providers that were specifically exempted from these site-neutrality reimbursement reductions by the Bipartisan Budget Act of 2015. Inside Health Policy reports that the "American Hospital Association, Association of American Medical Colleges and others that sued CMS over the cuts say in a Dec. 9 court notice that some hospitals 'recently received payments for claims processed over the past few weeks at the pre-2019 OPPS Rule payment rates for challenged services.' "Inside Health Policy further reports that: "the [court] notice says that hospitals haven’t been reimbursed for claims from previous months in 2019 and the government has not 'receded from its stated intention to continue to implement in 2020 the same plan this court already vacated.' "

CMS told Inside Health Policy that it began paying hospitals the higher reimbursement rate as of Nov. 4, and that Medicare Administrative Contractors will reprocess claims previously subject to the cut during the first few months of 2019.

ACCC's policy team will provide more information when it becomes available. Posted 12/12/2019

On Dec. 10, 2019, the American Society for Radiation Oncology (ASTRO) issued a new clinical guideline on the use of radiation therapy to treat patients diagnosed with basal cell and cutaneous squamous cell carcinomas (BCC, cSCC). The guideline suggests dosing and fractionation for these treatments.

An executive summary and full-text version of ASTRO's first guideline for skin cancer are published online in Practical Radiation Oncology . Read ASTRO press release .

Posted 12/10/2019

On Dec. 4, 2019, the National Comprehensive Cancer Network (NCCN) announced publication of updated genetic risk assessment recommendations for breast, ovarian and pancreatic cancers. Updates to the NCCN Clinical Practice Guidelines in Oncology ( NCCN Guidelines ) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic Version 1.2020 include new and expanded sections on risk assessment and management related to these cancer types, but retains a conservative approach toward testing practices where evidence is still lacking. Read NCCN press release .

Posted 12/6/2019

On Dec. 3, 2019, the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane ^® [paclitaxel protein-bound; nab -paclitaxel] and carboplatin) for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Read the corporate announcement . Read FDA announcement.

Posted 12/04/2019; updated 12/06/2019

On Thursday, Dec. 5 the Association of Cancer Care Centers (ACCC) will host a members-only webinar on the Centers for Medicare & Medicaid Services (CMS) CY2020 Hospital Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) final rules.

ACCC's summaries of the CY 2020 OPPS final rule MPFS final rule are available here [login required].

WebinarCMS CY2020 OPPS & PFS Final Rules: What You Need to KnowThursday, December 5, 20192:00 – 3:00 PM EST

REGISTER HERE . [Login required]

Posted 11/27/2019

On Nov. 8, 2019, the U.S. Food and Drug Administration (FDA) granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Beta thalassemia, also called “Cooley’s anemia,” is an inherited blood disorder that reduces the production of hemoglobin, an iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue and more serious complications. Supportive treatment for people with beta thalassemia often consists of lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. People with beta thalassemia are also at an increased risk of developing abnormal blood clots. Read the FDA announcement .

Posted 11/25/2019

Nov. 21, 2019, the U.S. Food and Drug Administration (FDA) - as part of Project Orbis , a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada - granted supplemental approval to acalabrutinib (Calquence ) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy. Read FDA announcement . Read AstraZeneca corporate press release .

Posted 11/21/2019
Re-posted 11/26/2019

The Centers for Medicare & Medicaid Services (CMS) Medicare Learning Network is holding a call on the final Hospital Price Transparency Final Rule on Dec. 3, from 1:30 - 3:30 PM EST.

Register here.

During this call, learn about provisions in the final rule effective Jan.1, 2021, including:

• Requirements for making public all standard charges for all items and services in a machine-readable format
• Requirements for displaying shoppable services in a consumer-friendly manner
• Monitoring and enforcement

A question and answer session follows the presentation. CMS encourages participants to review the fact sheet and final rule prior to the call. Posted: 11/21/2019

On Nov. 15, the Centers for Medicare & Medicaid Services (CMS) issued two rules that aim to increase price transparency and increase competition among all hospitals, group health plans, and health insurance issuers in the individual and group markets. The agency finalized the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public rule, and issued the Transparency in Coverage Proposed Rule. Both rules (final and proposed) require that pricing information be made publicly available.

The final "Price Transparency Requirements for Hospitals to Make Standard Charges Public" rule will require hospitals to make their standard charges public in two ways starting in January 1, 2021 :

• Comprehensive Machine-Readable File: Hospitals will be required to make public all hospital standard charges (including the gross charges, payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient, and the minimum and maximum negotiated charges) for all items and services on the Internet in a single data file that can be read by other computer systems. The file must include additional information such as common billing or accounting codes used by the hospital (such as Healthcare Common Procedure Coding System (HCPCS) codes) and a description of the item or service to provide common elements for consumers to compare standard charges from hospital to hospital.
• Display of Shoppable Services in a Consumer-Friendly Manner: Hospitals will be required to make public payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient for an item or service, and the minimum and maximum negotiated charges for 300 common "shoppable services" in a consumer-friendly way and update the information at least annually.

CMS fact sheet on final rule . Access final rule .

CMS states that the proposed "Transparency in Coverage" rule is issued in response to an Executive Order dated June 24, 2019. The Department of Health and Human Services, the Department of Labor, and the Department of the Treasury are collectively issuing the proposed rule. As written, the rule would require that most employer-based group health plan and health insurance issuers provide up-front disclosure of price and cost-sharing information to participants, beneficiaries, and enrollees.

If finalized, the "Transparency in Coverage" proposed rule would require health plans to:

• Provide consumers with real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered healthcare items and services, through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request. This would allow consumers to shop and compare costs between specific providers before receiving care.

Disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the healthcare industry. Access a CMS fact sheet on the proposed rule.Access the proposed rule .

More details are available in the HHS press release .

Posted 11/15/2019

On November 14, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa, BeiGene, Ltd.) for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

FDA granted this application priority review and zanubrutinib received orphan product and breakthrough therapy designations for treatment of MCL. Read FDA announcement .

Posted 11/15/2019

On November 5, the American College of Physicians (ACP) published a new evidence-based guidance statement that supports colorectal cancer screening for average-risk adults between ages 50 and 75 who do not have symptoms. The new guidance was published in the Annals of Internal Medicine .

The frequency of screening depends upon the screening approach selected, according to a statement from ACP, which suggests any of the following screening strategies:

• Fecal immunochemical test (FIT) or high sensitivity guaiac-based fecal occult blood test (gFOBT) every two years
• Colonoscopy every 10 years
• Flexible sigmoidoscopy every 10 years plus FIT every two years

Read the ACP press release .

Posted 11/06/2019

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

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

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:

1. The potential OCF Model would seek to improve health outcomes and quality of care for Medicare beneficiaries with cancer. How could the potential model support participants’ care transformation through practice redesign activities? Specifically, how could the potential model build on lessons learned from the implementation of the practice redesign activities included in the Oncology Care Model (OCM)? What revisions or additions should be made to the OCM practice redesign activities in the potential model?
2. We welcome feedback on the potential payment methodology, including the structure and design of the monthly population payment and the performance-based payment. We are considering the inclusion of additional services in the monthly population payment, such as imaging or lab services, and seek feedback on adding these or other services to the monthly population payment.
3. We encourage feedback on the conceptualized risk arrangements, in particular, how a downside risk arrangement might be best constructed in terms of the level of risk.

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

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

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

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

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

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

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