ONCOLOGY NEWSFEED

On October 9, the National Comprehensive Cancer Network (NCCN) announced the publication of a new set of Guidelines for Patients focused on neuroendocrine tumors. This cancer type can originate in many different parts of the body, has variable symptoms, and requires individualized and complicated treatment approaches. Read the new NCCN Guidelines for Patients here .

Posted 10/10/18

On October 5, the U.S. Food and Drug Administration expanded the approved use of Gardasil 9 (Human Papillomavirus [HPV] 9-valent Vaccine, Recombinant, Merck & Co.) to include individuals aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by nine types of HPV. Gardasil 9 was previously approved for individuals aged 9 through 26 years. Read the full FDA press release here .

Posted 10/8/2018

The Medicare Payment Advisory Committee (MedPAC), in its comments to CMS on the proposed 2019 Hospital Outpatient Prospective Payment System rule, suggests expansion of the proposed Drug Value Program (or, DVP, a revamped version of the agency's Competitive Acquisition Program) as a possible approach for "certain high-priced products regardless of the setting in which they are administered." Citing CAR T-cell therapy as an example, the commission's comment letter states: "The recent development of CAR-T immunotherapy, which is extraordinarily expensive and can be furnished in inpatient and outpatient hospital settings, has drawn attention to the issue of very high cost drugs across settings. The DVP model, with its management tools such as a formulary and binding arbitration, may be well suited for addressing very high priced drugs across settings."

Association of Community Cancer Centers (ACCC) comments to the Drug Value Plan proposal included within the 2019 OPPS rule urge that: "Any policy solution to rein in drug costs must preserve patients’ access to – and ability to afford – quality cancer care and, relatedly, mitigate any impact on already reduced payment rates for cancer care providers."

Further, ACCC requests that the agency ensure that any model based on Competitive Acquisition Program (CAP) authority is:

• voluntary for all participants,
• preserves patient access to treatment and provider flexibility, and
• promotes cost-efficiency through more effective distribution and delivery of drugs and biological rather than utilization management tools.

Read MedPAC comments to the proposed 2019 OPPS rule. Read ACCC comments to the proposed 2019 OPPS rule. MedPAC is an independent congressional agency established to advise the U.S. Congress on issues affected the Medicare program.

Posted 10/5/18

The Nobel Assembly at Karolinska Institute announced on Monday, Oct. 1, the 2018 Nobel Prize in Physiology or Medicine was awarded to James P. Allison, PhD, of The University of Texas MD Anderson Cancer Center in Houston, and Tasuku Honjo, MD, PhD, Deputy Director-General and Distinguished Professor of Kyoto University Institute for Advanced Study in Japan, for their discovery of cancer therapy by inhibition of negative immune regulation.

Their work laid the foundation for a new class of cancer drugs, checkpoint inhibitors, and established a fourth pillar of cancer treatment—immunotherapy.

In a statement, the Nobel Assembly lauded the two Laureates for creating “an entirely new principle for cancer therapy.”

Read the Nobel Assembly statement.Listen to Dr. Allison's remarks at a press briefing on Oct. 1 during the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference.

Posted 10/2/18

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has issued a report that raises concerns about the beneficiary impact of the Centers for Medicare & Medicaid Services’ (CMS) new “fail first” step therapy policy for Medicare Advantage (MA) beneficiaries beginning in 2019. The report's findings include:

• A “central concern” in the MA program is that planshave “potential incentives” to “inappropriately deny access to services and payment in an attempt to increase their own profit.”
• 75%of MA plans’ coverage or payment denials were overturned at the first level of appeal, and additional denials were overturned in later stages of appeal.
• Treatment disruptions and coverage delays that are already regularly taking place in the MA program will be exacerbated under the new “fail first” policy.
• Beneficiaries and providers appealed only one percent of denials by MA plans, which may be due to the “confusing and overwhelming” process for many beneficiaries.
• MA plans’ inaccurate coverage denials are particularly difficult for the MA patient population, finding that treatment delays “may be especially burdensome for beneficiaries with urgent health conditions.”

Read the full HHS OIG report here .

Posted 10/2/18

On September 28, 2018, the U.S. Food and Drug Administration announced that the agency is permitting marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow.

MRD is a general measure of the amount of cancer in the body (tumor burden), specifically the number of cancer cells that remain in a person’s bone marrow, either during or after treatment. Measuring MRD provides a tool to detect very low levels of tumor burden. MRD is useful to evaluate in patients who have responded to therapy when their tumor burden is below what can be detected with standard methods. The detection of MRD is associated with recurrence of the disease in those patients. Read details in the FDA announcement .

Posted 10/1/18

On September 28, the U.S. Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Sanofi) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC. Read the full FDA press release here .

Posted 10/1/18

On September 27, the Food and Drug Administration approved dacomitinib tablets (Vizimpro, Pfizer Inc.) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Read the full FDA press release here .

Posted 9/28/18

On Tuesday, September 25, 2018, the U.S. House passed by voice vote two Senate bills that ban so-called "gag clauses" which prevent pharmacists from informing consumers when it would cost less to pay out-of-pocket for prescriptions drugs instead of using their health insurance.

On Monday, the U.S. Senate passed two pieces of legislation that would prohibit such "gag clauses." The Patient Right to Know Drug Prices Act, S. 2554, impacts private health plans including those in the ACA marketplace, and the Know the Lowest Price Act of 2018, S. 2553, covers Medicare Advantage and Part D plans.

Having cleared the House, the legislation next moves to the White House for President Trump's signature.

Posted 9/25/18

On September 24, the U.S. Food and Drug Administration (FDA) approved duvelisib (Copiktra) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. Duvelisib also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Read the FDA press release here .

Posted 9/25/2018

On September 24, 2018, the Association of Cancer Care Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed CY 2019 Outpatient Prospective Payment System (OPPS) rule .

In its comments, ACCC recommends that CMS:

• Not finalize its proposal to reduce reimbursement to Wholesale Acquisition Cost (WAC) plus 3 percent for new drugs and biologicals that do not yet have adequate Average Sales Price (ASP) data;
• Not finalize its proposal to reduce payment for separately payable drugs purchased under the 340B program at nonexcepted hospital off-campus provided-based departments;
• Not finalize its proposal to reduce reimbursement to 40 percent of the OPPS rate for certain clinic visits furnished at excepted off-campus provider-based departments;
• Not finalize its proposal to reduce reimbursement to 40 percent of the OPPS rate for service-line expansions at excepted off-campus provider-based departments;
• Clarify how hospital should bill for furnishing certain outpatient services related to CAR T-cell therapies and ensure that hospitals are paid appropriately for furnishing these therapies; and
• Ensure that any model based on Competitive Acquisition Program (CAP) authority is voluntary for all participants, preserves patient access to treatment and provider flexibility, and promotes cost-efficiency through more effective distribution and delivery of drugs and biological rather than utilization management tools.

Read full comment letter here .

Posted 9/24/18

Pfizer Oncology has announced emergency relief protocols to ensure that patients who receive their Pfizer Oncology medicines through the Pfizer Patient Assistance Program and are impacted by Hurricane Florence have continued access to their medications.

In addition to these emergency protocols, Pfizer has also activated a comprehensive and coordinated plan at the company-wide level to provide further disaster support. Read more here .

Posted 9/24/18

On October 3, Hogan Lovells will host a complimentary webinar to discuss recent and proposed changes in the coverage of telehealth services, potential future developments, and key legal issues to consider. Topics will include:

• Recent and proposed expansion of Medicare coverage of telehealth services
• State law considerations in providing telehealth
• Fraud and abuse issues in telehealth
• Innovations, future trends, and the evolution of what’s considered “telehealth”

Click here to register for this complimentary webinar .

Posted 9/20/18

On September 17, the Centers for Medicare & Medicaid Services (CMS) released the Medicare & Medicaid; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction proposed rule for calendar year 2019. This proposed rule was released to build upon the administration’s ‘Patients Over Paperwork’ and ‘Cut the Red Tape’ initiatives. The deadline for submitting comments on the proposed rule is 60 days from the rule's release into the US Federal Register.

ACCC is currently analyzing the rule and will provide an update to members soon.

View the proposed CY 2019 rule .

Posted 9/17/2018

On September 12, the House of Representatives passed the Local Coverage Determination (LCD) Clarification Act, which aims to improve accountability and transparency in the process Medicare contractors use to make local coverage decisions. Key provisions in the bill include:

• Open and recorded Medicare Administrative Contractor (MAC) Carrier Advisory Committee meetings
• Upfront disclosure of evidence MACs consider when drafting an LCD, as well as the rationale they are relying on to deny coverage.
• Additional options for challenging an LCD
• Annual reports to Congress on the number of LCD appeals and actions taken in lieu of the creation of an ombudsman.

Read the College of American Pathologists (CAP) press release here .

Posted 9/13/2018

On September 13, the Food and Drug Administration approved moxetumomab pasudotox-tdfk (Lumoxiti, AstraZeneca) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL. Read the full FDA press release here .

Posted 9/13/2018

The Centers for Medicare & Medicaid Services (CMS) have announced efforts underway to support North Carolina and South Carolina in response to Hurricane Florence. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of Hurricane Florence. CMS has waived certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; created special enrollment opportunities for individuals to access healthcare immediately; and taken steps to ensure dialysis patients obtain critical services.

• Waivers for Hospitals and other Healthcare Facilities: CMS has temporarily waived or modified certain Medicare, Medicaid, and CHIP requirements. CMS issued a number of blanket waivers, listed on the website below, and the CMS Regional Offices have granted other provider-specific requests for specific types of hospitals and other facilities in North Carolina and South Carolina. These waivers work to provide continued access to care for beneficiaries. For more information on the waivers CMS granted, visit www.cms.gov/emergency .
• Special Enrollment Opportunities for Hurricane Victims: CMS has made available special enrollment periods for all Medicare beneficiaries and certain 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 immediately if eligible for the special enrollment period. For more information on these special enrollment periods, visit:
  - https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/8-9-natural-disaster-SEP.pdf
  - https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Past-Emergencies/Hurricanes-and-tropical-storms.html
• 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. For more information and to access the toolkit, visit https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/index.html .
• Dialysis Care: CMS is helping patients obtain access to critical services. The Kidney Community Emergency Response (KCER) program has been activated ahead of the storm and is working with the End Stage Renal Disease Network of the South Atlantic, ESRD NW 6, 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. The ESRD NW toll-free hotline is 800-524-7139 and the KCER hotline is 866-901-3773. Additional information is available on the KCER website www.kcercoalition.com .
• Medical equipment and supplies replacements: CMS temporarily suspended 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 necessary medical equipment and supplies. 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 North Carolina and South Carolina, 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.

For more information, visit www.cms.gov/emergency .

Posted 9/13/2018

On September 12, the American Association for Cancer Research (AACR) released its annual Cancer Progress Report highlighting how federally funded research discoveries are fueling the development of new and even more effective ways to prevent, detect, diagnose, and treat cancer.

Key advances outlined in the AACR Cancer Progress Report 2018 include the following:

• Twenty-two treatments for cancer were approved for the first time by the U.S. Food and Drug Administration (FDA) or approved for new types of cancer between Aug. 1, 2017, and July 31, 2018. Among these treatments are revolutionary new immunotherapeutics called CAR T–cell therapies, exciting new targeted radiotherapeutics, and numerous new targeted therapeutics that are expanding the scope of precision medicine.
• The U.S. cancer death rate declined by 26 percent for adults from 1991 to 2015, a reduction that translates into almost 2.4 million lives saved, according to the latest data.
• The cigarette smoking rate among U.S. adults has fallen to 14 percent, down from 42 percent in 1965, thanks to public education and important policy initiatives.

Read the full Cancer Progress Report for more information .

Posted 9/13/2018

On September 10, 2018, the Association of Cancer Care Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed Physician Fee Schedule rule for calendar year 2019.

Read the ACCC CY 2019 PFS comment letter .

Posted 9/11/2018

On September 6, the Laura and John Arnold Foundation, Peterson Center on Healthcare, and Gary and Mary West Foundation announced that they have committed $30 million to help establish Civica Rx , a new nonprofit generic drug company. The foundations join hospital groups representing more than 450 hospitals in the creation of the company.

Civica Rx has identified 14 hospital-administered generic drugs as its initial focus, seeking to stabilize the supply of essential medications, many of which have fallen into chronic shortage situations. The company expects its first products to be released in early 2019. Read the full press release here .

Posted 9/6/2018

On Wednesday, August 29, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a memo to Medicare Part D plans that will allow these plans to implement “indication-based formulary design” starting in 2020.

Currently, if a Part D plan includes a specific drug on its formulary, the plan must cover that drug for every FDA-approved indication, or patient condition, even if the plan would otherwise instead cover a different drug for a particular indication.

The CMS memo states that if a Part D plan limits formulary coverage of a drug to certain indications, the plan must ensure that there are other therapeutically similar drugs on formulary for the drug’s non-covered indications.

The ACCC policy team is currently reviewing this policy change. Read the CMS memo to Part D plans . Read the agency's fact sheet .

Posted 8/29/2018

On August 27, AbbVie announced that the FDA has approved ibrutinib (Imbruvica) (Pharmacyclics, LLC) plus rituximab for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). This approval represents the first and only chemotherapy-free combination treatment specifically indicated for the disease. Read the full AbbVie corporate press release here.

Posted 8/27/2018

On August 17, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.

Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product. Read the full FDA announcement here.

Posted 8/20/2018

On August 16, 2018, the Food and Drug Administration updated the prescribing information for pembrolizumab (Keytruda, Merck & Co., Inc.) and atezolizumab (Tecentriq, Genentech, Inc.) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq.

On August 16, 2018, the FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay (Dako North America, Inc.) as a companion diagnostic to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Keytruda. The 22C3 assay determines PD-L1 expression by using a combined positive score (CPS) assessing PD-L1 staining in tumor and immune cells.

On July 2, 2018, the FDA approved the Ventana PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic test to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Tecentriq. The SP142 assay determines PD L1 expression in immune cells. Read the full FDA announcement here.

Posted 8/20/2018