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Home / News / Oncology News

ONCOLOGY NEWSFEED

FDA Approves Elotuzumab, Pomalidomide, Dexamethasone for Multiple Myeloma

November 7, 2018

On November 6, Bristol-Myers Squibb Company announced that the Food and Drug Administration approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Read the Bristol-Myers Squibb press release here .

Posted 11/7/2018


FDA Approves Second Biosimilar to Neulasta

November 2, 2018

On November 2, the FDA approved pegfilgrastim-cbqv (Udenyca, Coherus BioSciences, Inc.) as a biosimilar to pegfilgrastim (Neulasta, Amgen, Inc.) for patients with cancer receiving myelosuppressive chemotherapy. Udenyca is the second pegfilgrastim biosimilar to be approved by the FDA following the approval of pegfilgrastim-jmdb (Fulphila, Mylan Inc.) in June. Read the Coherus press release here .

Posted 11/2/2018


CMS Releases CY 2019 OPPS Rule

November 2, 2018

On November 2, the Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2019 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rule .

Download the final 2019 OPPS rule from the Federal Register here .

Highlights from the CMS fact sheet on the final rule include:

  • CMS is exercising its authority by applying a Physician Fee Schedule (PFS)-equivalent payment rate for the clinic visit service when provided at an off-campus provider-based department that is paid under the OPPS. The agency will phase this change in over two years.
  • In the 2019 OPPS final rule, CMS finalizes a policy to pay ASP minus 22.5 percent for 340B-acquired drugs furnished by non-excepted off-campus PBDs paid under the Physician Fee Schedule.
  • For 2019, CMS is not finalizing its proposed policy that off-campus PBDs excepted from Section 603 of the Bipartisan Budget Act of 2015 could continue to be paid at OPPS rates for items and services in each of 19 proposed “clinical families of services” if a PBD furnished and billed for a service in that clinical family of services prior to November 2, 2015. CMS notes the agency will continue to monitor the expansion of services in excepted off-campus PBDs.

For more information, access the CMS fact sheet on the final CY 2019 OPPS rule here .

ACCC is currently reviewing the final 2019 OPPS rule and will provide an in-depth analysis to membership shortly.

Posted 11/2/18


CMS Releases 2019 PFS and QPP Final Rule

November 1, 2018

On November 1, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2019 Physician Fee Schedule (PFS) and Quality Payment Program (QPP) final rule .

The summary below is based on the CMS fact sheet on the 2019 PFS final rule.

For CY 2019 and CY 2020, the agency is implementing several documentation policies "to provide immediate burden reduction" and would implement additional changes to documentation, coding, and payment in CY 2021. Coding for E/M Office/Outpatient Visits
The CMS fact sheet states:
"For CY 2019 and CY 2020, CMS will continue the current coding and payment structure for E/M office/outpatient visits and practitioners should continue to use either the 1995 or 1997 E/M documentation guidelines to document E/M office/outpatient visits billed to Medicare."

For CY 2021, CMS would move forward to reduce payment variation for E/M office/outpatient visit levels by paying a single rate for visit levels 2 through 4 for established and new patients, "while maintaining the payment rate for E/M office/outpatient visit level 5 to better account for the care and needs of complex patients."

For 2019, CMS finalized its proposal to pay separately for two newly defined physicians’ services furnished using communication technology:

  • Brief communication technology-based service, e.g. virtual check-in (HCPCS code G2012) and
  • Remote evaluation of recorded video and/or images submitted by an established patient (HCPCS code G2010)

And for 2019, CMS also finalizes policies to pay separately for new coding describing chronic care remote physiologic monitoring (CPT codes 99453, 99454, and 99457) and interprofessional internet consultation (CPT codes 99451, 99452, 99446, 99447, 99448, and 99449).

Payment Rates for Non-excepted Off-campus Provider-Based Hospital Departments Paid Under the PFS
Since CY 2017, payment for certain items and services furnished in non-excepted off-campus provider-based departments has been made under the PFS using a PFS Relativity Adjuster based on a percentage of the OPPS payment rate. The PFS Relativity Adjuster in CY 2018 is 40 percent, i.e., non-excepted items and services are paid 40 percent of the amount that would have been paid for those services under the OPPS.

For CY 2019 CMS is finalizing that the PFS Relativity Adjuster remain at 40 percent.

Wholesale Acquisition Cost (WAC)-Based Payment for Part B Drugs: CMS Finalizes Reduction of Add-on Amount
Effective Jan. 1, 2019, WAC-based payments for Part B drugs determined under section1847A of the Social Security Act, during the first quarter of sales when average sales price (ASP) is unavailable, will be subject to a 3 percent add-on in place of the current 6 percent add-on. The agency reiterated that these changes only apply to WAC-based payment for new Part B drugs.

ACCC is analyzing the final rule and will provide in-depth analysis to the membership soon.

View the CY 2019 Physician Fee Schedule and Quality Payment Program final rule here . Access the CMS fact sheet on the CY 2019 Physician Fee Schedule final rule.

Access the CMS fact sheet on the CY 2019 Quality Payment Program final rule.
Posted 11/1/18


FDA Approves Pembrolizumab for First-Line Treatment of Metastatic Squamous NSCLC

October 31, 2018

On October 30, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC). Read the full FDA press release here .

Posted 10/31/2018


ACCC Statement in Response to Administration’s Part B Drug Pricing ANPRM

October 26, 2018

On Thursday, October 25, the Trump Administration released of a three-pronged proposal to overhaul Medicare Part B and tackle rising drug costs. ACCC looks forward to commenting on this proposal, but the Administration's actions are still in the nascent stages of development. An Advance Notice of Proposed Rulemaking (ANPRM) was released on October 25, with expectation that a formal proposed rule would be released in Spring 2019. Many questions are yet to be addressed regarding the intricacies in implementation of this model.

Under the proposal the Medicare Part B landscape would change significantly through the use of a mandatory demonstration through the Center for Medicare and Medicaid Innovation (CMMI) with an International Pricing Index (IPI) model .

In a policy statement , the Association of Community Cancer Centers (ACCC) expresses overarching concerns about the impact of the proposal on the entire cancer care delivery infrastructure and, in particular, those programs and practices that see a high percentage of Medicare, Medicare only, and dual-eligible patients. ACCC urges policymakers to be aware that this policy has the potential to drastically hamper access to vital patient care and harm innovation for cancer care treatment.

ACCC looks forward to working with the Centers for Medicare & Medicaid Services (CMS) to ensure that any model put forth to the public is voluntary, maintains appropriate safeguards for access to patient care, and drives increased value-based propositions for the oncology community.

Posted 10/26/2018


FDA Approves Levoleucovorin for Injection for mCRC, Osteosarcoma

October 23, 2018

On October 23, the FDA approved levoleucovorin for injection (Khapzory, Spectrum Pharmaceuticals, Inc.) for three indications:

  • Rescue after high-dose methotrexate therapy in patients with osteosarcoma
  • Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination
  • The treatment of patients with metastatic colorectal cancer (mCRC) in combination with fluorouracil.

Read the Spectrum Pharmaceuticals press release here .


HHS Secretary Azar Provides Updates to Drug Pricing Blueprint

October 17, 2018

Health and Human Services Secretary Alex Azar yesterday outlined updates to HHS’s “four strategies” for addressing prescription drug pricing in remarks delivered during the National Academy of Medicine’s President’s Forum on Affordable Medicines: Access, Innovation, and the Public Interest.

In his address, Secretary Azar called attention to the proposed rule issued yesterday by the Centers for Medicare & Medicaid Services (CMS) that would require manufacturers to include in their direct-to-consumer TV advertising the list price of drugs paid for by Medicare & Medicaid. While acknowledging a pharmaceutical industry announcement yesterday of an initiative to improve price transparency, Secretary Azar stated that HHS “will not rely on voluntary action to accomplish our goals.”

Secretary Azar’s speech centered on HHS’ four areas of drug-pricing focus under the Administration's blueprint for lowering drug prices released last May: negotiation, reducing consumer out-of-pocket costs, improving competition, and creating incentives for lower list prices. In his remarks, Secretary Azar highlighted specific actions the administration has taken to date and outlined possible future steps in each of the four areas.

The full text of Secretary Azar's address is available here .

ACCC policy staff will provide a more in-depth look at Secretary Azar's remarks shortly.

Posted 11/16/18


FDA Approves Talazoparib for gBRCAm HER2- Breast Cancer

October 16, 2018

On October 16, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.) for the treatment of patients with deleterious or suspected germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on the use of the FDA-approved companion diagnostic BRACAnalysis CDx (Myriad Genetics, Inc.). Read the full FDA press release here .

Posted 10/16/18


New Clinical Guideline Issued for Early-Stage Prostate Cancer Patients Treated with EBRT

October 12, 2018

On Oct. 12, the American Society for Radiation Oncology (ASTRO), American Society of Clinical Oncology (ASCO) and American Urological Association (AUA) issued a new clinical guideline for physicians treating men with early-stage prostate cancer using external beam radiation therapy (EBRT). Experts from the three medical societies developed the new guideline which recommends offering patients hypofractionated radiation therapy as an alternative to longer, conventional courses of radiation. The new guideline reflects evidence showing similar early cancer control and side-effect rates with hypofractionated treatment, compared to longer courses of conventional radiation. ASTRO, ASCO and AUA published the guideline in their respective journals, Practical Radiation Oncology , Journal of Clinical Oncology , and The Journal of Urology .

Posted 11/12/18


CMS Acts to Support Georgia in Response to Hurricane Michael

October 11, 2018

On Oct. 11, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that the agency has acted to support Georgia in response to Hurricane Michael. The agency is temporarily waiving or modifying certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare immediately; and taking steps to ensure dialysis patients obtain critical life-saving services.

Key administrative actions CMS is taking in response to the public health emergency declared in Georgia:

  • Waivers for Hospitals, Healthcare Facilities, and Clinicians: CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. The CMS Regional Offices will be granting other provider-specific requests for specific types of hospitals and other facilities in Georgia. These waivers work to provide continued access to care for beneficiaries. For more information, visit: www.cms.gov/emergency .
  • Special Enrollment Opportunities for Individuals Impacted by the Hurricane: CMS has made special enrollment periods available for certain individuals seeking health plans offered through the Federal Health Insurance Exchange and all Medicare beneficiaries. This gives people impacted by the hurricane the opportunity to gain access to health coverage on the Exchange or change their Medicare health and prescription drug plans immediately if eligible for the special enrollment period. For more information, 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, click here .
  • Dialysis Care: CMS is helping patients obtain access to critical life-saving services. The Kidney Community Emergency Response (KCER) program has been activated and is working with IPRO End Stage Renal Dialysis Network of the South Atlantic (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. 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 toll-free hotline for NW 6 is 1-800-524-7139 and the KCER hotline is 866-901-3773. Additional information is available on the NW website or the KCER website .
  • Medical equipment and supplies replacements: CMS will temporarily suspend certain requirements necessary for Medicare beneficiaries who have lost or sustained damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. 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 the affected areas of Georgia, 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 PHE, 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.

CMS will continue to work with all geographic areas impacted by Hurricane Michael. Beneficiaries and providers of healthcare services that have been impacted are encouraged to seek help by visiting CMS’ emergency webpage.

Posted 10/11/18


CMS Announces Steps to Support Florida in Response to Hurricane Michael

October 10, 2018

On October 10, the Centers for Medicare & Medicaid Services (CMS) announced steps taken by the agency to support Florida in response to Hurricane Michael. The actions include temporarily waiving or modifying certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare immediately; and taking steps to ensure dialysis patients obtain critical life-saving services.

Below are key actions CMS is taking in response to the Public Health Emergency (PHE) declared in Florida:

  • Waivers for Hospitals, Healthcare Facilities, and Clinicians: CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. CMS will be issuing a number of waivers as necessary, which will be listed on the website below, and the CMS Regional Offices will be granting 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. For more information on the waivers CMS will grant, visit the CMS website .
  • Special Enrollment Opportunities for Individuals Impacted by the Hurricane: CMS has made special enrollment periods available for certain individuals seeking health plans offered through the Federal Health Insurance Exchange and all Medicare beneficiaries. This gives people impacted by the hurricane the opportunity to gain access to health coverage on the Exchange or change their Medicare health and prescription drug plans 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 the Medicaid website .
  • Dialysis Care: CMS is helping patients obtain access to critical services. The Kidney Community Emergency Response (KCER) program has been activated and is working with Quality Insights Renal Network 7, ESRD NW 7, 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. Additional information is available on the NW’s websites ( 1 , 2 , and 3 ) or the KCER website .
  • Medical equipment and supplies replacements: CMS will temporarily suspend certain requirements necessary for Medicare beneficiaries who have lost or sustained 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 the affected areas of 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 PHE, 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.

CMS will continue to work with all geographic areas impacted by Hurricane Michael. Beneficiaries and providers of healthcare services that have been impacted are encouraged to seek help by visiting CMS’ emergency webpage .


NCCN Releases New Guidelines for Neuroendocrine Tumors

October 10, 2018

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


FDA Expands Approval of HPV Vaccine to People Aged 27 to 45

October 8, 2018

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


MedPAC Suggests Expansion of DVP to Inpatient Setting

October 5, 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


Nobel Prize in Medicine Awarded to Two Cancer Immunotherapy Researchers

October 2, 2018

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


HHS OIG Report Raises Concerns About Medicare Advantage Step Therapy

October 2, 2018

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


FDA Approves NGS Test to Detect MRD in ALL and Myeloma

October 1, 2018

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


FDA Approves Cemiplimab-rwlc for Cutaneous Squamous Cell Carcinoma

October 1, 2018

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


FDA Approves Dacomitinib for Metastatic NSCLC

September 28, 2018

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


House Approves Legislation Banning Pharmacist “Gag Clauses”

September 25, 2018

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


FDA Approves Duvelisib for CLL/SLL, FL

September 25, 2018

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


ACCC Submits Comments to Proposed 2019 OPPS Rule

September 24, 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 Announces Relief for Cancer Patients Affected by Hurricane Florence

September 24, 2018

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


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