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Oncology Newsfeed

  • CMS Releases 2019 PFS and QPP Final Rule

    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

    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

    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



  • President Trump to Make Announcement on Expected Medicare Part B Changes

    President Trump is expected to make an announcement this afternoon, October 25, detailing continued reform efforts in lowering drug prices. The proposal to be released this afternoon would use the Center for Medicare & Medicaid Innovation center to test three ways of lowering the cost of drugs in Medicare Part B. A report released from the Department of Health & Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE) advocates for the reform of Medicare Part B to align more with the negotiation and utilization management tactics currently utilized in Medicare Part D.

    Stay tuned for more updates from the ACCC Policy Team.

    Posted 10/25/18


  • FDA Approves Levoleucovorin for Injection for mCRC, Osteosarcoma

    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

    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

    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


  • CMS Issues Drug Pricing Transparency Proposed Rule

    On Oct. 15, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would revise the Federal Health Insurance Programs for the Aged and Disabled by amending the Medicare Parts A, B, C, and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC, or “list price”) of that drug or biological product. 

    According to a CMS statement, under the proposed rule, the price required to be posted would be for a typical course of treatment for an acute medication like an antibiotic, or a 30-day supply of medication for a chronic condition that is taken every month. The posting would take the form of a legible textual statement at the end of the ad, the agency said. The HHS Secretary would maintain a public list of drugs that were advertised in violation of this rule. CMS would provide an exception to the requirement to post prices for prescription drugs with list prices of less than $35 per month.

    Read the proposed rule here.

    CMS will accept comments on the proposed rule until Dec. 17, 2018.

    ACCC policy staff is currently analyzing the proposed rule.

    Posted 10/15/18



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

    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

    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:
    • 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