November 29, 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. ACCC has expressed 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.
As ACCC urges policymakers to be aware the effect this demonstration has on the oncology community, we invite you to hear from ACCC and our legal experts at Hogan Lovells to learn more about this proposed mode and what it could mean for your cancer program and your patients.
Webinar: Health Policy to Watch: Medicare Part B Drug Pricing Reform - The International Pricing Index (IPI) ModelWednesday, December 5, 20183:30 PM - 4:30 PM ESTRegister here (login required) .
Posted 11/29/2018
November 28, 2018
On November 28, the Food and Drug Administration approved gilteritinib (Xospata, Astellas Pharma US Inc.) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
The FDA also approved an expanded indication for a companion diagnostic, to include use with gilteritinib. The LeukoStrat CDx FLT3 Mutation Assay, (Invivoscribe Technologies, Inc.) is used to detect the FLT3 mutation in patients with AML. Read the full FDA press release here .
Posted 11/28/2018
November 27, 2018
On November 26, the FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment. Read the full FDA press release here .
Posted 11/27/2018
November 26, 2018
On November 26, the Centers for Medicare & Medicaid Services (CMS) announced proposed policies that continue to tackle drug pricing reform. Top-line takeaways from today’s proposals include:
Read the CMS fact sheet on the proposed rule here . Read the full proposed rule here .
The ACCC policy team is continuing to analyze this proposal. Stay tuned for more updates.
Posted 11/26/2018
November 26, 2018
On November 26, the Association of Community Cancer Centers (ACCC) joined dozens of cancer care organizations and associations in signing a letter of support for H.R. 6836 , the CLINICAL TREATMENT Act. This legislation would ensure that states cover routine care costs of participation in approved clinical trials for Medicaid enrollees with life-threatening conditions. Medicaid is currently the only major payer that is not required by federal law to cover these costs. Read the full letter of support for H.R. 6836 here .
Posted 11/26/2018
November 26, 2018
On November 21, the Food and Drug Administration granted accelerated approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Read the full FDA press release here .
Posted 11/26/18
November 26, 2018
On November 21, the Food and Drug Administration approved glasdegib (Daurismo, Pfizer Inc.) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy. Read the full FDA press release here .
Posted 11/26/2018
November 19, 2018
On November 19, the American Cancer Society (ACS) published a report in CA: A Cancer Journal for Clinicians discussing the status of cancer screening and proposing key areas where further attention is needed. ACS highlighted five key focus areas to help cancer screening realize its full potential:
Read the full report here . Read the ACS press release on the report here .
Posted 11/19/2018
November 19, 2018
On November 19, Walgreens announced the launch of its "Feel More Like You" program designed to assist people living with cancer manage the physical changes associated with treatment. Formed in collaboration with Look Good, Feel Better and Cancer Support Community, the program will feature trained beauty consultants and pharmacists working together to provide personalized support to individuals with cancers at more than 400 stores across the country. Read the full Walgreens press release here .
Posted 11/19/18
November 16, 2018
On November 16, the U.S. Food and Drug Administration expanded the approved use of brentuximab vedotin (Adcetris, Seattle Genetics) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnoses PTCL, and the agency used a new review program to complete the approval more quickly. Read the full FDA press release here .
Posted 11/16/2018
November 14, 2018
On November 14, the Centers for Medicare & Medicaid Services (CMS) announced that the agency has taken steps to support California residents displaced and recovering from the wildfires destroying portions of the state.On November 13, Health and Human Services Secretary Alex Azar declared a public health emergency (PHE) in areas of California retroactive to November 8. The PHE allows CMS to waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements if necessary to provide health services.
The agency will take the following steps to support the state of California and those residents impacted by wildfires:
People with federal benefits and providers and suppliers of healthcare equipment and services that have been impacted by the California wildfires are encouraged to seek help by visiting CMS' emergency webpage: http://cms.gov/emergency .
Posted 11/14/2018
November 14, 2018
On Monday, November 19, from 2:00 to 3:30 PM ET, the Centers for Medicare & Medicaid Services (CMS) will host a call to address three key topics stemming from the finalization of the CY 2019 Physician Fee Schedule (PFS) Final Rule. During this call, CMS experts will briefly cover three provisions and address questions related to:
Participants are encouraged to review the final rule prior to the call and the following materials:
The target audiences for this call are Medicare Part B fee-for-service clinicians; office managers and administrators; state and national associations that represent healthcare providers; and other stakeholders. Click here to register for this call and other Medicare Learning Network events .
Posted 11/14/2018
November 13, 2018
On November 1 and 2, the Centers for Medicare & Medicaid Services (CMS) finalized its CY 2019 Physician Fee Schedule (PFS)/Quality Payment Program (QPP) and Hospital Outpatient Prospective Payment System (OPPS) rules. ACCC has released summaries on these final rules, available for ACCC members here:
On Wednesday, November 28, join legal experts from Hogan Lovells for a one-hour overview and discussion about the Centers for Medicare & Medicaid Services (CMS) Final CY 2019 OPPS and PFS rules. The agency finalized several significant proposals this year and beyond that will impact payments to Evaluation & Management (E/M) visits, 340B hospitals and outpatient facilities, as well as access for biosimilars and telehealth, and much more. Webinar: CMS Final CY 2019 Outpatient Prospective Payment System (OPPS) & Physician Fee Schedule (PFS) Rules: What You Need to Know
Wednesday, November 28, 2018
3:30 – 4:30 PM EST Register Here (login required)
Posted 11/13/2018
November 12, 2018
On November 9, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read the Merck press release here .
Posted 11/12/2018
November 9, 2018
On November 8, Secretary of Health and Human Services (HHS) Alex Azar announced that the Centers for Medicare & Medicaid Services (CMS) plans to unveil a mandatory Medicare radiation oncology payment model for cancer patients in the coming weeks, as well as two new voluntary models for cardiac care. This announcement contradicts previous statements from the Trump Administration, which had previously promised it would not enforce payment models that would put them at risk of financial loss. Read news coverage from Modern Healthcare here .
Posted 11/9/2018
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
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
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:
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
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:
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
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
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
October 23, 2018
On October 23, the FDA approved levoleucovorin for injection (Khapzory, Spectrum Pharmaceuticals, Inc.) for three indications:
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
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