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
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
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:
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
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:
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 .
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
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
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:
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
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
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:
Read the full HHS OIG report here .
Posted 10/2/18
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