Medicare and Medicaid Guidelines for Epoetin and Darbepoetin for Non-Renal Indications(8/3/2007) The Centers for Medicare and Medicaid Services (CMS) has published new guidelines for the use of erythropoiesis stimulating agents (ESAs) for non-renal indications.These guidelines are important since they guide reimbursement for epoetin (Procrit®, Epogen®) and darbepoetin (Aranesp®) in cancer patients.
Oncotype DX® Meets Blue Cross and Blue Shield Technology Evaluation Criteria(7/23/2007) Genomic Health has announced that the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) has approved the Oncotype DX® criteria for women with estrogen receptor-positive, node-negative, tamoxifen-treated cancer.
ASH Publishes Comments on Medicare and Medicaid Coverage of Erythropoiesis Stimulating Factors.(4/19/2007) On April 12, 2007 the American Society of Hematology (ASH) issued comments to the Centers for Medicare and Medicaid Services on coverage for erythropoiesis stimulating agents (ISA’s) including Procrit®, Epogen® and Aranesp® for patients other than end stage renal disease. The details of these comments can be accessed on ASH's website at www.hematology.org.
Aetna and Genomic Health Form Agreement on Oncotype DX™(12/11/2006) Aetna Health, one of the nation's largest health benefits companies, has formed an agreement with Genomic Health to establish pay rates for the use of Oncotype DX.
Medicare Agrees to Cover Costs of Oncotype DX™(1/18/2006) The National Heritage Insurance Company (NHIC) that administers Medicare programs in California has agreed to cover the costs of Oncotype DX™ in eligible women with breast cancer beginning February 27, 2006.
Bristol-Myers Squibb Reports BiCNU Supply Shortage(10/11/2005) Bristol-Myers Squibb is experiencing a supply outage of BiCNU (carmustine injection) chemotherapy, the drug maker reported Oct. 6. Bristol has not confirmed an availability date for the product but says it is working to resolve the outage.
CMS Invites Response to Proposed Rule for 2006 Physician Fee Schedule(9/22/2005) The Centers for Medicare and Medicaid Services (CMS) is currently seeking public comment regarding their Proposed Rule for Medicare reimbursement for cancer care and other services in 2006. Before the rule is put into effect on January 1st, the finalization process will incorporate a review of these comments.
Free EHR Software from HHS Delayed Indefinitely(9/12/2005) The release of free electronic health record (EHR) software, which physicians could download from the Department of Health and Human Services (HHS), has been delayed indefinitely, a department official said yesterday.
CMS Waiving Certain Documentation Requirements for Katrina Victims(9/12/2005) In response to the devastation caused by Hurricane Katrina, CMS officials have eased certain billing requirements on providers that are serving victims of the storm. The compliance reprieve applies to providers and suppliers in the following states where HHS Sec. Mike Leavitt has declared a public health emergency: Alabama, Florida, Louisiana, Mississippi, and Texas.
Core Health Plan Services Resume in Katrina Aftermath(9/7/2005) Health insurers, preferred provider organizations (PPOs), and managed care organizations (MCOs) in the Gulf Coast region are mobilizing to make sure staff members are safe, reorganize facilities, and adjust policies to best provide for citizens in the hurricane’s aftermath, Managed Care Week, an Internet healthcare news source reported last week.
Respond to CMS: Competitive Acquisition Program (CAP) Interim Final Rule(9/2/2005) Your comments are very important! When CMS recently suspended its implementation of CAP, it stated "This (delay) will allow us time to review public comments as well as to implement further clarifications to the bidding process before we accept bids from vendors." These comments must be filed by September 6th—if you have not already done so, please take this opportunity to tell CMS what you think about CAP!
Medicare Proposes Changes for Part B ASP Reporting(9/2/2005) The Centers for Medicare and Medicaid Services (CMS) is proposing to expand average sales price (ASP) data reporting requirements for manufacturers to include wholesale acquisition costs of Medicare Part B drugs.
New Indications from USP for Oncology Agents(8/30/2005) Erbitux® (cetuximab) (Bristol-Myers Squibb Company and ImClone Systems, Inc.) has received a new indication from the United States Pharmacopeia compendium for the treatment of malignant tumor of head and neck, relapsed/refractory. Zometa® (zoledronic acid) (Novartis) has received a new indication from the United States Pharmacopoeia compendium for the treatment of the drug-induced osteopenia, secondary to androgen-deprivation therapy in prostate cancer patients (prophylaxis).
Bill Would Scrap Doc-Pay Formula for Quality Bonuses(8/18/2005) Rep. Nancy Johnson (R-Conn.) introduced a bill to scrap Medicare's sustainable-growth-rate formula, now used to set annual updates to physician reimbursement, and instead reward doctors for meeting quality standards.
GAO: Medicare Claims-Processing Plan Flawed(8/18/2005) Senate Finance Committee Chairman Charles Grassley (R-Iowa) said Wednesday that the Centers for Medicare and Medicaid Services (CMS) should heed the recommendations of a new Government Accountability Office (GAO) report criticizing the agency's Medicare contracting reform plan.
Survey Shows Lack of Provider Compliance with HIPAA Security Rules(8/18/2005) A large segment of healthcare organizations are still not in compliance with the federal Health Insurance Portability and Accountability Act (HIPAA) of 1996. As well, more than one-quarter reported data security breaches, though a recent survey found there is also a lack of concern about the situation.
CMS Seeking Input on Oncology Demonstration Extension(8/17/2005) The Centers for Medicare and Medicaid Services (CMS) will base a decision on whether to extend the Medicare "quality of care" oncology demonstration project into 2006 on input from providers, patient groups, and other stakeholders.
CMS Sets Deadline for HIPAA-Compliant Claims(8/5/2005) As of October 1, CMS will no longer process any electronic fee-for-service Medicare claim that does not meet standards set by the Health Insurance Portability and Accountability Act (HIPAA) of 1996.
Important Update: CMS Releases Proposed Rule for the 2006 Physician Fee Schedule(8/5/2005) The Centers for Medicare and Medicaid Services (CMS) has just released its Notice of Proposed Rulemaking (NPRM) for the 2006 Physician Fee Schedule. This proposed regulation provides key insights into changes the Agency may make to its payment policies for a wide range of Medicare priorities.
CMS Previews Online Tool to Compare Drug Costs(8/4/2005) August 03, 2005—CMS on Tuesday previewed an Internet tool that allows Medicare beneficiaries to compare medication prices based on the individuals' health plans and personal information, TechnologyDaily reports. The tool, which will be available October 15, will coincide with CMS's roll-out of the new Part D prescription drug benefit.
Grassley Introduces First P4P (Pay for Performance) Bill(7/27/2005) On June 30, 2005, Senator Chuck Grassley, R-Iowa, chairman of the Senate Finance Committee, introduced the Medicare Value Purchasing Act of 2005 (S. 1356), also known as “MVP”, to start the ball rolling on Medicare Pay for Performance.
Hospitals and Physicians Face Different Challenges with MMA(7/27/2005) Hospitals and physician-owned cancer centers were treated differently in the Medicare Modernization Act (MMA). An analysis of the proposed revisions to the Hospital Outpatient Prospective Payment helps to illuminate the issues both types of care centers face in 2006.
CMS Releases CY 2006 HOPD Proposed Rule(7/20/2005) The CY 2006 hospital outpatient department (HOPD) proposed rule was put on display July 18, 2005. Among the many issues presented in the 800-page rule, the Centers for Medicare and Medicaid Services (CMS) is proposing to pay for most Part B drugs, biologicals, and radiopharmaceuticals administered in HOPDs based on competitive market prices.
U.S. Senators Send Letter to President Bush Regarding Medicare Reimbursement(7/7/2005) A letter discussing Medicare reimbursement cancer care, written by Senator Arlen Specter (R-PA) and Senator Bill Nelson (D-FL), was sent to President Bush. Thirty-nine members of the United States Senate requested that the President prolong the $300 million demonstration project through 2006 and work to resolve issues within the cancer community regarding the deficit in Medicare reimbursement.
Web-Based System Would Check Eligibility and Benefits(7/5/2005) It is anticipated that a web-based system will be available by the end of 2005 that will allow providers to review patients’ eligibility and benefits.
Medicare Pay-for-Performance Bill Presented(7/5/2005) Senator Chuck Grassley (R-Iowa) and Senator Max Baucus (D-Montana) have presented a bill that entitles providers that report quality data and satisfy particular quality standards to obtain full Medicare reimbursement along with bonuses.
New Oral Oncologics Increases Cancer Therapy Spending(5/19/2005) Medco Health Solutions has reported that the introduction of new oral oncology agents is changing the cancer therapy category. These changes are creating more opportunities to treat those suffering with the disease, but it is also creating a management challenge for health plan sponsors and employers.
The Preserving Patient Access to Physicians Act of 2005(5/19/2005) The Preserving Patient Access to Physicians Act of 2005 bill was presented to Congress by Rep. E. Clay Shaw Jr. and Rep. Benjamin Cardin on Wednesday. The bill proposes to line up the increasing costs of patient care with reimbursement to the physicians who treat them.
New Cancer Drugs are Raising the Cost of Care(5/17/2005) It is expected that global spending on cancer drugs within the next year will rise to $31.7 billion, an increase from $22.3 billion in 2004. This cost is due in part to the new drugs, called targeted drugs, available for cancer care.
Initial Results for the Quality of Care Demo Project(5/12/2005) The Centers for Medicare & Medicaid Services (CMS) Administrator, Mark McClellan, has announced the first results in the oncology “quality of care” demonstration project as showing an important variability in the quality of life among chemotherapy patients.
Zevalin® and Bexxar® Coverage Will Not Change(5/10/2005) The Centers for Medicare & Medicaid Services (CMS) issued a radioimmunotherapy decision memo on May 4, 2005 that said Medicare contractors will still be able to determine coverage of Zevalin® and Bexxar® for off-label use in non-Hodgkin’s lymphoma.
The National Quality Forum Receives a Grant(5/9/2005) The National Quality Forum (NQF) will be receiving a $2.5 million grant from the Robert Wood Johnson Foundation (RWJF) to aid in developing a consensus set of performance measures for physicians in the ambulatory care setting.
Radioimmunotherapy for Non-Hodgkin’s Lymphoma Decision Memo(5/4/2005) It has been suggested by the Centers for Medicare & Medicaid Services (CMS) that there is inadequate evidence to change the present policy with the off-label use of Zevalin® or Bexxar® for the treatment of non-Hodgkin’s Lymphoma.
A New Drug Program is Launched(5/4/2005) Patients nationwide are looking into a new program that is helping those in need get prescription medicines. This program, the Partnership for Prescription Assistance, has matched 100,000 patients in the past three weeks to patient assistance programs that satisfy their needs.
ASCO Comments on CAP(5/3/2005) ASCO submitted detailed comments last week to the Centers for Medicare & Medicaid Services (CMS) on the proposed rule for the Competitive Acquisition Program (CAP).
AMA Releases Survey on Medicare Rate Cuts(5/3/2005) One in 10 responded that they would retire if payments fell more than 5% next year. Sixty percent said they would put off purchasing new equipment, and 38% said they would accept fewer Medicare patients.
Amgen posts strong results under the ASP Reimbursement System(5/3/2005) Amgen remains confident that its switch to average sales price-based (ASP) reimbursement for Medicare Part B drugs will continue to be a positive move for its growth prospects.
Call for CAP Plan Changes(5/2/2005) During the April 18, 2005 American Conference Institute/Pharmaceutical Care Management Association conference, attorney Carolyn McElroy discussed the significant changes that the Centers for Medicare and Medicaid Services (CMS) need to make on their proposal for the competitive acquisition program (CAP) to be successful.
Xeloda® Treatment for Adjuvant Colorectal Cancer(4/22/2005) Roche Laboratories have reported that Xeloda® prescription patterns have shown “very good signs of growth” for the off-label use in adjuvant colorectal cancer and they are anticipating its approval by mid June.
Reducing Medicare Payments may Halt Physician IT Investment(4/20/2005) The American Medical Association (AMA) held a survey regarding the possible Medicare payment cuts that could take place and how physicians felt about it. Results from the survey showed that half of those physicians that responded will delay purchasing and investing in new medical equipment or technology if their Medicare payments are reduced next year.
AWP Moving to Alternate Benchmark Pricing(4/19/2005) First Databank is looking toward the government and industry in assisting their move from using Blue Book average wholesale prices (AWPs) in their price reporting products. This cannot be easily done without the cooperation and direction from public and private sectors.
Medicare Focuses on Part-B Cost(4/15/2005) Wood Mackenzie has determined that an influential proportion of pharmaceutical and biotechnology firms are at high risk with their U.S. revenues since the Centers for Medicare and Medicaid Services (CMS) are focusing on the improved cost controls of Part B drugs provided by the Medicare Modernization Act (MMA).
AMA begins lobbying assault(4/6/2005) Medicare is expecting a reimbursement cut of 4.3% in fiscal 2006, which has the American Medical Association (AMA) urging their members to contact members of Congress and displaying posters in doctors’ offices stating that the cut could force physicians to stop accepting Medicare patients. The AMA is also planning to organize patients to lobby congress.
2004 Showed Part B Drug Use Higher(4/4/2005) The Centers for Medicare & Medicaid Services (CMS) have reported that 2004 figures show a substantial increase in the utilization of physician-administered drugs under Medicare Part B.
Medicare Part B ASP cost savings fall below Government Expectations(4/4/2005) William Sarraille, a Sidley Austin Brown & Wood partner, reported at the March 30th Philadelphia International Pharmaceutical Compliance Summit that “Medicare Part B cost savings from the change to average sales price-based drug reimbursement have not met government standards.”
Small Practices May Close due to Oncology Reimbursement Changes(3/31/2005) Discussions at the March 29th Smith Barney Citigroup healthcare Conference held in Washington, D.C. on March 29, 2005 indicate that while large physician practices will likely “survive and adapt” to reimbursement changes, smaller, less efficient practices may suffer as patients go to hospital settings or perhaps larger clinics for care.
CMS UPDATES:(3/29/2005) The Centers for Medicare & Medicaid Services has posted the Medicare payment rates for chemotherapy and supportive care drugs that will be effective April 1, 2005.
National Patient Assistance Clearinghouse will be Launched April 5(3/29/2005) On April 5, the Pharmaceutical Research & Manufacturers of America’s (PhRMA) “Partnership for Patient Assistance” (PPA) will be available nationwide as the clearinghouse for prescription drug support programs.
Discounted and Free Drugs are Available(3/25/2005) Drug manufacturers have made discounted or free medication available to 6 million Californians in a one-stop access way.
Physician Prices Jump(3/24/2005) The U.S. Bureau of Labor Statistics’ Consumer Price Index (CPI) shows that in February the price charged to consumers by physicians jumped 0.7 percent and consumer hospital prices maintained a steady growth rate at 0.7 percent as well.
NCD Requests Continue Regardless of Cost(3/24/2005) The Association of Community Cancer Centers (ACCC) has proposed that national coverage determinations (NCD) should be started regardless of cost by the Centers for Medicare & Medicaid Services (CMS).
Stem Cell Transplantation Coverage Expanded(3/17/2005) The Centers for Medicare & Medicaid Services (CMS) announced Tuesday that it is expanding Medicare coverage of autologous stem cell transplantation (AuSCT) for primary amyloid light chain (AL ) Amyloidosis.
Insurers Reimbursing Physician EMail Consultations(3/14/2005) Insurers nationwide have begun reimbursing physicians for email consultations with their patients. Some physicians have been emailing patients for years, but most have never been reimbursed for these exchanges.
CMS Contracts Awarded Under Bidding Program(3/10/2005) Under the competitive acquisition program, Medicare could award five to 250 separate Part B vendor contracts depending on how the Centers for Medicare & Medicaid Services (CMS) end up defining their bidding areas.
Aetna Members to Use Specialty Pharmacy(3/9/2005) The Aetna/Priority Healthcare joint venture has said that by October 2005, Aetna members will receive specialty medications exclusively through Aetna Specialty Pharmacy.
Part B Competitive Acquisition Rule(3/9/2005) The Centers for Medicare & Medicaid Services is considering phasing in competitive acquisition of prescription drugs under Medicare Part B.
R2 Signs with FirstChoice(3/3/2005) R2 Technology, a manufacturer of medical computer-aided detection (CAD), has entered into a new three-year, sole source contract with the FirstChoice Cooperative of Texas, a member-owned purchasing cooperative.
Medicare to Improve Cancer Patient Care(2/11/2005) The Centers for Medicare & Medicaid Services (CMS) plan to expand cancer patient coverage of diagnostic tests and chemotherapy treatments for Medicare beneficiaries.
GlaxoSmithKline Receives Amended Agreement for Cervical Cancer Vaccine(2/8/2005) MedImmune, Inc. reported an amended agreement with GlaxoSmithKline (GSK) that will allow them to receive certain milestone payments and royalties for future development and sales of an investigational human papillomavirus (HPV) vaccine in a Phase 3 development by Merck & Co., Inc .
Court to Notify Those Who Paid for Prescription Drug Lupron(1/7/2005) BOSTON, Jan. 7, 2005 /PRNewswire/ -- A national notification program began today, as ordered by the United States District Court for the District of Massachusetts, to alert consumers, insurers, employee welfare benefit plans and other entities who paid for Lupron(R) about a proposed $150 million settlement of litigation against TAP Pharmaceuticals Products Inc.
HHS will use 10 sources to calculate 'Widely Available Market Price'(11/19/2004) The U.S. Department of Health and Human Services Office of Inspector General will collect market price data from 10 different sources to determine the “widely available market price” (WAMP) of drugs, HHS IG Chief Counsel Lewis Morris told the Pharmaceutical Compliance Congress in Washington D.C. Nov. 15.
Average Sales Price final rule includes PhRMA's estimation method(9/20/2004) The methodology for estimating drug price concessions when submitting average sales prices (ASP) for Medicare Part B will follow a proposal made by drug manufacturers in comments to the interim final rule.
ASCO Data Shows Reduction In Resources For Cancer Care Greater Than Anticipated(9/14/2004) At a Congressional briefing Sept. 8 on Capitol Hill, the American Society of Clinical Oncology (ASCO) released findings from an analysis of the effect of the Medicare Modernization Act (MMA) on cancer care in the United States, showing a loss of funds for community-based cancer care in the range of 43 to 54 percent beginning in 2005.
The Next Step: Proposed Medicare Part B Regulation(7/27/2004) July 27, 2004 - This morning, the Centers for Medicare & Medicaid Services (CMS) released the Notice of Proposed Rule Making (NPRM)for portions of Medicare Part B including changes to physician payment policy and reimbursement for physician-administered medications (AWP/ASP) (CMS press release,CMS fact sheet). In releasing this proposed rule, CMS is providing the public an opportunity to review and comment on the steps CMS proposes to take in its implementation of the Medicare Modernization Act (MMA).
Proposed Physician Fee Schedule(7/26/2004) July 26, 2004 - LegisLink has learned that the proposed Physician Fee Schedule rule will likely be issued tomorrow. This proposed regulation is expected to invite public comment on a wide variety of important matters, including:
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