March 07, 2014
HHS Notice of Benefit and Payment Parameters for 2015 Final Rule Released
On March 5, CMS released the HHS Notice of Benefit and Payment Parameters for 2015 final rule.
Keep up with the latest Avalere marketplace insights affecting pharmaceutical, biopharmaceutical, medical device, diagnostic, and generic manufacturers. Follow new data on Affordable Care Act implementation, Medicare Part D, Medicare Advantage, and hospital readmissions. Stay updated on what's new at Avalere.
On March 5, CMS released the HHS Notice of Benefit and Payment Parameters for 2015 final rule.
On Feb. 24, CMS released an advance notice of proposed rulemaking and request for comments on two potential methodology changes to adjust Medicare fee schedule payment amounts or other Medicare payment amounts for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).
FDA will hold a public hearing on April 1 to receive feedback from key stakeholders on 1) demographic subgroup representation in clinical trials, 2) analysis of demographic subgroup data, and 3) communication of demographic subgroup information to the public.
The financial alignment demonstrations (FAD), designed to coordinate care for dual eligible beneficiaries, are gaining momentum as states begin implementation and final planning.
On Feb. 28, Washington State’s Health Care Authority (HCA), which administers the state’s Health Technology Assessment (HTA) Program, recommended five technologies to undergo initial review and coverage decisions, and recommended one topic for re-review, beginning in 2015.
On Feb. 24, FDA issued draft guidance on exclusivity determinations for certain fixed-combination drug products (FCDs).
On Feb. 19, OIG released a claims analysis of 2011 hospital inpatient Medicare cases, finding that Medicare and its beneficiaries could achieve substantial cost savings by expanding the inpatient hospital Medicare Severity Diagnosis Related Group (DRG) window.
FDA has now confirmed that the first widespread generic-drug equivalency testing program was initiated last September (without public notice).
On Feb. 18, FDA released guidance outlining how an applicant can obtain FDA feedback on a potential or planned medical device submission reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), including the Pre-Submission (formerly…
On Feb. 21, CMS enhanced the Physician Compare website to include the addition of quality measures to indicate the performance achieved on a set number of specific metrics.
Last week, CMS awarded First Coast Service Options, Inc. (First Coast) the contract for the administration of Medicare Part A and Part B fee-for-service claims in Jurisdiction N, which encompasses Florida, Puerto Rico, and the U.S. Virgin Islands.
In this week’s edition of McKnight’s Long-Term Care News & Assisted Living, Avalere’s Anne Tumlinson wrote a guest post based on acute care and post-acute care relationships moving into 2014.
Avalere analysis from its “Medicaid Monthly” shows that since Oct. 1, 2013, 7.7 million individuals have been deemed eligible for Medicaid and the Children’s Health Insurance Program (CHIP).
On Feb. 19, the National Committee for Quality Assurance (NCQA) released its 2015 Healthcare Effectiveness Data and Information Set (HEDIS) for public comment, proposing eight new measures, proposing changes to seven existing measures, and retiring two measures.
This month, Avalere Health proudly joins the Health Data Consortium (HDC), an organization comprised of government, private sector, and non-for-profit entities, whose goal is to improve health and healthcare by advancing the availability and innovative use of data.
On Feb. 18, the United States Prevention Services Task Force (USPSTF) released for public comment a draft recommendation statement, “Screening for Carotid Artery Stenosis.”
On Feb. 10, the Government Accountability Office (GAO) released a report discussing the results of its drug shortages analysis, and reported that although the total number of ongoing drug shortages continues to increase, new drug shortages decreased in 2012.
On Feb. 4, the United Kingdom’s National Institute for Health and Care Excellence (NICE) published their first Medtech Innovation Briefings (MIB), providing objective information on device and diagnostic technologies to aid local decision-making by clinicians and policymakers.
On Feb. 10, CMS opened a national coverage analysis (NCA) on the use of lung cancer screening with Low-Dose Computed Tomography (LDCT) devices.
On Feb. 10, the IRS issued a final rule to implement the ACA-mandated employer mandate and associated penalties.
On Feb. 4, the Office of the Inspector General (OIG) released a report describing select covered entities’ contract pharmacy arrangements and their oversight to prevent diversion of 340B purchased drugs to ineligible patients, and to prevent duplicate discounts through Medicaid.
On Feb. 3, the Agency for Healthcare Research and Quality (AHRQ) released a white paper that provides payer perspectives on how to improve the usability of reports produced by AHRQ’s Effective Health Care (EHC) program.
Avalere analysis from the February “State Reform Insights” shows that in addition to the 26 states and D.C. committed to expending Medicaid in 2014, Utah, Tennessee and Indiana could follow suit.
On Feb. 3, the Measures Application Partnership (MAP) released its final pre-rulemaking report, providing recommendations on the adoption of new measures in more than 20 federal public reporting and payment programs, including clinician programs (e.g., Physician Quality Reporting System, Physician Compare)…
On Feb. 4, CMS published a draft letter to issuers seeking to offer qualified health plans (QHPs) and standalone dental plans (SADPs) in the FFM or federally-facilitated small business health options program (FF-SHOP).
In a rule published on Feb. 3, HHS will henceforth allow patients or persons designated by the patient, access to the patient’s completed laboratory test reports.
CMS released financial results on Jan. 30 indicating that nearly half of the Medicare ACOs (54 of 114) had lower expenditures than projected in their first year of participation.
On Jan. 27, the IRS published a proposed rule to clarify and modify the requirement that individuals have minimum essential coverage (MEC) starting in 2014.
On Jan. 28, the United States Prevention Services Task Force (USPSTF) released the draft recommendation for public comment, “Screening for Abdominal Aortic Aneurysm.”
PCORI will fund more head-to-head trials that compare two or more efficacious treatment alternatives for the therapeutic area being examined.
The Government Accountability Office (GAO) released a report comparing ACA-based federal upper limit (FUL) amounts to National Average Drug Acquisition Cost (NADAC) amounts for 1,035 Medicaid-reimbursed outpatient drugs.
The American College of Radiology (ACR) is leading a coalition to encourage CMS to open a national coverage determination (NCD) on lung cancer screening.
In this week’s edition of McKnight’s Long-Term Care News & Assisted Living, Avalere’s Anne Tumlinson wrote a guest post based on our most recent Vantage Care Positioning System® (“Vantage CPS”) program research paper, “Physician Relationships Hold Key to SNF Success.”
NEWS RELEASE: PuttingPatientsFirst.net uses Avalere Health analytics to educate consumers about marketplace choices.
Despite the challenging exchange rollout, more than 1.8 million individuals signed up for exchange coverage in December alone, bringing total enrollment to 2.2 million during the first three months of open enrollment.
On Jan. 14, HHS announced it would extend the closing of the high-risk pools an additional two months to align with the end of open enrollment, in order to help smooth the transition into exchange coverage.
On Jan. 14, FDA issued draft guidance for industry called “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”
On Jan. 14, HHS announced that it will begin responding to Freedom of Information Act requests for physician-payment information.
On Jan. 13, the Measure Applications Partnership (MAP) released a draft report providing recommendations on what measures to include in federal quality programs, such as physician and hospital quality reporting programs.
Today the Department of Health and Human Services released updated health insurance enrollment figures.
On Jan. 9, CMS released a final coverage decision restricting coverage of percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis to CMS-approved clinical trials.
The HHS OIG released a report on the local coverage determination (LCD)-caused variation in coverage of Part B items and services.
On Dec. 23, the Measure Applications Partnership (MAP), a public-private partnership tasked to provide HHS with pre-rulemaking input on measures included in federal programs, released a draft report offering guidance on the Qualified Health Plan (QHP) Quality Reporting System (QRS) for the Health Insurance…
On Jan. 6, FDA released final guidance outlining the qualification process for drug development tools (DDTs).
On Jan. 6, CMS released a proposed rule seeking to implement key policy changes to the MA and Part D programs for Contract Year (CY) 2015.
As states begin covering newly eligible Medicaid beneficiaries under the ACA, a few states are enrolling some of their newly eligible beneficiaries in qualified health plans (QHPs) via the exchanges.
On Dec. 26, President Obama signed into law a two-year budget resolution that reduces budget uncertainties through fiscal year (FY) 2015.
On Dec. 1, the Administration re-launched Healthcare.gov after largely resolving the IT problems that plagued the site for the first two months of open enrollment.
On Dec. 12, CMS released an interim final rule (IFR) codifying recently announced changes that permit consumers to enroll in health insurance coverage through an exchange as late as Dec. 23 for coverage effective Jan. 1, 2014.
Join Avalere, Armada and SPAARx for an educational series that examines the potential role of specialty pharmacies within Accountable Care Organizations (ACOs).
As of Dec. 11, 1.99 million individuals were determined or assessed eligible for Medicaid or the Children’s Health Insurance Program (CHIP).
NEWS RELEASE: An analysis by Avalere Health finds that consumers who enroll in exchange plans will, on average, face dramatically different deductibles based on the metallic level plan (i.e., bronze, silver, gold, platinum).
On Dec. 6, CMS and the Office for the National Coordinator for Health Information Technology (ONC) proposed a one-year extension for Stage 2 of Meaningful Use for eligible providers who began attesting in 2011 or 2012.
NEWS RELEASE: An analysis from Avalere Health finds that most individuals in exchanges who reach their maximum out-of-pocket (OOP) cap will be underinsured, despite reduced OOP caps for those below 250 percent of poverty. The Commonwealth Fund defines underinsurance as OOP costs greater than 10…
On Nov. 27, FDA released three draft guidances on the regulation of compounding pharmacies following the enactment of the Drug Quality and Security Act (DQSA).
NEWS RELEASE -- Today Avalere Health, a private data analysis firm, released a study that refutes past claims that commercial plans pay lower rates for lab services than Medicare. Instead, the study found that Medicare rates are almost always lower than average rates paid by private plans.
On Nov. 25, HHS released the Proposed Notice of Benefit and Payment Parameters for 2015 that provides technical details and policy parameters related to the advance payments of the premium tax credits (APTC), cost-sharing reductions (CSRs) and premium stabilization programs.
On Nov. 27, CMS announced a yearlong delay of online enrollment for small business employers seeking health insurance through the federally-facilitated small business health options program (FF-SHOP).
On Nov. 22, CMS released its final Calendar Year (CY) 2014 End Stage Renal Disease (ESRD) PPS rule, finalizing a 2014 base per treatment rate of $239.02, reduced slightly from $240.36 in CY 2013.
On Nov. 22, FDA issued a warning letter to 23andMe, Inc., asking them to immediately discontinue the marketing of their saliva collection kit and Personal Genome Service (PGS) Kit.
NEWS RELEASE -- A new Avalere Health analysis shows that, as of November 2, 30 percent of exchange applicants are eligible for federal subsidies to reduce their monthly insurance premiums and out-of-pocket costs for medical care, far below the 84 percent of enrollees who are ultimately expected to qualify…
Six weeks into open enrollment, the federally-facilitated exchange (FFE) website healthcare.gov —serving residents of 36 states—continues to face technological challenges.
Please join Senior Vice President Gillian Woollett next month at the 2013 FDA/CMS Summit session, Regulatory Gaps: What's Left to "Fix" at FDA?
On Nov. 18, the Senate passed the Drug Quality and Security Act, roughly two months after it passed the House in September, seeking to clarify laws related to human drug compounding and to strengthen the prescription drug supply chain by creating a national system.
On Nov. 18, CMS opened a national coverage analysis (NCA) for Transcatheter Mitral Valve Repair (TMVR) devices.
On Nov. 14, the U.S. Preventive Services Task Force (USPSTF) released a draft research plan for Public Comment on “Screening for Breast Cancer,” which intends to re-evaluate the effectiveness of routine mammography screening in women age 40 and older.
On Nov. 8, HHS and the Departments of Labor and Treasury jointly released a final rule implementing the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).
Avalere is seeking qualified candidates at the Associate and Senior Associate level as part of its annual recruitment program.
MedPAC makes no formal recommendations at their November meeting, and does not offer a new SGR replacement plan in order to keep momentum moving with the House’s current replacement legislation.
Avalere Health has named Danny Krifcher as Executive Vice President for Operations.
Open enrollment on the new health insurance exchanges is now under way, and understanding the landscape of health plan participation, benefits and formulary coverage will be critical to your success in these new markets.
An analysis from Avalere Health finds that 12 state-based exchanges1 have enrolled about 3 percent of their expected 2014 exchange participants. Together, the 12 states have enrolled 49,100 people in exchanges based on data released by the states, as of Nov. 10. By the end of 2014, Avalere…
ISPOR recognized Avalere Health for its contribution in diabetes research at this week’s ISPOR 16th Annual European Congress in Dublin.
In September, Arkansas received approval from the federal government to expand Medicaid using a premium assistance model or “private option” for 2014 through 2017.
On Oct. 30, CMS released a final decision memo on ventricular assist devices (VADs) used for bridge to transplant (BTT) and for destination therapy (DT).
On Oct. 24, CMS released its final program integrity standards rule, detailing: advance payments of the premium tax credit (APTCs) and cost-sharing reductions (CSRs); the premium stabilization programs; issuers offering coverage in the Federally Facilitated Marketplace; and standards for enrollee satisfaction…
On Oct. 30, HHS sent a letter to Rep. McDermott, R-Wash., indicating that it does not consider qualified health plans (QHPs) purchased through insurance exchanges to be federal healthcare programs.
On Oct. 28, CMS released the calendar year (CY) 2014 benefit parameters for Medicare Parts A and B, which cover hospital inpatient and all outpatient drugs and services, and begins Jan. 1, 2014.
Bread For The City recognized Avalere Health today at its Good Hope Awards with the Corporate Partner Award for Avalere’s commitment to the organization over the past several years.
On October 24, Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at FDA, issued a statement indicating the Agency’s intent to recommend reclassifying hydrocodone combination products from Schedule III to Schedule II products.
A new analysis from Avalere Health found that the number of applications submitted to date for exchange coverage exceeded comparable enrollment in Medicare Part D over the same time period during each program’s launch.
The share of Medicare Advantage (MA) plans with a star rating of 4 stars or higher in 2014 (43 percent) will increase substantially relative to 2013 (27 percent) according to a new Avalere Health analysis of the Centers for Medicare & Medicaid Services’ (CMS) recently released data on 2014 plan quality…
Dan Mendelson reiterated on the Diane Rehm Show Tuesday morning that it is too early to call healthcare.gov an ultimate failure, but sees the many glitches as an embarrassment for the Obama Administration.
Prime Therapeutics, America’s largest privately held PBM, conducted a study examining member use of cost-sharing assistance programs across a variety of specialty drugs during the first half of 2013.
Consumers in 30 states (60%) will have the option of at least one plan operating as both a qualified health plan (QHP) in the health insurance exchange and as a Medicaid managed care organization (MMCO), according to an Avalere analysis.
After the first three weeks of open enrollment, healthcare.gov and state exchanges continue to experience a multitude of technical difficulties; however, according to Avalere Health CEO, Dan Mendelson, there’s no cause for panic.
Insurance exchanges were set to launch October 1, but technical glitches and enrollment delays have plagued most exchanges.
The Centers for Medicare and Medicaid Services (CMS) posted the star ratings for 2014 Medicare Advantage (MA) and Part D plans on the Medicare.gov website. Avalere Health is available to answer questions about this new information.
On September 30, CMS posted revised gapfill prices for molecular pathology Current Procedural Terminology (CPT®) codes, including calculations of the 2014 National Limit Amounts (NLAs).
Express Scripts Inc., the world’s largest PBM for employers and health plans, recently released a list of 44 drugs that they will now exclude from coverage beginning January 1, 2014.
Some states are exploring novel approaches that will create closer alignment between Medicaid and the coverage that will be available through the commercial health plan market.
Health insurance exchange marketplaces opened on October 1 for enrollment across the country, as well as premium subsidies for those with limited incomes.
Avalere Health is carefully analyzing the landscape file of health plan offerings on the federally-facilitated marketplace recently released by the Department of Health and Human Services (HHS).
On October 1st, Avalere FDA and Regulatory Expert Gillian Woollett was featured on POLITICO Pro’s panel discussion on the impact of regulations and policy changes on the development and access to drugs and what it will mean for patients.
Biosimilar Innovation and its Dependence on Regulatory Framework
Medicare Advantage HMO offerings grow while PPO and PFFS offerings are exiting the market. Analysis also shows significant variation in PDP premiums in 2014; five out of top 10 prescription drug plans have double digit increase
Today, the Centers for Medicare & Medicaid Services (CMS) released the 2014 landscape files containing data on plan participation, premiums and benefit designs for the Medicare Part D and Medicare Advantage (MA) markets.
Avalere examines states participating in the ACA expansion that may reduce eligibility levels for some current beneficiaries.
States, HHS Focus on Final Details as Exchanges Ready for Launch
As a member of the senior leadership team, Matt will guide the firm's focus on reform, health plans, providers, and data and analytics.