August 22, 2014
Meet our Experts: Gillian Woollett
Meet Gillian Woollett, Avalere’s go-to FDA and regulatory strategy expert.
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.
Meet Gillian Woollett, Avalere’s go-to FDA and regulatory strategy expert.
In an analysis funded by the Council for Affordable Health Coverage, Avalere Health estimated the cost savings resulting from a new, less-expensive tier of insurance coverage, if legislation were to permit it.
On Aug. 11, Celltrion announced the completion of their 351(k) filing procedure to FDA on Aug. 8, for its Remicade (infliximab) biosimilar product, Remsima (infliximab).
On Aug. 11, Cologuard became the first technology to receive a simultaneous FDA approval and proposed Medicare national coverage determination (NCD) through the FDA-CMS Parallel Review program.
On Aug. 7, CMS released a final national coverage determination (NCD) for Transcatheter Mitral Valve Repair (TMVR).
On Aug. 4, CMS released the Fiscal Year (FY) 2015 Inpatient Prospective Payment Systems (IPPS) final rule. The rule made important changes to quality reporting programs and clarifies criteria for hospital inpatient admissions, in addition to its regular payment policies.
What: Avalere will be hosting a conference on the future of market access for diagnostics and personalized medicine, which will focus on key developments spanning the entire market access continuum, ranging from evidence generation and regulatory strategy to coverage, coding and payment.
Lakshman Ramamurthy, PhD, director of FDA & Regulatory Policy at Avalere Health, has been appointed by the Centers for Medicare and Medicaid (CMS) to serve as an industry representative to the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).
On July 31, CMS released Calendar Year (CY) 2015 regional and national benchmarks that help determine beneficiary premiums in Medicare Part D, including the regional low-income subsidy (LIS) amounts.
On July 28, the Medicare Board of Trustees released their 2014 report, addressing the financial health of the Medicare program.
On July 31, FDA released the details of its draft guidance regulating laboratory developed tests (LDTs).
The Health Resources and Services Administration (HRSA) has issued an “interpretive rule” that reflects the same interpretation of the 340B orphan drug exclusion as the agency included in the July 2013 orphan drug final rule, before the rule was vacated by the U.S. District Court for D.C. in May…
On July 22, the U.S. Court of Appeals for the D.C. Circuit issued a 2-1 ruling in Halbig v. Burwell, deciding contrary to lower courts and striking down the IRS’s regulations allowing consumers to receive subsidies for insurance purchased on federally-facilitated exchanges.
This July, Avalere’s Tanisha Carino and Scott Gottlieb published a paper on AEI.org, discussing the ways in which medical research for major diseases continues to advance, while simultaneously making cures more expensive upfront.
On July 3, CMS released the Calendar Year (CY) 2015 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule.
On July 3, CMS released the Calendar Year (CY) 2015 Medicare Physician Fee Schedule (MPFS) proposed rule.
In the Calendar Year (CY) 2015 End Stage Renal Disease (ESRD) Prospective Payment System (PPS) proposed rule released on July 2, CMS proposes a 2015 base per treatment rate of $239.33, up slightly from $239.02 in CY 2014.
On June 27, CVS Caremark announced partnerships with seven additional Medicare accountable care organizations (ACOs) to improve pharmacy care and reduce drug spending for beneficiaries enrolled in CVS’ SilverScript Medicare Prescription Drug Plan (PDP).
NCQA has released new technical specifications for the 2015 version of Health Effectiveness Data and Information Set (HEDIS) to include four new measures, changes to seven measures, the retirement of two measures and minimal changes to various other measures.
In a 5-4 ruling on June 30, the U.S. Supreme Court issued a majority opinion on Burwell v. Hobby Lobby Stores, Inc., holding that the contraceptive mandate violates the Religious Freedom Restoration Act (RFRA) as applied to closely held, for-profit corporations.
In the spring 2014 edition of the Journal of Health Information Management (JHiM), Avalere’s Chris Boone published an article addressing modern-day challenges to clinical data registries (CDR).
On June 16, MedPAC issued a letter to CMS, advising the agency to make critical changes to its two accountable care organization (ACO) programs—the Pioneer demonstration and Medicare Shared Savings Program (MSSP).
In this week’s edition of McKnight’s Long-Term Care, Jeff Terkowitz wrote a guest column discussing new payment models, and the opportunities they present for SNFs.
On May 28 WellPoint/Anthem BlueCross BlueShield announced the launch of the WellPoint Cancer Care Quality Program – a new pay-for-adherence initiative which incentivizes physicians to follow certain evidence-based WellPoint Cancer Treatment Pathways.
On June 2, CMS announced that it will not finalize the Average Manufacture Price (AMP) based Federal Upper Limits (FULs) for reimbursement of multiple source drugs in Medicaid in July 2014, as expected.
On May 30, CMS released results from the March week of ICD-10 acknowledgement testing.
Avalere-Pope Woodhead collaboration a natural fit to deliver global market services.
Avalere’s experts will be presenting several posters at AcademyHealth’s Annual Research Meeting in San Diego.
Many of Avalere's experts are heading north to Canada for ISPOR's 19th Annual International Meeting, where we'll have several panel discussions and poster presentations.
On May 23, the U.S. District Court for the District of Columbia issued a decision striking down the 340B orphan drug rule that was finalized by the Health Services and Resources Administration (HRSA) in July 2013 and took effect Oct. 1, 2013.
In this month’s edition of McKnight’s Long Term Care News & Assisted Living, Avalere’s Sally Rodriguez wrote a guest blog discussing value-based payment strategies for post-acute care (PAC) providers, given the Affordable Care Act’s (ACA) current focus on value over volume.
On May 19, CMS released the Final Rule on policy changes to the Medicare Advantage (MA) and Medicare Part D programs for Contract Year (CY) 2015.
On May 16, HHS released the final Exchange and Insurance Market Standards for 2015 and Beyond rule.
On May 14, CMS released a proposed national coverage determination (NCD) for Transcatheter Mitral Valve Repair (TMVR), and proposed to cover TMVR under its Coverage with Evidence Development (CED) program.
On May 13, FDA released a draft guidance describing the clinical pharmacology data needed to support a demonstration of biosimilarity to a reference product.
On April 9, HHS made public CMS reimbursement data for 880,000 Medicare providers for the first time in the Agency’s history; but the bigger story was the social media response that followed.
On May 14, the Health Care Cost Institute (HCCI) announced that it will work with Aetna, Humana and, UnitedHealthcare to provide consumers free access to an online tool that displays information about the price and quality of healthcare services beginning in 2015.
Avalere is pleased to announce a new formalized collaboration with Michael “Buz” Waitzkin.
At least four states -- Arizona, Colorado, Louisiana and Missouri -- have recently proposed bills that would allow physicians to prescribe investigational drugs, biologics or devices to eligible terminally ill patients.
On May 5, the American Society of Clinical Oncology (ASCO) released a novel methodology for physician payment for cancer care services under Medicare.
On April 30, CMS released the Fiscal Year (FY) 2015 Inpatient Prospective Payment Systems (IPPS) proposed rule.
On April 24, CMS announced a Special Enrollment Period (SEP) for individuals losing coverage through the Pre-Existing Condition Insurance Program (PCIP).
The launch of the exchanges this year marked significant change for our healthcare system.
On April 21, the Journal of the American Medical Association (JAMA) published a study about beneficiary assignment and leakage in the two Medicare ACO programs, the Pioneer program and Medicare Shared Savings Program (MSSP).
This April, Avalere experts finalized a paper surrounding the policy issues of control, access and usage for products containing pseudophedrine (PSE).
In this week’s edition of McKnight’s Long-Term Care News & Assisted Living, Avalere’s Jennifer Rak wrote a guest blog piece on the effects of the recently released Final Medicare Advantage (MA) Rates.
On April 17, the HHS Office of Inspector General (OIG) released a report evaluating the impact on total Medicare expenditures of the payment differential between hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs).
On April 15, CMS released a revised version of the ESRD Seamless Care Organizations (ESCOs) Request for Application (RFA).
In this week’s edition of McKnight’s Long-Term Care News & Assisted Living, Avalere’s Brian Fuller wrote a guest post discussing the merits behind PAC provider bundling.
On April 14, the Congressional Budget Office (CBO) and the Joint Committee on Taxation (JCT) released updated estimates on health insurance coverage provided through the ACA.
On April 11, UHC announced that they will no longer implement their policy to ban the use of manufacturer-provided retail copay coupons.
On April 9, the World Health Organization (WHO) issued its first guidance for the treatment of hepatitis C infection (HCV).
On April 9, CMS released cost and utilization data on services provided to Medicare fee-for-service (FFS) beneficiaries by physicians and other healthcare professionals in calendar year (CY) 2012.
On April 9, pharmacy benefit manager (PBM) Express Scripts released a report highlighting prescription drug utilization by enrollees in new exchange plans.
On April 7, CMS finalized their Calendar Year (CY) 2015 capitation rates, methodological changes to rates and risk models, and other payment and program policies for Medicare Advantage (MA) and Part D plans.
On March 27, the American College of Cardiology (ACC)/ American Heart Association (AHA) announced that they will begin to include cost and value information in their guidelines recommendations, while simultaneously publishing a methodology statement on how guideline writing committees should incorporate…
On April 3, HHS released a draft report with proposed strategies and recommendations for health information technology (HIT) regulation.
In 2014, most states are choosing to cover new Medicaid eligibles with the same benefit package that current eligibles receive.
On March 31, the Senate passed the “Protecting Access to Medicare Act of 2014,” which was passed in the House last week, to provide a temporary fix to the Sustainable Growth Rate (SGR) formula.
On March 27, the United States Prevention Services Task Force (USPSTF) released for public comment a draft research plan, “Primary Care Screening for Depression in Adults,” taking the first step in the process to update its recommendation released in 2009.
On March 26 and 27, FDA’s Advisory Panel reviewed two DNA-based colorectal cancer (CRC) screening tests, Epigenomics-Epi proColon® Septin 9 test and Exact Sciences-Cologuard®.
On March 25, OIG released an updated report on Medicare payments for End Stage Renal Disease (ESRD) drugs.
Beginning July 1, retail pharmacies in United Healthcare’s (UHC) network will no longer accept manufacturer-provided retail copay coupons.
On March 25, the House released the bill text for the “Protecting Access to Medicare Act of 2014,” which provides a temporary fix to the Sustainable Growth Rate (SGR).
On March 18, the HHS OIG released a report providing an overview of specific Medicare Part B drugs where the Average Sales Price (ASP) exceeded the Average Manufacturer Price (AMP) by at least five percent in 2012.
The bipartisan, bicameral legislative framework for a repeal of the Sustainable Growth Rate (SGR) formula and shifts toward quality/value-based payment and adoption of alternative payment models for physicians has been primed since early February.
With only two weeks left of 2014 exchange open enrollment, issuers and states are deeply engaged in maximizing enrollment before the end of the month.
On March 18, FDA released draft guidance containing recommendations for sponsors and new applicants preparing bioavailability (BA) and bioequivalence (BE) data for products in investigational new drug applications (INDs), new drug applications (NDAs) and NDA supplements.
On March 14, HHS published an interim final rule on third party payments requiring qualified health plans (QHPs) and standalone dental plans (SADPs) to accept third party payments on behalf of enrollees from the Ryan White program, Indian tribes, tribal organizations, urban Indian organizations, and…
On March 14, CMS released the Exchange and Insurance Market Standards for 2015 and Beyond proposed rule.
From July 21 to 25, CMS will conduct end-to-end testing on the International Classification of Disease, Tenth Revision (ICD-10) coding system.
In this week’s edition of McKnight’s Long-Term Care News & Assisted Living, Avalere’s Anne Tumlinson wrote a guest post discussing ways to improve medication management communications at skilled nursing facilities (SNFs).
At March’s MedPAC meeting, staff discussed improving Medicare spending value by linking Fee-for-Service (FFS) payment to the comparative clinical effectiveness of healthcare therapies.
Brian Fuller, Director, brings more than 10 years of experience and strategic support to clients in the post-acute care and long-term care settings.
MedPAC’s latest public meeting was March 6 and 7 and covered topics such as equalizing payments across post-acute settings of care, improving quality measurement, exploring alternative methods to pay for Part B drugs, enhancing delivery of primary care services through payment incentives, and ways…
The American Medical Association’s (AMA) Current Procedural Terminology (CPT®) Editorial Panel (Panel) announced on March 5 its acceptance of a set of codes that will be used to report testing for large-scale, multianalyte genomic sequencing procedures typically performed using Next Generation Sequencing…
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)…