Stem Cell Transplant: CMS Opens NCD Revision; LA Times Criticizes Wild Hype

An  interesting collision of events in the past month.  Medicare has a longstanding policy for limited coverage of stem cell (bone marrow) transplants.  On April 30, 2015, it opened the NCD for comment and expansion, based on a request from the National Marrow Donor Program and the American Society for Blood and Bone Marrow Transplantation (webpage here; request here).  CMS will review future coverage for stem cell transplantation in patients with myelofibrosis and patients with sickle cell disease.

Just a couple weeks later, the Los Angeles Times publishes an expose on the field (at least under the same name) being "infected with hype" and populated even with doctors with revoked licenses (here, here).   Discussion of these puzzle pieces after the break.

Update:
FDA is holding a workshop on stem cell research & therapy & FDA regulation, according to an October 29, 2015 article in Pink Sheet (here).  The workshop will be April 13, 2016.  Pink Sheet writes, "[FDA] is planning an April public meeting to discuss the product category and four recently issued draft guidance documents addressing the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps)."

Medicare Announces MEDCAC on Peripheral Arterial Disease

On April 27, 2015, Medicare announced the second MEDCAC of 2015: a public workshop on therapies for peripheral vascular disease.  Federal Register announcement here (80 FR 23007); Medicare webpage here.  The meeting will be held at CMS on July 22, 2015.  Written comments must be submitted by June 15.  Registration may be submitted until July 15.

The questions for the meeting were posted by CMS on May 4, and the technology assessment is likely the same as one published by the AHRQ in 2013.

Medicare publishes draft coverage for Nanostring Prosigna test

On May 14, 2015, the Palmetto MolDX contractor published a draft local coverage decision favorable to the Nanostring Prosigna test.  Prosigna is a gene panel algorithmic test which is cleared by the FDA as a distributed test running on the Nanostring nCounter platform.

Draft LCD DL36125 is online here or in the cloud as a PDF here.   Nanostring's website is here.  Press release here.  Coverage at Genomeweb here (subscription).

Cancer Letter: MED-C in 10,000 Words

Cancer Letter, a trade journal edited by Paul Goldberg, has published a cover article on MED-C, a proposed genomic registry to collate genomic and community outcome data in oncology.   I discussed the MED-C program in an earlier post (February 1, 2015; "Is the Learning Healthcare System Almost Suddenly Here?" -  here).

On May 8, the Cancer Letter published a detailed article on MED-C, plus a lengthy interview with its leader, Dr. Dane Dickson.  Together, the articles total almost 10,000 words.   Links after the break.

Congress Creates the Ten-Year Medicare Contractor

A little-commented passage in MACRA - aka the SGR reform passed in April, 2015 - changes Medicare Administrative Contractor durations from a standard of 5 years, to a new standard of 10 years.

SEC. 509. RENEWAL OF MAC CONTRACTS. 

Congress Puts FDA "Structured Risk Benefit" Aims into Clearer English

One of the most popular posts on this blog is a 2014 post on FDA and structured risk-benefit.  That post also asks whether there are any lessons-learned for coverage decisions at payers.  (For that earlier article, see here).

Several years ago, in FDASIA, Congress added two sentences the a key section of FDA law (FFDA Section 505(d)), instructing the agency to use structured risk benefit in decision making.  Now, Congress proposes to revise that language a little.  Continued after the break.

PMC 2015 White Paper: How ACOs Impact Personalized Medicine

In April 2015, the Personalized Medicine Coalition released a new 40-page white paper entitled, "Paying for Personalized Medicine: How Alternative Payment Models Could Help or Hinder the Field."  The white paper discusses the impact of ACOs, bundling, and other payment systems on precision medicine.    Download here.

The white paper is authored by Andrew Shin (here), of ML Strategies, the consulting arm of Mintz Levin LLP.

Congress Gives CMS a Free Hand to Reset RVUs

Sound bite:

The rules for establishing RVUs are greatly changed, and the power balance tipped far in favor of the Medicare agency, by § 220 of the Protecting Access to Medicare Act of April 2014.  Medicare has not yet begun to implement its new value-setting powers, but it will probably begin to do so by mid 2015.   

More after the break.

The Wall Street Journal won the 2015 Pulitzer Prize for investigative reporting for its series, "Medicare Unmasked."

See also:  The GAO's negative report on the RVU system, published May 21, 2015 (here), and a blog on the GAO report, 5/22/2015, here.  See a May 31, 2015, New York Times article on the GAO report, here.  

For further recent RUC critiques, both cited within the GAO report, see Urban Institute, June 2014, "Development of a model for the valuation of work relative value units: Objective service time task status report," Auckerman et al., 139 pp, here.   RAND, 2015, "Development of a model for the validation of work relative value units for the Medicare Physician Fee Schedule," Wynn et al., 263 pp, here.

Coalition Announces FDA Diagnostics Reform Plan; FDA-CMS Announce Dx Quality Collaboration

Out of the Hat - The Diagnostic Test Working Group (DTWG)

As noted today on the Hyman Phelps FDA Law Blog (here), an emerging coalition called the Diagnostic Test Working Group has released a broad plan to up-end the way FDA regulates diagnostics.   If enacted by Congress, the FDA, CMS, and states would undertake a very substantial revamping (including changes in law) of FDA's governance of diagnostics.

Details are on the Personalized Medicine Coalition website (here); see also my cloud archive - executive summary, here;  full white paper, here;  one pager, here.

The proposal would leave diagnostic test design and validation in the hands of the FDA, but would extend this authority for both IVD (kit-distributed) and LDT diagnostics.   Once the test is designed and validated, operations to run the test would be in the hands of CLIA (or its designated examining agencies).   Unusually, the proposal leaves much of the claims and sign-out authority in the hands of the states.

For those with subscription access, see Genomeweb, "Small Group of Labs, Dx Manufacturers Float Alternative to FDA LDT Guidance" - here, which comments the Hyman Phelps blog.  See also "Coalition of Manufacturers, Labs Floats Alternative to LDT Approach" at Inside Health Policy, here.

FDA and CMS announce "Task Force" on LDT Quality 

Webpage announcement here, at Blogs.FDA.gov.  Co-authored by Jeff Shuren (FDA) and Patrick Conway (CMS), the agencies describe some stakeholder confusion in the wake of the FDA's plan to regulate LDTs under FDA law but in a phased-in fashion.   The two-agency "task force" will

...Establish an interagency task force that will continue and expand on our collaboration related to the oversight of LDTs, which are tests intended for clinical use and designed, manufactured, and used within a single lab. The task force, comprised of leaders and subject matter experts from each agency, will work to address a range of issues, including those involving quality requirements for LDTs.

Of course, this is a poke in the eye to those stakeholders who felt that CLIA already enforced the quality of laboratory developed tests.

More analysis and insight on these topics, to follow....

What Mississippi, Telemedicine, and CVS have in common.

In 2013, Mississippi passed a major telemedicine bill (see here, here).   A February 2015 article at Politico describes Missisippi as a leader in telemedicine (here; see also the University of Mississippi Center for Telehealth, here.)

In June 2014, I attended a CVS presentation on advances in healthcare delivery at the annual Washington healthcare conference, Health Datapalooza (2015 meeting website, here.)   I was impressed by the CVS presentation and asked the Minute Clinic President Alan Sussman what would be the most important policy changes he'd like to see.   Better coverage for telemedicine was one of the five policy topics he rapidly named for the audience:

Flurry of Media on Competition versus Scale in US Healthcare

I was asked to give a talk later this month on "how payers think," and one key concern of payers is consolidation of the providers they must negotiate with.   This has been a longstanding policy issue in healthcare, but was accelerated by the push for larger and more integrated Accountable Care Organizations under the Affordable Care Act.

FTC-DOJ Workshop
On February 24-25, for example, the Federal Trade Commission and the Department of Justice held a joint public workshop on "Examining U.S. Healthcare Competition" -- conference announcement here, conference webpage here (agenda, materials, video).

FDA Announces Workshop on Companion Diagnostics Policy: March 24, 2015

FDA has scheduled a public workshop entitled “Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies.”

The objective of the workshop is to facilitate an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. The workshop aims to foster collaborations in the clinical cancer research community; provide a deeper understanding of anticancer drug and device development related to personalized medicine; provide a unique perspective of personalized medicine; and help incorporate emerging scientific findings to harmonize companion diagnostics across a class of targeted therapies.

The FDA workshop will be co-sponsored by the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO).

Date and Time: March 24, from 8:30 to 4:30.
Location:  Mayflower Hotel, Washington DC

Federal Register announcement, here.  ASCO's announcement, here.

CMS is holding a MedCAC (public advisory panel) on genomic tests on the same day (here).

Note that the FDA carefully refers to "drug and device" development - LDT's are "devices" here.

Two Online Articles on Payer Utilization Controls for Diagnostics

The trade journals DARK DAILY and MANAGED CARE published two separate articles on rising utilization controls on diagnostic tests.

The links are here:

Managed Care:  (here, 3000 words)...  Health Plans Deploy New Systems To Control Use of Lab Tests 

Dark Daily: (here, 1500 words)...  As Medical Laboratory Test Utilization Grows, Health Insurers Develop Programs to Manage Rising Costs

Sound bite [Dark Daily]:

After seeing a rise in the volume of clinical lab tests physicians order, managed care plans are develop a variety of strategies to manage utilization and costs

Health insurers are taking more aggressive actions to control the cost of clinical laboratory testing. For many years, clinical laboratories and pathology groups have been concerned about the strategies used by Medicare to control the utilization and costs of medical laboratory tests. Private health insurers usually follow the actions of Medicare, the nation’s largest health insurer. But today, managed careplans are developing their own lab-test-utilization strategies in addition to following those of Medicare.

Recently, Managed Care magazine explained many of the steps health insurers take to keep the costs of clinical laboratory tests under control. The cover story in the October issue of the magazine, “Health Plans Deploy New Systems To Control Use of Lab Tests,” outlined how health insurers Cigna, Group Health Cooperative, Priority Health, and UnitedHealthcare (UHC) are managing lab test utilization.

Two Interesting Reports from Milken Institute: Innovation in Healthcare

The Santa Monica-based Milken Institute released two interesting reports on healthcare innovation in the past year, one in March 2015 and one in July 2014.

IOM hosted Precision Medicine Conference on April 1, 2015

The Institute of Medicine will hold a public conference on precision medicine on April 1, 2015, under the title, "Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies."

The April 1 workshop webpage is here; the series webpage is here.  There was a prior meeting in this series on January 29.

Full details after the break.