NEJM Publishes Six Papers on Genomic Testing (May 27, 2015)

On May 25, 2015, the New England Journal of Medicine published six policy papers on genomic sequencing applications, policy, and challenges.

Links after the break.

FDA Continues Down-Classifying Genomic Tests

Would FDA Overrun LDTs?
In 2014, the FDA announced an extensive plan by which it would regulate laboratory-developed tests.   Concerns were quickly raised that the agency's regulation process would be far to cumbersome.

The FDA has issued several guidances that so its flexibility in approaching the classification of genomic tests.  More after the break.

CMS Releases Draft Gapfill Pricing for 2015 Molecular CPT Codes

Addendum, September 2015: 
May 2015 draft gapfill prices discussed in this blog entry.  
Final September 2015 prices discussed here.
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What is going on?

1. CMS put 29 brand new molecular CPT codes into its contractor-based gapfill process on 1/1/2015.  This included high-profile new codes like "exome sequencing" and "tumor gene panel, >51 genes."
2. By May, CMS contractors had come up with proposed prices for 10 of the 29 codes.  CMS has published those prices on a state-by-state basis (published May 26, 2015).
3. CMS is accepting public comment on the proposed test prices until July 20, 2015.
4. In July and August, Medicare contractors may review incoming public comments.  The contractors may hold, raise, or lower their proposed prices in August.  
5. In September, CMS will publish the median price for each priced test.  This will become a national fee schedule price on 1/1/2016 and forward.   

What do we know so far?

1. Contractors only priced 10 of the 29 molecular CPT codes.  19 were left blank.
2. The more advanced test codes - for genomes, exomes, mitochondrial genomes, and sets of 51+ tumor genes - show no proposed prices at this point.
3. The Genomic Health Oncotype DX test received a range of prices, between $2000 and $3400, with about half of the MAC regions reporting.

More after the break.

Growing Awareness that Pathology Policy is Crucial for Precision Oncology

Over the past several days I noticed a flurry of interesting, potentially connectable policy articles in precision medicine for oncology.   I'll list them and draw some lines among them in this blog.

If you work on the laboratory side of precision oncology, you've been familiar with challenges created by the outdated CPT/RVU/CLFS payment and pricing system.  You've either never heard of the Medicare "14 day rule" -- or it makes you tear your hair out.

Clinicians are paying attention now, too. And so is biopharma.

Two interesting entry points, from different associations, are ASCO's position on next-generation sequencing reimbursement and a CAP TODAY feature article on pharmas that are paying a lot of attention to the delivery side of combination diagnostics.

CCLA Federal Lawsuit Against LCDs: Dismissed for Lack of Standing.

Over the past year, this blog has carried several entries about the California Clinical Lab Association effort to overturn Medicare LCDs as being inconsistent with federal authority to defer policymaking to private entities (e.g. Medicare contractors.)  July 2014 blog, here.  April 2014, here.  The case got further than many attempts to sue HHS, because it reached oral argument a few months ago rather than just being dismissed on the paper record.

On May 20, 2015, a federal court ruled that the case participants lacked standing to sue HHS in federal court.

• A patient (Jane Doe) had not suffered injury justifying standing, and 
• the laboratory association had not exhausted its administrative appeals within the agency, before proceeding to federal court.   

The decision is in the cloud, here.  Detailed analysis at Pathology Blawg, here.

MolDX Finalizes Coverage for Lung Cancer Comprehensive Genomic Profiling (CGP)

In January 2015, the Medicare MolDX program published a draft coverage determination for comprehensive genomic profiling (CGP) in lung cancer patients if initial genetic tests had failed to find mutations for EGFR or ALK.   See earlier coverage, here.  The policy covered first-line CGP testing but only in non- and light-smokers.

MoLDX has finalized the LCD with minimal changes, with a 45-day effective date of July 6, 2015.  The final (future effective) version is here.

Some details and a redline comparison after the break.

CMS issues draft coverage for Genomic Health Oncotype DX Prostate Test

On May 21, 2015, the Medicare contractor Palmetto GBA released draft coverage for the Oncotype DX Prostate prognostic gene panel test, as part of Palmetto's MolDX program.

The draft LCD is on line here or here; Genomic Health's press release is here and coverage at Genomeweb (subscription), here.

Coverage conditions are similar to those proposed and finalized for the Myriad Genetics Prolaris test.

Medicare's 0.0023% Budget for Telemedicine - What Does New Legislation Do?

According to an article in the May 14, 2015 "Inside CMS" trade journal, Medicare spending for telemedicine is currently at $14M - which is 0.0023% of Medicare's $615B budget.

The article is based on a new industry report from the Waters Center for Telehealth and eHealth Law (here).  Medicare's thin coverage for telemedicine opened with a short section of the Balanced Budget Act of 1997, providing limited benefits for live video interviews between centrally located physicians and patients located in remote areas (here).  Although this limited benefit has been expanded in baby steps, it contrasts sharply with a recent forecast for telemedicine becoming a $17 billion dollar global industry in the 2015-2020 range (here).  Mid-2015 investments in dhealth are running in the $2B range (for 3 estimates, see here).  Outside of Medicare, barriers are falling.  United Healthcare recently began providing some coverage for virtual visits (here) and Walgreens is setting up to provide telemedicine visits as well (here).

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.