Who We Are
Efraim (Eric) Katz, JD:
When a healthcare innovation faces a major regulatory challenge, success usually depends on diagnosing "What's Bothering Washington" – that elusive key for transforming a bureaucratic roadblock into a simple plan of action. Efraim Katz builds those paths, with an experienced approach to Washington’s complex mosaic of regulators, lawmakers and opinion leaders.
The result: confidence in tackling today’s challenges and anticipating tomorrow’s.
Efraim spent ten years at CMS, gathering a birds-eye perspective on Medicare reimbursement. Another decade in FDA policy provided insights into approval and post-approval demands. The combination of CMS and FDA insights is key in helping companies facing a product launch.
Efraim has helped clients:
Efraim doesn’t stop with the big picture, but incorporates the detailed technical acronyms: NCD & ASP; CPT & ICD, ACO & Part C; IND & NDA, 510k & PMA; 505(b), (c) & (j). He’s mastered reimbursement rates, technology add-on payments, breakthrough drug status and other keys to profitable market entry. He speaks the language of every flavor of healthcare player: FDA, CMS, NIH, HHS, AHRQ, DEA, DoJ, SEC, White House, Congress, OIG, FBI.
His career history lends credibility to his reputation as national expert for industry and investors. He was Executive Director of the US Advisory Committee on the FDA, then ran an R&D staff at CMS looking at innovative Medicare payment models. Efraim has been a pharma lawyer, a Fulbright Fellow, a public health researcher and an author of national health reforms. He reads JAMA for fun and reads Medicare Public Dockets as his personal cure for insomnia.
Efraim’s client base includes startups with a single product, pharma and device-makers with a mature market presence, investment funds, expert networks, law firms, other consulting firms and patient advocacy groups. He’s reachable at PharmaAndHealth.com.
(update: October 2018)
Sample Publication:
Public – Private Partnerships In Israeli Pharma
Who We Are
Adam Fein creates in-depth research useful to Wall Street, industry regulatory staff, and others. His firm also produces reports on pharma developments, often free for the download.
Part of a larger bloc of “fierce-X” sites, this news site show the “what’s hot, what’s not” with major pharma companies worldwide. You’ll find their “fiercebiotech” and other sites similarly informative.
A rich tickertape of news across the pharma and biotech space. Proof that you don’t have to subscribe to pricey newsletters anymore to get the latest.
Ed Silverman’s excellent blog covering today’s emerging issues that often become tomorrow’s headlines across the pharma and healthcare space. His sources are broad and deep.
The Hyman Phelps law firm keeps track of legal developments at FDA, which of course is most of the fun stuff, and puts it out for its clients, its would-be clients, and the rest of us.
q1medicare.com/PartD-2012MedicarePartD-PlanStatistics.php
Facts at a glance for the Medicare drug benefit, as played out in real life and (nearly) real time.
For those who thought Medicare sets its own prices and we all need to obey, take a look at reimbursement for certain medical devices and supplies. Bidders enter a fight to the finish for market rights in a geographic area. The wave of the future?
cms.gov/Regulations-and-Guidance/Guidance/FACA/MEDCAC.html
When the coverage decisions get tough, the tough recommend the coverage decisions. At least, that’s how it looks when CMS calls its Advisory Committee in to do the heavy lifting on coverage decisions involving expensive, complicated, or just plain thorny technologies.
cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html
Everything, often including the kitchen sink, gets tossed into the annual Physician Fee Schedule that sets payment rates, conditions of participation, and everything else that touches Medicare spending for physician services. Reading this is not for the faint of heart.
Kaiser maintains a huge trove of data on Medicare, Medicaid, health reform, and most of the healthcare system. Often, the figures will be cleaner, newer, and easier to read than what comes out of CMS itself.
In addition to its multiple mandates to protect Medicare’s trust funds, craft program refinements, and generally leap tall buildings in a single bound, MedPAC also puts out some great statistics on how we’re doin’ in Medicare. Click on the June, 2013 Data Book for a good example.
The Office of the Actuary at CMS produces some of the best and cleanest Medicare data on planet earth, much to the occasional chagrin of the Agency Head and even the White House. Which just makes its in-depth summary of Medicare finances all the more fascinating.
Federal Agencies
No words of introduction are needed for major health-related agencies.
Trade associations
If you need to find the issues burning a hole in the hearts of an industry, check its trade association for policy papers (also known as lobbying talking points).
- Brand name Rx drugs -- Phrma.org
- Prescription drug access (industry-funded) pparx.org
- Generic drugs -- Gphaonline.org
- Biotechnology -- Bio.org
- Medical devices -- Advamed.org, MedicalDevices.org
- Managed Care Organizations -- Ahip.org
- Physicians -- Ama-assn.org
- Hospitals – aha.org
Contact Us
Address:
Pharma & Health
2833 Smith Ave. Suite 349
Mt. Washington, MD 21209
Email:
[email protected]
[email protected]
Phone Number:
Tel: +1.202.656.7711
Mideast Office Tel: +972.53.708.7080