Article States It's Possible to Game PAMA via Appeals

2017 online article states it's possible to game PAMA through appeals during the window of claims capture.  You appeal low-paid claims so they fall outside the window and aren't reportable (it doesn't matter if you win the appeal or not).

http://www.cablecarcapital.com/tag/exas/

I wrote about similar topics in March 2018 - here.

Placeholder for OIG CLFS Report CY2018 (Due in 2017)

For the last several years, OIG issued a PAMA-related CLFS report every fall based on data from the prior year.  It counted lab test payments for OPPS setting (hospital outreach labs billing on the 1450 form) as well as Part B CLFS.

The 2018 report will be the first that looks retrospectively at a year of new pricing under PAMA. 

As of February 2020, OIG has a placeholder page for the report, but it hasn't come out yet.

https://www.oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000336.asp

Medicare Payments for Clinical Diagnostic Laboratory Tests in 2018: Year 1 of New Payment Rates

Medicare is the largest payer of clinical laboratory services in the Nation. Medicare Part B covers most lab tests and pays 100 percent of allowable charges, with no beneficiary copayment. In 2017, Medicare paid $7.1 billion for lab tests, a total that has changed very little in the 4-year period from 2014 through 2017. The Protecting Access to Medicare Act of 2014 (PAMA) requires CMS to set payment rates for lab tests using current charges in the private health-care market, under Title XVIII of the Social Security Act. (Pub. L. No. 113-93 § 216(c)(2)(A)). On January 1, 2018, CMS began paying for lab tests under the new system mandated by PAMA. PAMA requires OIG to publicly release an annual analysis of the top 25 laboratory tests by expenditures. In accordance with PAMA, we will publicly release an analysis of the top 25 laboratory tests by expenditures for 2018, the first year of payments made under the new system for setting payment rates.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
June 2019	Centers for Medicare & Medicaid Services	Medicare Payments for Clinical Diagnostic Laboratory Tests in 2018: Year 1 of New Payment Rates	Office of Evaluation and Inspections	OEI-09-18-00100	2020

Decks on Reimbursement I Presented on Feb 27, 2020 and March 3, 2020

This is a placeholder where I will provide cloud links to decks I presented on reimbursement and CMS trends, in Feb/March 2020.

THIS WEBSITE:

https://tinyurl.com/BQDECKSQ12020



DECK PRESENTED FEB 27, 2020:
FOLEY LARDNER "BUSINESS OF PERSONALIZED MEDICINE"
SOUTH SAN FRANCISCO

https://drive.google.com/file/d/1_F7rBxlagkudn8rpBBOL08TBtxovT0Er/view?usp=sharing



TRICON "REIMBURSEMENT SHORT COURSE"


DECK PRESENTED MARCH 3, 2020:
SAN FRANCISCO


https://drive.google.com/file/d/1FMi2KJThYA9jKDEGUFgWItLx1qQSC7FJ/view?usp=sharing 

Surprise Billing Bills, and Arkansas Rejection

House Committees Mark Up Surprise Billing Bills

On Tuesday and Wednesday, the House Education & Labor (E&L) and House Ways and Means Committee held a markup for their respective surprise billing proposals. To date, three separate surprise billing proposals have passed through three separate House committees, illustrating the pressure on Congress to end the practice of balance billing practices. The House E&L bill is similar to the bill passed by the Energy and Commerce Committee last year that favors benchmark pricing to end balance billing disputes with minimum thresholds for arbitration. Under the E&L bill, medical bills would need to be higher than $750, or $25,000 for air ambulance bills (while the Energy and Commerce bill does not address air ambulance) before they could be arbitrated. The Ways and Means measure would allow all billing disputes to be arbitrated, regardless of the price. In all three proposals, arbitrators would be instructed to “consider” median in-network rates. The Ways and Means version could result in more medical bills going to arbitration because it doesn’t include minimum thresholds or benchmarks for out-of-network services but does include a time-limited open negotiation period prior to arbitration.

All Congressional leaders involved in these measures have stated a wish to pass bipartisan legislation this Congress with the ideal path forward being to discuss all three options on the House floor. The agreed-upon legislation would be included within the extenders package set to be discussed before the May deadline.

Articles & Resources

Link to Energy and Commerce bill, HR 3630

Link to House Ways and Means bill, HR 5826

Link to House Education and Labor bill, HR 5800

Older article - "Pelosi Enters Fight" - Feb 04 - https://thehill.com/policy/healthcare/481287-pelosi-enters-fight-over-surprise-medical-bills

---

Appeals Court Strikes CMS-Approved Arkansas Medicaid Demonstration

On Friday morning, a three-judge panel of the U.S. Court of Appeals for the District of Columbia ruled unanimously to affirm the district court’s decision finding the Trump Administration’s approval of Arkansas’ demonstration program was arbitrary and capricious. The panel included one Republican-appointed judge. Arkansas implemented work requirements to require certain non-disabled Medicaid recipients to meet work or similar requirements to maintain eligibility in the program; limited Medicaid’s standard retroactive coverage period to 30 days prior to application; and terminated an employer-sponsored coverage premium assistance program. Approximately 18,000 people (about 25% subject to the work requirement) lost Medicaid coverage in five months due to an inability to meet work requirements, failure to successfully report, or simple unawareness of the requirements. Citing case precedent, the court concluded, “While furnishing health care coverage and better health outcomes [the latter being the alternative objective pursued by the demonstration] may be connected goals, the text specifically addresses only coverage. 42 U.S.C. §1396-1.  The Supreme Court and this court have consistently reminded agencies that they are ‘bound, not only by the ultimate purposes Congress has selected, but by the means it has deemed appropriate, and prescribed, for the pursuit of those purposes.’” Further, the Court found HHS acted arbitrarily and capriciously by not considering the coverage losses in its approval: “While we have held that it is not arbitrary or capricious to prioritize one statutorily identified objective over another, it is an entirely different matter to prioritize non-statutory objectives to the exclusion of the statutory purpose.”

While the Administration will likely seek Supreme Court review for the 2020-21 term so long as President Trump wins reelection, in the short run, the decision will further jeopardize about 20 states’ work requirements demonstrations that have been approved or are pending.

Articles & Resources

Link to Gresham v. Azar decision

Arkansas' Medicaid work rule rejected by appeals court

Surprise Billing Links

House Education and Labor Clears; rival W&M bill
https://medcitynews.com/2020/02/proposal-to-tamp-down-surprise-billing-clears-house-committee/

Article on "clarity" issues, primarily affecting hospital labs

https://www.360dx.com/clinical-lab-management/labs-brace-potential-plusses-minuses-price-transparency-regulations?_ga=2.154009265.805548739.1581034459-1843693620.1551814236

JAMA on February 11 (see bottom of my June 18 2019 blog)
(FYI- also Resneck and Gaines/Berwick on Feb 3 on prior auth)

Surprise Billing / Atlantic Feb 11
https://www.theatlantic.com/health/archive/2020/02/surprise-bills-can-come-even-when-hospital-and-surgeon-network/606391/

Based on:
JAMA, Chhabra et al.
https://jamanetwork.com/journals/jama/fullarticle/2760735?guestAccessKey=9774a0bf-c1e7-45a4-b2a0-32f41c6fde66&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=021120

https://jamanetwork.com/journals/jama/fullarticle/2760735


Three views - Three Bills
https://www.healthcaredive.com/news/3-surprise-billing-proposals-compared-side-by-side/572268/


When your doc is a lobbyist
https://medcitynews.com/2020/02/when-your-doctor-is-also-a-lobbyist-inside-the-war-over-surprise-medical-bills/

##

US admin costs 4X Canada's
https://www.salon.com/2020/02/15/american-health-care-system-costs-four-times-more-than-canadas-single-payer-system/
About:  Himmelstein et al., Ann Intern Med, Jan 2020, https://annals.org/aim/article-abstract/2758511/health-care-administrative-costs-united-states-canada-2017 

RCT shows flaws in less rigorous methods

FAIL

JAMA - Feb 26 2019
PACT-HF trial

Van Spall et al.
Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure
The PACT-HF Randomized Clinical Trial
https://jamanetwork.com/journals/jama/fullarticle/2725688

FAIL
Health care hot spotting  NEJM 

https://www.nejm.org/doi/pdf/10.1056/NEJMsa1906848?articleTools=true

Health Care Hotspotting — A Randomized,
Controlled Trial
Amy Finkelstein, Ph.D., Annetta Zhou, Ph.D., Sar


OP ED NEJM

https://www.nejm.org/doi/full/10.1056/NEJMsb1901642

The Magic of Randomization versus the Myth of Real-World Evidence
List of authors.
Rory Collins, F.R.S., Louise Bowman, M.D., F.R.C.P., Martin Landray, Ph.D., F.R.C.P., and Richard Peto, F.R.S.

2020 NEJM 382_674 Collins Need RCT_Other Designs FAIL Op ed


___
Note that both articles above find flaws in the amount of value created by home health care (such as for intensive patients) - but this is often taken for granted, as in Harvard Business Review 10/2019 here.   You shouldn't take it for granted, as noted by Finkelstein.

See also "Why Nobody Believes the Numbers," about disease management flaws, by healthcare guru Al Lewis (here).

See also a too-little-noticed example where machine learning worked very well in retina diagnosis studies, but fizzled when used in real life (too many real world variables) - picked up by TechCrunch here.  Secondary article also here - commendably, by Google itself.   And original real world fizzle article is here as a conference proceeding abstract by Beede et al. 

These appeared about the same time as a favorable article on (controlled condition) machine learning retinal testing by Milea in NEJM, 4/30/2020, here.   (Milea pairs with an Op Ed by Ghandi et al., here.)

Jones Day Reboots Elaborate Digital Health Newsletter

https://www.jdsupra.com/legalnews/vital-signs-digital-health-law-update-93337/


For full view, see link above.

Sample below.  International topics included also (see link).

NOTE FROM THE EDITORS

Welcome to the first issue of "Vital Signs"—a refreshed and reframed revival of Jones Day's Digital Health Law Update, given our long-standing commitment, experience, and leadership in digital health. We plan to issue Vital Signs near the beginning of each quarter to cut through all the noise and provide access to a curated resource on "must know" legal and regulatory topics impacting digital health.

As you will see in this first issue, our team of contributors from around the globe culled through various information across legal specialty areas (cybersecurity, health regulatory, IP, litigation, tax, and transactional) to present complex issues in a user-friendly fashion. Hot links to underlying legal and regulatory materials are included within each section, enabling Vital Signs to serve as your ongoing quick reference for all the notable recent legal and regulatory materials.

In this issue, we start with "Industry Insights"—dedicated in each issue to an overarching topic of industry interest—covering the evolving nature of how disparate industry stakeholders are advancing their vision, collaboration, and utilization of digital health, especially in the decade ahead. You'll also learn about: (i) U.S. federal efforts focused on streamlining FDA's digital health approach and advancing Medicare's telehealth reimbursement, while enforcement attention and methods evolve; (ii) U.S. states' legislative attention around telehealth and data privacy; (iii) Europe's flurry of digital health policy covering privacy, cross-border services, device development, and interoperability; (iv) Mexico's adoption of a novel tax on digital intermediaries supporting telemedicine; and (v) Japan's adoption of significant modifications to its Pharmaceuticals and Medical Devices Act.

INDUSTRY INSIGHTS

Worlds Colliding—A New Decade for Digital Health

By Maureen Bennett, Ian Pearson, and Laura Koman

Over the past decade, unprecedented advances in technology and know-how have resulted in an ever-expanding and diversified "digital health" universe. From the growing use of communication technologies to deliver clinical care, to the rise in fitness and healthy living apps, to improvements in diagnostic medical devices, digital innovation has increasingly defined many of our health care experiences over the past 10 years. As we enter a new decade, it is certain this trend will continue.

We expect the next 10 years, however, to encompass something more than continued vertical growth. If the last decade was defined by innovation and forward advancement in numerous yet siloed sectors of the health care industry, the next decade is likely to be defined by horizontal growth—a growing overlap in disparate digital health worlds to create one, integrated digital health ecosystem. We began to see some of this overlap at the tail end of the 2010s.

For example, traditional telehealth services are starting to incorporate medical devices (particularly diagnostic and triaging software) as part of patient-facing platforms. Software has long been used for administrative functions in health care settings. In the last few years, however, we began to see new types of clinical decision support ("CDS") software being utilized for things like patient screening, as well as for assisting providers in identifying the most appropriate treatment plan for a patient's disease or condition. To date, these functionalities have been relatively simplistic, but with the rise of machine-learning algorithms and AI, it seems certain that more sophisticated medical software will soon be upon us. We anticipate that CDS software will become a ubiquitous and indispensable aspect of patient care in the 2020s.

Digital health is also being utilized to bring therapies to market. Sponsors of clinical trials increasingly use digital means, such as data mining through claims and electronic health records, to more rapidly and comprehensively identify, recruit, and engage with clinical trial participants. The use of wearable technologies has also improved the means of collecting and transmitting clinical data to trial investigators. Together with the more traditional means of communicating patient reported outcomes, the use of data from wearables enhances a sponsor's ability to demonstrate the achievement of applicable clinical trial endpoints. In addition, technological advances are being further deployed to support the development of "decentralized" or "virtual" clinical trial protocols, in which an increasing percentage of trial procedures are administered from a patient's home or other remote locations.

The promise of digital health in each of these contexts is significant. These developments could result in less expense, more expedient and more accurate outcomes, and better engagement with subjects, patients, and consumers. But these developments, of course, also give rise to attendant practical and legal challenges, particularly given the different rules and regulators involved. For example, the use of sophisticated medical software and data mining gives rise to privacy and security concerns and may require the use of special informed consents. Likewise, while clinical trials are typically regulated at the federal level, the rise in "virtual" clinical trial protocols may require careful consideration of state telehealth and practice of medicine rules. While the development of technology invariably lurches ahead of regulation, all stakeholders will need to work together to advocate for continued evolution of the regulatory process to allow for a responsible deployment of innovative technologies to improve patient care.

UNITED STATES DEVELOPMENTS

Federal

FDA Proposes New Guidance on Clinical Decision Support ("CDS") Software

In 2016, the 21st Century Cures Act ("Cures Act") explicitly excluded CDS software from FDA regulatory authority. Due to the impressive diversity of digital products that provide some type of clinical decision support (including many that incorporate artificial intelligence and machine learning algorithms), industry stakeholders have since grappled with significant uncertainty about whether certain applications might qualify as CDS software or, alternatively, fall under FDA's regulatory authority. FDA initially issued draft guidance in 2017 to help resolve some of this uncertainty but later withdrew that draft guidance in response to public feedback. FDA recently issued new draft guidance in September 2019 to again address the lingering uncertainty. The September 2019 draft guidance identifies three distinct categories of software: (i) that which meets the Cures Act definition of "CDS software" and, therefore, falls outside of FDA regulatory authority; (ii) that which falls under FDA's regulatory authority but over which FDA intends to exercise "enforcement discretion" due to the lower risk of the applications; and (iii) that which falls under FDA's regulatory authority and over which FDA intends to focus its regulatory oversight. Industry should closely monitor FDA's oversight activities with regard to CDS software in 2020 to gain further insight into FDA's interpretation of its regulatory reach.

FDA Modernizes Regulations to Facilitate Utilization of Digital Technologies in Clinical Trials

In 2019, FDA continued its initiatives focused on modernizing the clinical trial process by issuing numerous draft and final industry guidance supporting the use of adaptive and complex innovative trial designs, novel trial endpoints and enrichment strategies, and duly qualified biomarkers and other drug development tools. Certain of these initiatives are pursuant to mandates under the Cures Act and incorporate evolving technologies such as complex algorithms and digital tools. FDA also recently articulated policies intended to provide patients with a more pronounced voice in clinical investigation design and to permit industry to mine and utilize certain real-world evidence in the drug development process. FDA provides additional information regarding real-world evidence and patient engagement on its website.

Proposed CONNECT Act Transfers Telehealth Reimbursement Eligibility Decisions to Regulators

The CONNECT for Health Act of 2019 ("CONNECT Act") was introduced into the U.S. Congress House and Senate in October 2019. If adopted, the Connect Act could significantly expand reimbursement for telehealth services provided to Medicare beneficiaries. Specifically, the CONNECT Act would empower the U.S. Department of Health and Human Services ("HHS") to waive the specific geographic, modality, provider type, and other limitations currently in effect under §1834(m) of the Social Security Act. HHS may grant such waivers where proposed outlays: (i) reduce spending without reducing quality; (ii) improve quality without increasing spending; or (iii) serve health shortage areas. The CONNECT Act would also eliminate the rural geographic limitation for tele-mental health services and tele-specialist consultations in the emergency department, all §1834 limitations for hospice recertifications following an in-person visit, and the originating site limitation for certain Indian Health Service and Native Hawaiian Health Care facilities.   [CONTINUES...]

2012 WH Bioeconomy Blueprint (CED) vs Trump 2021 Budget (CED)

https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/national_bioeconomy_blueprint_april_2012.pdf

Expanding the Coverage with Evidence Development Program to Drive Innovation: Reimbursement for medical treatments is a powerful driver of industry investment. Under the Coverage with Evidence Development (CED) program, Medicare reimburses for promising new technologies that do not currently meet the standard for full coverage. The CED program requires more evidence to be collected to determine full potential benefit of new technologies. The CED authority has existed for more than a decade but has been applied sparingly. The Centers for Medicare & Medicaid Services (CMS) is poised to implement the next phase of CED by better defining the parameters and guidance for CED so it can be used more widely and effectively as a driver of innovation. CMS believes that the lessons learned during the initial implementation of CED can inform its more frequent use and create predictable incentives for innovation while providing greater assurance that new technologies in fact fulfill their initial claims of benefit.

Reducing the Time to Market by Implementing Parallel Regulatory Reviews for Medical Products: FDA approval and CMS coverage significantly influence the development and commercial success of new medical products. The time required for FDA and CMS to sequentially review new medical products—often multiple years—is frequently cited as a disincentive for innovators and investors in the medical technology industry. A significant portion of this delay is due to the fact that most sponsors of new products approach each reviewing agency separately, first working to meet the evidentiary requirements of the FDA and only later focusing on the requirements of CMS. To address this problem, the FDA and CMS initiated a pilot program for the parallel review of medical devices, creating a pathway for new medical products to be simultaneously reviewed by both agencies. By engaging CMS earlier in the process, the parallel review program is expected to limit the duplication of effort on the part of product sponsors and agency reviewers and reduce the time it takes new products to enter the market and receive payments from Medicare and other providers.

:  https://www.hhs.gov/sites/default/files/fy-2021-budget-in-brief.pdf. 

Improve Clarity and Transparency of the Medicare Coverage Process

Many stakeholders find the process and standards for the Medicare coverage determination process lack clarity. This proposal requires CMS to issue additional guidance around the Medicare coverage process, including sub-regulatory guidance on the evidence standards that CMS utilizes in assessing coverage and the process to appeal coverage determinations, in an effort to improve clarity around Medicare coverage. [Budget Neutral]

Strengthen the Parallel Review Process to Streamline Medicare Coverage

The Parallel Review program is a collaborative effort between the Food and Drug Administration (FDA) and CMS that reduces the time between FDA approval of a device and Medicare coverage of that item. This proposal strengthens the existing parallel review process to improve device manufacturer participation and increase transparency. [Budget Neutral]

LInks for FDA AI Radiology & New Caption Health AI / US / Cardio device

Business news

https://medcitynews.com/2020/02/fda-oks-first-of-a-kind-ai-that-guides-cardiac-imaging/

https://www.healthcaredive.com/news/fda-oks-1st-ai-tool-to-help-non-specialists-take-cardiac-ultrasounds/572010/



Company

https://captionhealth.com/


FDA press release
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-cardiac-ultrasound-software-uses-artificial-intelligence-guide-user

Webpage for FDA Feb 25 26 conference

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-workshop-evolving-role-artificial-intelligence-radiological-imaging-02252020-02262020


Somewhere I saw name of FDA category eg "AI devices for imaging" 21 CFR 888.xyz
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN190040

Discussion paper
https://www.fda.gov/files/medical%20devices/published/US-FDA-Artificial-Intelligence-and-Machine-Learning-Discussion-Paper.pdf

CMMI Legislation 2020.02.06

https://www.healthcaredive.com/news/lawmakers-push-for-more-oversight-at-cms-innovation-center/571742/


https://sewell.house.gov/media-center/press-releases/reps-sewell-smith-lead-bipartisan-push-increase-cmmi-transparency-and

https://www.congress.gov/bill/116th-congress/house-bill/5741/text?r=8&s=1

##
9-2016
http://www.discoveriesinhealthpolicy.com/2016/09/house-hearing-on-cmmi-website-pdfs-and.html

tables flipped

##

OIG Advisory Opinion for Kymriah Allows Needs-Tested Travel Support

Historically, OIG has frowned on any kind of "kickback" to patients or providers, even small ones.  This is based both on existing regulations, a long series of Advisory Opinions, and case law.

A January 30, 2020 (subscription) article in STAT-PLUS looks at a January 2020 advisory opinion that allows travel to be paid for patients who'll get Kymriah, which has both a cell-harvesting stage and a therapy stage.   The article is here; the advisory opinion is here.

The STAT article quotes experts that the opinion "at first glance" appears contradictory to prior opinions. 

Tidbit:  The name "Kymriah" is redacted, but the fact patterns make it clear that Kymriah must be the drug whose name is redacted.