Fishery regulation involves onboard observers at sea--a very dangerous job

 Next time you eat a salt water fish, spare a thought for how fisheries are regulated to keep them viable as a common pool resource.  There are catch limits, whose enforcement requires deep sea fishing boats to have onboard inspectors, called observers.  Apparently that's a dangerous job.

The Guardian has the story:

Death at sea: the fisheries inspectors who never came home.  by Bernadette Carreon 

"Being an observer, which involves monitoring fishing practices and catches to make sure boats follow the rules, is a dangerous job that can put observers in conflict with the crews on the vessels on which they are working, often hundreds, or even thousands, of kilometres from the nearest port.

"According to the Association of Professional Observers, there have been over a dozen cases of observers dying on the job since 2009 alone, including three involving Kiribati nationals."

***********

The Association of Professional Observers maintains a site that includes a page on Observer Deaths and Disappearances, as well as one on Harassment of observers, for example in ways that may compromise their data. 

Reforming organ transplant regulation: create an Office of Organ Policy (Roth and Segal in STAT)

 Here's an opinion piece published yesterday in STAT, which applauds some recent changes in transplant regulations, and suggests some more, including bringing the regulators under one roof, the better to see the many different moving parts that are now regulated separately.

Reforming and improving organ transplant systems will save lives, taxpayer dollars, By Alvin E. Roth and Greg Segal   April 2, 2021

"All of this work raises an even more important question: What is wrong with the U.S. policymaking approach to organ donation that it took decades to enact such commonsense, bipartisan, and popular policies?

"We believe the problem has largely been a fracturing of governmental responsibilities, leading to siloed thinking and lack of clear responsibility to develop good policy. Because no single person or agency in government has ownership of the organ donation process, the buck is continually passed, to the detriment of patients and taxpayers.

"The Biden-Harris administration has a chance to fix this, and should heed calls to create a dedicated Office of Organ Policy. Such an office could execute a unified vision that puts patients first, rather than falling victim to a bureaucracy that lets problems go unsolved for decades."

The pandemic market for disinfectants (including Bourbon scented hand sanitizer)

Disinfectants, particularly those used in medical settings, are regulated, both to make sure that they are effective at disinfecting, and to make sure that they don't have negative (e.g. toxic) properties on people or animals or households.

The OECD summarizes the situation in a few countries from (in alphabetical order) Australia to the United States:

Emergency responses for the supply of disinfectants against Covid-19

Some further information is available on the website of the European Chemicals Agency (ECHA)

Some regulatory processes have been speeded up during the covid-19 pandemic, to allow new entrants into the market to relieve shortages.  One consequence of that is that, in the U.S. you can now buy bourbon-scented hand sanitizer, from bourbon distilleries in Kentucky and elsewhere:

See Public Sale of Hand Sanitizer – Kentucky Bourbon Trail

Hoarding, price gouging, and backlash in the time of corona virus--updated

The NY Times has the story (followed by an update):

He Has 17,700 Bottles of Hand Sanitizer and Nowhere to Sell Them
Amazon cracked down on coronavirus price gouging. Now, some sellers are holding stockpiles of sanitizer and masks.
By Jack Nicas

"On March 1, the day after the first coronavirus death in the United States was announced, brothers Matt and Noah Colvin set out in a silver S.U.V. to pick up some hand sanitizer. Driving around Chattanooga, Tenn., they hit a Dollar Tree, then a Walmart, a Staples and a Home Depot. At each store, they cleaned out the shelves.

"Over the next three days, Noah Colvin took a 1,300-mile road trip across Tennessee and into Kentucky, filling a U-Haul truck with thousands of bottles of hand sanitizer and thousands of packs of antibacterial wipes, mostly from “little hole-in-the-wall dollar stores in the backwoods,” his brother said. “The major metro areas were cleaned out.”

...

"Mr. Colvin said he had posted 300 bottles of hand sanitizer and immediately sold them all for between $8 and $70 each, multiples higher than what he had bought them for. To him, “it was crazy money.” To many others, it was profiteering from a pandemic.

"The next day, Amazon pulled his items and thousands of other listings for sanitizer, wipes and face masks. The company suspended some of the sellers behind the listings and warned many others that if they kept running up prices, they’d lose their accounts. EBay soon followed with even stricter measures, prohibiting any U.S. sales of masks or sanitizer.
**********

And here's the update:

The Man With 17,700 Bottles of Hand Sanitizer Just Donated Them
A Tennessee man had planned to sell his stockpile at marked-up prices online. Now he is under investigation for price gouging.

"On Sunday, Amazon and eBay suspended him as a seller, which is how he has made his living for years. The company where he rented a storage unit kicked him out. And the Tennessee attorney general’s office sent him a cease-and-desist letter and opened an investigation.

“We will not tolerate price gouging in this time of exceptional need, and we will take aggressive action to stop it,” Attorney General Herbert H. Slatery III of Tennessee said in a news release.

"Tennessee’s price-gouging law prohibits charging “grossly excessive” prices for a variety of items, including food, gas and medical supplies, after the governor declares a state of emergency. The state can fine people up to $1,000 a violation."
************

Here are all my posts on price gouging

Transplantation under scrutiny in Washington and the media: compilation of recent links by Greg Segal, via Frank McCormick

The organ transplant ecology is complex, with sometimes perverse incentives in the interfaces among OPOs (Organ Procurement Organizations), donor hospitals, and transplant centers (not to mention dialysis clinics, nephrology practices, government agencies, and subcontractors like UNOS).  Frank McCormick forwards the following compilation distributed by Greg Segal, mostly focused on recent criticisms (some more informed than others) of OPOs. (Having recently spent a day talking to OPO leaders, and not long before that to those running transplant centers, I'm aware that there are different opinions on the multiple causes of  problems afflicting transplantation

Frank writes:
"Greg Segal (founder & CEO of Organize, which is attempting to reduce the U.S. organ donation shortage) sends along this excellent compilation of references for those who want to comment on two current proposals by agencies of the Department of Health and Human Services (HHS):

a.    Health Resources and Services Administration (HRSA): “Removing Financial Disincentives to Living Organ Donation” (deadline – 2/18/20)

 https://www.federalregister.gov/documents/2019/12/20/2019-27532/removing-financial-disincentives-to-living-organ-donation

b.    Center for Medicare and Medicaid Services (CMS): “Revisions to the Outcome Measure Requirements for Organ Procurement Organization” (deadline – 2/21/20)

https://www.federalregister.gov/documents/2019/12/23/2019-27418/medicare-and-medicaid-programs-organ-procurement-organizations-conditions-for-coverage-revisions-to#open-comment

Key points for comments (due by February 21st at 5pm ET, via submission here)

• Although 95% of Americans support organ donation, objective research suggests that organ procurement organizations (OPOs) only recover about 35% of potential donors, leaving as many as 28,000 organs unrecovered every year.
• Because the majority of patients on the organ waiting list are in need of kidneys, OPO underperformance contributes to a $35 billion annual expense to Medicare. 
• As Senators from the Finance Committee wrote in a February 10th 2019 oversight letter: “Because OPOs operate as regional monopolies, rigorous oversight is critical to ensure that all 58 OPOs are faithfully executing their mission of organ recovery.”
• As Secretary of Health and Human Services Alex Azar said: “We’re going to stop looking the other way while lives are lost and hold OPOs accountable."
• With almost 115,000 patients waiting for a lifesaving organ transplant, it is imperative that CMS implements the proposed metrics as strongly and quickly as possible, especially since the majority of OPOs (37 of 58) are failing one or both key metrics.

Context on why OPO reform is critical to helping more patients access organ transplants

• Every day, 33 Americans die or are removed from the organ waiting list because a transplant is unavailable. Additionally, because there is such a large gap between supply and demand, many Americans in need of transplant never even reach the waiting list. Research indicates that the true death toll may be as high as 118 Americans per day just from the kidney shortage alone.
• The shortage of deceased donor organs results in part from inefficiency from federal monopoly contractors, called organ procurement organizations (OPOs), which too often fail to recover organs for transplant. (See NYT whistleblower video.) 
• Research cited by the Trump Administration shows that a more efficient organ donation system could recover up to 28,000 more organs for transplant each year.
• This includes 17,000 kidneys; almost 8,000 livers; 1,500 hearts; and 1,500 lungs.
• Because of costs to Medicare, OPO reform could also save up to $12 billion over 5 years in avoided dialysis costs.
• A key problem is OPOs are allowed to self-interpret and self-report their own performance, leading to a lack of transparency and accountability. As a result, no OPO has lost a government contract in decades.
• In fact, reporting suggests the current standards are unenforceable.
• The New York Times Editorial Board highlighted “an astounding lack of accountability and oversight in the nation’s creaking, monopolistic organ transplant system is allowing hundreds of thousands of potential organ donations to fall through the cracks.” 
• HHS/CMS’s proposed rule, published on December 17th, moves to objective data from the Centers for Disease Control, and shows the majority of the nation’s 58 OPOs are failing proposed performance metrics.
• CMS estimates that just bringing OPOs up to minimum compliance standards would mean 5,000 more deceased donor transplants every year. 
• Responses to the proposed rule are due by February 21st at 5pm ET.

Additional Resources

• Day One Project paper co-authored by Donna Cryer (President & CEO of Global Liver Institute), Jennifer Erickson (former Obama staffer), Crystal Gadegbeku (Council member, American Society of Nephrology and Section Chief of Nephrology, Temple University), Greg Segal (founder & CEO of Organize), and Abe Sutton (former Trump staffer)
• Senate Finance Committee oversight letter to Inspector General inquiring about OPO underperformance, fraud, waste and abuse, and conflicts of interest
• Senate Finance Committee oversight letter to UNOS inquiring about abdication of oversight responsibilities over OPOs 
• Representative Katie Porter oversight letter regarding OPOs, specifically the LA-based OPO known as One Legacy
• Senators Elizabeth Warren and Richard Blumenthal oversight letter to CMS regarding OPO performance and evaluation metrics
• Patient groups writing to Administrator Verma calling for OPO accountability: American Association of Kidney Patients, American Society of Nephrology, Cholangiocarcinoma Foundation, Fatty Liver Foundation, Global Liver Institute, Liver Education Advocacy and Prevention Services, Renal Physicians Association
• Politico Pulse Podcast interview with Greg Segal about the need for OPO reform

News

• Washington Post on Senate Finance Committee OPO oversight letter
• Associated Press on HHS proposed OPO rule

• Politico Pulse on HHS proposed OPO rule
• Full Frontal with Samantha Bee on OPOs never losing contracts
• Kaiser Health News about UNOS and OPOs losing organs in transit

Op eds

• USA Today: Andy Slavitt and Adam Brandon, “Here's how organ donation reform could save thousands of lives, billions in tax dollars”
• The Hill: Jennifer Erickson & Abe Sutton, “It’s Time to Provide Needed Reform to the Organ Donation System”
• New York Post: Dara Kass, “America’s Deadly Failure on Organ Donations”
• CNN: Bakari Sellers, “Dealing with a broken organ donation system after my 4 month old had liver failure”
• STAT: Laura and John Arnold, “A simple bureaucratic organ donation fix will save thousands of lives”
• Washington Post: “The Trump administration is actually doing something great on health care”
• Washington Post: Erika Zak, 39-year old mother who died during transplant, “A posthumous letter to my daughter”

The organization of organ donation: Jennifer Erikson and Abe Sutton call for an Office of Organ Policy

White House staffers from two very different administrations call for a reorganization of organ donation:

It's time to provide needed reform to the organ donation system
BY JENNIFER ERICKSON AND ABE SUTTON

"Every day, Americans are dying because of an inefficient organ donation system. That reality is as tragic as it is fixable, and cemented a seemingly unlikely friendship between us as two former White House staffers who served two very different presidents.

"It might seem like there are not many points of policy agreement between the Trump and Obama White House, but organ donation reform is one.
...
"Organ donation policy has been split between different agencies within the federal government and even an external federal contractor called the Organ Procurement Transplantation Network. This splintering of responsibilities has led to an unaccountable system with patients left behind. As for one federal contractor responsible for oversight of other contractors, Grassley and Young called out the problem, writing: “we can no longer stand by idly while the fox guards the hen house.”

"The answer is to create a centralized Office of Organ Policy within HHS able to identify opportunities for reform, manage the system, and ensure that lives are saved and taxpayer dollars meant to support the system are not wasted."



HT: Frank McCormick 

Regulation of transplant centers and OPO's

I'll be speaking this morning on regulation of transplantation at the 2020 Winter meetings of the American Society of Transplant Surgeons in Miami.

I'll be in a  Special Invited Presidential Session: Transplantation Metrics Roundtable     Moderators:Lloyd Ratner, MD, MPH Timothy Pruett, MD

Transplantation Metrics Roundtable
Time	End Time	Presentation	Speaker	Moderators
10:05 AM	10:20 AM	Welcome and Introduction	Lloyd Ratner, MD, MPH	Lloyd Ratner, MD, MPH Tim Pruett, MD
10:20 AM	10:35 AM	Introductory Presentation from Dr. Pruett	Tim Pruett, MD
10:35 AM	10:50 AM	Introductory Presentation from Dr. Roth	Al Roth, PhD
10:50 AM	12:00 PM	Transplantation Metrics Roundtable Discussion	All panelists (listed below)

Panel Participants

Paul Conway – Chair of Policy and Global Affairs and Immediate Past President of AAKP

Alexandra Glazier – CEO of New England Donor Services

Rick Hasz, BS, MFS, CPTC – Vice President of Clinical Services for the Gift of Life Donor Program

Maryl Johnson, MD – President of UNOS and Professor of Medicine, Heart Failure & Heart Transplantation at University of Wisconsin

Richard Knight, MBA – President of AAKP

Kevin Longino – CEO of the National Kidney Foundation (NKF)

Jean Moody-Williams, RN, MPP – Deputy Director of the Center for Clinical Standards and Quality at Centers for Medicare and Medicaid Services (CMS)

Ken Moritsugu, MD, MPH, FACPM – Rear Admiral, U.S. Public Health Service (Retired) and Acting Surgeon General of the United States in 2002 and from 2006–2007

Alvin Roth – Professor of Economics at Stanford University and awarded the 2012 Nobel Memorial Prize in Economics

The title of my talk (which Alex Chan and I prepared) is:
Performance Metrics and Regulation of Transplantation

Risk attitudes in transplantation--then and now

Organ transplantation has become much more organized since its early days, for both good and ill.

Today there's a good deal of regulation of transplant centers, which need very high success rates (one year graft survival rates in particular) to remain in the good graces of government and private payers.

It wasn't always so.

Here's a quote from Lloyd Ratner's Message from the ASTS President for November 2019:

"In the transplant world, this [perseverance] is best exemplified by Thomas Starzl’s ceaseless quest to make liver transplantation a reality. Between March 1963 and May 1967, Dr. Starzl performed his first 7 liver transplants at the University of Colorado, all of whom died in the peri-operative period. The longest survivor succumbed after 23 days to “sepsis, bile peritonitis, and liver failure.” Despite this disastrous start, Dr. Starzl persevered. Starzl’s eighth patient, transplanted for hepatocellular carcinoma, lived 400 days before dying from carcinomatosis. By 1990 the programs that Dr. Starzl directed in Pittsburgh would perform 571 liver transplants in a single year and would train many of the world’s leaders in the field."

Reforming stock exchange governance, from the SEC

It's good to know that sometimes the SEC reads papers by market designers (in this case Budish et al.):

Statement on Reforming Stock Exchange Governance by Commissioner Robert J. Jackson Jr., Jan. 8

"As today’s release explains, America’s stock markets are riven by a fundamental conflict of interest: exchanges both operate public data feeds and profit from selling superior private ones.[1] Because exchanges have no economic reason to produce robust public data on stock prices, investors have long demanded a vote on how the public feeds are run.[2] Rather than give investors a real say over the data that drives our markets, today’s release merely invites for-profit exchanges to draft their own rules on these questions. Because that approach has failed investors before, and there’s no reason to expect it to succeed now, I respectfully dissent.

*          *          *          *

In 1934, American investors struck a fundamental bargain with our stock exchanges. The Commission was created to oversee the markets, and nonprofit exchanges were given the special legal status they needed to play a role in protecting ordinary investors.[3] But over a decade ago the deal changed: Exchanges became for-profit entities with powerful incentives to maximize profits, not protect investors.

That’s how we ended up with the two-tiered system for market data we have today. Congress mandated the creation of a public feed when exchanges were still nonprofits, but today’s for-profit exchanges also sell their own private feeds. So it’s unsurprising that exchanges underinvest in the public feed—it’s a product they directly compete with. The only question is what the Commission should do about it. Rather than recognize the reality of the exchanges’ incentives, the Commission today chooses hope over experience, asking exchanges to act contrary to their own economic interests.[4] For two reasons, we should not expect that approach to produce the robust public data that American investors deserve.

First, by proposing an order under a national market system (NMS) plan, we’re asking the exchanges to tell us how best to address the conflicts of interests that currently allow them to profit by controlling the public feed while selling superior private data.[5] No one should be surprised when the exchanges respond that, rather than give investors votes on the operation of the public feed, they’d rather continue controlling it themselves.[6] Instead of a clear solution to an obvious problem, today’s proposal will produce little more than a long process that will benefit lobbyists and lawyers—but not the ordinary investors living with the tax of rising data costs in our markets.[7]

Second, our history governing markets through NMS plans is hardly encouraging. One need look no further than the consolidated audit trail to see what happens when the Commission replaces real regulation with mere hope that stock exchanges will act against their own interests. The CAT was launched in the wake of a terrifying market event nearly a decade ago. Both Chairman Clayton and Director Redfearn have done tremendous work to move it forward. But our predecessors left the construction of the CAT to the NMS process. And the CAT will protect investors, not produce profits. So it’s no surprise that the CAT is still not complete.[8] I hope our successors won’t someday say the same about today’s attempt to reform exchange governance.

*          *          *          *

Those who, like me, are frustrated by today’s failure to require real reform may be tempted to direct their ire towards our stock exchanges. But it’s a mistake to blame private enterprises for maximizing the profit opportunities the law gives them.[9] Instead, we should change the law to address the incentives produced by giving exchanges both control over our public feeds and the opportunity to profit by selling private ones.[10] Without changing those incentives, we cannot and should not expect the market to fix the market.[11]

That’s why I hope commenters will come forward and urge the Commission to do more than merely hope that stock exchanges will act contrary to their private interests. Until we do, our stock markets will continue to fall short of the level playing field that ordinary American investors deserve."

....

"[11] Important recent research shows that, even when the market for trading is perfectly competitive, exchanges can extract supra-competitive rents from selling speed technology in the form of proprietary data feeds. See Eric Budish, Robin S. Lee & John J. Shim, Will the Market Fix the Market? A Theory of Stock Exchange Competition and Innovation, National Bureau of Economic Research Paper No. w25855 (2019)."

Kidney exchange explained in 1 minute (video), and a BBC story

Here's a link to a 1 minute BBC video that was recorded when I was in Berlin recently, discussing how changes in the German transplant law (which presently allows only immediate family members to donate a kidney to someone) could be minimally modified to allow kidney exchange also.

 (a short ad comes on first--my part is only 48 seconds:-)


Here's an accompanying story that somewhat confusingly (it seems to me)  mashes together discussions of kidney exchange, global kidney exchange, and compensation for donors.

How an economist helped thousands get a new kidney By Ian Rose, BBC News
Berlin
...
"Roth, working with Tayfun Sönmez and Utku Unver, has revolutionised kidney donation around the world by using an economic theory to make kidneys more available.
...

"German exchange change?
"We meet in Berlin as Nobel laureates and other luminaries gather to discuss the future of healthcare. Alvin Roth is there in part because Germany is one of the only major industrialised countries where kidney exchange is not lawful.

"I think that the bureaucratic rules and regulations for kidneys as for every market have to be revisited from time to time in the in the light of new developments, and should be modernized and adapted to current capabilities," he says.

"When contacted about the issue the German Health Ministry tells me that they are planning to organise a public debate on the issue but have no schedule for that yet.

"Prof Roth says he understands the concerns behind the German ban. "They're worried about organ trafficking.

"They're worried that if I showed up and wanted to give you a kidney, it would mean that you had paid me and it may be I was a poor and desperate person. But on the other hand, if your brother shows up and wants to give you a kidney, they're not worried about that."
********
update:
The BBC publishes in many languages, and so you can read the story in Chinese, Indonesian, Turkish, Spanish, Portuguese, and here's a site that has translated it to Hungarian.

Further scrutiny of Organ Procurement Organizations (OPOs), now by the Senate Finance Committee

The Senate is piling on to the the recent regulatory changes that have been announced for OPOs.

Here's a letter from the Senate Finance Committee, asking for financial investigations.  The letter begins this way:

December 18, 2019
Ms. Joanne M. Chiedi
Acting Inspector GeneralOffice of Inspector General
U.S. Department of Health & Human Services3

"Dear Acting Inspector General Chiedi: We write  today  to  request  that  your  office  conduct  a  comprehensive  examination  of  the adequacy of the organ procurement and transplantation system in the United States."
**************

Here's the story from the WaPo:

Senate Republicans seek probe of organ transplant system  By
Kimberly Kindy and Lenny Bernstein Dec. 19, 2019

"Members of the Senate Finance Committee Thursday requested an in-depth examination of the nation’s organ recovery and transplant system, raising questions about suspected financial fraud and criticizing the system for its “poor performance.”

"The request to the Office of the Inspector General comes one day after the Trump administration announced a sweeping proposal to boost the number of organs collected for transplant by dozens of underperforming organ collection agencies and increasing federal payments to living kidney donors.

"In their letter to the Inspector General, Sens. Charles E. Grassley (R-Iowa) and Todd C. Young (R-Ind.) praised the proposed regulations but pointed out it will be years before they take effect. In the meantime, they said, Americans are dying each day as they wait for organ transplants and more action should be taken now.
...
"Grassley, finance committee chairman, said in a statement that “more can be done right now to improve a system that is mired by inefficiency, waste and a serious lack of accountability.”

New U.S. rules proposed for organ donor reimbursements and Organ Procurement Organizations

Here's the press release from HHS.gov:
Trump Administration Proposes New Rules to Increase Accountability and Availability of the Organ Supply  December 17, 2019

"The U.S. Department of Health and Human Services (HHS) today took major steps to increase the availability of organs for the 113,000 Americans on waitlists for lifesaving organ transplants – 20 of whom die each day. As directed by President Trump in his July 10 Executive Order on Advancing American Kidney Health, the Centers for Medicare & Medicaid Services (CMS) is issuing a proposed rule to change the way organ procurement organizations (OPOs) are held accountable for their performance, and the Health Resources and Services Administration (HRSA) is issuing a proposed rule to remove financial barriers to living organ donation.
...
"Removing Financial Disincentives to Living Organ Donation

The President’s Executive Order on Advancing American Kidney Health emphasized that supporting living organ donors can help address the current demand for kidney transplants. HRSA’s proposed rule would expand the scope of reimbursable expenses for living donors to include lost wages, and childcare and eldercare expenses for those donors who lack other forms of financial support. This proposal could increase the number of transplant recipients receiving a better quality organ in a shorter time period from living donors. In general, recipients of kidney transplants from living organ donors have better clinical outcomes than those who continue on dialysis or those who receive a deceased donor kidney transplant. HRSA also is reviewing a notice that would increase the income threshold for living donors eligible for reimbursements.

"Organ Procurement Organization (OPO) Conditions for Coverage Proposed Rule

OPO act as a link between organ donors and organ recipients, procuring organs from hospitals and delivering them to transplant centers. Federal law tasks CMS with conducting inspections (“surveys”) of OPOs and certifying them for participation in Medicare based on whether they meet Medicare’s Conditions for Coverage – which are basic quality and safety regulations – including outcomes and process requirements.

OPOs’ performance is currently assessed through self-reported data based on measures that were last overhauled in 2006. Today, CMS is proposing much needed changes to hold OPOs accountable and incentivize them to actively collect donated organs and improve transplantation rates in their donation service area (DSA).

CMS estimates that if all OPOs were to meet both the donation and transplantation rate measures, the number of annual transplants would increase from about 32,000 to 37,000 by 2026, for a total of almost 15,000 additional transplants in that time.

The proposed rule would improve the current measures by using objective and reliable data, incentivize OPOs to ensure all viable organs are transplanted, and hold OPOs to greater oversight while driving higher OPO performance. To better serve organ transplant recipients and the many people waiting for a transplant, CMS is proposing:

• Donation rate measure: The donation rate would be the number of actual deceased donors as a percentage of the donor potential, which would be defined as total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not preclude a potential donor from donating an organ.
• Transplantation rate measure: The organ transplantation rate would be the number of organs transplanted as a percentage of the donor potential, which would be defined as total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not preclude a potential donor from donating an organ.
• Top 25 percent benchmark: CMS is proposing that all OPOs meet the donation and transplantation rates of the current top 25 percent of OPOs, which would be made public.
• 12-month reviews: At the end of each re-certification cycle (every four years), an OPO would have to meet the CMS requirements for both the donation rate and transplantation rate measures. CMS is proposing to review OPO performance every 12 months throughout the four year re-certification cycle to more quickly identify OPOs that need improvement and ensure fewer viable organs are wasted and more timely transplants occur.

Most of the proposed changes would not take effect until 2022. "

************

Here are the particular announcements:

Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984 (NOTA)

Fact Sheet | December 2019

and

Organ Procurement Organization (OPO) Conditions for Coverage Proposed Rule: Revisions to Outcome Measures for OPOs  Dec 17, 2019 

************

Earlier post:

Tuesday, July 16, 2019

President Trump's Executive Order on kidney care

Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984 (NOTA)Fact Sheet | December 2019

Notice of Proposed Rulemaking (NPRM) to amend the regulations implementing the National Organ Transplant Act of 1984 (NOTA)Fact Sheet | December 2019

Regulations gone awry -- an example from transplantation

A general lesson of market design is that participants have big strategy sets, so any given set of rules can have unanticipated undesirable consequences.  Here's an example from transplantation. Transplant centers are regulated in part based on their one-year survival rate.

Here's a story from the BMJ:

US hospital is accused of keeping vegetative patient alive to boost its transplant survival rate

"Federal agents are investigating a New Jersey hospital accused of keeping a patient with catastrophic brain damage alive for a year and barely consulting his family, in order to keep its one year transplantation survival rate from falling to a level where the programme’s Medicare certification might be withdrawn.

"The Centers for Medicare and Medicaid Services, which has its own law enforcement agency, will lead the investigation into Newark Beth Israel Medical Center. The hospital has launched its own internal probe.
...
"Newark Beth Israel’s heart transplantation programme is among the top 20 in the country by volume. A banner on the hospital’s facade says, “1000 hearts transplanted. Countless lives touched.”

"But in 2018, its one year survival rate fell significantly below the 91% national average. Young’s death would bring the average down to 81%, which staff feared would trigger sanctions from the public payer."

HT: Alex Chan

A substantial change in how transplant centers are regulated

From the website of the American Society of Transplant Surgeons:  it appears (although the Final Rule is hard to parse) that reporting requirements including one-year graft survival numbers have been relaxed, which will change the way transplant centers are regulated...

CMS Removes Outcomes Requirement for Transplant Center Re-approval

Sep 27, 2019

ASTS applauds the Centers for Medicare and Medicaid Services for the elimination of outcomes requirements as a condition of transplant center re-approval.

The announcement was part of the Omnibus Burden Reduction (Conditions of Participation) Final Rule, which will be published in the Federal Register on September 30, and the outcomes requirements are included in the data submission requirements being eliminated.

In announcing the Final Rule, CMS stated, “In an effort to improve patient care, CMS is responding to President Trump’s Executive Order on improving kidney health in America by strengthening the organ donation process. Specifically, the rule finalizes changes to transplant center requirements giving providers greater flexibility and freedom to support patients who need organ transplants. Current Medicare transplant center regulations for re-approval are burdensome. They are so burdensome, in fact, that they have led to some transplant programs avoiding performing transplants for certain patients, causing some organs to be discarded. The Omnibus rule will eliminate these requirements – specifically for data submission – which will reduce the number of organs that are discarded and increase the number of organs that are available for transplantation. As a result, more patients on the transplant waiting list will have access to lifesaving organ transplants. “