Category: Regulations

How Health Insurance Slows Medical Innovation

(p. A8) A recent study led by Wendell Evans at the University of Sydney supports growing evidence that early tooth decay, before a cavity forms, can often be arrested and reversed with simple treatments that restore minerals in the teeth, rather than the more typical drill-and-fill approach.
The randomized, controlled trial followed 19 dental practices in Australia for three years, then researchers checked up on the patients again four years later. The result: After seven years, patients receiving remineralization treatment needed on average 30% fewer fillings.
. . .
There is a substantial body of research supporting remineralization as a treatment for early tooth decay, and little opposition in the dental profession, says Margherita Fontana, a professor of cariology at the University of Michigan School of Dentistry. Tradition, however, has been an obstacle to widespread use of the treatment. “For older generations [of dentists], it just feels wrong to leave decay and not remove it,” Dr. Fontana says. “That’s how they were trained.”
Reimbursement is another obstacle. Insurance typically covers application of fluoride varnish in children, but not adults. The cost ranges from $25 to $55, according to the American Dental Association’s Health Policy Institute. Other preventive treatments also generally aren’t covered.

For the full story, see:
DANA WECHSLER LINDEN. “Simple Dental Treatments Can Help Reverse Decay.” The Wall Street Journal (Tues., APRIL 12, 2016): D3.
(Note: ellipsis added.)
(Note: the online version of the story has the date April 11, 2016, and has the title “Simple Dental Treatments May Reverse Decay.”)

Feds’ Regulatory Delay Supports High-Fare Trans-Atlantic Airline Oligopoly

(p. B1) In the past three years, Norwegian, one of Europe’s biggest low-cost airlines, has quietly established a beachhead in the trans-Atlantic market by offering low-fare, no-frills service on long-haul flights.
Thanks to a small but expanding fleet of fuel-efficient planes combined with deeply discounted ticket prices, Norwegian Air Shuttle has attracted a growing number of leisure travelers looking for cheap flights.
It is all part of the vision of Norwegian’s outspoken chief executive, Bjorn Kjos, who is determined to force the same kind of low-fare competition on international routes that has been so successful in domestic markets for airlines like Southwest and Spirit, and Ryanair in Europe.
. . .
But Norwegian’s expansion has been stymied by vigorous opposition. Legacy airlines on both sides of the Atlantic see a low-cost competitor on their cash-cow routes as a major threat to their long-term profitability. Labor unions object to Norwegian’s plans to hire flight crew from Thailand, a practice they have repeatedly described as “labor dumping.”
The airline has also faced lengthy delays in receiving regulatory approvals in the United States.
. . .
(p. B4) A spokeswoman for the Transportation Department did not give any reasons for the delays that have left Norwegian in bureaucratic limbo in the United States. The airline’s first request was filed more than two years ago. . . .
The long delay in approving the application “does not reflect well on the political independence of the Department of Transportation with respect to the free trade principles behind the E.U.-U.S. open skies agreement,” according to a report by analysts at the CAPA Center for Aviation. “The calculated inaction only serves to restrict competition and to deny consumer choice.”
. . .
“There is still a lot to do,” Mr. Kjos said. “We have to think about how to fly more people more cheaply. There are hundreds of millions of people that don’t have access to cheap flights.”

For the full story, see:
JAD MOUAWAD. “Norwegian Air Flies in the Face of the Trans-Atlantic Establishment.” The New York Times (Tues., FEB. 23, 2016): B1 & B4.
(Note: ellipses added.)
(Note: the online version of the story has the date FEB. 22, 2016.)

Government Regulations Protect Health-Care Incumbents Against Innovation

(p. A15) As people age, the main valve controlling the flow of blood out of the heart can narrow, causing heart failure, and sometimes death. In the past the only way to repair the damage was risky open-heart surgery. But an ingenious medical device now allows the heart to be repaired using a catheter that introduces a replacement valve through a main artery in the leg–another miracle of modern medicine.
In 2011, more than four years after they hit the European market, the Food and Drug Administration finally approved aortic heart valves for use in the U.S. The total cost of the new procedure is about the same as open-heart surgery. But government bureaucrats feared that the new replacement valve’s lower risks and easier administration would mean that many more elderly patients would seek to fix their failing heart valves, pushing up Medicare’s total spending. To limit their use, regulators created coverage rules based on a set of strained medical criteria. It was a budget prerogative masquerading as clinical reasoning.
This episode is a vivid example of the government’s increasing practice to regulate medicine and ration care. A series of landmark studies published earlier this month in the Lancet and the New England Journal of Medicine, and presented at the annual meeting of the American College of Cardiology in Chicago, makes clear how contrived the original Medicare guidelines were.
For a patient to be qualified for the aortic valve device, Medicare required two cardiac surgeons to certify first that a patient wasn’t a candidate for the open-heart repair. Also mandated was the presence of a cardiothoracic surgeon and an interventional cardiologist in the operating room during the procedure.

For the full commentary, see:
SCOTT GOTTLIEB. “Warning: Medicare May Be Bad for Your Heart; Aortic valve replacements are superior to open-heart surgery and less risky. So why are they hard to get?” The Wall Street Journal (Tues., April 12, 2016): A15.
(Note: the online version of the commentary has the date April 11, 2016.)

The Lancet article mentioned above, is:
Thourani, Vinod H., Susheel Kodali, Raj R. Makkar, Howard C. Herrmann, Mathew Williams, Vasilis Babaliaros, Richard Smalling, Scott Lim, S. Chris Malaisrie, Samir Kapadia, Wilson Y. Szeto, Kevin L. Greason, Dean Kereiakes, Gorav Ailawadi, Brian K. Whisenant, Chandan Devireddy, Jonathon Leipsic, Rebecca T. Hahn, Philippe Pibarot, Neil J. Weissman, Wael A. Jaber, David J. Cohen, Rakesh Suri, E. Murat Tuzcu, Lars G. Svensson, John G. Webb, Jeffrey W. Moses, Michael J. Mack, D. Craig Miller, Craig R. Smith, Maria C. Alu, Rupa Parvataneni, Ralph B. D’Agostino, Jr., and Martin B. Leon. “Transcatheter Aortic Valve Replacement Versus Surgical Valve Replacement in Intermediate-Risk Patients: A Propensity Score Analysis.” The Lancet (April 3, 2016), DOI: 10.1016/S0140-6736(16)30073-3.

The New England Journal of Medicine article mentioned above, is:
Leon, Martin B., Craig R. Smith, Michael J. Mack, Raj R. Makkar, Lars G. Svensson, Susheel K. Kodali, Vinod H. Thourani, E. Murat Tuzcu, D. Craig Miller, Howard C. Herrmann, Darshan Doshi, David J. Cohen, Augusto D. Pichard, Samir Kapadia, Todd Dewey, Vasilis Babaliaros, Wilson Y. Szeto, Mathew R. Williams, Dean Kereiakes, Alan Zajarias, Kevin L. Greason, Brian K. Whisenant, Robert W. Hodson, Jeffrey W. Moses, Alfredo Trento, David L. Brown, William F. Fearon, Philippe Pibarot, Rebecca T. Hahn, Wael A. Jaber, William N. Anderson, Maria C. Alu, and John G. Webb. “Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients.” New England Journal of Medicine (April 2, 2016), DOI: 10.1056/NEJMoa1514616.

Government Limits Hospital Competition

(p. A9) When the 124-bed StoneSprings Hospital Center opened in December, it became the first new hospital in Loudoun County, Va., in more than a century. That’s more remarkable than it might at first seem: In the past two decades, Loudoun County, which abuts the Potomac River and includes growing Washington suburbs, has tripled in population. Yet not a single new hospital had opened. Why? One big reason is that StoneSprings had to fight through years of regulatory reviews and court challenges before laying the first brick.
County officials and the Hospital Corporation of America, or HCA, began talking about building a new hospital in 2001. But Virginia is one of the 36 states with a “certificate of need” law, which requires health-care providers to obtain a state license before opening a new facility. Getting a license is supposed to take about nine months, according to the state Health Department. HCA first submitted an application in July 2002 but didn’t win approval for a new facility until early 2004.
Then the plan faced a series of legal challenges from the Inova Health System, an entrenched, multibillion-dollar competitor. Over decades Inova has become the dominant player in the Virginia suburbs.
. . .
It’s not hard to understand why Inova might fight so hard to keep out challengers: There’s a direct correlation between prices and competition. In a paper released in December, economists with Yale, Carnegie Mellon and the London School of Economics evaluated claims data from Aetna, Humana and UnitedHealth. They found that rates were 15.3% higher, on average, in areas with one hospital, compared with those serviced by four or more. In markets with a two-hospital duopoly, prices were 6.4% higher. Where only three hospitals compete they were 4.8% higher.
Research by Chris Koopman of the free-market Mercatus Center suggests that Virginia could have 10,000 more hospital beds and 40 more hospitals offering MRIs if the certificate of need restrictions did not exist. “In many instances, they create a quasi-monopoly,” he says. “In essence, it’s a government guarantee that no one will compete with you, until you get notice and an opportunity to challenge that person’s entry into that market.”

For the full commentary, see:
ERIC BOEHM. “CROSS COUNTRY; For Hospital Chains, Competition Is a Bitter Pill; Building a new medical center in Virginia can take a decade, because state laws favor entrenched players.” The Wall Street Journal (Sat., Jan. 30, 2016): A9.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date Jan. 29, 2016.)

The academic paper mentioned above that relates hospital charges to the number of hospitals in the area, is:
Cooper, Zack, Stuart V. Craig, Martin Gaynor, and John Van Reenen. “The Price Ain’t Right? Hospital Prices and Health Spending on the Privately Insured.” NBER Working Paper # 21815. National Bureau of Economic Research, Inc., 2015.

Chris Koopman’s research, mentioned above, can be found in:
Koopman, Christopher, and Thomas Stratmann. “Certificate-of-Need Laws: Implications for Virginia.” In Mercatus on Policy: Mercatus Center, George Mason University, 2015.

Owner Wants to Give Up Business Due to Regulations

(p. A11) D. Joy Riley, 59, of Brentwood, Tenn., who went to hear Mr. Rubio speak last weekend in the affluent Nashville suburb of Franklin, said that his story struck a chord with her personally. Her father was a coal miner. She is now a physician with a master’s degree in bioethics. “We’re all one or two generations away from some story like that,” she said, repeating a line Mr. Rubio often uses in his speeches.
. . .
Mr. Rubio’s story is intended to pull at the heartstrings. At his rally in Franklin, he spoke of his mother’s struggles growing up in poverty in rural Cuba.
“My mother was one of seven girls raised by a disabled father,” he said as he looked out on a horde of gingham shirts, khaki, fine Sunday dresses and derby hats.
He recalled how she left him with a strong understanding of selflessness and sacrifice. “My mother says her and her sisters never went to bed hungry,” he continued. “But she’s sure her parents did many nights.”
As he tells these personal stories, Mr. Rubio weaves in the policy prescriptions he would act on as president, making his case for a smaller, more conservative government.
When he talks of the need for lower taxes, he cites the work his parents found in hospitality. The only reason the hotel where his father worked could exist, he insists, was because the business climate in Miami Beach was friendly enough that someone wanted to invest. And had it not been for taxes that were low enough to allow people the disposable income to vacation in Las Vegas, he says, his mother would not have had any hotel rooms to clean.
. . .
Nancy Conklin, 52, a business owner from North Hampton, N.H., was nodding along as Mr. Rubio spoke near Portsmouth last month. “You get older, have a family, employ people, and you start to realize how difficult all these regulations are,” she said. “You don’t want to have a business because you can’t afford it.”

For the full story, see:
JEREMY W. PETERS. “Rubio’s Bootstraps Entice a Receptive Constituency: The Well-to-Do.” The New York Times (Sat., FEB. 27, 2016): A11.
(Note: ellipses added.)
(Note: the online version of the story has the date FEB. 26, 2016, and has the title “Marco Rubio Entices a Receptive Constituency: The Well-to-Do.”)

Arbitrary Regulatory Waivers Undermine Rule of Law

(p. A11) Who cares about the swelling power of bureaucratic discretion in Washington over big business, since it doesn’t threaten your personal freedom and prosperity. Or does it? That question lurked in the background of a Hoover Institution discussion on June 25, hosted by economist and podcaster extraordinaire Russ Roberts. The occasion was the 800th anniversary of Britain’s Magna Carta, a landmark in the struggle for a rule of law.
One of the participants, Hoover economist John Cochrane, spoke of fears that America is drifting toward a “corporatist system” with diminished political freedom. Are rules knowable in advance so businesses can avoid becoming targets of enforcement actions? Is there meaningful appeal? Are permissions received in a timely fashion or can bureaucrats arbitrarily decide your case simply by sitting on it?
The answer to these questions increasingly is “no.” Whatever the merits of 1,231 individual waivers issued under ObamaCare, a law implemented largely through waivers and exemptions is not law-like. In such a system, where even hairdressers and tour guides are subjected to arbitrary licensing requirements, all the advantages accrue to established, politically-connected businesses.
Another participant, Lee Ohanian, a UCLA economist affiliated with Hoover, drew the connection between the regulatory state and today’s depressed growth in labor productivity. From a long-term average of 2.5% a year, the rate has dropped to 0.7% in the current recovery. Labor productivity is what allows rising incomes. A related factor is a decline in business start-ups. New businesses are the ones that bring new techniques to bear and create new jobs. Big, established companies, in contrast, tend to be net job-shrinkers over time.

For the full commentary, see:
HOLMAN W. JENKINS, JR. “BUSINESS WORLD; The New Slow-Growth Normal and Where It Leads; On the 800th anniversary of the Magna Carta, an unhinged regulatory state is our doomsday machine.” The Wall Street Journal (Sat., Aug. 1, 2015): A11.
(Note: the online version of the commentary has the date July 31, 2015.)

After Wife’s Cancer, F.D.A. Regulator Cuts Decision Time from Six to Five Months (Beyond Years Spent Testing)

(p. 1) BETHESDA, Md. — Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators.
So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr. Richard Pazdur, has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.
He was also Mary’s husband.
In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and passion to fight the disease that patient advocates thought he lacked.
. . .
(p. 13) Certainly there has been a change at the powerful agency. Since Ms. Pazdur learned she had ovarian cancer in 2012, approvals for drugs have been faster than at any time in the F.D.A.’s modern history. Although companies go through a yearslong discovery and testing process with new drugs before filing a formal application with the F.D.A., the average decision time on drugs by Dr. Pazdur’s oncology group has come down to five months from six months. That is a major acceleration in a pharmaceutical industry where every month’s delay can mean thousands of lives lost and sometimes hundreds of millions of dollars in sales that, given limited patent times, can never be recovered.
When asked specifically how his wife’s illness had changed his work at the F.D.A., Dr. Pazdur said he was intent on making decisions more quickly.
“I have a much greater sense of urgency these days,” Dr. Pazdur, 63, said in an interview. “I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate.”

For the full story, see:
GARDINER HARRIS. “A Wife’s Cancer Prods the F.D.A.” The New York Times, First Section (Sun., JAN. 3, 2016): 1 & 13.
(Note: ellipsis added.)
(Note: the online version of the story has the date JAN. 2, 2016, and has the title “F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval.”)

Federal Regulations Restrict Concrete Innovation

(p. B1) Chris Tuan, a professor of civil engineering for the University of Nebraska at the Peter Kiewit Institute, has been perfecting an electrically semiconductive concrete over the past 20 years.
The mixture includes a 20 percent mix of steel fibers, shavings and carbon added to a traditional concrete mix. Steel reinforcing bars serve as the conductor, and once electricity is added, the concrete heats to 35 to 40 degrees — just enough to melt the ice and snow.
. . .
For now, the concrete can’t be used in public spaces. Anything exposed and electrified above 48 volts — much less than the 208 volts used in Tuan’s concrete — is considered high voltage and is not allowed. Federal law will have to be rewritten to change that.
. . .
Tuan said traditional concrete needs to be replaced every five years or so. Without chemical use, the electric concrete lasts much longer, with fewer potholes. His concrete is also maintenance-free, because the power cords and conductive rods are encased in the concrete and not exposed to the elements.
. . .
In 2013 Tuan also implemented his concrete on ramps in China. He recently installed a private driveway in Regency using the legally allowed 48-volt limit, which is less energy efficient.
“If the government or if insurance agencies approve this technology, then everybody can use it,” Tuan said. “But right now, it’s almost cost prohibitive.”

For the full story, see:
Reece Ristau. “In Concrete World, This Is Hot Stuff.” Omaha World-Herald (Tues., JAN. 15, 2016): B1 & B2.
(Note: ellipses added.)
(Note: the online version of the story has the title “Special Concrete Mix Can Melt Snow and Ice All by Itself — Just Add Electricity.”)

Ugly, Invasive, Depressing Federal LEDs Disrupt Sleep and Increase Risk of Breast Cancer

(p. B1) In my repellently contented middle age, I don’t seek blue light. Like most sane people, I spurn restaurants whose lighting glares. I recoil from mirrors under fluorescent tubes. I switch on an overhead only to track down a water bug while wielding a flip-flop. Yet each evening from March onward, in the Brooklyn neighborhood where I live part of the year, it seems as if the overhead is always on.
Along with other parts of South Brooklyn, Windsor Terrace is an early recipient of the Department of Transportation’s new light-emitting diode streetlights. New Yorkers who have not yet been introduced to these lights: We are living in your future.
Our new street “lamps” — too cozy a word for the icy arrays now screaming through our windows — are meant to be installed across all five boroughs by 2017. Indeed, any resident of an American municipality that has money problems (and what city doesn’t?) should take heed.
In interviews with the media, my fellow experimental subjects have compared the nighttime environment under the new streetlights to a film set, a prison yard, “a strip mall in outer space” and “the mother ship coming in for a landing” in “Close Encounters of the Third Kind.” Although going half-blind at 58, I can read by the beam that the new lamp blasts into our front room without tapping our own Con Ed service. Once the LEDs went in, our next-door neighbor began walking her dog at night in sunglasses.
Medical research has firmly established that blue-spectrum LED light can disrupt sleep patterns. This is the same illumination that radiates in far smaller doses from smartphone and computer screens, to which we’re advised to avoid exposure for at least an hour before bed, because it can suppress the production of melatonin. . . .
While the same light has also been associated with increased risk of breast cancer and mood disorders, in all honesty my biggest beef with LEDs has nothing to do with health issues. These lights are ugly. They’re invasive. They’re depressing. New York deserves better.
. . .
Even fiscally and environmentally conscientious California has compromised on this point. Berkeley, Oakland and San Francisco have all opted for yellow-rich LEDs. These cities have willingly made the modest 10-15 percent sacrifice in efficiency for an ambience that more closely embodies what Germans call Gemütlichkeit and Danes call hygge: an atmosphere of hospitality, homeyness, intimacy and well-being.
. . .
As currently conceived, the D.O.T.’s streetlight plan amounts to mass civic vandalism. If my focus on aesthetics makes this issue sound trivial, the sensory experience of daily life is not a frivolous matter. Even in junior high school, I understood that lighting isn’t only about what you see, but how you feel.

For the full commentary, see:
LIONEL SHRIVER. “Ruining That Moody Urban Glow.” The New York Times, SundayReview Section (Sun., OCT. 18, 2015): 5.
(Note: ellipses added.)
(Note: the online version of the commentary has the date OCT. 17, 2015.)

Regulatory Costs Slow Development of Lifesaving Antibiotics

(p. A13) In the 1980s, 29 new antibiotics were approved; another 23 were approved during the 1990s. But only nine new drugs made it to market from 2000-10, and a study by the Pew Charitable Trusts shows few drugs in development for the most serious microbial threats such as multidrug resistant Acinetobacter and Pseudomonas aeruginosa.
. . .
To revitalize the search for lifesaving antibiotics, the Food and Drug Administration needs a new way to approve them. Legislation proposed in both the House and the Senate would create a new regulatory pathway that would enable the FDA to approve drugs specifically for patients whose serious infections can’t be treated with existing drugs, and for whom there are few or no other treatment options.
For these patients, the FDA would be empowered to approve new drugs based on fewer or smaller clinical studies than for antibiotics intended for broader use. The goal is to reduce the cost of development and accelerate the availability of new drugs for a targeted public health need.

For the full commentary, see:
JONATHAN LEFF And ALLAN COUKELL. “How to End the Regulatory Slowdown for New Antibiotics; With the threat from lethal drug-resistant bacteria growing, the FDA needs to speed up its approval process.” The Wall Street Journal (Fri., July 3, 2015): A13.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date July 2, 2015.)