First Edition: July 10, 2015

Kaiser Health News: Maryland Revamps Its In Vitro Coverage Mandate To Accommodate Same-Sex Couples
Maryland same-sex couples who wanted to take advantage of a state law that requires insurers to cover pricey in vitro fertilization treatments used to face insurmountable obstacles. The law generally mandated that couples demonstrate a history of infertility of at least two years’ duration, and insurers often interpreted that to mean having intercourse during that time without conceiving. What’s more, by law, coverage would be permitted only for infertility treatments that used the husband’s sperm. This month, however, those restrictions were eliminated for married same-sex couples under a new law. (Andrews, 7/10)

Kaiser Health News: The App Will See You Now, But May Not Get The Diagnosis Right
There’s a warning out today for those who go online or to apps to figure out why they have an upset tummy or nagging cough or occasional chest pain. Symptom checkers, those tools that ask for information and suggest a diagnosis, are accurate only about half of the time.(Bebinger, 7/9)

The Wall Street Journal: Medicare Plans To Fix Rates On Knee, Hip Replacements
Medicare wants to start paying hospitals fixed amounts for hip and knee replacements, rather than letting providers bill individually for each surgical and recovery service provided to older Americans, health officials said Thursday. The proposal, which would apply to two of the most common procedures for Medicare beneficiaries, is another step by the Obama administration to try to curb costs in the insurance program for people 65 years old and older as well as the disabled. (Radnofsky and Armour, 7/9)

The Washington Post: Medicare Proposes Payment Changes To Hospitals For Hip, Knee Replacement
Federal health officials are proposing a major change in the way Medicare pays for hip and knee replacements, requiring hospitals to partly repay the government if patients get avoidable infections and other complications but rewarding them with extra payments if patients do well. The proposal announced Thursday by the Centers for Medicare and Medicaid Services is part of the Obama administration’s efforts to overhaul the health-care system, in part by using the payment system to reward quality of care rather than volume of services. Under the current system, doctors and hospitals typically get paid set fees for every procedure they perform, regardless of how patients fare. (Sun, 7/9)

USA Today: Feds Want To Penalize Hospitals With Too Many Hip, Knee Surgery Problems
Federal health care regulators on Thursday proposed cutting Medicare payments to hospitals with high rates of complications for hip or knee replacements. The proposed rule, announced by the Centers for Medicare and Medicaid Services, will affect more than 800 hospitals in both large and small cities, including New York City, Los Angeles, Flint, Mich., and Lubbock, Texas. (O'Donnell, 7/9)

The Associated Press: House Bill Would Speed Drug Approvals, Boost Research
Pressed by industry and patients' groups, the House is nearing approval of a bipartisan bill that would speed federal approval of drugs and medical devices and boost biomedical research. Passage seemed likely Friday despite warnings from consumer organizations and others that the measure would weaken government safeguards against dangerous or ineffective products. Supporters said that with genetic mapping, biologic medicines produced in living cells and other advances, it was time to streamline how federal regulators assure the safety of new treatments and let them reach market. (Fram, 7/10)

The Wall Street Journal: House Medical Bill Sparks Drug-Safety Debate
The House plans to vote Friday on a bill to boost federal funding for medical research, but the measure’s changes to drug approvals have drawn the ire of medical-safety advocates, who contend it would jeopardize safety by lowering scientific standards. The multifaceted bill would increase funding for the National Institutes of Health by about $9 billion over five years. Largely for that reason, House Democrats who might have opposed the changes at the Food and Drug Administration have supported the bill, which passed the House Energy and Commerce Committee by a vote of 51-0. (Burton, 7/9)

NPR: Bill To Boost Medical Research Comes With A Catch
The House of Representatives is planning to consider a bill Friday that could give a big cash infusion to medical research, which has been struggling in recent years. But the bill would also tweak the government's drug approval process in a way that makes some researchers nervous. Despite those worries, many scientists are cheering on the legislation. (Harris, 7/10)

The New York Times: Hillary Clinton’s Economic Agenda Aims At A Party Shifting Left
Nearly 20 years after President Bill Clinton declared that “the era of big government is over,” Hillary Rodham Clinton is proposing muscular federal policies that would require hundreds of billions of dollars in new spending and markedly expand Washington’s influence in a host of areas, from universal prekindergarten to Alzheimer’s disease research. Her presidential campaign has said little yet about the costs of her policy ideas or how she would pay for them, but Mrs. Clinton is calling for government activism on a scale that she has not sought since her failed health care initiative in 1993 and 1994. (Healy and Haberman, 7/9)

NPR/Center for Public Integrity: Federal Audits Of Medicare Advantage Reveal Widespread Overcharges
Government audits just released as the result of a lawsuit detail widespread billing errors in private Medicare Advantage health plans going back years, including overpayments of thousands of dollars a year for some patients. Since 2004, private insurers that run Medicare Advantage plans, an increasingly popular alternative to traditional Medicare, have been paid using a risk score calculated for each patient who joins. Medicare expects to pay higher rates for sicker people and less for those in good health. But the internal audits, never before made public, provide striking new evidence of billing mistakes — mostly overcharges — in the Medicare Advantage plans. (Schulte, 7/10)

Reuters: Obamacare Acting Administrator Slavitt Nominated To Head Agency
Andy Slavitt, the acting administrator of the Centers for Medicare and Medicaid Services, which oversees the Obamacare healthcare program, has been nominated as head of the agency, the White House said on Thursday. Slavitt, who joined CMS last year to oversee the once-troubled HealthCare.gov website, has been acting administrator since March following the resignation of Marilyn Tavenner as head of the agency that also manages the Medicare and Medicaid government healthcare programs. He was previously an executive at a government contractor working on the HealthCare.gov site and a leader of the rescue team that turned it around after a botched rollout. (Cooney, 7/9)

The New York Times: F.D.A. Extends Deadline For Calorie Counts On Menus
The Food and Drug Administration has delayed by a year the deadline for the nation’s chain restaurants, pizza parlors and movie theaters to post calorie counts on their menus in what some consumer advocates said was a setback for public health but others contended would simply give companies enough time to comply. Pressure had been growing to delay the rule, which was proposed in November and would have taken effect at the end of this year. ... Menu labeling became law in 2010 as part of the Affordable Care Act, and the F.D.A. issued a proposal for how it should be carried out the next year. But the final rule was delayed for three years, due in part to fierce opposition from some national chains, including pizza restaurants and movie theaters.(Tavernise, 7/9)

The Washington Post: The FDA Has Delayed Menu Calorie Count Rules
The move comes amid persistent pressure on the agency from various corners of the food industry to delay enforcement of the rules. The FDA said that since February, it has received numerous requests from for a postponement, including from groups such as the Food Marketing Institute, the National Association of Theater Owners, the American Beverage Association and Publix Super Markets. (Dennis, 7/9)

The Associated Press: FDA: Calories On Menus, Menu Boards Delayed Until 2016
FDA said it is extending the deadline after restaurants and other retailers said they needed more time to put the rules in place. The agency said those businesses are in the process of training workers, installing menus and menu boards and developing software and technology for more efficient and specific calorie label displays. (Jalonick, 7/9)

The Wall Street Journal: FDA Extends Deadline For Listing Calories On Menus
The Food and Drug Administration is giving restaurants and other food purveyors an additional year to comply with new rules that require calorie counts on menus, a response to concerns by some food establishments that the requirements are confusing and broad. ... The agency said it would post a draft guidance document in August to answer some of the frequently asked questions from the industry, and Mr. Taylor said the agency now and after the Dec. 1, 2016, compliance date “will work flexibly and collaboratively with individual companies making a good-faith effort to comply with the law.” (Gasparro, 7/9)

The Associated Press: FDA Strengthens Heart Risk Warning In Popular Pain Relievers
Federal health regulators are bolstering warning labels for popular pain relievers, adding information about the risk of heart attack and stroke in the short term. The changes announced Thursday apply to prescription non-steroidal anti-inflammatory drugs, or NSAIDs, including arthritis treatments like Celebrex. The agency said it plans similar changes to over-the-counter drugs in the same class, such as Advil and Motrin. (Perrone, 7/9)

The New York Times: F.D.A. Is Set To Toughen Nonaspirin Warnings
The Food and Drug Administration is strengthening warnings on painkillers like ibuprofen to say that they cause an increased risk of heart attack and stroke. The over-the-counter forms include Advil, Motrin IB and Aleve. The distinction was subtle: The labels already say such drugs “may cause” increased risk of heart attack and stroke. But the agency said that new data from a recent analysis provided stronger evidence of the increased risk of heart failure from such drugs. (Tavernise, 7/9)

The Wall Street Journal: FDA Strengthens Warnings On Class Of Popular Painkillers
The FDA said new data have caused it to conclude that the medicines—called NSAIDs, for nonsteroidal anti-inflammatory drugs—definitely cause an increased risk of heart attack and stroke. It long has required a warning on the class of drugs, saying they “may cause” an increased risk. The agency will require that makers of prescription versions of the medications change their labels. The change will include the statement that the risk may be present throughout the entire course of NSAID use, even within the first weeks of treatment. (Burton, 7/9)

Los Angeles Times: FDA Strengthens Warning On Prescription Anti-Inflammatory Medications
A decade's worth of research on nonsteroidal anti-inflammatory drugs, or NSAIDs, has prompted the Food and Drug Administration to demand stiffer warnings on the labels of such prescription medications as celecoxib (marketed commercially as Celebrex) and diclofenac (Voltaren) about the increased risk of heart attacks and strokes in those taking the drugs. ... Those warnings come a decade after the FDA issued a public health advisory on the use of rofecoxib, better known as Vioxx, after it was found that those taking the medication had higher rates of heart attack and stroke. The pharmaceutical giant Merck subsequently pulled Vioxx from the market. (Healy, 7/9)

USA Today: Dental Problems -- Sometimes Deadly -- Driving More People To ERs
What started as a toothache from a lost filling became a raging infection that landed Christopher Smith in the emergency room, then in intensive care on a ventilator and feeding tube. "It came on so quickly and violently. I was terrified," says Smith, 41, of Jeffersonville, Ind., who lacked dental insurance and hadn't been to a dentist for years before the problem arose last month. "I had no idea it could get this serious this quickly." Smith is one of a growing number of patients seeking help in the ER for long-delayed dental care. An analysis of the most recent federal data by the American Dental Association shows dental ER visits doubled from 1.1 million in 2000 to 2.2 million in 2012, or one visit every 15 seconds. ADA officials, as well as many dentists across the nation, say the problem persists today despite health reform. (Ungar, 7/9)

The Wall Street Journal: Novartis Looking At Ways To Win Over Cost-Concerned Health Insurers
Novartis AG might offer a bundle of health-care services alongside its promising new heart-failure drug to win over increasingly cost-conscious insurers, its chief executive said. The drug, called Entresto, has been shown to reduce the rate of hospitalization and cardiovascular death in heart failure compared with the current standard treatment. The U.S. Food and Drug Administration approved it earlier this week .... But at $12.50 per patient a day, it also carries a substantially higher price tag than the older drugs, which cost less than a dollar a dose. ... Chief Executive Joe Jimenez said Thursday Novartis was “looking hard” at going to insurers with add-on services intended to further improve outcomes for patients on Entresto. He said this could involve providing a device that allowed doctors to monitor patients remotely so they could pick up on early signs of deterioration. (Roland, 7/10)

The Wall Street Journal: FDA Should Withdraw Sanofi Device Over Safety Concerns: Advocacy Group
A consumer group is asking the FDA to remove a Sanofi device used in stomach and pelvic surgeries over concerns the product is neither safe nor effective, and has also been associated with deaths and injuries. In a petition filed with the agency, Public Citizen maintains that Seprafilm, which is marketed by the Genzyme unit at Sanofi, should never have been approved. Why? The advocacy group alleges that clinical studies the FDA relied on for approval were “plagued with problems,” including the failure of one researcher to follow the study protocol or report adverse event data. ... [A] Sanofi spokeswoman adds that “we stand behind the clinical trial results and nearly 15 years of post-marketing surveillance data reported to the FDA for Seprafilm… and have been reviewing safety data on an ongoing basis since the product was first introduced in the clinical trial setting.” (Silverman, 7/9)

The Associated Press: Poll: Sandwich Generation Worried About Own Long-Term Care
Caught between kids and aging parents, the sandwich generation worries more than most Americans their age about how they'll afford their own care as they grow older, a new poll shows. But most aren't doing much to get ready. Nearly 1 in 10 people age 40 and over are "sandwiched" — they're supporting a child while providing regular care for an older loved one, according to the poll by The Associated Press-NORC Center for Public Affairs Research. (Neergaard, 7/10)

The Wall Street Journal: Release Of Pierre-Paul Medical Records Draws Scrutiny
Federal and state authorities who enforce the protection of private medical information are watching the case of Jason Pierre-Paul, the National Football League star whose medical records were publicized Wednesday. “We are aware of the incident,” said a spokeswoman for the Health and Human Services’ Office for Civil Rights. She said the office could open a case based on media reports, and has done so in the past. She declined to comment further, saying the office does not release information on “current or potential investigations.” (Woo and Radnofsky, 7/9)

The New York Times: History Of Abuse Seen In Many Girls In Juvenile System
As many as 80 percent of the girls in some states’ juvenile justice systems have a history of sexual or physical abuse, according to a report released Thursday. The report, a rare examination of their plight, recommends that girls who have been sexually trafficked no longer be arrested on prostitution charges. The study, “The Sexual Abuse to Prison Pipeline: The Girls’ Story,” found that sexual abuse was among the primary predictors of girls’ involvement with juvenile justice systems, but that the systems were ill-equipped to identify or treat the problem. (Williams, 7/9)

NPR: Teens Dying Of Cancer Face Intensive Treatments In The Final Days
In real life, most teenagers and young adults with terminal cancer have to suffer through chemotherapy and other intensive treatments in their final days of life, a study finds. ... For 68 percent of patients, those interventions include chemotherapy, treatment in the intensive care unit or emergency department, or hospitalization in their final month. The study, published in JAMA Oncology on Thursday, is the first of its kind to study end-of-life care for people ages 15 through 39. (Yang, 7/9)