Unapproved Drugs Prompt FDA Alert To 5 Connecticut Doctors

Five Connecticut physicians have received letters from the U.S. Food and Drug Administration (FDA) alleging that they may have purchased unapproved drugs that put patients at risk of adverse health consequences, documents obtained by C-HIT show. The FDA documents show the five doctors were alerted as part of a wide-reaching federal probe involving Gallant Pharma International Inc., which sold more than $12.4 million in unapproved chemotherapy and injectable cosmetic drugs in the United States before the government shut down the operation in 2013. The letters to the doctors, dated April 1, 2015, say that “In addition to putting patients at risk, receiving misbranded or adulterated drugs and devices in interstate commerce and delivering or offering to deliver those drugs and devices to (or use on) others violates federal law.”

None of the doctors has been charged with wrongdoing, and only one acknowledged receiving the letter from the FDA. The case comes to light as drug companies and pharmacies are urging Congress and law enforcement officials to crack down on an increasing number of dangerous unapproved and counterfeit drugs being sold to doctors and consumers nationwide. Sales of counterfeit drugs and drugs not approved by FDA have soared into a multi-billion dollar industry with the growth of the Internet, and drug companies say efforts by governments to tackle illegal online drug sales are not sufficient.

Medicare Backs Off Plan To Limit Coverage For Advanced Prosthetics

The Centers for Medicare and Medicaid Services has backed off a controversial plan that would have changed the way it determines Medicare coverage for advanced prosthetics – a plan critics said would have affected tens of thousands of veterans nationwide. CMS had issued a draft proposal, known as a Local Coverage Determination for Lower Limb Prostheses, that critics feared would limit access to prosthetics for amputees, including veterans. Following a public comment period that ended in August and a review of those comments, CMS on Monday announced it would not finalize the draft policy. “Both CMS and its contractors have heard concerns about access to prostheses for Medicare beneficiaries,” according to a statement provided by CMS spokeswoman Helen Mulligan. CMS said it would convene a work group in 2016 to examine the lower limb prostheses issue.

Veterans Are Not Applying For Discharge Status Upgrades, Pentagon Blamed

Very few veterans take advantage of a Pentagon policy designed to make it easier for veterans with Post Traumatic Stress Disorder (PTSD) to upgrade their discharge status and become eligible to apply for veterans’ benefits, according to a Yale Law Clinic report. At a news conference Monday, U.S. Sen. Richard Blumenthal, D-Conn., veterans, and Yale law students, blamed the Department of Defense for not adequately publicizing the policy to veterans with less than honorable discharges. Since new guidelines were announced last year, just 201 of tens of thousands of eligible veterans applied for a PTSD-related service upgrade, according to the report. Blumenthal called the statistic “a staggering, outrageous fact.”

“Veterans on the streets of New Haven or Connecticut or the rest of the country have no idea about this,” Blumenthal said. “It takes a vigorous and rigorous effort, which the DOD committed to and they have failed,” he added.

Blumenthal, Grassley Call For Expanded Drug Company Reporting

US Sen. Richard Blumenthal (D-Conn.) and U.S. Sen. Chuck Grassley (R-Iowa) have introduced legislation that would require drug companies and medical device manufacturers to start reporting their payments to nurse practitioners and physician assistants, as they do for physicians. “Requiring companies to disclose gifts and payments made to other health care providers – not just doctors – is absolutely essential,” Blumenthal said in a statement Tuesday. “The Provider Patient Sunshine Act will rein in dishonorable behavior by increasing transparency and accountability across the entire healthcare industry.”

Grassley added: “It makes sense to apply the sunshine (provisions) to anyone who prescribes medicine.”

The proposed Provider Payment Sunshine Act, would require drug companies and device makers to publicly disclose payments to nurse practitioners and physician assistants for promotional talks, consulting and other services. The companies already report such payments to physicians in a national Open Payments database, under prior legislation co-authored by Grassley. The payments to nurse practitioners and physician assistants would be added to that database. Nurse practitioners and physician assistants write a significant number of prescriptions in the federal Medicare program, data show.

Medicare Advantage Plans Need Tougher Oversight, GAO Says

Federal investigators have found that Medicare officials rarely enforce rules for private insurance plans intended to make sure beneficiaries will be able to see a doctor when they need care. It’s a problem many Connecticut seniors know too well. In 2013, UnitedHealthcare, the nation’s largest health insurance company, dropped hundreds of health care providers from its Connecticut Medicare Advantage plan, including 1,200 doctors at the Yale Medical Group and Yale-New Haven Hospital. Medicare Advantage beneficiaries scrambled to find new insurance or new doctors while the Fairfield and Hartford counties medical associations went to court to try to stop the terminations. The report by the Government Accountability Office, the investigative arm of Congress, said that Medicare did not check provider networks to ensure that doctors were available to beneficiaries and cited Connecticut as a “case study” in what can go wrong.

Tainted Dietary Supplements Frequently Hit The Market

Every week for the past 7½ years, the U.S. Food and Drug Administration has identified an average of two dietary supplements being sold to consumers that were “tainted” and “potentially hazardous,” a C-HIT analysis of data reveals. The supplements contained prescription drug ingredients, controlled substances or untested pharmaceutical ingredients, which is prohibited by federal law and “can pose considerable dangers to consumers,” including stroke, liver damage, kidney failure and death, according to the FDA. C-HIT’s analysis of FDA data reveals 615 dietary supplements that were identified as tainted since Jan. 1, 2008. In the first half of this year alone, 59 tainted dietary supplements were posted on the FDA’s site.

Vet Suicide Prevention Bill Wins Approval

Legislation pushed by U.S. Sen. Richard Blumenthal, D-Conn., to strengthen suicide prevention programs for veterans won Senate approval Tuesday and is expected to become the first veterans’ bill of 2015 to be signed by President Obama. The measure – dubbed the Clay Hunt Suicide Prevention for American Veterans Act, for a Texas Marine who killed himself in 2011 – won House approval last month. Its passage was blocked last year by Republican Sen. Tom Coburn, who has since retired from the Senate. The bill will require the Pentagon and Department of Veterans Affairs to submit to independent reviews of their suicide prevention programs. It also establishes a program to repay loans to psychiatrists who agree to work with veterans, improves VA collaboration with non-profit agencies, and calls for more online and community outreach mental health services for veterans. In the Senate, Blumenthal, ranking member of the Committee on Veterans’ Affairs, worked with Republican John McCain, R-Ariz., to expedite the bill’s approval.

New Generation Of Vets Has Higher Suicide Risk, Study Shows

Justin Eldridge’s family will never fully understand why nothing seemed to ease the anguish of the young Marine and father of five, as he wrestled with post-traumatic stress disorder and traumatic brain injury after a deployment to Afghanistan in 2004-05. Despite stints in VA hospitals and an array of medications, he killed himself in his Waterford home on Oct. 28, 2013. He was 31. “He did his part – he followed the treatment they gave him,” said his widow, Joanna Eldridge, who is now raising their children alone.

Medicare May Help Seniors If Advantage Plans Drop Doctors

Next year, seniors with private Medicare Advantage insurance policies whose doctors leave their plan may be able to leave, too, under a new Medicare rule. The Centers for Medicare & Medicaid Services (CMS), which oversee Medicare Advantage programs, will create a special three-month enrollment period in any state where insurers make network changes “considered significant based on the affect or potential to affect, current plan enrollees,” according to an update to Medicare’s Managed Care Manual. The special enrollment period – if granted by CMS – would allow Medicare Advantage members to switch out of their plans and join traditional Medicare or another Medicare Advantage plan whose provider network includes their doctors. The mid-year special enrollment period wasn’t an option in 2013 when more than 32,000 UnitedHealthcare Medicare Advantage members in Connecticut were affected by the company’s decision to drop thousands of doctors from its network of providers. The Fairfield County Medical Association sued the company to stop the terminations but was ultimately unsuccessful.