Highlight on New York: Governor, task force plan to end AIDS by 2020

On June 29, 2014, Governor Andrew Cuomo announced an initiative with an ambitious goal: to end the AIDS epidemic in the state by the end of 2020. He appointed a task force of 63 members and charged it to develop a plan to make it happen.

The targets:

  • reducing the number of new AIDS cases per year to 750, about the same as the number of new cases of tuberculosis;
  • reducing deaths from AIDS to zero; and
  • ending discrimination against people with HIV.

The three points of Cuomo’s initiative, called “Bending the Curve,” were:

  • identifying people with undiagnosed HIV and connecting them to health care;
  • connecting those diagnosed as HIV-positive with treatment, including antiviral therapies to suppress the virus and stop the transmission of the disease; and
  • providing access to pre-exposure prophylaxis (PrEP) to individuals at high risk for AIDS to keep them HIV-negative.

 Previous progress

At the peak of the epidemic, in 1993, there were 14,000 new diagnoses in New York each year. In 2014, there were about 3,000. The number of New Yorkers living with AIDS has grown—from 112,000 in 2002 to 132,000 in 2012—because the number of AIDS-related deaths has declined. Because medication has been made available, between 44 percent and 51 percent of infected New Yorkers have suppressed the virus, meaning that it is no longer at a detectable level.

Nationally, the number of new infections per year has remained stable at about 50,000, and only about 25 to 30 percent of people with HIV have reached suppression.

Related actions taken

Routine screening for HIV and targeted screening of individuals at risk are key to detection and treatment, but it has been necessary for the state to remove legal obstacles in recent years. In 2014, the law requiring written consent to HIV testing was amended to require only verbal consent, as is standard for other laboratory tests. Some prosecutors and police departments have forsworn or limited the practice of confiscating condoms for use as evidence in criminal cases involving prostitution.

The task force believes that transgender individuals are at higher risk for AIDS, so that legal protections against discrimination and coverage of their unique health care needs are helpful in the achievement of the goal of minimizing the spread of the disease. Therefore, the state Department of Health has adopted regulations requiring Medicaid to cover the treatment of gender dysphoria, including medically necessary gender reassignment surgery. The legislature also is considering bills that would ban discrimination based on gender identification. Both Medicaid and most private insurers will cover daily medication that prevents the transmission of the virus to the partners of HIV-positive individuals.

The task force and the blueprint

The task force formed four committees, each with its own focus: care, prevention, housing and supportive services, and data. They held public listening sessions and considered some 300 recommendations submitted to them. They then formulated 44 recommendations and tied each to at least one of the three elements of the Bending the Curve initiative.

The blueprint was presented to the governor in late April, 2015. The recommendations go beyond the goal of reducing new infections to 750, with the aim of reaching zero by 2025. An essential part of the plan is continuous monitoring to identify the populations currently most affected or at greatest risk of contracting HIV, and, as well, those most affected by “systemic health, economic, and racial disparities that act as catalysts for new infections.”

 

Low-volume hospitals bring high risks: a drive might save your life

Patients who undergo procedures at low-volume hospitals are subjecting themselves to an increased risk of complications and death because surgical teams at those hospitals perform too few procedures to maintain adequate levels of skill. According to a U.S. News & World Report analysis, large numbers of low-volume hospitals continue to put patients at increased risks despite three decades of research tying low-volume hospitals to higher incidents of complications and death.

Increased risk

According to an evaluation of five procedures from the U.S. News analysis, as many as 11,000 deaths might have been prevented between 2010 and 2012 if patients had undergone procedures at the highest-volume fifth of hospitals rather than the lowest-volume fifth. Some evaluations suggest that if other procedures are considered, tens of thousands of deaths might have been avoided. The increased risk of dying at a low-volume hospital from relatively safe procedures is staggering. For example, at one 25-bed Colorado hospital, the relative risk of death for elective knee replacement patients at the hospital was 24 times the national average. Similarly, at a 331-bed medical center in Florida, the relative risk of dying following a hip replacement was nine times the national average and, at a 316-bed New Jersey Medical Center, the risk for patients who had heart bypass surgery was four times above the national average.

Ultra-low-volume

Ultra-low-volume hospitals were identified as those which treated “fewer than 25 traditional Medicare inpatients from 2010 through 2012 for nearly 20 frequent procedures and conditions.” Between 2010 and 2012, ultra-low-volume hospitals performed or treated an average of 3.3 hip replacements per year, 3.7 knee replacements per year, 4.1 basic heart bypass surgeries per year, 3.9 cases of heart failure per year, and 4.3 cases of chronic obstructive pulmonary disease per year. Knee-replacement patients at the ultra-low-volume hospitals had “double the national average death risk and a 25 percent higher rate of readmission because of post-discharge complications.” Similarly, “hip-replacement patients faced a 77 percent higher risk of death and a 25 percent higher risk of readmission.” The problem stems from the simple fact that surgical teams at low-volume hospitals are out of practice.

Patients

The problem is exacerbated by the fact that few patients ask hospitals or physicians how many similar procedures a hospital has treated. U.S. News offers questions that patients can ask hospitals when trying to determine whether a low-volume hospital is a safe place to undergo a particular procedure. The findings of the analysis suggests that longstanding patient preference for local care should give way to a preference for travel and better outcomes, if safety is what patients are after.

FDA informs doctors of rogue distributors, offers drug purchasing tips

To reduce the threat to patients posed by unapproved, counterfeit, or otherwise unsafe prescription drugs, the FDA has issued letters to doctors who may have obtained these drugs from a rogue distributor. In addition to warning about the rogue distributors, the letters also contain tips on how doctors can avoid purchasing drugs that: (1) are fake, contaminated, ineffective, or otherwise unsafe; (2) have not been approved as safe and effective by the FDA; (3) do not contain the appropriate amount of active ingredients; (4) contain harmful ingredients; (5) were not manufactured using quality manufacturing processes; or (6) were stored under improper conditions.

These letters are part of the FDA’s “Know Your Source” program, which works to inform doctors about how to protect their patients from unsafe drugs. Here is a list of the most recent letters:

  • On April 1, 2015, the FDA sent more than 300 letters to medical practices that may have purchased unapproved prescription drugs, or unapproved injectable devices, from a foreign supplier, Gallant Pharmaceutical International, Inc., also known as Gallant Medical International, Inc.
  • On July 11, 2013, the FDA sent approximately 250 letters to medical practices that purchased Botox® from “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox.” The medication’s outer carton was counterfeit, while the vial inside was labeled as a foreign version of Botox.
  • On May 13, 2013, the FDA sent more than 1,000 letters to medical practices that may have received prescription drugs from Pharmalogical, Inc., d/b/a Medical Device King, that contained a counterfeit version of Altuzan (bevacizumab) that had no active ingredient. Bevacizumab is approved in the U.S. as Avastin®, and sold by Genentech, Inc.

Many of the distributors of these unsafe drugs have had criminal actions brought against them.

Growing trend

Ilisa Bernstein, Pharm.D., J.D., Deputy Director of FDA’s Center for Drug Evaluation and Research’s Office of Compliance, says she has seen a “growing trend of health care professionals and medical practice administrators who purchase prescription drugs from rogue wholesale drug distributors outside of the legitimate supply chain.” Bernstein offers a number of tips for doctors:

  • If an offer sounds too good to be true—it probably is. Deep discounts may indicate that the products are stolen, counterfeit, or unapproved.
  • Doctors should ensure they are receiving FDA-approved prescription drugs.
  • Only purchase from state-licensed wholesale drug distributors.
  • Check to see if the packaging, labeling, warnings, and dosing recommendations differ in any way from the FDA-approved packaging, labeling, warnings, and dosing for the product.
  • If several patients report that they are experiencing a new side effect or lack of therapeutic effect from the same product, consider that the drug may be substandard or counterfeit.

New tracing, verification, and identification system

The FDA is also working with prescription drug manufacturers, wholesale distributors, repackagers, and dispensers to establish and implement a new system that allows product tracing, verification, and identification as drugs travel through the U.S. market. This effort is part of FDA’s implementation of the Drug Supply Chain Security Act (DSCSA)—Title II of the Drug Quality and Security Act signed into law on November 27, 2013. Under the DSCSA, doctors who dispense or administer prescription drugs are required to purchase their prescription drugs only from authorized trading partners licensed by or registered with the state or federal government.

 

Despite expanded health coverage, expensive ER visits are on the rise

Despite the implementation of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), 75 percent of emergency physicians indicate that emergency room (ER) visits are on the rise. When the American College of Emergency Physicians (ACEP) conducted this poll one year before, less than half of physicians reported increases. ACEP’s president, Dr. Michael Gerardi, stated that emergency care remains a valuable model of care, pointing out that the ER is the only place that remains open at all hours and that no one is ever refused care.

Polling results

Poll respondents reported that the availability of alternative models of care, such as urgent care centers and triage lines conducted by telephone, has not reduced the volume of ER visits. The large majority said that the severity of illnesses among these patients is either the same or has increased, compared to the past. Over half of respondents also said that the number of Medicaid patients is rising, as well.

ACA

The ACA’s goal of seeing more people covered by health insurance was furthered by the individual mandate, requiring people to have health care coverage or pay a penalty. ACEP reports that the rise in ER visits comes after the date that the individual mandate went into effect. The ACA also provided an opportunity for states to expand Medicaid programs to cover those who were previously ineligible, with additional financial contributions from the federal government. ACEP notes that a Health Policy Alternatives report also indicates that efforts to direct Medicaid enrollees away from ERs to primary care is failing.

More patients, no providers

Despite Medicaid expansion covering more patients, providers cannot be forced to see these patients. Medicaid reimburses providers at the lowest rate, although the ACA includes a provision to offer a slightly higher rate to primary care physicians willing to treat Medicaid enrollees. However, since the ACA resulted in more coverage by private insurance that typically pays providers at much higher rates, providers are even more interested in boosting their bottom line with those patients. Even providers listed on Medicaid managed care plans are busy, with median wait times for appointments at two weeks and a quarter of providers forcing patients to wait over a month.

This problem is exacerbated by the shortage of providers overall, particularly primary care providers. A 2014 report from the Association of American Medical Colleges (AAMC) indicated that the primary care physician shortage would reach 45,000 by 2020. This shortage is explained by aging physicians, Medicaid expansion, and more people newly insured through the ACA. In 2015, these projections were updated through 2025, indicating that the shortfall of primary care physicians would be somewhere between 12,600 and 31,100. The lower numbers will require aggressive changes to payment and delivery models, such as accountable care organizations (ACOs). ACOs unite providers and coordinate patient care in an effort to save government funding. However, provider participation is voluntary.

Emergency model of care

According to Dr. Orlee Panitch, an ACEP fellow, access to both primary and specialty care for Medicaid patients is not timely, resulting in ER visits as the last, or only, resort. Panitch is also concerned by some state policies that discourage Medicaid patients from seeking emergency care, noting that it could have dangerous results. Gerardi points out that this polling offers evidence that the emergency care model is valuable and desirable. There is evidence that this model is evolving. The Mayo Clinic offers a joint Emergency and Urgent Care Center, where triage evaluates the seriousness of a patient’s condition and determines the appropriate level of care. Directing patients to urgent, rather than emergency care, in situations that are not life-threatening or do not warrant immediate attention may result in cost savings. Although information is available from places such as Blue Cross Blue Shield to help patients determine where to seek care, a possible emergency or even urgent situation might not allow a patient to take precious time to make these decisions.