Why are so many people still uninsured?

A recent study sponsored by the University of Massachusetts Medical School and Blue Cross Blue Shield Foundation asked that very question.  Although the state’s individual mandate became effective in 2006, somewhere between 3 percent and 5 percent of Massachusetts residents were uninsured in 2015, about 200,000 people.

Massachusetts has the lowest rate of uninsurance in the United States at 3 percent. In contrast, the national average as of mid-2014 was 12.2 percent. It is noteworthy that the uninsurance rate in Massachusetts has not decreased since 2008. Actually, according to the study, the Massachusetts uninsurance rate has grown from 2.6 percent in 2008 to 3.7 percent in 2015.

The study authors interviewed 33 individuals who were uninsured in July 2015 to ask them why they became uninsured, why they were still uninsured, and what would help them to obtain insurance.

There were several reasons that people were uninsured:

  • loss of employer-sponsored insurance (ESI);
  • loss of eligibility for Medicaid;
  • expense of available ESI; and
  • loss of eligibility for subsidized insurance

There also were several common obstacles to becoming insured:

  • the materials were hard to understand (this was especially true for indivduals whose primary language was not English);
  • it was difficult to reach someone who could help, navigators and assisters were not necessarily available during the hours that the uninsured individuals could go for help; and
  • there was no one available to help who spoke the individual’s language.

Some individuals chose not to apply for insurance because they were healthy and did not see a need for it. Some also were satisfied with the health care that was available to them at free clinics. But most of the uninsured believed they needed insurance and preferred to have it.

Some tried to apply but could not complete the application process. Others were afraid that applying would endanger their immigration status or that of a family member. Still, the most important obstacle was financial. Even if they were eligible for subsidies, many felt they simply could not afford coverage. The existence of penalties did not influence many who chose to remain uninsured. Some said that the penalties were less expensive than insurance. When asked what would make it easier for them to become uninsured, the individuals surveyed wanted more in-person assistance to be available. The availability of assisters who spoke their language was very important to them.

The authors found that the uninsured are a diverse group, and no single outreach strategy was likely to work for everyone. It is noteworthy that there is no “coverage gap” in Massachusetts because the state expanded Medicaid. In other states, such as Texas, that have not expanded Medicaid, the unavailability of assistance is an additional obstacle.

Pew reports find weaknesses, best practices in compounding pharmacy regulation

State agencies that regulate compounding pharmacies often lack the authority to require compliance with appropriate standards, according to a recent report issued by the Pew Charitable Trust. In two related reports, Pew researchers assessed the extent to which state regulatory agencies oversee the safe operations of compounding pharmacies and recommended best practices for the agencies’ use.

Regulation of compounding pharmacies

Compounding pharmacies prepare drugs that are not commercially available. Under Federal Food, Drug, and Cosmetic Act section 503A, compounding pharmacies are permitted to prepare medications by prescription for the use of an identified patient. However, manufacturers began to use compounding pharmacies as outsourcing facilities to prepare larger batches of drugs. These outsourcing facilities challenged the restrictions on compounding pharmacies that prohibited advertising and solicitation of prescriptions. In 2012 and 2013, contaminated drugs manufactured by compounding pharmacies caused multiple injuries and deaths (see FDA inspects 29 compounding pharmacies, continues to find violations, Health Law Daily, April 12, 2013) Congress enacted the Drug Quality and Security Act, including the Compounding Quality Act. This law provided for FDA regulation of outsourcing facilities. The regulation of traditional compounding pharmacies remains under state control.

State oversight

The Pew researchers surveyed state boards of pharmacy and reviewed other materials to determine how states regulated compounding pharmacies. The 43 states that responded to the survey varied in their definition of compounding, the extent of their tracking of the activities of compounding pharmacies, the standards they enforced, and the enforcement actions available to them. For example, most states defined “compounding” to include combining two or more ingredients, but some definitions included repackaging, diluting, pooling, and/or reconstituting.

Many states do not track the pharmacies that perform compounding functions. A few require separate licensure. Of the 43 that responded, 34—79 percent—required compounding pharmacies to comply with at least some of the standards published by the United States Pharmacopeia (USP) in Chapter 797, but 13 of them did not require compliance with the entire chapter. Of the eight that did not apply USP chapter 797 at all, seven reported that policy changes to adopt part or all of Chapter 797 were pending. A few required more extensive training than the USP for some activities. In particular, some states required hands-on training and evaluation in which the evaluator observed the participant compounding a drug.

Enforcement authority

Most states did not track the violations of compounding pharmacies separately from retail pharmacies. Most did not require compounding pharmacies to report voluntary recalls either to the state or to the FDA. Eighty-eight percent of the responding states required pharmacies to report the number of drugs that they compounded, but only 30 percent required reporting of adverse events.

Thirty percent of states had the authority to require a compounding pharmacy to recall a product, while 44 percent did not. The staff who responded on behalf of the remaining 26 percent of states did not know whether their agencies had the authority to require a recall.

Best practices

An advisory committee compared states’ monitoring and enforcement practices and proposed recommended best practices for states to adopt if they could. The recommendations included:

  • application of the quality standards of USP Chapter 797;
  • identification of pharmacies that perform sterile compounding;
  • separate tracking of violations of requirements governing sterile compounding;
  • requiring training of all pharmacists who either perform or supervise sterile compounding;
  • annual inspections of compounding pharmacies; and
  • harmonizing state requirements for compounding without a prescription with those of federal law.

Highlight on Utah: New tool cuts costs, improves outcomes

In a study published by the Journal of Hospital Medicine,  investigators from the University of Utah Medical Center (UUMC)  found that a Value Driven Outcomes (VDO) tool reduced the number of unnecessary laboratory tests performed on hospitalized patients and cut costs. Investigators Peter Yarbrough, M.D., Kensaku Kawamoto, M.D., Ph.D.,  and three physician colleagues from UUMC estimated that their multifaceted intervention saved the hospital more than $250,000 the first year. Although patients often need daily laboratory work, Yarbrough said, “it can create a culture where you’re ordering tests without thinking about what you’re going to do with the results.” The goal of the study was to try to create a thoughtful process for deciding what laboratory tests to order for hospitalized patients.

Study design

The study compared the changes in laboratory costs between the hospitalists and other physician providers at UUMC.  The hospitalist services were performed by four teams of Internal Medicine residents and medical students. The control group comprised physicians from the surgical, cardiology, pulmonary, hematology, and oncology departments. Patients admitted to the psychiatric, rehabilitation, or obstetrics units were excluded from the study.  Their use of laboratory tests was measured during a seven-month baseline period, after which the intervention was introduced. The study period continued for 15 months. the design controlled for differences in age and took into account the level of comorbidity.

After an informal review of patient charts, an examination of the physicians’ work flow, and a review of the literature, Yarbrough, Kawamoto, and their coauthors noted that interns ordered the most tests and were responsible for the greatest variation in utilization of laboratory services. They noted that unnecessary testing  poses several risks to patients. False positives results lead to additional unnecessary testing. Over long hospital stays, frequent blood draws increase the risk of anemia. One cardiology study found that cardiac patients lost an average of 454 ml of blood per stay, nearly half a liter. Being awakened early in the morning for daily blood draws can deprive patients of needed rest, negatively affecting their hospitalization experience, as well.

The interventions

The first component of the UUMC intervention was education of the physicians involved on the cost of overuse of laboratory services, the results of previous interventions, and the current intervention and its goals. The residents were issued pocket cards with the most common laboratory tests and the amount charged for each. The rounding process was standardized, incorporating a checklist that required review of previous lab results, pain, telemetry, lines and tubes, nursing presence, and follow-up needed for each patient. All plans for lab testing were to be discussed during rounds. A third year medical student was tasked with making sure that the entire checklist was addressed for every patient.

Each month, the hospitalists reviewed laboratory costs using their VDO tool. The data were presented as a monthly average, though individuals could compare their performance to that of other providers in the group.  There was a financial incentive for the Department of Internal Medicine as a whole, in that 50 percent of the savings would be shared with the department to use for future quality improvement projects, but there was no financial incentive for individual physicians. The results were measured every two weeks.

Results

The number of basic metabolic panels, complete metabolic panels, and complete blood counts dropped significantly. The average daily cost of laboratory services per patient fell from $138 to $123. The laboratory cost per visit dropped by $128.  Length of stay was not significantly affected, but remained constant in both the control group and the intervention group. Readmissions within 30 days fell from 14 percent to 11 percent in the intervention group.

The multifaceted nature of the intervention makes it difficult to tease out the relative effects of the various components. The hospitalists involved, however, believed that the use of the VDO checklist and the feedback at monthly meetings were the most important factors affecting the changes in their behavior.

CMS suspends new enrollment in CIGNA’s Medicare plans

CMS suspended new enrollment in CIGNA’s Medicare Advantage (MA) (Part C) and stand-alone prescription drug plans under Medicare Part D as of 11:59 p.m. on January 21, 2016. In a filing with the Securities and Exchange Commission (SEC), the company stated that the agency imposed “intermediate sanctions” based on findings that CIGNA failed to meet required standards for: (1) grievances and appeals in Part C and Part D plans; (2) formulary and benefit administration in prescription drug plans; and (3) compliance programs.

The company may neither market to nor enroll new members in any of its Part C or Part D plans. In the SEC filing, CIGNA stated that it was cooperating fully with the agency and is moving to resolve the issues as quickly as possible.

Under 42 C.F.R. sec. 422.752(b), CMS may impose suspension of marketing and enrollment of new members, when it finds serious violations of regulations that could lead to termination of a contract. It was reported that CMS’ January 21, 2016, letter to CIGNA said that the agency found “widespread and systemic failures impacting Cigna enrollees’ ability to access medical services and prescription medications” that “posed a serious threat to the health and safety of Medicare beneficiaries.” The letter also described Cigna’s “longstanding history of noncompliance.” It was also reported that the insurer must submit a corrective action plan by January 29, 2016.