Coverage, treatment improves for individuals with HIV

Individuals with HIV are more knowledgeable about their health insurance options than they were in 2014, and many are receiving care that meets their needs, according to a report by the Kaiser Family Foundation (KFF). While those who gained coverage under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) reported using their coverage regularly to treat their HIV, the expansion of Medicaid in states that have not yet done so would improve the health of HIV-positive individuals in those states. While the Ryan White program helps them manage their HIV, other health issues are going unaddressed.

The ACA and individuals with HIV

The ACA expanded access to affordable health insurance to millions of Americans, including those with HIV. Many individuals with HIV faced exclusions and other discriminatory road blocks in gaining health insurance before the ACA. Provisions that largely affected individuals with HIV include the creation of health insurance marketplaces and the availability of subsidies, the expansion of Medicaid in certain states, prohibitions on discriminatory market practices such as rate setting based on health status, preexisting condition exclusions, and the use of annual and lifetime coverage limits.

KFF studied focus groups of HIV-positive individuals in California, Florida, Georgia, New York, and Texas in mid-2014 to examine the care experiences under the ACA of people with HIV. As a follow-up, KFF took a second look at the same focus groups to see how the ACA affects individuals with HIV two years later. The focus groups consisted of HIV-positive individuals who gained health insurance coverage through marketplaces or Medicaid expansion, as well as those who remained uninsured because they fell into the coverage gap.

Increased understanding and security

KFF found that, in 2014, participants with new insurance coverage were in the early stages of learning how to use their insurance. In this round of research, participants reported that they used their coverage regularly to meet their care and treatment needs. The participants also reported that their health was easier to manage after gaining coverage and that they found relief and security in being covered. However, some still worried about being able to maintain coverage. However, those with Medicaid find recertification to be stressful.

Knowledge of insurance

Despite being better able to navigate using insurance compared to their 2014 counterparts, some participants remained unsure of how to fully assess plan options and, thus, relied on case managers to help them make enrollment decisions. These individuals continued to lack some basic insurance literacy, but KFF found that the individuals were more knowledgeable about how access to health care varied across the U.S.

Medicaid expansion

Individuals in states that did not expand Medicaid who remained uninsured because they fall into the coverage gap feel like they can meet their care and treatment needs through the Ryan White Program, but they feel like other health problems are unaddressed. Nearly every participant—especially those with past Medicaid coverage—said if their state later expanded Medicaid, they would enroll.

$6.50 not the max for PHI record fees

The HHS Office for Civil Rights (OCR) is reminding covered entities (CEs) that they there is no cap on the fees they may charge individuals or their personal representatives for providing them, or third parties to whom the CEs are directed, with copies of protected health information (PHI)—within specific limits. Rather, in a new FAQ, the office states that CEs that would prefer not to engage in arduous calculations have the option to charge a flat fee of not more than $6.50 for electronic copies of PHI maintained electronically.

Permissible fees

The Health Information Portability and Accountability Act (HIPAA) (P.L. 104-191) Privacy Rule permits CEs to charge fees for copies of PHI. Charges may only include labor, supplies, and postage (45 C.F.R. sec. 164.524(c)(4)). Labor for copying includes only labor for creating and delivering the copy in the form and format (electronic or paper) agreed upon, once the relevant PHI has been identified, gathered, and prepared for copying; search and retrieval costs are not permitted. Labor to prepare a summary or explanation may be included if the individual requests such a summary or explanation and agrees to the costs in advance. Supply costs include costs for paper and toner costs for paper copies and the cost of portable electronic media, if the individual requests a copy on portable media.  However, individuals have the right to ask that PHI is simply mailed or emailed.  CEs may not charge fees when they simply fulfill a HIPAA access request using its certified electronic health record technology (CEHRT) view, download, and transmit feature.  CEs must notify individuals of the approximate fees they will charge in advance of providing the copies.

Flat fee

CEs may calculate actual costs individually for each request or develop a schedule of labor costs based on the average costs required to fulfill standard requests. CEs may not charge per-page fees for PHI maintained electronically, even when individuals request paper copies. The FAQ clarifies that CEs may charge a flat fee not to exceed $6.50 for standard requests, although they may wish to calculate actual costs in the event of non-standard requests. The OCR reminds CEs, in those situations, that they must still notify individuals of the approximate fee they will charge in advance of providing the copies. Actual costs and average costs may exceed $6.50, provided the fees comply with 45 C.F.R. sec. 164.521(c)(4).

DMEPOS suppliers accept adjusted fee schedule rates

Durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers in non-competitive bidding program areas are accepting adjusted payment rates that were phased in beginning in 2016. CMS posted quarterly monitoring data suggesting that the adjusted rates are adequate to cover the costs of furnishing DMEPOS and have had no negative impact on beneficiary access. The fully adjusted billing rates will take effect in non-competitive bidding areas beginning July 1, 2016.

Competitive bidding program

CMS has operated the DMEPOS competitive bidding program (CBP) since January 2011 to improve upon the prior DMEPOS fee schedule, which was based on historic supplier charges from the 1980s and resulted in excessive payments. Medicare saved more than $580 million upon the completion Round 1’s three-year contract period, which lasted from 2011 through 2013. After the first two years of Round 2 and the national mail-order programs, which began in July 2013, it saved approximately $3.6 billion.

Non-CBP areas

Section 1834(a)(1)(F) of the Social Security Act requires CMS to adjust fee schedule amounts for durable medical equipment (DME) on January 1, 2016, in non-CBP areas. Section 1842(s)(3)(B) authorizes adjustments to the fee schedule amount for enteral nutrients, equipment and supplies based on information from CBPs. To combat stakeholder concerns that the adjustment might negatively impact quality and access to items and services, CMS decided to phase in the adjustments to the fee schedule amounts for claims with dates of service January 1, 2016, through June 30, 2016, with each fee schedule amount based on a blend of 50 percent of the fee schedule amount that would have gone into effect on January 1, 2016, if not adjusted based on information from the CBP, and 50 percent of the adjusted fee schedule amount.


Suppliers in non-CBP areas are not required to accept assignment of Medicare claims for items subject to competitive bidding and may instead collect the extra money needed to cover their costs directly from the beneficiary. However, the data for 2016 show that suppliers in non-CBP areas have accepted the new, adjusted rates as payment in full. Overall, there was no change in the rate of assignment for the first four months of 2015 (99.87 percent) compared to the first four months of 2016 (99.88 percent). The data are also broken down by geographic regions, rural versus non-rural classification, and DMEPOS item category. CMS will continue to monitor data for the second quarter of 2016 and after the fully adjusted payment rates are implemented beginning in the third quarter.

Lunada settlement settlement halts false marketing of Amberen®

Lunada Biomedical, Inc., and its principals (Lunada, collectively) agreed to settle charges by the Federal Trade Commission (FTC) that it deceptively marketed Amberen®, a dietary supplement, to perimenopausal and menopausal women over 40 by making a range of unsupported claims about the drug’s ability to aid in weight loss and relieve menopause-related symptoms. The proposed stipulated order prohibits Lunada from making unsubstantiated efficacy or health benefit claims for any dietary supplement, food, or drug or conducting any other illegal activities related to consumer satisfaction claims, “risk-free trial” offers, and consumer endorsements. Lunada will pay $250,000 of a $40 million judgment, based on its inability to pay the full amount.


The FTC filed a complaint in May 2015 and amended it in December 2015. The amended complaint alleges that Lunada made unsubstantiated claims that Amberen causes substantial and sustained weight loss, loss of belly fat, and an increase in metabolism in women over 40 who are perimenopausal or menopausal and that it is clinically proven to cause substantial and sustained weight loss in such women. The FTC also alleged that Lunada made unsubstantiated claims that the drug was clinically proven to alleviate nearly all common symptoms of menopause, including hot flashes, night sweats, sleep problems, fatigue, and irritability. According to the FTC, a 2001 clinical trial by the scientists who developed the formula used a double dose of Amberen and did not specifically measure weight loss. A subsequent clinical study failed to show a statistically significant difference in the weight lost by control group and test group participants.

In addition to making unsubstantiated claims, the FTC alleged that Lunada failed to disclose its relationship with certain consumer endorsers and made false claims of consumer satisfaction and success rates of nearly 93 percent. It also falsely told consumers they could try Amberen “risk-free” for 30 days. In fact, instead of receiving a 30-day supply, consumers were given a 90-day supply of the product and, to qualify for a refund, were required to return two unopened product boxes at their own expense within 30 days of placing the order.

Settlement Terms

The proposed stipulated order bars Lunada from:

  • claiming that any dietary supplement, food, or drug causes weight loss, sustained weight loss, or loss of belly fat; boosts metabolism; relieves hot flashes, night sweats, and other specific symptoms of menopause; or cures, mitigates, or treats any disease, unless they have human clinical testing that meets certain requirements and is sufficient to substantiate that the claims are true;
  • making any misleading or unsubstantiated claim about the health benefits or efficacy of any dietary supplement, food, or drug;
  • misrepresenting the results of any test of the product;
  • misrepresenting any material fact about the product or any material terms and conditions of any offer for it; and
  • failing to disclose any material connections (such as financial relationships) they have with endorsers.