Essential resources for health care providers & attorneys during hurricane season

Hurricane season has arrived and health care providers in affected areas are focusing on providing services to injured individuals and rebuilding damage to facilities, but not necessarily on compliance with Medicare and Medicaid laws and regulations. To assist providers, federal and state agencies are temporarily waiving some regulatory requirements and providing other emergency services. While active hurricane recovery efforts are underway, Health Law Daily will feature links to federal and state resources.

Federal information:

State- and commonwealth-specific information:

Timing key for internal audits, self-disclosure

There is an art to conducting internal compliance audits and determining when to begin a self-disclosure protocol—the ideal compliance program should promote prevention, detection, and resolution of any conduct that fails to comply with the requirements of state and federal health care programs. Knowing when to perform an internal investigation or audit to encourage a healthy program is key, according to Leia C. Olsen, shareholder, Hall Render, who was presenting at a Health Care Compliance Association (HCCA) webinar.

Olsen noted that many qui tam actions arise when employees do not feel as though their concerns are being heard and taken seriously. She stressed the importance of having a mechanism for reporting incidents, and timely monitoring identified issues and implementing remedial measures. However, she noted that qui tam suits can potentially be prevented not only by conducting an internal investigation, but also by self-disclosing, which can trigger the public disclosure bar. Self-disclosure of identified wrongdoing is encouraged by the Department of Justice and HHS, but, per the Yates memorandum, all relevant facts must be provided by a company before it can receive credit for cooperating and voluntary self-disclosure. Therefore, it is important to conduct a thorough investigation, collecting all available information and documentation, before self-disclosing.

The 60-day refund rule, promulgated under Sec. 6402 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), together with the Fraud Enforcement and Recovery Act of 2009 (FERA) (P.L. 111-21), creates False Claims Act (FCA) liability for providers who fail to report and return identified overpayments within 60 days of identifying the overpayment. Therefore, Olsen said, the time to meet the reasonable diligence standard after learning of a potential overpayment is limited. Having a protocol in place to quickly decide whether to self-disclose is critical in securing the greatest amount of cooperation credit.

Prescription drug spending in U.S. among highest worldwide

Prescription drug spending in the United States exceeds spending in nine other high income countries, with generic drugs comprising 84 percent of the total pharmaceutical market. Besides the U.S., a Commonwealth Fund issue brief looked at prescription drug spending in Australia, Canada, France, Germany, the Netherlands, Norway, Sweden, Switzerland and the United Kingdom.

Prescription drug spending in U.S. increases in 1990s

According to the Commonwealth Fund review, spending on prescriptions drugs increased substantially in the mid-1990s due largely to the growth of the pharmaceutical industry. For instance, FDA approved drugs were at an all-time high and sales of cancer drugs increased. Additionally, drug spending increased due to the expansion of federal programs such as the Children’s Health Insurance Program, Medicaid, and Medicare.

Prescription drug spending increased by 20 percent over a period of two years during the mid-2000s. The growth was primarily due to introducing many expensive specialty drugs to treat hepatitis C, cystic fibrosis and other conditions. Passage of the Affordable Care Act likely led to such increases as well. U.S. spending on pharmaceuticals surpassed $1,000 per person in 2015 and was 30 percent to 190 percent higher than in the nine other countries. The next countries, behind the U.S., in spending in 2015 were Switzerland with $783, Germany with $686, and Canada with $669.

Reasons U.S. spending on prescription drugs is so high

The Commonwealth Fund offered possible reasons to explain why the U.S. spends so much on prescription drugs, including country population and volume of drugs consumed, drug utilization per person, type and mix of drugs consumed (e.g., generics versus brand-name drugs), and prices at which drugs are sold.

Although the U.S. population is ranked among the largest and has the highest prescription drug spending as a country, spending per capita remains much higher in the U.S. than that of other countries. Higher per person spending is not due to the large population of the U.S., however.

The impact of generic prescription drugs

Generic drugs make up 84 percent of the total U.S. pharmaceutical market, which is a larger share than in all other countries, excluding the U.K., which is tied with the U.S. with 84 percent. Followed by the U.S. are Germany with 81 percent, Netherlands with 71 percent and Canada with 70 percent of the share of generic prescription drugs. Lower prescription drug prices in the other countries reflect more centralized processes for obtaining pharmaceuticals and setting coverage.

Conclusion. Price continues to play a primary factor in the high prices associated with prescription drugs in the U.S. The reasons can be attributed to the fragmented nature of health care delivery and payment, as well as separate negotiation arrangements between drug manufacturers and payers and complicated arrangements for federal and state health programs. Also, the U.S., unlike other countries, allows for greater latitude for monopoly pricing of brand name drugs.

The ACA makes a measureable difference with HIV coverage

People with HIV experienced significant coverage gains under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) as a result of Medicaid expansion, the creation of the health insurance marketplaces, and the elimination of pre-existing condition exclusion. According to a Kaiser Family Foundation (KFF) Issue Brief, as long as the future of the ACA remains uncertain, those access and coverage gains are at risk.

Baseline

To develop a baseline for understanding current access to care for people with HIV, KFF examined multiple variables across the three main pathways for HIV coverage and care: (1) Medicaid, (2) private insurance and the ACA marketplace, and (3) the Ryan White HIV/AIDS program. KFF considered factors like states’ Medicaid expansion status, the number of health insurance issuers per county, and AIDS Drug Assistance Program (ADAP) eligibility levels.

Medicaid 

Prior to the ACA’s Medicaid expansion, most individuals with HIV obtained Medicaid coverage through the disability pathway, meaning that coverage was often not obtained prior to a beneficiary’s development of AIDS. Currently, 62 percent of people with HIV live in a Medicaid expansion state, where care is more likely to be accessible through the income pathway, regardless of disability level. Additionally, 24 states provide Medicaid coverage through the disability pathway above the federally mandated level of 73 percent of the federal poverty level (FPL).

Marketplaces 

In 33 states, where 83 percent of people with HIV live, there are three or more issuers in the ACA marketplace. While five states—Arkansas, Oklahoma, South Carolina and Wyoming—had only one issuer in 2017, some states had several. For example, Wisconsin had 15 insurers, New York had 14, and California had 11. KFF also looked at issuer representation in counties with high incidence of people with HIV. While 43 percent of people with HIV live in one of the eighteen (18) states with an average of three or more issuers per county, the majority of people with HIV—57 percent—live in one of the 33 states with less competition—one or two issuers per county.

Ryan White

The Ryan White HIV/AIDS Program provides outpatient HIV care and treatment to low and moderate income individuals. The program serves more than half of the people diagnosed with HIV in the country. The average eligibility level for the medication assistance program is 386 percent FPL. While 17 states use an eligibility level of 400 percent, 72 percent of people with HIV live in a state with eligibility levels at or above the national average. While the Ryan White program would continue to operate with an ACA repeal, many individuals currently covered by marketplace or Medicaid plans would likely turn to the program for coverage. Due to the program’s limited resources, KFF estimates that such an over-reliance could cause individuals to lose access to care.