The United States Environmental Protection Agency (“EPA”) regulates pharmaceutical hazardous waste. Under the EPA, unused and disposed of pharmaceuticals are evaluated, managed and disposed of as potential “hazardous waste” under the Resource Conservation and Recovery Act (RCRA) Regulations. The RCRA establishes procedures and standards for hazardous and solid waste material management and disposal. Under the RCRA, solid waste includes “solids, liquids and gases and must be discarded to be considered waste.”[i]
The False Claims Act (“FCA” or “Act”) is a federal anti-fraud statute that protects against persons and companies defrauding the government. The Act has been dubbed the government’s “primary litigation tool for recovering losses resulting from fraud.” The FCA imposes civil liability on any one who “knowingly presents…a false or fraudulent claim for payment or approval” to the federal government. It is used extensively to protect against fraud in healthcare.
The Department of Justice designated 12 federal prosecutors across the country as part of the Opioid Fraud and Abuse Detection Units. These Units are assigned to areas where the most opioid drug-related deaths have occurred: California, Nevada, Alabama, Central Florida, East Tennessee, West Virginia, North Carolina, Kentucky, Ohio, Pennsylvania, Michigan, and Maryland. Members of these Units also includes numerous federal, state, and local law enforcement and governing entities including the DEA, FBI, HHS, and other federal and state agencies (Medicaid Fraud Control Units, FDA, IRS, State Pharmacy Boards, etc.). These Units have a specific mandate to target physicians, pharmacists, and ancillary services (addiction treatment centers, etc.).
2017 was the first year for participation in the Merit-based Incentive Payment System (MIPS), a Quality Payment Program (QPP) implemented by CMS, to award or penalize participating clinicians with regard to future Medicare reimbursements based upon reporting under four categories:
Studies have shown that almost 9 out of 10 adults have difficulty using the health information they receive. This difficulty reflects a gap in patients’ capacity to obtain, process, and understand basic health information and the services needed to make appropriate health decisions. In other words, the studies reflect a gap in health literacy.
It is especially important for smaller practices to be mindful of Electronic Protected Health Information (ePHI) security regulations – a breach of ePHI can lead to costly notification requirements and potential monetary penalties under the HITECH Act. Managing physicians of small independent practices hold many responsibilities, including the duty to comply with the Security Rule within HIPAA regulations. This article provides a brief overview of federal ePHI compliance safeguards required in a practice. While not meant to be a comprehensive discussion of all requirements, it highlights legal considerations and safeguards a practice must implement to comply with HIPAA ePHI regulations. The federal Security Rule under HIPAA requires a health care provider (typically known as a Covered Entity) to have the minimum ePHI safeguards, listed below.
On Friday, January 19, 2018, the Department of Health and Human Services (HHS) issued a proposed rule that will complicate the issues healthcare providers face in providing treatment to LGBTQ patients.
At the core of the Affordable Care Act (ACA) is the three-legged stool: (1) insurance reforms; (2) the individual mandate; and (3) premium and cost-sharing subsidies. Removal of any one of these legs could destabilize the ACA. The ACA established insurance marketplaces in every state to provide access to ACA compliant private health insurance coverage (Qualified Health Plans) in the individual and small group markets. The ACA provides premium subsidies on a sliding scale for persons with incomes up to 400% FPL for the purchase of an individual policy on the marketplace exchange. It also provides cost-sharing subsidies for persons with incomes below 250% FPL. Prior to the implementation of the ACA, manual rating was typically used by insurers for rate-making in the individual and small group markets and exclusions from coverage for pre-existing conditions were common. Age-based rates were typically 5:1. The insurance reforms in the ACA are largely directed at the small group and individual markets (e.g., guaranteed issue/renewal, no preexisting condition limitations, adjusted community rating capped at a 3:1 ratio for age). Standardization of benefits is achieved by requiring coverage for ten essential health benefits (EHBs) and certain preventive services which in the latter case services must be provided without cost-sharing.
Physicians and other medical care professionals spend years studying, training and preparing themselves to provide best possible care to their patients. In many instances, these professionals spend the bulk of their attention and energy on treating their patients and meeting the day-to-day challenges that come with providing the best care possible. Unfortunately, practicing in today’s economic climate within a medical industry undergoing a vast transformation has forced many medical professionals to place equal value on business issues that effect their practice. Often times, the business of operating a medical practice is never discussed in medical school. Instead, many healthcare professionals are forced to learn fundamental business principles on the fly in private practice. With the emergence of electronic medical records and coding, many healthcare providers and practices are spending a substantial amount of time concentrating on the business of healthcare in addition to patient care. Of all the business issues that must now be prioritized by the medical industry, medical billing and managing account receivables can bear the most burden of all.
The assessment of patient compliance is very difficult. Many patients may not want to disappoint their physician and will not be completely accurate about their degree of compliance. Other patients are not able to accurately evaluate or do not know their degree of compliance. In one study, 10% of patients reported that they were 100% compliant with their medication use. Using pill count methods, however, the use of the prescribed medications ranged from 2% to 130% of the prescribed pills.
Physicians serve on the frontlines of our healthcare system, and by extension the many social programs guaranteed by the Social Security Administration. It’s a large responsibility and we owe them a debt of gratitude. These dedicated care providers, across many areas of practice and at varied levels within our medical system, help more than 57 million children and adults who live with disabilities across the United States.
Noncompliance (non-adherence) to medical recommendations can have a significant impact on a patient’s overall health quality, resulting in decreased opportunities for prevention, delayed diagnosis, and incomplete or ineffective treatment. There may also be significant liability and financial risks to a responsible healthcare professional treating this patient, particularly as patient outcomes increasingly become connected to quality indicators and reimbursement.
There is a lot of confusion about SSDI and SSI, the two types of disability benefits that can be received from Social Security. The definition of disability is the same under both programs, but that is where the similarity ends. The following is a very basic description of the disability programs provided under the Social Security Act, titles II and XVI.
No matter the size of the business, a successful business must be paid promptly and in full. However, often a business, including a medical practice is dealing with numerous overdue accounts receivables. Such a financial position can be commonplace in today’s business environment. Although this financial condition is often perceived as “normal” or “accepted” business practice”, savvy business owners should collect promptly and protect their rights in resolving overdue receivables with the proper policy and procedures in place. Effective policy and procedures generally begin with utilizing a new patient form and/or the credit application.
As of September 30, 2017, the Department of Health and Human Services Office of Civil Rights (OCR) has received notices of 237 breaches. 46% occurred as result of hacking or IT security incidents; many at the business associate level. Ransomware is rampant and projected to increase 670%. As a covered entity, although a breach occurs at your business associate, under HIPAA, you are responsible for your protected health information and responding to the breach. OCR has been clear that breaches of 500 or more records will be investigated. Given the significant increase in breaches over the past few years, advance preparation is critical and can reduce the cost and burden of breach response.
An Oklahoma physician agreed on August 28, 2017 to pay the government $580,000 to resolve allegations that he violated the False Claims Act by submitting claims to the Medicare program for services he did not provide or supervise. According to the government, the physician allowed a company that employed him and in which he had an ownership interest to use his NPI numbers to bill Medicare for physical therapy evaluation and management services that he did not provide or supervise. The government further alleged that after he separated from the company and deactivated his NPIs associated with the company, he reactivated those NPIs so that the company could use them to bill Medicare for services he neither performed nor supervised.
On June 20th, CMS issued its proposed rule for year 2 of the Quality Payment Program (QPP) under Medicare Access and CHIP Reauthorization Act of 2015( MACRA). Comment period ends August 20.
Social Security Disability under Title II of the Social Security Act*
Surveys have shown that most Americans know little about Social Security law and the vital benefits it provides. By far, the least understood Social Security benefit is Social Security Disability Insurance (SSDI). This lack of knowledge has been measured through objective testing in various academic studies. Anecdotally, I know this to be true based on recurring questions and comments I have received from the public and clients alike over the last several decades of my work as a social security disability attorney.
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