Physician Practices

Healthcare Providers and Business Partners Get Ready: The Next Phase of HIPAA Audits is Here

March 28, 2016 | Little Health Law

medical-doctor-1314902-m The U.S. Department of Health & Human Services (HHS) announced its preparation to move into its next phase of audits of healthcare covered entities and their business associates. According to HHS, “[t]he 2016 Phase 2 HIPAA Audit Program will review the policies and procedures adopted and employed by covered entities and their business associates to meet selected standards and implementation specifications of the Privacy, Security, and Breach Notification Rules.” Physicians, medical practices, other providers and healthcare businesses, and their business associates, should take steps to ensure they are current and compliant with respect to HIPAA requirements.

Federal Investigation/ Medical Audit Lawyers

HHS is charged by federal law with the responsibility to enhance and protect the health and well-being of all Americans. To that end, HHS, through its Office of Civil Rights (OCR), endeavors to ensure high quality health and human services and promote advances in medicine and public health. Federal law known as the Health Information Technology for Economic and Clinical Health Act (HITECH) requires HHS to conduct periodic audits of healthcare providers and their business associates to ascertain compliance (or lack thereof) with the HIPAA Privacy Rule, the HIPAA Security Rule, and the HIPAA Breach Notification Rule. The HIPAA Privacy, Security and Breach Notification Rules, though very important to our government’s efforts to protect protected health information (PHI), are additional burdens for those in the business of providing healthcare and their business partners who might have access to PHI.

A few years ago, OCR used a “pilot” audit program to assess a sampling of covered entities’ progress in implementing HIPAA’s requirements for protecting PHI. Now, utilizing the information obtained by its pilot audit program, OCR will begin auditing both healthcare providers and their business associates. Beginning this year, OCR will review and analyze policies and procedures adopted by covered entities and business associates against the requirements of the HIPAA Privacy, Security and Breach Notification Rules.

Physician Employment and Contracting

March 7, 2016 | Little Health Law

to-sign-a-contract-2-1221951-m In making a decision to pursue medicine and healthcare as a livelihood, it is likely that most physicians today did not contemplate the extent to which legally binding contracts would govern and impact their professional lives. Few other careers carry the same potential for commitment to so much paper and binding agreements that simultaneously foster professional opportunities and create hazardous legal and professional risks (for example, a non-compete agreement that bars future employment needed to avoid selling the house and moving; a contract with a hospital system that memorializes a compensation arrangement but, unbeknownst to the doctor when he signs, violates STARK law). In this day, all physicians should be mindful of the critical importance of good contracting principles and practices.

Physician employment

The healthcare industry, perhaps more dramatically than other industries, is prone to changes, trends, and developments. A sustained trend has been physician employment (versus private practice ownership). In the 1990s, with the evolution of HMOs, the industry trended toward high levels of physician employment, a trend that petered out some during the 2000s with decreasing physician employment as HMOs dissolved. In recent years, however, the healthcare industry returned to a strong trend toward physician employment driven by numerous factors derived from healthcare “reform.” Whether the current physician employment trend is more permanent than the last one is unknown, but some experts predict that the high level of physician employment is here to stay. As reported last year in the Dallas/Forth Worth Healthcare Daily, some experts believe that physicians’ need for stability with regard to future income will drive a lasting employment trend.

Medicare Reimbursement and Legal Issues in End of Life Planning

February 29, 2016 | Little Health Law

romanticism-1309299 Of the 2.5 million people who die in the U.S. in a year about 75% of those are 65 and older. As such, Medicare is the largest insurer of the cost of medical treatment during the last year of life, according to an article by the Henry J. Kaiser Family Foundation. Given this reality, health care providers regularly encounter practical questions and concerns about end-of-life issues. Examples of patient and provider concerns in end-of-life care include: Who is authorized to make medical decisions for patients unable to understand and decide for themselves? Does a patient want to receive artificial nutrition and hydration if in a coma? Does a patient wish to be resuscitated regardless of their medical condition? How can patients communicate and provide proof of their wishes about end-of-life medical decisions in a way that their families and health providers know and understand, and the law will support?

To ensure that a patient’s wishes are followed in the immediacy of meeting medical needs at the end of life, patients and their families should plan ahead to consider their options, make decisions, and communicate their wishes to their physicians and other health care providers in advance. Recognizing the significance to patients and providers in discussing end-of-life plans, effective January 1, 2016, Congress has authorized Medicare reimbursement to health providers for time spent in such discussions.

Physicians Continue in Trend of Medicare Opt Outs

February 4, 2016 | Little Health Law

medical-doctor-1314903-m In the past two decades, a growing number of physicians in private practice dissatisfied with reimbursement rates, paperwork and other aspects of the federal Medicare program have opted out of the program. According to an article by William Buczko available on the Centers for Medicare and Medicaid Services (CMS) website that explains the history and details of the Medicare Opt Out process: 2,839 physicians and other providers opted out of Medicare between 1998 and 2002. They comprised 0.42 percent of providers eligible to opt out in that period.

Since then, those numbers have continued to grow, with Medicare officials recently reporting about 4 percent of U.S. physicians and other providers having opted out.

The Opt Out Process

The Medicare Opt Out process requires three steps, according to an article by Physicians Practice. These include:

DOJ Concludes Medicare Billing Investigation and Issues Press Release: Medicare Billing Company Will Pay $500,000 to Settle False Claims Allegations

January 25, 2016 | Little Health Law

US-SUP-CT This week the United States Department of Justice (DOJ), through the United States Attorney for the Southern District of New York, Richard S. Hartunian, announced a settlement with Medical Reimbursement Systems, Inc. (MRI) of DOJ’s allegations that MRI submitted false claims to the Federal TRICARE Program in violation of the Federal False Claims Act (FCA). According to the DOJ investigation, MRI falsely presented claims to TRICARE as “HPSA” claims. MRI paid $500,000 to resolve the issue with DOJ.

Healthcare Law and Medical Billing

TRICARE is a Federal health care program for about 9.5 million beneficiaries that include active duty service members, National Guard and Reserve members, retirees, as well as the families of such. “HPSA” stands for Health Professional Shortage Areas, which (like sister Medically Underserved Areas known as “MUAs”) are designations based upon Federal standards applied by the United States Health and Human Services (HRSA).

Legal and Compliance Concerns in Telemedicine and Other Healthcare Technology in 2016

January 5, 2016 | Little Health Law

mobile-phone-in-hand-1438231-1-m High on the list of trends in the healthcare industry in 2016 is the advancement of technology in the diagnosis and treatment of disease and medical conditions. According to a recent online article in Healthcare Finance, thirty-two percent of consumers in 2015 had at least one health, medical or fitness app on their mobile devices. Such apps can be useful for primary care and chronic disease management, among other areas. Telemedicine will continue to grow in 2016 as well, with physicians and other health providers consulting and treating patients remotely. Providers increasing their use of technology can expand the geographic reach of their practice to include a greater number of patient consumers. Indeed, the Affordable Care Act anticipates and encourages the use of telemedicine and other remote technologies as an efficient and cost-effective method for expanding the reach of healthcare services.

Of course, with the increasing use of technology in healthcare comes attendant legal and compliance concerns, ranging from issues of patient privacy and cybersecurity to state regulatory and medical ethics requirements governing patient care, billing and reimbursement.

Providers considering increasing their use of telemedicine and other technology in the provision of services should first evaluate the legal and regulatory issues carefully, understanding that federal and state entities have specific definitions, compliance and legal requirements governing these practices. Some concerns as to this mode of healthcare delivery are as follows:

CMS’ New Final Rule for Durable Medical Equipment Requires Prior Authorization

December 31, 2015 | Little Health Law

orthopedic-leg-brace-1258501

The U.S. Centers for Medicare and Medicaid Services (CMS) issued a Final Rule earlier this week, which created prior authorization rules applicable to particular durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The impetus for the rule is CMS’ determination that prior authorization will curb past issues with unnecessary utilization of DMEPOS, saving the government money and enhancing the care of Medicare beneficiaries.

Atlanta and Augusta Business and Healthcare Law Firm

The Social Security Act (the Act) authorizes CMS to periodically revise its list of DMEPOS that is subjected to unnecessary utilization and to develop a prior authorization process for such items. See the Act, § 1834(a)(15). CMS broadly considers “unnecessary utilization” to include “the furnishing of items that do not comply with one or more of Medicare’s coverage, coding, and payment rules.” The Final Rule creates a Master List of specific DMEPOS potentially subject to prior authorization. The so-called “Master List,” together with pertinent other information regarding the list, can be accessed via this link. An items presence on the Master List does not automatically create a prior authorization requirement. CMS will implement a subset of items on the Master List, a “Required Prior Authorization List,” which will be published in the Federal Register with 60 days’ notice before implementation.

Healthcare Fraud Report: Nine Years in Federal Prison for 24-year-old Pharmacist

December 14, 2015 | Little Health Law

gavel-952313-m Daniel Suarez, 24, was sentenced earlier this month to nine years in prison following his guilty plea to healthcare fraud and abuse charges. According to the Miami Herald, Suarez, a pharmacy technician, was involved in a family ring of Medicare fraud that involved submitting false claims to Medicare for prescription drugs. Medicare has been a victim of extensive fraud and abuse over the years, resulting in a greatly enhanced regulatory environment that, unfortunately, burdens all healthcare providers, honest and dishonest.

Georgia Business and Healthcare Law Firm

The Medicare Program is funded by federal dollars and provides benefits and services for free (or low cost) to about 40 million elderly, blind or disabled, known as Medicare “beneficiaries.” Medicare has several different programs referred to as “parts.” The Medicare Part D Program subsidizes the cost of prescription drugs needed by Medicare beneficiaries. Beneficiaries enroll in Medicare drug plans, operated by private entities known as “sponsors” (insurers), which pay pharmacies for the beneficiary’s drugs and are, in turn, reimbursed by the Medicare Program.

Creative schemes to bilk the Medicare Program have been rampant. Healthcare fraud and abuse continue to cost the federal taxpayer staggering sums of money and, for that and other important reasons, remain a top priority of federal law enforcement. The federal government, through the United States Department of Health & Human Services/Office of Inspector General (OIG) and other federal law enforcement agencies, utilizes numerous methods to identify, combat and prosecute healthcare fraud. According to the OIG, as of September 20, 2015, $1.8 billion has been recovered by the federal government in healthcare fraud and abuse actions.

ACP Report Considers Patient Care Ramifications of Continued Growth of Concierge and Direct Pay Medical Practices

November 30, 2015 | Little Health Law

doctor The American College of Physicians (ACP) recently released an informative policy position paper that assesses how “concierge” and similar direct pay health care arrangements between doctors and patients impact patient care. Our Georgia business and healthcare law firm follows developments in the healthcare industry that affect physicians, medical practices and other healthcare businesses.

“Direct Pay” refers to an important and evolving alternate payment model and health care arrangement between medical practices and patients. Rather than traditional fee-for-service reimbursement models that render physicians and medical practices dependent upon steerage of patients from insurers or other third-party payers, a typical direct pay contracting model utilizes a flat fee, often paid monthly or annually, which the patient pays out of pocket and “direct” to the doctor (as opposed to through an insurance transaction) to compensate the physician for access to a contractually-agreed menu of health care services. The hallmark of direct pay practices is, for the patient, greater access to the physician and, for the doctor, less red tape and a more rewarding professional experience focused on providing care. Direct pay physicians, of necessity, typically limit the number of patients they see, compared to a traditional, third-party payer based model.

The Eleventh Circuit Court of Appeals: A violation of AKS or Stark Law cannot be used to prove state law claims against a competitor for statutory unfair competition and common law

October 2, 2015 | Little Health Law

1330873_courthouse This litigation involves claims of unfair competition and tortious interference under nine different states’ laws, where the claims are based, in part, upon alleged violations of the federal Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b), and Stark law (“Stark”), 42 U.S.C. § 1395nn(a). Our Georgia business and healthcare law firm follows legal developments in the world of healthcare.

This particular dispute is between Ameritox Ltd and Millenium Laboratories, Inc. These laboratories are competitors in the drug-screening/testing marketplace. Each sells to physician practices and other healthcare providers products and services that facilitate analysis of patient drug use, including point-of-care (POCT) cups. POCT cups are used by physician practices to collect and store urine samples. Additionally, POCT cups contain chemically activated strips that indicate the presence of particular drugs in the patient’s system. POCT cups thereby facilitate “qualitative testing,” informative of patients’ drug use. Such information is very limited, however; it does not, for example, reveal the precise quantity of a drug in the patient’s system. To obtain more meaningful information about the patient, a doctor must send the POCT cup to a clinical laboratory, for “confirmatory testing.” These two laboratories compete for that business.