Little Health Law Blog

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

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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.

Fall Edition (2015), Epic publishes Lee Little’s article, Georgia Certificate of Need Law Facing Multiple Challenges.

December 1, 2015 | Little Health Law

Epic, the magazine of the Georgia College of Emergency Physicians, publishes Lee Little’s article, Georgia Certificate of Need Law Facing Multiple Challenges in their Fall issue.

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.

ACA Open Enrollment Season: Answers to Consumer Frequently Asked Questions

November 16, 2015 | Little Health Law

1084630_question_mark_1 Open Enrollment Season for federal and state exchanges offering insurance coverage in the “Health Insurance Marketplace” for 2016 began this month, and will run through January 31, 2016. During this period, individuals may newly enroll with, renew or change their health insurance plans or providers. In fact, more than 543,000 people have already obtained coverage in the Marketplace during the first week of open enrollment for 2016. Thirty-four percent of those were new consumers, per a report by the federal Centers for Medicare and Medicaid Services.

According to an article published by “Shots,” the online channel for health stories from the National Public Radio Science Desk, the occasion of Open Enrollment Season has prompted many consumer questions about details of enrollment and available marketplace plans, including the impact of high deductible plans; options in obtaining in- and out-of-network health services; and confronting cost increases in marketplace health plans.

Some guidance provided in response to consumer questions are as follows:

HHS Lauds Savings Opportunities Available to American Consumers with ACA November 1, 2015 Open Enrollment

October 31, 2015 | Little Health Law

The United States Department of Health & Human Resources (HHS) is promoting what it styles as “affordability and choice” in the Health Insurance Marketplace used by US consumers to buy health insurance mandated by the Affordable Care Act (ACA). Tomorrow, the Open Enrollment Period for shopping health insurance coverage within the Health Insurance Marketplace begins. In a 33-page report, entitled “2016 Marketplace Premium Landscape Issue Brief 10-30-15 Final,” issued yesterday, HHS indicates that the ACA is “continuing to promote competition, choice and affordability in the Marketplace for plan year 2016.”

Atlanta/Augusta Georgia Business and Healthcare Law Firm

As new and prior enrollees weigh options available in the Health Insurance Marketplace to determine what insurance plans may best suit their needs and resources, they should consider the “premiums, deductibles, out-of-pocket costs, provider network, formulary, and customer service” particulars of the various plan options, according to the report. The HHS report outlines “Key Findings,” which include those summarized as follows:

The ACA promotes access to affordable health insurance plans
Shopping saves money: about 86 percent of enrollees “can find a lower premium plan in the same metal level before tax credits by returning the Marketplace to shop for coverage.
About 72 percent of current enrollees can find a plan for $75/month, or less, after factoring tax credits.
About 57 percent of current enrollees can find a plan for $75/month or less within their metal level.
Next year, a 27-year-old with $25,000/year income will on average receive an annual tax credit of $1,164, compared to $972 this year. A family of four with an income of $60,000 will on average receive an annual tax credit of $5,568, compared to $4,848 this year.
The average consumer has 10 insurance issuers in his/her state. On average, enrollees can pick from 5 issuers for coverage next year.

Prosecutors Investigate Pharmaceutical Drug Pricing Practices

October 16, 2015 | Little Health Law

Exorbitant inflation of the price of prescription medication is a lingering concern for U.S. patients unable to afford to pay for the medication they need. According to a 2013 study by Walgreens, four out of ten senior citizens delay prescription refills or skip doses to save money.

The recent dramatic price increases of certain specialty pharmaceutical drugs has prompted recent action by federal prosecutors, according to articles by MSN and the Wall Street Journal.

The MSN article notes that two pharmaceutical companies: Valeant Pharmaceuticals International and Turing Pharmaceuticals, described as among the “worst offenders” in so-called drug “price gouging” received formal requests from prosecutors investigating their drug pricing and other business practices. This action followed a Congressional hearing last summer addressing Valeant’s price increases of Isuprel, a drug used to treat cardiac arrest, and Nitropress, a blood pressure drug. The cost of Isuprel increased more than 600%, from $215 to over $1,300, while the cost of Nitropress increased more than 300%, from$257 to just over $800 per vial. Turing made waves last summer when it purchased the marketing rights to Daraprim, used to treat an infection that can be life threatening in infants and patients with diseases such as AIDS and cancer, raising the price of the 60-year old drug from $13.50 to $750 a pill. Responding to public criticism, its CEO, Martin Shkreli, agreed to lower the price of the medication, but never did so.

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.

Will Employee Flexible Spending Accounts Be Eliminated Under Looming ACA Tax?

September 14, 2015 | Little Health Law

dark-dollar-2-1193021-m Many employers planning ahead as to their employee health benefit plans are considering modifying or eliminating employee flexible spending accounts (FSAs), according to an article this week in the Atlanta Business Chronicle. The Affordable Care Act (ACA) will begin to tax high-cost employer health insurance at 40 percent on benefits over a set threshold in 2018. The Chronicle notes that numerous other news sources have cautioned that this upcoming tax, known as the “High Cost Plan Tax” or “Cadillac Tax,” will cause employers to rethink their offering of employee FSAs, with some employers capping the amounts their employees may place in the accounts, and other employers eliminating FSAs altogether. See Wall Street Journal article; Politico article; Healthline article. The intent behind the ACA’s Cadillac Tax was to discourage employers from offering premium health insurance plans that drive up healthcare costs and to generate revenue to help pay for coverage of the uninsured.