Little Health Law Blog

Medical Practice Compliance 101

February 18, 2014 | Little Health Law

Patients tend to see physicians only as providers of care — meeting their medical needs. The reality is that a physician’s efforts to stay compliant with regulations and laws may consume as much or more time than actually rendering care. With consequences for regulatory violations ranging from financial to criminal, compliance is a subject of the utmost importance for any physician practice.

The best way to avoid penalties is to have a serious compliance program in place to prevent, detect, and respond to any possible violation. With regulations always changing on both a federal and state level, especially now with the implementation of the Affordable Care Act (ACA), having a compliance program in place is critical. The benefits of creating an effective compliance program range from better sleep, higher ethical standards, satisfying government auditors and regulators’ requirements, and ensuring that business operations align with proper legal protocol. Given all the possible problems that may derive from doing otherwise, the absence of a strong compliance program invites problems.

To create an effective compliance program, physicians must first understand that there is no one-size-fits-all model. Compliance programs must be adaptable to each practice’s unique structure, services, and personnel. An experienced consultant and/or healthcare attorney should be considered to help set up or review the program and minimize particular risks applicable to your specific type of practice. You must also keep in mind that an effective compliance program will require time and resources to set it up properly and to modify it as needed to adapt to changes in our regulatory environment.
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An Ounce of Prevention: Identify and Mitigate HIPAA Compliance Issues to Avoid Costly HIPAA Penalties

December 31, 2013 | Little Health Law

An unencrypted thumb drive cost a dermatology practice $150,000. On December 26, 2013, the U.S. Department of Health & Human Services (HHS) announced a settlement with Adult & Pediatric Dermatology, P.C. of Concord, Massachusetts (APD) of alleged violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). APD, a “covered entity” for HIPAA purposes, has offices in Concord, Westford, Marlborough, and Ayer, Massachusetts, and Wolfeboro, New Hampshire.

The thumb drive contained unsecured electronic protected health information (ePHI) relating to the performance of Mohs surgery for about 2,200 patients. The thumb drive was stolen from the vehicle of one of APD’s employees. APD informed its patients of the theft of the thumb drive and provided a media notice.

HHS investigated and determined that APD did not timely conduct an accurate and thorough analysis of the risks associated with potential exposure of the ePHI. HHS also determined that APD did not fully comply with the administrative requirements of HIPAA’s breach notification requirements to have written policies and procedures and train employees regarding breach notification requirements. HHS also determined that APD disclosed ePHI in violation of HIPAA by the access gained to it when APD did not reasonable safeguard an unencrypted thumb drive.

HHS fined APD $150,000 and required APD’s execution of a Corrective Action Plan. The Corrective Action Plan requires APD to develop a comprehensive risk analysis and risk management plan to ensure future compliance with HIPAA and to periodically report to HHS the status of APD’s implementation of the plan. HHS released its right to take further action against APD, conditioned upon full compliance by APD with the Corrective Action Plan. See HHS Resolution Agreement.
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The Affordable Care Act Will Enhance Direct Practice Medicine Opportunities

December 28, 2013 | Little Health Law

The Affordable Care Act (ACA), widely known as “Obamacare,” will create new opportunities for primary care doctors (and some specialists) who weigh starting or converting to a direct primary care model. At first blush direct care medicine practices, also known as “concierge,” “boutique” and “retainer-based” practices, which charge patients a monthly or annual membership fee and tend to exclude (or limit) third party payer involvement (one of the strong points for pursuing the model), would seem limited as an opportunity by the ACA’s objective of getting everyone “insured.” But the opposite may prove to be the case. Actually, the ACA may drive a strong need for new concierge medicine doctors.

A New Era of High Deductibles

While a stated goal of the ACA is to decrease the number of uninsured Americans, a consequence of the ACA will likely be that many newly insured patients under plans obtained via the new insurance exchanges will soon realize that due to very high deductibles, much or all of the costs of treatment (i.e., all non-preventive care) incurred over the course of a year must be paid out of pocket by the insured. For a typical household in Richmond County, Georgia, for example, as of this writing there are 18 plans available via the exchanges: 7 “Bronze Plans,” 6 “Silver Plans,” 4 “Gold Plans,” and 1 “Platinum Plan.” For the Bronze Plans, the annual deductibles range from $4,000 to $6,300. It is widely expected that most people will seek to minimize their premiums and opt for one of the Bronze Plans, only two of which have annual deductibles of less than $5,000.

What will that mean? That will mean most doctor visits (excluding preventive care) will be paid out of pocket by the “insured” patients who presently may not realize what is in store for them by way of doctor bills. As the public becomes aware of how the ACA will actually work for them (i.e., even though they are “insured” they are writing checks for doctor bills), the appeal to consumers of concierge options will increase. As recently reported in the Wall Street Journal, “People with deductibles of $5,000 or more should think about how many times a year they typically see the doctor and for what, keeping in mind that annual checkups are free under the ACA. If doctor visits typically cost $150 and the patient has six appointments a year, a concierge practice offering the same services for $40 or $50 a month might be cheaper.” Pros and Cons of Concierge Medicine (November 1, 2013).
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Don’t Work for Free: Obtaining Timely Physician Reimbursement

November 28, 2013 | Little Health Law

Nobody likes to work for free. Physicians and other healthcare providers are frequently at risk of non-payment for valuable services to patients due to third-party payer mistakes and/or attempts to arbitrarily delay, reduce or avoid reimbursement. A common practice of payers is, for example, to deny reimbursement based on an allegation that the provider did not submit correct paperwork or alleged improper coding. Another tactic of third third-party payers is to simply adjust a payment downward because the payer concludes the physician is entitled to less reimbursement based on what was paid on a prior, “similar” claim. Reimbursement issues have led 49 states to enact laws to address such problems. Unfortunately, State laws only mildly abate the problem for healthcare providers.

Action that a healthcare provider can take to address payer abuse often depends largely on the State in which the provider is located. Some states allow physicians to take direct court action against a third-party payer with regard to reimbursement issues. Other States require providers to appeal to their insurance regulatory agencies to take action against a payer for any prompt pay issues, or similar exhaustion of administrative remedies. A regulatory agency may investigate and take action against a third-party payer. Provider options may also be affected by whether a State’s prompt pay laws are preempted by the Employee Retirement Income Security Act (ERISA), which provides its own remedies in some circumstances.

Steps physicians can take to protect reimbursement revenue and reduce the chance of disputes with payers include:

Read every word in your payer-physician contract: Pay close attention to the language used in the contract and the terms and conditions. Are the policies and procedures affecting payment clearly laid out? Does the language include a requirement for the payer to submit advance notice of any modifications to payment? Does the contract clearly define what is considered a “clean claim”?

Don’t procrastinate: In submitting claims, believe Murphy. Allow your practice more than enough time to submit a claim to a payer. You never know what delays, issues, or human errors could give a payer the opportunity to contend your claim was late or submitted incorrectly.

Breaking Up is Hard to Do: Dividing Medical Practice Assets

November 28, 2013 | Little Health Law

Ending a professional relationship is not easy for anyone. But the demise of a healthcare business relationship among doctors often involves more risks, greater headaches, and more issues to tackle than non-healthcare businesses. Dividing up medical business assets is, for example, much more complex and involved than simply drawing a line down the middle of the office. Federal laws and regulations affecting healthcare providers pose significant business risks and adverse legal ramifications where the division of assets is not done properly. If you and other physician owners are leaving a practice, it is critical to ensure any division of big ticket items — e.g., medical equipment leases, practice branding, and electronic health records – is done in a legally compliant manner.

Most often, medical equipment in physician practices is leased. The leased status creates potential complications if multiple owners want a particular item or if, on the other hand, no one wants the accompanying financial obligations. Whichever side of the coin your practice breakup falls on, medical practice owners should take into account the depreciating value of the equipment when determining the division of assets. Sometimes, outstanding liabilities or personal guarantees that equipment may be subject to are mistakenly overlooked in the process of dividing assets. The division process should begin with an experienced consultant who can aid in the necessary number crunch and ensure fair and balanced allocation of value and financial responsibilities that attend leased equipment assets.

While a practice’s name and brand may not be easy to value with precision, the inherent value should be weighed and factored into the division of assets. As with any business, the reputation of a brand or identity is a key to success. A medical practice’s good reputation carries critical patient confidence, which is a valuable asset for any practitioner. When physicians choose to work in the same field and geographic area, the division of such an asset is problematic and may raise difficult business and legal issues.
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Letters of Intent: Framing the Sale/Purchase of a Medical Practice

November 27, 2013 | Little Health Law

The parties have talked in abstract terms and danced. There seems to be a deal in the making. Negotiating the particulars of a written purchase agreement for the sale/purchase of a medical practice – the real test to see if you have a deal — is time consuming and potentially expensive. Before you dive into that process, you want to know you have a deal and its specific parameters. A letter of intent is the tool that allows you to do just that. A letter of intent is, generally speaking, a non-binding way to see if you have a deal and establish a framework for the more involved process of negotiating a purchase agreement.

After initial discussions and meetings, the letter of intent is the first opportunity to commit specific thoughts and ideas to writing and bring the parties closer to committing. The letter of intent should set forth basic points of agreement that the seller and buyer want to cover in the purchase agreement. The shift from abstract talk to written words helps focus the parties on true terms and consideration, to see if they really want to commit. Once the basic terms of the deal are established by a letter of intent, the parties can more easily and with greater efficiency transition to the process of preparing a complete purchase agreement.

The letter of intent should cover all of the basic terms, including price and payment. Will the purchase price be paid in full at closing or paid in installments? If the payment will be made in installments, with what payment schedule, interest rate and security? The letter is also an opportunity to specify who is responsible for payment of expenses associated with the transaction. Usually, the seller and buyer are responsible for their own professional fees. There are instances when one party agrees to pay all or a portion of the other party’s expenses, however. Such details should be covered in the letter of intent.
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Good Physician Recruitment Agreements

November 27, 2013 | Little Health Law

The amount of attention that physician recruitment receives from government eyes warrants recruitment agreements that are, ideally, airtight. So, what are key criteria for a physician recruitment agreement that is compliant and will work for both parties? There are many important elements of a good physician recruitment agreement, including the following.

First, it is vital to show that a community need exists for the doctor’s services. A specific need for the physician’s specialty area or an opportunity to lower costs and improve access to care in that community, demonstrated with proper evidence (such as statistical or demographic studies), can lend strong support a physician recruitment agreement. It is a good idea to hire a third party to analyze supply and demand for specialties in the local community. Additionally, the recruitment agreement itself should spell out the need and demonstrate that an objective of the agreement and relationship is to serve community interests.

A hospital can provide subsidies to the physician for working in the local area such as reduced rent, a traditional net income guaranty, and payment of malpractice insurance premiums. No matter what type of benefits the hospital provides, however, the physician should sign a promissory note that requires repayment of all subsidies from the hospital. Generally speaking, this repayment obligation can only be waived if the physician remains in the local area for a period of two to three years after the end of the guaranty period. The waiver is to ensure the community’s need for that physician is effectively met through the recruitment agreement.

Any guaranty payments made to a group that employs the physician rather than to the physician directly should be with caution in light of the STARK Law, to avoid perceived abuse. Any portion of the guaranty payment made to the physician’s group that is not returned to the recruited physician must be accounted for. The physician group can only retain portions of the payment that directly go to additional expense that attends addition of the new physician. No portion of the guaranty payment can be withheld to pay for existing overhead costs that the medical group already incurs. For example, the medical group employing the physician cannot charge its rent costs to the new physician when he or she did not cause any increase to the expense. Both the hospital and practice should keep careful records that show what formulas are used to calculate the payment amount in order to prevent the use of expenses for preexisting medical group expenses.

Any formulas used for calculating the payments to the physician should be very specific. Avoiding vague language in the agreement will reduce the likelihood of disputes. The agreement should specifically state the salary, what expenses are included in the guaranty, and whether the collections of the recruited physician will be reconciled monthly or quarterly. Taking proper care of these specifics will reduce the chance of disputes and unnecessary headaches in calculating payments.
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THE INEVITABLE CHOICE for many primary care doctors: Direct Primary Care, a/k/a Concierge Medicine

October 12, 2013 | Little Health Law

Many doctors feel the involvement of an insurance company or other third party payer in the practice of medicine is a source of headaches for their medical practice. Nothing on the horizon seems to indicate that red tape, administrative burdens, and an arbitrary manner by which some insurers and other payers decide when and how claims get paid will abate. There seems to be no chance that a third party payer’s involvement in the practice of medicine will make rendering patient care better and easier. So what should doctors do to make a happy living providing care? How can patients afford and get the care and attention they need to protect their health?

The inevitable choice for many primary care doctors (and patients) is direct primary care, or “concierge” medicine. The driver of this model is obvious: no more insurance company (or, at least, a lot less third party payer involvement in medical practice). For consumers, concierge plans are no longer just for the wealthy, but are affordable for most individuals and families. For a direct monthly fee, often less than a cell phone bill, “members” get personalized, ready access to a doctor who can take the time to get to know them and help them stay healthy. Primary care physicians will see concierge medicine grow as an opportunity in coming years, particularly with the unavoidable commotion and difficulties the Affordable Care Act (ACA) will cause all providers and patients as myriad struggles in ACA implementation unfold.

Primary care doctors that get serious about evaluating a concierge business model will also realize, however, that this business model presents particular legal pitfalls that must be carefully dealt with to ensure the viability of the business over the long term. Some potential issues to be considered and addressed, for example, concern:

– the unlicensed practice of medicine in states where the “treating” doctor does not have a license (if, for example, the doctor is consulting by email with a patient who has moved his residence)

– compliance with HIPAA privacy and security rules in a practice that relies more heavily upon electronic communications Continue reading ›

Health Services Company Owners Plead Guilty to Healthcare Fraud

September 21, 2013 | Little Health Law

On September 5, 2013, owners of Trust Care Health Services, Inc. (Trust Care) pled guilty in a Florida federal court to federal healthcare fraud charges. Roberto Marrero, Sandra Fernandez and Enrique Rodriguez, owned and operated Trust Care. Trust Care was a Florida corporation, incorporated in 2005 that did business as a home healthcare services business in the Miami and South Florida area. Trust Care provided home health and physical therapy services to Medicare beneficiaries.

Trust Care was an authorized Medicare provider, approved to submit claims to Medicare. The Government’s allegations of Medicare fraud were based on the Government’s contention that physical therapy and home health services were billed to Medicare but not medically necessary, or not provided, or both.

According to the indictment, the defendants and co-conspirators paid patient recruiters to provide Trust Care with patients to whom defendants sold healthcare services that were not medically necessary and/or not provided. Kickbacks and bribes were also paid to obtain for Trust Care prescriptions, medical certifications and other documents needed to facilitate the scheme. Specifically, the government alleged:

It was the purpose of the conspiracy for the defendants and their conspirators to unlawfully enrich themselves by: (1) paying and accepting kickbacks and bribes for referring Medicare beneficiaries to Trust Care so that their Medicare beneficiary numbers would serve as the bases of claims filed for home health care; and (2) submitting and causing the submission of claims to Medicare for home health services that the defendants and their conspirators purported to provide to those beneficiaries.

Indictment, para. 3.
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WILL THE AFFORDABLE CARE ACT BE AFFORDABLE FOR EMPLOYERS?

August 31, 2013 | Little Health Law

The price Americans will pay for Affordable Care Act (ACA) changes may include lost wages and job benefits due to the price tag of ACA compliance for employers. It may seem to many like a good and noble thing to require insurers to insure everyone irrespective of health conditions and the attending financial risks and costs the insurer must assume; to make all individuals buy health insurance, irrespective of whether they want or need it; and to force employers to provide what the government decides says is the right kind of health insurance to employees. But nothing is free or without consequence, especially sweeping legislation intended to overhaul healthcare. Unfortunately, while the ACA will undoubtedly benefit many Americans, the true costs of the ACA will prove unaffordable for many employers and likely result in lost wages and job benefits for many Americans.

For example, the University of Virginia and United Parcel Service recently informed employees that it would no longer offer healthcare coverage to employee spouses able to obtain insurance from other sources. UVA announced what it described as “major changes” in their health plan options to employees and explained the changes were necessary based on UVA’s projections that the ACA will result in $7.3 million in additional costs associated with its health plans in 2014 alone. UVA is attempting to defray the cost of complying with the ACA by cutting health benefits to many spouses. UPS indicated that costs of complying with the ACA contributed to its need to drop spouse coverage, which will affect as many as 15,000 employees. UPS explained that due in part to the ACA, it is “increasingly difficult to continue providing the same level of health care benefits to our employees at an affordable cost.” Other employers have limited non-management workers’ hours to 29.5 for the purpose of circumventing ACA requirements that are triggered by having 50 or more “full time” employees (i.e. 30 hours or more, under the ACA). For example, Forever 21 recently announced to its employees that effective August 31 they would not be full-time employees.
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