The United States Department of Health and Human Resources (HHS) and the United States Department of Justice (DOJ) recently issued a joint annual report for 2016 (the Report) providing details about the federal fraud and abuse program and, in particular, annual financial recoveries. Fraud and abuse law enforcement efforts continued to be a top priority for the Federal Government and an important means of defraying the rising costs of our nation’s healthcare delivery system. According to the Report, the Federal Government obtained over $2.5 billion in additional revenue in 2016 by way of health care fraud judgments and settlements.
The US Department of Health & Human Services (HHS) says that it cannot meet the requirements of a federal court order to reduce the horrible backlog of Medicare appeals cases that for many years has plagued the United States and adversely impacted the ability of health care providers to be paid. The problem has been under scrutiny for some time, and the US General Accountability Office (GAO) has outlined in a report various inefficiencies to which the GAO attributes the problem. Health care providers in many instances are completely unable to, in a timely manner, vindicate their claims in Medicare appeals. Nevertheless, HHS contends that it needs more money from Congress to fix the problem.
In a case styled Am. Hosp.Assn v. Burwell, D.D.C., No. 14-cv-851, the United States District Court for the District of Columbia entered a recent Order wherein the Federal Court set annual backlog reduction targets of 30, 60, 90 and 100 percent over the next four years. In the case, the American Hospital Association and affiliated entities requested that the United States District Court compel HHS to adjudicate pending Medicare-reimbursement appeals in compliance with statutory deadlines. As explained in the Order, hundreds of thousands of appeals have languished in a terrible backlog. In the case, HHS contended that mandamus (i.e., a Court-ordered solution) was not necessary and that HHS would, eventually, resolve the issue. The Plaintiff, however, contended that a Court-ordered (and enforceable) time table for a solution was required in light of HHS’ failure thus far to fix the problem. The Plaintiff proposed the following timetable for reduction of the backlog:
Credentialing is used to evaluate physicians for different purposes and is required of almost all physicians. It is utilized by hospitals when evaluating physicians for medical staff positions and hospital privileges and when enrolling in health insurance plans as a participating provider. Unfortunately, this process has not been streamlined and can be very time consuming and complex.
Provider credentialing is meant to verify experience, expertise, and willingness to provide medical care. It is often a complex, ongoing process that can take several months to be completed and approved and is an administrative hassle for employers, insurance companies, and physicians. While credentialing was historically just proof of licensure, modern credentialing goes far beyond proof of diploma and license.
Earlier this month, the United States General Accounting Office (GAO) issued its monthly anticipated report (the Report) to Congress about the status of the Medicare Appeals backlog. The Report states on the first page, “Opportunities Remain to Improve Appeals Process,” which is a gross understatement and will likely be received with frustration by unpaid providers. At least it appears the backlog is on Congress’ radar and someone is trying to do something to improve this very difficult problem that adversely impacts so many providers.
Vitreo Retinal Consultants of the Palm Beaches, P.A. (VRC) sued the U.S. Department of Health and Human Resources (HHS) to recover payments it made to Medicare, having previously refunded the payments to Medicare based on Medicare’s notice of overpayment. The Eleventh Circuit affirmed the decision of the U.S. District Court, which upheld the administrative decision supporting Medicare’s overpayment notice. The ophthalmologist/owner of the VRC was indicted and charged with 46 counts of healthcare fraud, according to a Department of Justice press release.
Georgia Medicare Reimbursement Attorneys
VRC treated Medicare patients who suffered from age-related macular degeneration (AMD) and similar retinal diseases with intravitreal injections of Lucentis, a Medicare Part B drug approved by the FDA. There was no dispute in the case that the drug was medically reasonable and necessary for treatment of AMD. However, the FDA labeling instructed that the full contents of the 2.0-mg vial be injected into a syringe for purposes of injecting a single 0.5-mg dose of Lucentis into the patient’s eye once a month. The label clearly stated that “[e]ach vial should only be used for the treatment of a single eye.” VRC did not follow the labeling instructions; rather, it treated up to three patients from a single vile.
Based on applicable Medicare reimbursement rates, if administered as per the FDA label, a physician would inject 0.5 mg into the patient’s eye, dispose of 1.5 mg, and receive reimbursement in the amount of approximately $2,025, the average total cost of the vial. VRC would bill Medicare $2,025 for every 0.5-mg dose it administered, however, and be reimbursed $2,025 for every dose. Since VRC would get up to three doses from a single vial, it was reimbursed up to $6,075 per vial, about three times the allowed reimbursement.
Medicare’s contractor issued a preliminary overpayment determination of $8.9 million. Reconsideration was denied and the overpayment determination was upheld by and administrative law judge and the Medicare Appeals Council. VRC filed suit, and the US District Court deferred to the agency decision.
The U.S. Centers for Medicare & Medicaid Services (CMS) recently finalized a final rule to effectuate the federal government’s ability under the Affordable Care Act (ACA) to recover self-identified overpayments, applicable to Medicare Parts A and B. CMS’ implementing overpayment rule is the latest sword in the government’s formidable arsenal to combat fraud and abuse with regard to healthcare reimbursement under federal programs. Physicians and other healthcare businesses and suppliers should take heed, as they will be subject to considerable potential financial liability and professional risks for noncompliance with the new overpayment rules. Our Atlanta/Augusta business and healthcare law firm follows developments in healthcare fraud and abuse laws.
New Teeth for ACA Fraud and Abuse Provisions
Section 6402 of the ACA requires physicians, healthcare providers and suppliers, managed care plans, and other groups to self-report and refund to the government any Medicare or Medicaid overpayments by the latter of 60 days from the date the overpayment is identified or the date any corresponding cost report is due. The failure to do so subjects the offending party to civil monetary penalties and exclusion from all federal healthcare reimbursement programs. Additionally, according to the new overpayment rules, the retained overpayment is an “obligation” under the False Claims Act (FCA), subjecting the violator to all the financial consequences that attend FCA liability. The new rule is part of CMS’ final regulations to implement the ACA’s requirements with regard to overpayments as concerns Medicare Part A and B.
CMS recently announced what it describes as the largest-ever multi-payer initiative to improve primary care in America,” known as Comprehensive Primary Care Plus (CPC+). Though much of the press release is couched in terms of improving patient care — and surely CPC+ is intended to do so — the real impetus appears to be the government’s critical need to control healthcare costs funded by federal programs.
Atlanta/Augusta, Georgia Physician Practice Lawyers
The idea is to support a new primary care delivery model that will incentivize and reward value and quality. The current Administration’s goal is to have 50% of all Medicare fee-for-service payments made via alternative payment models by 2018. The Center for Medicare and Medicaid Innovation, which exists pursuant to Section 1115A of the Social Security Act (added under the Affordable Care Act) for the purpose of testing new payment and service delivery models, developed CPC+ as part of its mission, to aid the federal government in its efforts to curb its healthcare costs and enhance the quality of healthcare delivery.
For several years, hospital administrators have been adjusting to changes in federal rules for calculating patients’ unpaid medical bills into hospital Medicare reimbursement.
The federal government provides funding to hospitals that treat indigent patients under so-called “Disproportionate Share Hospital (DSH) programs,” which provide partial compensation to facilities based on a formula. Many of the roughly 3,100 hospitals receiving DSH payments are teaching hospitals or those in large urban areas.
The Patient Protection and Affordable Care Act changed the formula for calculating DSH payments in fiscal year 2014, significantly reducing the share hospitals received, with goals of reducing funding for the Medicare DSH payments initially by 75 percent and subsequently increasing payments based on the percent of the population uninsured and the amount of uncompensated care provided; and to reduce the Medicaid DSH program by $18.1 billion by 2020.
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.
More than ever, physician innovation is needed in business models for medical practices to deal with problems associated with our cumbersome third party payer healthcare system. Our Atlanta health care law firm supports direct pay practice medicine as a positive trend. Many doctors are now setting up direct pay (a/k/a “concierge”) medical practices. This practice model in its purest form eliminates third party payers, and the patient-“member” of the concierge plan pays a fixed, prepaid fee for a menu of physician services that typically offer the patient greater access to the doctor. Varying hybrid concierge models exist that include some limited use of insurance plans. Direct Pay practices will likely continue to emerge and flourish as doctors seek smart business alternatives to deliver care in spite of a challenging regulatory and third-party payer healthcare environment.
For patients, belonging to a concierge practice usually means more access to and time with a doctor who really gets to know them and increasingly with flexible, affordable financial options to suit individual needs. For doctors, direct pay practice models can offer handsome compensation and desired relief from the medical hamster wheel of having to see a patient every six minutes to make reimbursement numbers work, with all the red tape and other burdens that attend having to spend too much time dealing with insurance companies. So what is the downside to a direct pay practice?
There are many legal and business issues unique to health care that confine doctors in how they set up a medical practice. These issues must be carefully evaluated to ensure medical compliance and avoid unpleasant business issues down the road. Although policy makers have not created direct restrictions prohibiting the concierge practice model, for those physicians who want to start or convert to this model, many legal considerations warrant caution and special care in setting up the business. Medicare presents a strong example. Doctors that accept Medicare reimbursement can either accept assignment and bill Medicare directly for their services or seek payment from the patient (who, in turn, seeks reimbursement from Medicare). Physicians can execute “participation agreements” with Medicare and receive greater reimbursement (5%). However, Medicare participating doctors cannot charge more than what is allowed by the Medicare fee schedules. Non-participating doctors who do not accept assignment cannot charge more than 115% of applicable amounts in the Medicare fee schedules. Violations of Medicare assignment rules can be prosecuted under the federal False Claims act.