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Articles Posted in Health Law News

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In its recent Advisory Opinion No. 17-05, OIG stated that the Proposed Arrangement (“Arrangement”) would not violate the anti-kickback statute (“AKS”) nor would it prompt administrative sanctions under the Civil Monetary Penalties (“CMP”) provision of the Social Security Act, prohibiting inducements to beneficiaries.

The Proposed Arrangement discussed in the Opinion centers around a retail pharmacy chain offering a voluntary membership program to Federal healthcare program beneficiaries that includes discounts on certain prescriptions and clinic services.

OIG further noted that Program Members receiving discounts would also be eligible to earn rewards in the form of credits when certain merchandise in-store photo-finishing services were purchased. On its face, the Arrangement would appear to invoke prohibitions of the CMP and AKS, since the discounted items and services and earned credits could induce a beneficiary to select the retail pharmacy chain as his or her supplier for federally reimbursable items or services.

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Home Health Agencies will now have an additional 6 months to comply with a new CMS rule intended to advance the quality of patient care.

CMS published a final rule on July 10th delaying the effective date for its rule addressing conditions of participation for home health agencies. CMS has moved the effective date of the rule back 6 months from its original July 13, 2017 to January 13, 2018. This delay pushes back the implementation of regulations primarily focused on improving patient quality of care.

Under the new rule Home Health Agencies are directed to begin implementing data-driven performance improvement projects. These data-driven programs are concentrated on quality assessment programs targeting indicators related to improved outcomes for patients and other quality indicators across the home health spectrum of care. This quality program requirement is now set to phase-in on July 13, 2018 instead of January 13, 2018.

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The Health Law Partners (HLP) is proud to be part of the upcoming Physician Legal Issues Conference co-sponsored by the American Bar Association Health Law Section and Chicago Medical Society.  The conference will take place at the Intercontinental Hotel in Chicago on June 8-9, 2017.  Adrienne Dresevic, Esq., a founding partner of the HLP, is Co-Chairing the conference this year.  Abby Pendleton, Esq., a founding partner of the HLP, will be a featured speaker at the conference. Ms. Pendleton’s speech is titled, Your Practice is Being Audited: Complying, Fighting and Winning. Her session addresses key issues when facing an audit including: appeals processes and auditors’ concepts, considerations affecting the decision to appeal, successful strategies for appeals, and using the audit to enhance future compliance. Attend the conference to learn the latest on health reform, payor alignment, clinical integration, and other issues that impact the legal profession. Programming includes topics such as: Stark Law, Health Reform, Anti-Kickback, and more!

 

To the view the brochure with program details please click here.  To register for the conference please click here.

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Compliance programs are mandatory (pending final regulations) for all health care organizations post-Affordable Care Act. In some states, and for some provider/supplier types, compliance programs are already mandatory. In any event, compliance programs in health care organizations are crucial in today’s overregulated environment, with qui tam attorneys, whistleblowers, regulators, and payors seeking any potential excuse to recoup.

Compliance programs work as a set of internal controls that assist in preventing, detecting, and resolving illegal or unethical conduct/errors that may take place. In order to ensure compliance with all appropriate laws and regulations, radiology providers and suppliers should implement compliance programs that at a minimum meet all laws and regulations.

The elements of effective compliance programs are relatively straightforward and known. However, many organizations struggle to implement, execute, measure, and evaluate their compliance programs.

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On March 6, 2017, House Republicans released the much-anticipated American Health Care Act (“AHCA”) bill that would effectively replace the Patient Protection and Affordable Care Act (the “ACA”), which is currently responsible for covering approximately 20 million individuals through a combination of health insurance offered through state-based and federally-run Exchanges and the expansion of healthcare coverage.

One of President Trump’s policy promises has been that “On day one of the Trump Administration, we will ask Congress to immediately deliver a full repeal of Obamacare.” Now that President Trump is in office, and Republicans control the legislative branch of the government, members of Congress are actively working through the legislative process to repeal and replace the ACA.

In fact, the AHCA passed by the House Energy and Commerce Committee and the House Ways and Means Committee on March 9, 2017 and passed the House Budget Committee on March 26, 2017.  The AHCA is proceeding to the Rules Committee, which will set the terms of the debate before the bill goes to the full House.  Upon passage by the House, the bill will move to the Senate under budget reconciliation rules.

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The OIG issued a Policy Statement regarding Gifts of Nominal Value to Medicare and Medicaid Beneficiaries.

Under section 1128A(a)(5) of the Social Security Act (the Act), enacted as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of Medicare or Medicaid payable items or services may be liable for civil monetary penalties (CMPs) of up to $10,000 for each wrongful act. For purposes of section 1128A(a)(5) of the Act, the statute defines “remuneration” to include, without limitation, waivers of copayments and deductible amounts (or any part thereof) and transfers of items or services for free or for other than fair market value. The statute and implementing regulations contain a limited number of exceptions.

Prior to issuing this Special Advisory Bulletin, the OIG interpreted the prohibition to permit Medicare or Medicaid providers to offer beneficiaries inexpensive gifts (other than cash or cash equivalents) or services without violating the statute in a 2002 Special Advisory Bulletin.  For enforcement purposes, inexpensive gifts or services were said to be those that have a retail value of no more than $10 individually, and no more than $50 in the aggregate annually per patient.

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Private practitioners who wish to remain independent, but who are struggling to survive because of decreased third-party reimbursements and increasing overhead expenses, are being aggressively courted by various business entities that will analyze-often for free-whether the concierge model of medicine, or some variation thereof, might add significant profitability to the practice’s bottom line.

The earliest concierge models generally required patients to pay an annual membership fee in order to receive enhanced accessibility to their physician. In return, the physician would agree to limit his patient base to, say, 600 patients. In this way, the physician would conceptually be able to spend more time with each individual patient, yet still maintain (if not increase) his historic revenue stream. This meant that those patients who chose not to participate in the physician’s new concierge program would be required to leave the practice in order to find another physician to care for their healthcare needs.

In the past, many patients who have been approached to transition to a physician’s concierge practice chose not to do so because they did not perceive that the enhanced accessibility to their physician was worth the cost of the annual membership fee. Oftentimes, they were already able to get same day or next day appointments, and prompt return phone calls from their doctor so, the thought went, why pay all that money? What does one get in return?

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Medicare has developed a new incentive payment framework (“MACRA”) which is intended to fundamentally change the way in which the Federal Government evaluates and pays for the healthcare services that are provided to Medicare beneficiaries. It is designed to move us away from a volume-based “fee-for-service” reimbursement system to one which emphasizes the quality of the care provided. The new reimbursement program is scheduled to begin on January 1, 2017.

To avoid penalties and qualify for bonuses under MACRA, physicians must participate in the new Merit Based Incentive Payment System (MIPS, for short) unless they have a substantial amount of their revenue at risk under a qualifying alternative payment model (“APM”) — and the vast majority of physicians do not.

Physicians were supposed to start reporting performance data next year, and many complained that smaller practices in particular wouldn’t be ready. The framework calls for them to choose from an array of measures in four categories: 1. quality; 2. resource use; 3. clinical practice improvement; and 4. meaningful use of electronic health records.

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The California state legislature passed a bill that will prevent unexpected out-of-network medical bills.

The bill declares that patients who receive non-emergency care in in-network facilities would only have to pay in-network cost sharing. This would eliminate surprise billing from out-of-network claims. Suitable provider networks will also be more strictly demanded of health plans. A similar law has been in effect in New York for more than a year, and has shown promising results. Many consider it to be a fair compromise between hospitals, doctors, and plans. Florida has also passed a comparable law, and numerous other states are discussing legislation on the issue.

Jerry Brown, the Democratic Governor of California, is expected to sign the bill. The passage of this bill in California may spur other states to pass similar legislation.

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The U.S. Senate Committee on Finance released a whitepaper, which addresses proposed reforms of the Stark law (which prohibits physicians from referring Medicare beneficiaries to an entity in which they have a financial relationship for designated health services).

The whitepaper asserts that support for reform of the Stark Law has grown tremendously in recent years, especially since the enactment of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which addresses alternative payment models, in accordance with which the Stark law needs to be reformed. The Committee notes that, while the goals and effects of the Stark law were appropriate when it was initially implemented, the “huge penalties, and the breadth, complexity, and ambiguities of the Stark law” currently create a “minefield” for the healthcare industry. The spectrum of changes to the Stark law proposed in the whitepaper range from an expansion of its exceptions to the law’s repeal.

If enacted, such changes could have revolutionize the compliance efforts of healthcare agencies. Senator Orrin Hatch stated that the Committee will attempt to take action before next year.

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