The New York State Hepatitis C Testing Law: A Focus on Baby Boomers

by Varsha Koripella, M2, Wayne State Medical School; Terri L. Wilder, MSW, Mt. Sinai Institute for Advanced Medicine, & Antonio E. Urbina, MD, Mt. Sinai Institute for Advanced Medicine

Hepatitis C virus (HCV) is a serious, often under-recognized public health problem in the U.S, especially in New York State (NYS) where an estimated 195,000 of the affected 3.2 million people live. If left untreated, HCV can cause serious liver damage and/or liver cancer, and is the leading cause of liver transplants in the U.S. Due to recent advances in medicine, new, more effective treatments are now available that can cure most people living with HCV.

To increase HCV testing and ensure timely diagnosis and linkage to care, the NYS Hepatitis C Testing Law was put into effect on January 1, 2014. The law has three main provisions:

  1. An HCV screening test must be offered to every individual born between 1945 and 1965 receiving inpatient services at a hospital or primary care services through a hospital outpatient clinic or diagnostic/treatment center or from a physician, physician assistant, or nurse practitioner regardless of setting. Exceptions occur if the individual is being treated for a life-threatening emergency, has previously been offered or received a HCV screening test, or lacks the capacity to consent. Emergency Departments are encouraged, but not required to offer testing;
  2. The offer of testing must be culturally and linguistically appropriate;
  3. If an individual accepts the offer and the test is reactive, the provider must offer the individual follow-up health care or refer them to a provider who will

The law specifies baby boomers because more than 75% of adults infected with HCV were born between 1945 and 1965, and most were infected in the 1970s and 1980s when drug use was highest. Even now, sharing needles is the most common way for people to become infected. In addition, some may have been infected by contaminated blood products before universal screening of the blood supply began in 1992. Early HCV screening is necessary for improving health outcomes and preventing HCV transmission to others. HCV is a curable disease for most, and the success of treatments depends on providers properly identifying and linking patients to care and treatment.

Are you up-to-date on the NYS Hepatitis C Testing Law?

The NYS Department of Health Clinical Education Initiative (CEI) provides free CME/CNE trainings on HCV for medical providers in NYS. To request a training or to view on-line HCV courses, please visit To speak with a clinician experienced in managing HCV, call the CEI Line toll-free at 1-866-637-2342.



  1. Smith, Bryce D., Rebecca L. Morgan, Geoff A. Beckett, Yngve Falck-Ytter, and Deborah Holtzman. “Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born during 1945-1965.”Morbidity and Mortality Weekly Report 4 (2012): 1-32. Print.
  2. New York State Department of Health. Web. 6 June 2015. <;.

Preventing HIV: What Every Clinician Needs to Know about Non-Occupational Post-Exposure Prophylaxis

By Varsha Koripella, M2, Wayne State Medical School, Terri L. Wilder, MSW, Mt. Sinai Institute for Advanced Medicine, Antonio E. Urbina, MD, Mt. Sinai Institute for Advanced Medicine

This is part 3 in a 4 part series of articles detailing New York’s efforts to combat HIV through PrEP and other regiments

If a patient presents to a medical provider with a recent HIV exposure, immediate nPEP (non-occupational post-exposure prophylaxis) administration may prevent HIV transmission. This 28-day regimen is recommended for exposed patients of at least 13 years of age, and the recommended regimen is tenofovir + emtricitabine plus either raltegravir or dolutegravir. Situations that prompt a request for nPEP include condom slippage, breakage or lapse in use, and unsafe needle-sharing.

The NYS Department of Health nPEP guidance states: for maximum effectiveness, nPEP must be administered within 36 hours of exposure, ideally within two hours. If the source person is known to be HIV-infected, the provider should obtain information about his/her viral load and antiretroviral medication history, but do not delay administration of the first dose. After administration, telephone or in-person consultation with an experienced HIV provider is recommended. To speak with a clinician experienced in managing nPEP, call the CEI Line toll-free 24/7 at 1-866-637-2342.

When deciding whether to prescribe nPEP, the clinician should assess the patient’s risk of HIV acquisition based on the type of exposure. The behaviors that confer the highest risk are needle-sharing and receptive anal intercourse with an HIV-infected person. Treatment of these exposures should be combined with a strong educational component that emphasizes prevention of future exposures.

All patients receiving nPEP should be re-evaluated within 3 days of the exposure and weekly during the recommended 28-day regimen to assess adherence and side effects. In addition to the baseline test, HIV testing should also be done at week 4 and week 12 post-exposure regardless of whether nPEP was initiated. If the HIV test result is positive at any time, perform a FDA-approved confirmatory assay to confirm the diagnosis. A negative HIV test result at 12 weeks post-exposure reasonably excludes HIV infection related to this exposure.

A member of the health care team should provide risk-reduction counseling whenever someone is assessed for nPEP, and medical providers should assess for other factors that can contribute to risk behavior. Persons who present with repeated high-risk behavior should be the focus of intensified education and considered for initiation of pre-exposure prophylaxis (PrEP).

Are you up-to-date on nPEP?

The NYS Department of Health Clinical Education Initiative (CEI) provides free CME/CNE trainings on nPEP for medical providers in NYS. To request training or to view online nPEP courses, please visit

The complete NYS DOH PEP guidelines can be found at


  1. HIV Clinical Resource. NYS Department of Health AIDS Institute, Oct. 2014. Web. 8 June 2015. <;
  2. “I might have been exposed to HIV. What should I do?” Web. 8 June 2015. <;.

Pre-Exposure Prophylaxis: A New Strategy in HIV Prevention

by Varsha Koripella, M2, Wayne State Medical School, Terri L. Wilder, MSW, Mt. Sinai Institute for Advanced Medicine, Antonio E. Urbina, MD, Mt. Sinai Institute for Advanced Medicine

This is part 2 in a 4 part series of articles detailing New York’s efforts to combat HIV through PrEP and other regiments

Although the total number of new HIV infections in NYS is decreasing, rates continue to rise in some populations. For these persons, an effective intervention may be pre-exposure prophylaxis, or PrEP, a once-daily pill consisting of 300 mg tenofovir and 200 mg emtricitabine.

Who should be prescribed PrEP?

HIVPrEP is beneficial for individuals who are HIV-negative, but at ongoing high risk for HIV infection, namely men who have sex with men, injection drug users, and serodiscordant couples where one partner is HIV-positive and the other is HIV-negative. It is important that a negative HIV test result be confirmed immediately before initiation of PrEP. Since PrEP is a prevention tool to use during high-risk periods and not a life-long intervention, the length of use will depend on the individual’s risk behaviors.


Before prescribing PrEP, providers must explain to the patient how the medication works and the need for strict adherence. Patients must also understand that PrEP is not a sole intervention, but part of a comprehensive prevention plan that includes counseling about the following: consistent condom use, safer-sex practices, the importance of frequent HIV testing and, for individuals in serodiscordant relationships, the importance of suppressive ART (anti-retroviral treatment) for the HIV-infected partner.

Follow-Up and Monitoring

The first prescription of PrEP should be for 30 days. A follow-up visit should be scheduled at 2 weeks and 30 days to assess adherence and tolerance. At the 30-day visit, a prescription for 60 days may be given and, after that visit, prescriptions for 90 days may be given as long as the patient is adherent. Follow-ups should occur at least every 90 days. At each follow-up, the medical provider must give an HIV test, provide risk-reduction counseling, and manage side-effects.

Discontinue PrEP immediately if the patient receives a positive HIV test result, develops renal disease, is non-adherent or using the medication for unintended purposes, or has reduced risk behaviors to the extent that PrEP is no longer needed.

Are you up-to-date on PrEP?

The New York State (NYS) Department of Health Clinical Education Initiative (CEI) provides free trainings on PrEP for medical providers in NYS. To request a training or to view on-line PrEP courses, please visit To speak with a clinician experienced in managing PrEP, call the CEI line toll-free at 1-866-637-2342.

The complete NYS DOH PrEP guidelines can be found at


  1. HIV Clinical Resource. NYS Department of Health AIDS Institute, Jan. 2014. Web. 15 June 2015. <;

The New York State Plan to End AIDS: What Every Medical Provider Needs to Know

by Varsha Koripella, M2, Wayne State Medical School, Terri L. Wilder, MSW, Mt. Sinai Institute for Advanced Medicine, Antonio E. Urbina, MD, Mt. Sinai Institute for Advanced Medicine

New York State (NYS) has made tremendous strides in decreasing HIV infection rates over the past decade. In order for the AIDS epidemic to be brought to sub-epidemic levels and the first ever decrease in HIV prevalence, NYS must aim to decrease new HIV infections from 3,300 to 750 annually, and reduce the rate at which persons diagnosed with HIV progress to AIDS by 50%. In June of 2014, Governor Andrew M. Cuomo announced a three-point plan to end the AIDS epidemic in NYS by the end of 2020. The plan’s stated goals involve:

  • Identifying persons with HIV who remain undiagnosed and linking them to health care. There are approximately 22,000 people living with HIV in NYS who are unaware of their status. It is critical that access to voluntary HIV testing be increased so individuals can access treatment if they test HIV-positive. Since 2010, NYS Public Health Law has required that medical providers offer HIV testing to all patients ages 13 to 64 as a routine part of health care.
  • Linking and retaining persons diagnosed with HIV to health care and getting them on anti-HIV therapy to maximize HIV virus suppression so they remain healthy and prevent further transmission. In NYS, approximately 64,000 of the 132,000 persons living with HIV are receiving sub-optimal treatment. It is imperative that medical providers identify and link patients to care as soon as possible.
  • Providing access to pre-exposure prophylaxis (PrEP) for high-risk persons to keep them HIV-negative. PrEP is a biomedical intervention for high-risk individuals who are currently HIV-negative. It involves the person taking Truvada, a once-daily pill consisting of tenofovir and emtricitabine. In order to expand on the utilization of PrEP as a prevention tool, the Governor’s plan recommends focusing on education and awareness, affordability, and enhanced availability.

Are you up-to-date on the Governor’s Plan to End AIDS?

The NYS Department of Health Clinical Education Initiative (CEI) provides free CME/CNE trainings for medical providers in NYS. To request a training or to view on-line HIV courses, please visit To speak with a clinician experienced in managing HIV or PrEP, call the CEI Line toll-free at 1-866-637-2342.


  1. “2015 Blueprint to End AIDS.” NYS Department of Health, 30 Mar. 2015.

CMS Issues Final Rule for Medicare Shared Savings Program

by Carly Eisenberg Hoinacki, Robin Fisk, and Christopher Raphaely (from the offices of Nixon Peabody, Fisk Law Office PC, and Cozen O’Connor, respectively)

The Centers for Medicare & Medicaid Services (CMS) released a Final Rule on June 4 addressing changes to the Medicare Shared Savings Program. CMS made these modifications to the proposed regulations after considering comments received from the December 8, 2014 Notice of Proposed Rulemaking (NPRM). The majority of the Final Rule goes into effect August 3, with certain provisions being effective November 1 and another on January 1.

ACO Eligibility and Governance/Leadership Requirements

The new rule makes several modifications with respect to the following requirements for accountable care organizations (ACOs), ACO participants, and ACO providers/suppliers: eligibility; ACO participant agreements; identification and reporting requirements; governance; and leadership and management. A number of these changes codified existing ACO sub-regulatory guidance from CMS. Some key provisions include the following:

  • ACOs must now submit an executed ACO participant agreement for each ACO participant at the time of its initial application, participation agreement renewal, and when adding to its list of ACO participants.
  • CMS now has discretion regarding whether to impose any remedial measures to terminate an ACO for failure to satisfy the minimum assigned beneficiary threshold during a performance year.
  • The new rule establishes requirements and processes for maintaining, updating, and submitting the required ACO participant and ACO provider/supplier lists.
  • Absent unusual circumstances, CMS will not make adjustments during the performance year to an ACO’s assignment, historical benchmark, or quality and financial performance metrics based on modifications to an ACO participant list.
  • An ACO may request that CMS consider, for purposes of beneficiary assignment and establishing the ACO’s benchmark, claims billed by Medicare-enrolled entities’ tax ID numbers that have been acquired through sale or merger by an ACO participant.
  • The new rule incorporates the statutory requirement that an ACO have a “mechanism for shared governance” among ACO participants.
  • The new rule explicitly prohibits an ACO provider/supplier from serving as the Medicare beneficiary representative on the governing body of an ACO.
  • The new rule provides additional flexibility regarding the qualifications of an ACO medical director and eliminates the provision permitting an ACO to request consideration to enter the Medicare Shared Savings Program without satisfying certain requirements regarding operations and clinical management.
  • The new rule establishes a process for the transition of Pioneer ACOs into the Medicare Shared Savings Program.

Establishing and Maintaining the Participation Agreement

The new rule establishes procedures for the renewal of the participation agreement of an ACO and clarifies that, in general, an ACO is subject to all regulatory changes that become effective during the three-year agreement period.

Sharing of Aggregate Reports and Beneficiary Identifiable Claims Data

CMS will include additional beneficiaries and data in the reports it shares with ACOs and has changed the process by which Medicare beneficiaries may opt out of claims data sharing:

  • More Beneficiaries Included in Aggregate Reports and Claims Data:
    • CMS will now include each beneficiary who has a primary care visit with an ACO in the aggregate reports and claims data it shares with Track 1 and 2 ACOs even if the beneficiary is not preliminarily assigned to the ACO.
    • CMS will only share aggregate reports and claims data of those beneficiaries who are prospectively assigned to Track 3 ACOs with Track 3 ACOs.
  • Additional Data to be Shared:
    • CMS will begin including the following information regarding preliminarily/ prospectively assigned beneficiaries in the aggregate data reports provided to ACOs in all three Tracks: enrollment status, heath status information, and utilization rates and related expenditure information.
  • Streamlined Opt-Out Process:
    • CMS will no longer require ACOs to provide opt-out notices to beneficiaries prior to requesting individually identifiable claims data on such beneficiaries.
    • Beneficiaries may only opt out through CMS directly (1-800-MEDICARE) and will no longer have the option to opt out by notifying the ACO.

Beneficiary Assignment

CMS made numerous adjustments to its beneficiary assignment process for performance years 2016 and thereafter. The highlights are as follows:

  • Transitional and chronic care management codes will be included in primary care services used for beneficiary assignment.
  • Claims for primary care services provided by non-physician practitioners (e.g., nurse practitioners) will be included in “Step 1” of the assignment process, placing greater importance on these practitioners’ services in the assignment methodology.
  • Certain physician specialists such as gastroenterologists and interventional cardiologists will be excluded from the assignment process.

Shared Savings and Losses

Track 1: Consistent with the NPRM, CMS agreed to allow ACOs that have completed one contract under Track 1 and are compliant with the quality and other participation requirements to continue in Track 1 for a second contract period. ACOs remaining in Track 1 for a second contract period are subject to the same Minimum Savings Rate (MSR) and 50% maximum sharing rate.

Track 2: Beginning January 1, ACOs choosing Track 2 may choose at the time of application to set their MSR/Minimum Loss Rate (MLR) symmetrically at 0% or in increments of 0.5% ranging between 0.5% and 2% or by varying the MSR/MLR according to their patient population using the existing scale for the one-sided model. Once selected, the ACO may not change the MSR/MLR during the agreement term.

Track 3: The eligibility transparency and data sharing requirements, quality performance standards, and monitoring rules for Track 3 are based on the rules for Tracks 1 and 2:

  • Beneficiaries will be prospectively assigned to Track 3 ACOs using the same method (42 CFR 425.402(b)) as Tracks 1 and 2; however, there will be no retrospective reassignment, except to quarterly remove ineligible beneficiaries (e.g. beneficiary enrolls in a Medicare Part C plan). A beneficiary prospectively assigned to a Track 3 ACO will not be reassigned even if they receive the majority of services from another ACO.
  • Depending on its quality performance, a Track 3 ACO can share up to 75% of savings—not to exceed 20% of its benchmark, and 75% of losses—not to exceed 15% of its benchmark. Track 3 ACOs with high-quality performance could reduce the shared loss to 40%.
  • Track 3 ACOs have the same options for selecting MSR/MLR as Track 2 ACOs.
  • Effective January 1, 2017, Track 3 ACOs may apply to admit beneficiaries into a skilled nursing facility (SNF) for otherwise-covered services without satisfying the prerequisite three-day inpatient hospital stay. The SNF must have an overall quality rating of three or more stars and have entered into a “SNF Affiliate Agreement” with the ACO. Guidance on the application process will be forthcoming.

The benchmarking method will be revised for ACOs entering their second and subsequent contract periods to equally weight all three benchmarking years and to reflect the ACO’s average per capita shared savings during the first contract period. Weighting of benchmarking years for initial contracts will continue unchanged. Future rulemaking will address incorporating regional cost trends into rebased benchmarks.

The Final Rule replaces the current annual repayment mechanisms with a single mechanism for the contract period and allows any combination of escrowed funds, surety bonds, and line of credit. The Final Rule incorporated tables comparing the different tracks at 80 Fed. Reg. 32692 at 32811-12.

Additional Program Requirements and Beneficiary Protections

The new rule makes several changes related to program integrity and transparency, such as public reporting, terminations, and reconsideration review. Specifically, the new rule requires that each ACO maintain a dedicated webpage on which the ACO must publicly report certain information using a template specified by CMS. Such information includes: a list of the ACO’s key clinical and administrative leaders; the types of ACO participants or combinations of ACO participants that form the ACO; the ACO’s performance on all quality measures; and shared savings and losses information (e.g., amount of any payment of shared savings received by the ACO or shared losses owed to CMS).

Physician Compensation Arrangements on OIG Radar

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As physician compensation arrangements continue to run the risk of violating the federal anti-kickback statute, it’s more important than ever for physicians to understand the terms and conditions of these arrangements to avoid enforcement action.

by Nixon Peabody Attorneys Jill H. Gordon, Rebecca Simone, and Gretchen E. Harper

The Department of Health and Human Services Office of Inspector General (the “OIG”) issued a fraud alert last week highlighting certain physician compensation arrangements that run a high risk of violating the federal anti-kickback statute (the “AKS”). The OIG emphasizes that in order to prevent AKS violations, physician compensation arrangements—including medical directorships—must reflect fair market value for the bona fide services that physicians actually provide under the arrangements.

The alert serves as a reminder that under the AKS, physician compensation arrangements may not include illegal remuneration for federal health care program referrals, and any arrangement that takes into account a physician’s volume or value of referrals or does not reflect fair market value for services provided raises red flags to regulators and may subject physicians to possible criminal, civil and administrative sanctions. Further, even if one purpose of the arrangement is to compensate a physician for his or her past or future referrals of federal health care program business, the arrangement violates the AKS.

Not only do physician compensation arrangements continue to be on the OIG’s enforcement radar, but the alert’s reference to 12 recent settlements with individual physicians who were involved in suspicious payment arrangements highlights the fact that the physicians who are an integral part of a fraudulent compensation scheme are subject to liability under the Civil Monetary Penalties Law. The questionable arrangements subject to recent settlement involved improper remuneration under the AKS for reasons including: payments that took into account the physician’s volume or value of referrals, payments that did not reflect fair market value and payments where the physicians did not actually provide the services called for under the agreements. One of the arrangements at issue even relieved physicians of a financial burden they otherwise would have incurred by allowing for an affiliated health care entity to pay the salaries of the physicians’ front office staff.

Given the threat of expensive settlements and enforcement actions, it is imperative that physicians work with counsel to carefully consider the terms and conditions of medical directorships and other physician compensation arrangements. There is also an available AKS safe harbor for personal services and management agreements where payments made by a principal to an agent as compensation for services of the agent do not qualify as illegal remuneration as long as certain specified conditions are met.

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