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Roma Sharma

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Roma Sharma is an associate in Crowell & Moring’s Washington, D.C. office and a member of the firm’s Health Care Group. Roma primarily works with health care clients seeking to comply with regulations for state and federal health care programs, health care anti-fraud and abuse laws, and licensing laws.

Roma’s work incorporates her Master of Public Health degree in Health Policy as well as her past experiences as an extern at the Office of the General Counsel at the American Medical Association and as an intern at the Illinois Office of the Attorney General, Health Care Bureau.

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On January 28, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would change the methodology used to evaluate and adjust the performance of Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs). The proposed rule is intended to improve long-term incentives for ACOs and create a path for long-term sustainability.

ACO performance is currently measured using a multi-step process that evaluates an ACO’s effectiveness in lowering expenditures for a group of assigned beneficiaries against a benchmark established based on an ACO’s historical costs. At the beginning of the ACO’s three-year agreement period, CMS sets an average per capita historical benchmark. CMS adjusts the historical benchmark on an annual basis based on projected growth in national per capita expenditures for Medicare Parts A and B services under the fee-for-service (FFS) program.Continue Reading CMS Proposes New ACO Performance Measures

On January 11, 2016, the Centers for Medicare & Medicaid Services (CMS) announced that 100 new Accountable Care Organizations (ACO) began participating in the Medicare Shared Savings Program (MSSP). CMS also announced that 21 new providers and hospitals have signed up to participate in other ACO-focused shared savings programs, including the Pioneer ACO Model,…

On September 15, 2015, the U.S. Department of Justice (DOJ) announced the settlement of a qui tam action in the amount of $69.5 million with North Broward Hospital District (NBHD). The amount is a small fraction of the $442 million in treble damages to the Medicare and Medicaid programs alleged in the Third Amended Complaint. The settlement resolves allegations that NBHD violated the False Claims Act and the Stark Law by engaging in improper financial relationships with referring physicians. This settlement is an example of a troubling trend in which the DOJ imposes its views of the fair market value (FMV) and commercial reasonableness of employment compensation arrangements upon hospitals and providers. As the DOJ continues to successfully challenge physician compensation by analyzing the monetary impact of such compensation on hospitals’ profits and losses, hospitals are increasingly hamstrung in their ability to rely on FMV opinions to set physician compensation.

NBHD is a special taxing district of the state of Florida that operates hospitals and other health care facilities in the Broward County, Florida region. NBHD was named in a whistleblower suit originally filed in 2010 by Dr. Reilly, an orthopedic surgeon who held staff privileges to practice medicine at Imperial Point Medical Center, a hospital within the NBHD system. The Third Amended Complaint alleged that nine employed cardiologists and orthopedic surgeons were provided compensation packages in excess of FMV, in a system that illegally compensates physicians for the volume or value of their referrals to NBHD. It alleged that from 2004 to present, the overcompensation of the orthopedic surgeons generated net operating losses of over $40 million – an amount offset by referral profits monitored by NBHD in purported “secretive Contribution Margin Reports.”Continue Reading South Florida Hospital System Settles Stark Allegations for $69.5 Million

The federal government has spent billions to promote adoption and “meaningful use” of health information technology (HIT). There is growing government interest in ensuring that HIT is used to support patient care, but doing so requires electronic exchange of information. Congress, the Department of Health and Human Services (HHS), and States have taken action to identify and prevent “information blocking”—interference with the exchange or use of electronic health information—by health care providers, hospitals, technology developers, and service providers. And there likely will be more guidance, statutory and regulatory changes, and enforcement by federal agencies and states in the coming year.

Congress Requests Information and Takes Action

On December 21, 2014, Congress raised concerns about health information blocking, claiming that such activities “frustrate Congressional intent” under the Health Information Technology for Economic and Clinical Health (HITECH) Act, “devalue taxpayer investments,” and make HIT “less valuable and more burdensome” to hospitals and health care providers. Congress urged the Office of the National Coordinator for Health Information Technology (ONC) at HHS to certify only HIT that does not block health information exchange. Congress also requested ONC publish a detailed report on the scope of health information blocking and a strategy to address it, within 90 days.Continue Reading Health Information Blocking Leads to New Requirements and May Lead to Enforcement Actions

On June 17, 2015, the Health Resources and Services Administration (HRSA) published a Proposed Rule revising regulations governing the 340B Drug Pricing Program (340B Program) found in 42 C.F.R. Part 10. The Proposed Rule applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. Notably, it sets forth the calculation of the ceiling price and application of civil monetary penalties. The Proposed Rule does not address concerns that have been expressed by manufacturers about the recent expansion of entities able to be covered entities and the expansion of pharmacy outlets serving those patients. These revisions may indicate HRSA’s interest in more stringent compliance by manufacturers of drugs that are eligible for 340B Program pricing. Comments to the Proposed Rule are due August 17, 2015.

340B CEILING PRICE

The Proposed Rule provides that a manufacturer must calculate the ceiling price for all of its covered outpatient drugs on a quarterly basis. The ceiling price is calculated by subtracting the unit rebate amount (URA) from the average manufacturer price (AMP) for the smallest unit of measure and will be calculated using six decimal places. The number is then multiplied by the drug’s package size and case package.

PENNY PRICING AND DISTRIBUTION

To address the situation where the URA equals the AMP, resulting in a $0.00 per unit of measure 340B ceiling price, HRSA proposes that a manufacturer charge $0.01 per unit of measure for a drug with a ceiling price below $0.01. For those 340B drugs whose calculated price is less than $0.01, the effective ceiling price will be $0.01 per unit of measure. Prices for 340B products must be based on the immediately preceding calendar quarter pricing data.Continue Reading HRSA Proposes Rule on 340B Ceiling Pricing, Removes Orphan Drug Regulations and Sets Forth Civil Monetary Penalties