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Health and Dental Law

Bill Mandell Revisits the Need for Clarity under Massachusetts Law for Permitted Health Provider Disclosure to Protect Public Safety

Friday, June 17, 2016

by Bill Mandell

In the wake of yet another senseless mass killing tragedy I am posting an article I wrote in 2013 for the Boston Bar Association Health Law Reporter on the need for a new law in Massachusetts allowing health care providers to report dangerous persons or situations. Click here to read the article.

Bill Mandell was Quoted in ED Legal Letter – Boston, MA

Wednesday, October 14, 2015

Bill Mandell was quoted in the attached article Are ED Policies Inflexible? featured in the publication ED Legal Letter (November 2015), discussing the importance of having good EMTALA policies for hospitals and their medical staffs. To see the article click here.



Addiction Treatment Centers in Massachusetts Being Overrun By Epidemic

Tuesday, May 05, 2015

By Brandon Saunders

Governor Charlie Baker’s recent description of drug addiction in Massachusetts as a “public health emergency” is a welcome acknowledgement of a crisis that is swamping treatment centers, hospitals and the criminal justice system. The Governor is asking a task force he assembled to come back with strategies for dealing with addiction, treatment and recovery. Those recommendations are expected soon.

Governor Baker’s Secretary of Health and Human Services, Marylou Sudders, describes the problem in stark terms: "The costs associated with treating opioid addiction are great, however inaction or not labeling it for what it is - which is an epidemic - is actually much greater," Secretary Sudders said, as the Baker task force held public meetings to better understand the threat. "I recognize that there are no quick fixes and that we have lots to do."

The scale of this crisis is unprecedented. In 2014, there were more than 1,000 accidental opiod-based drug overdoses in Massachusetts, and 868 confirmed opiod overdoses the year before that. The state Department of Public Health’s Bureau of Substance Abuse Services (BSAS) reports that 107,358 people in Massachusetts were admitted into a substance abuse program in fiscal year 2014, 44 percent of whom reported prior mental health treatment, and nearly 60 percent self-reported heroin use. Those numbers reflect only those who were admitted to rehabilitation centers.  A large number of addicts refuse treatment.

These individuals repeatedly present themselves to the emergency department of acute care hospitals, putting an even greater strain on an already overrun system.  Once their acute conditions are treated, physicians at the facilities prescribe substance-abuse treatment, but often to no avail.  In my representation of a large, Boston-based acute care hospital, I have dealt with individuals who had presented themselves to the ER more than a hundred times in one year for substance-abuse related conditions.

Under existing Massachusetts law, those suffering from severe drug or alcohol addiction can be involuntarily committed to a treatment program for up to 90 days. The law that enables interested parties to commit someone to a treatment center (Chapter 123, Section 35) establishes a process by which family members, a physician, or legal guardian can petition a district court judge to order that commitment when all other efforts have failed.

The reality, however, is that Section 35 cannot cope with the rising tide of addiction, particularly for the uninsured or MassHealth recipients who are invariably sent to the Massachusetts Alcohol and Substance Abuse Center (MASAC) at the Bridgewater State Hospital for men, and MCI Framingham for women under an involuntary commitment. Both of those facilities are chronically overcrowded and underfunded, resulting in a “spin dry” detox that often sends them out on the streets after just 10 days without a real opportunity for a meaningful change or lasting sobriety that the 90-day commitment might have afforded. And then the cycle repeats itself.

Acute care hospitals are not the only system choking under the pressure of untreated addiction.  The systemic failure to successfully treat addiction is also swamping our criminal justice system. Those who continue down the path of addiction are often arrested and prosecuted for drug- or alcohol-related offenses, contributing to overcrowded conditions in state and county correction facilities when they might have been more successfully, and more appropriately, treated in a substance abuse or mental health facility.

Governor Baker is to be commended for taking this issue on, but it will take the leaders of our healthcare and legal systems, together with our elected officials, to get ahead of what is still a rising tide of needless deaths and hopeless addiction. We need to solve the ineffective and often wasteful ways we handle substance abuse and addictions in the Commonwealth and hopefully these most recent initiatives will move us in the right direction.

Brandon Saunders is an associate attorney at Pierce & Mandell LLC in Boston and specializes in guardianships, incapacitated adults and civil commitments

Medicare Physician Payment: A Brave New MACRA and MIPS World

Thursday, April 30, 2015

By William Mandell, Esq. and Karen Rabinovici, Esq.

The Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”)  --  passed this month in an unusual bipartisan effort  -- permanently repealed the Medicare Part B Sustained Growth Rate formula that would have resulted in a 21.2% cut to physician reimbursement scheduled to take effect on  April 1, 2015. It also notably establishes a new Medicare Part B performance driven payment system.

Under MACRA – which became effective on April 1, 2015 -- the Medicare Part B payment system for physicians has undergone perhaps its most dramatic change since the enactment of Medicare in 1965 or certainly since the adoption of the RBRVS fee system. MACRA gradually increases Medicare Part B rates over the next 4 ½ years and will then reward or penalize physicians financially based on measures of their performance. During this initial 4 ½  year period, Medicare participating doctors will receive a 0.5% increase each year as Medicare transitions away from a primarily fee-for-service system to one designed to reward physicians based on the quality of the care that they provide.  The first increase takes effect on July 1, 2015, followed by annual 0.5% increases going into effect each January 1 through 2018.  From January 2020 through 2025, there are no increases to rates but physician will be subject to performance based adjustments. For 2026 and beyond, physicians who are participating in alternative payments systems will be eligible for an annual update of 0.75% with all others receiving a 0.25% increase.

Between this year and 2018 the Physician Quality Reporting System, Meaningful Use, and the Value-Based Payment Modifier programs continue in their current form. Beginning in 2019, these program will end and elements of each will be included in a new Merit-based Incentive Payment System.

The MIPS Medicare Part B reimbursement system goes into effect in 2019 and is intended to move physician and other professional Part B reimbursement from a fee-for-service to a quality and performance driven system. Under MIPS physicians, and other practitioners such as physician assistants, nurse practitioners, clinical nurse specialists and certified registered nurse anesthetists, participating in the Medicare program will be evaluated via a composite score based on four factors: quality, resource use, meaningful use, and clinical practice improvement activities. Each doctor’s composite score will result in positive or negative adjustments to Medicare reimbursement based on the doctor’s performance on these factors. Physicians may receive a bonus or be assessed a penalty that will be calculated using a sliding scale based on whether the doctor is above or below performance thresholds.

MACRA requires the United States Department of Health and Human Services to establish an annual list of quality measures from which doctors and other MIPS-eligible professionals may choose for purposes of assessing the quality factor. HHS is also required to establish MIPS performance standards that consider historical performance, improvement and the opportunity for continued improvement.

Under MACRA there is a provision that prohibits plaintiffs from using a physician's performance on federal quality measures, including MIPS as well as the remainder of the Meaningful Use, Physician Quality Reporting System and Value-Based Payment Modifier programs, as the sole basis to prove negligence in a medical malpractice lawsuit.

Before the passage of MACRA the medical community was very concerned about the use of quality metrics as evidence by plaintiffs as a basis to assert that a doctor committed negligence. Now medical malpractice plaintiffs may not assert a negligence claim against a doctor on the sole basis that he or she did not earn an incentive or was penalized under any federal health care guideline or standard, used in the MU, PQRS, VBPM or MIPS programs. Furthermore, the fact that a physician did not render a service covered under the Affordable Care Act may not be the sole fact to assert that a physician breached his or her duty of care to a patient.

The MACRA liability protections, however, do not totally prevent the introduction of these facts into evidence in a medical malpractice case. And, it certainly does not go as far as legislation that has been sought by many medical associations that would have provided immunity from liability and other civil suit protections for doctors who are sued and can prove they followed any evidence-based clinical guidelines.

MACRA provides $100 million in funding -- $20,000,000 for each of the fiscal years 2016 through 2020 --   to underwrite technical support to small medical practices with 15 or fewer professionals that desire to participate in the new alternative payment models.  HHS is to work with quality improvement organizations and other regional entities certified by the federal government to provide guidance to such small practices on how to prepare for and transition to quality driven reimbursement, with priority given to rural practices, locations with provider shortages, and medically underserved areas.

In order to devise alternative payment models, develop measures to judge the quality of care provided, and determine how physicians will be rewarded or penalized based on their performance, MACRA mandates the establishment of a 11 person technical advisory committee This committee is charged with reviewing and recommending physician-developed alternative payment models based on criteria developed through an open comment process. Not later than July 2016, HHS is required to submit to Congress a study on the feasibility of integrating alternative payment models in the Medicare Advantage payment system.

MACRA also establishes Medicare payment for chronic care management when performed by a physician, physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife.

Alternatively, physicians who choose to participate in ongoing and future new payment models such as accountable care organizations (ACOs), patient-centered medical homes, and initiatives under Medicaid waivers can receive annual bonuses of 5 percent for services in 2019-2024 and not be subject to MIPS requirements.

As with any major federal health reform legislation many more details will be forthcoming in agency rules and other implementation actions required under the law. So while much has yet to be seen, what is clear is that all medical practices and other Part B providers must begin to prepare now for adapting to a substantially overhauled Medicare reimbursement system where performance measures will drive payments and the infrastructure needed to capture and utilize performance data effectively will be essential to maximizing revenues and fulfilling patient expectations and payer requirements.

If you would like more information about any part of MACRA, please do not hesitate to contact us.

William Mandell is a shareholder and health law practice leader, and Karen Rabinovici is an associate, at Pierce & Mandell, P.C, of Boston. 

Obama Administration Announces “Next Generation ACOs”

Thursday, March 19, 2015

by Curtis Dooling

On March 10th, the Centers for Medicare and Medicaid Services launched a new Accountable Care Organization (ACO) program called the Next Generation ACO. The Next Generation ACO builds on earlier ACO models. ACOs were established under the Affordable Care Act to provide high-quality care to Medicare beneficiaries through coordination of doctors, hospitals, and other health care providers. ACOs differ from Medicare Advantage plans in that beneficiaries can retain their choice of providers, whereas in Medicare Advantage plans beneficiaries are confined within a network.

The Next Generation ACO will differ from existing ACOs in several ways. First, they will be permitted to take on greater financial risk while also qualifying for a greater portion of shared savings. Next Generation ACOs will also be encouraged to coordinate care by enhancing and expanding services to beneficiaries, including skilled nursing care and post-discharge home services. Next Generation ACOs will also be able to offer reward payments to beneficiaries.

ACOs traditionally created care and performance benchmarks based on an ACO’s historical expenditures. Thus, some high performing health care providers were reluctant to joint ACOs. Next Generation ACOs are changing benchmarking methods to transition away from comparisons to past performance. By making this change, high performing health care systems will have a greater incentive to join the ACO program because they won’t be penalized for past quality and cost containment success.

Next Generation ACOs represent a bold move toward population-based payment and greater care coordination. They also allow for greater engagement of beneficiaries, a more predictable financial model and greater tools to coordinate care for beneficiaries. For further information on Next Generation ACOs, visit: innovation.cms.gov/initiatives/Next-Generation-ACO-Model/.

Pierce & Mandell, P.C. to Sponsor the Annual Schwartz Center Health Attorneys Breakfast - Boston

Wednesday, March 19, 2014
Pierce & Mandell, P.C. is proud to be a sponsor law firm for the Annual Schwartz Center Health Policy Breakfast, to be held on Friday, April 4. This year’s program will focus on the Schwartz Center's Call to Action, which outlines seven guiding commitments to create a more compassionate healthcare system. Peter Slavin, MD, CEO of MGH; Sandra Fenwick, CEO of Boston Children’s Hospital; and Kevin Tabb, MD, CEO of Beth Israel Deaconess Medical Center, will comment on the Commitment to Compassionate Healthcare Leadership.
The Schwartz Center for Compassionate Healthcare, named after Boston healthcare attorney and patient compassion advocate, Ken Schwartz. Ken was an excellent health lawyer and a wonderful person who left us tragically way too early. His family, friends and colleagues have established a fitting and enduring organization in his honor. The Schwartz Center is a nationwide non-profit organization with a long and respected history of providing patient-centered, compassionate care while striving to strengthen the relationships between patients and providers.  

In 1995 Ken wrote about his experience as a cancer patient in an article for the Boston Globe Magazine entitled “A Patient’s Story.”  In it, he cited how doctors and nurses can make “the unbearable bearable” for patients with “the smallest acts of kindness.” This article was a source of strength and solidarity for my late father who was undergoing cancer treatment at that time.

Please take a moment to learn about the history and remarkable work of The Schwartz Center for Compassionate Care and we encourage all of you who care about improving the training and resources available for compassionate care to support the Schwartz Center.

The HIPAA/HITECH Mega Rule Compliance Deadline is Fast-Approaching

Monday, September 09, 2013
By Karen Rabinovici, Esquire

The September 23, 2013 deadline for compliance with the final Omnibus Rule which amends HIPAA and the HITECH Act, called the “Mega Rule,” is just 15 days away.  The Mega Rule, which became effective on March 26, 2013, calls for medical providers to update and revise privacy policies, procedures and notices, business associate relationships and agreements, and employee training.  The Mega Rule affects both Covered Entities and Business Associates.  

What is Protected Health Information (“PHI”)?

PHI refers to individually identifiable health information.  Individually identifiable health information is information that can be linked to a particular person.  This can relate to an individual’s past, present, or future physical or mental health or condition, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.  Common identifiers are names, social security numbers, addresses, and birth dates.

What is a Covered Entity?

A Covered Entity is a health care provider, a health plan, or a health care clearinghouse.  A health care provider is a Covered Entity only if the provider transmits information in an electronic form in connection with transactions that involve the transmission of information between two parties to carry out financial or administrative activities related to health care.  Simply put, a Covered Entity is any entity that handles and transmits health information.
What is a Business Associate?

A Business Associate is a person/entity who, with respect to a Covered Entity, performs or assists in the performance of a function or activity involving the use or disclosure of PHI, or provides management, administrative, accreditation, or financial services to or for a Covered Entity, where such services involve the disclosure of PHI by a Covered Entity to a Business Associate.

The definitions of Covered Entity and Business Associate can be found at 45 CFR 160.103.  

What are the main Mega Rule requirements of which Covered Entities and Business Associates should be aware?

The following are the main components of the Mega Rule of which Covered Entities and Business Associates should be aware and should incorporate into their practices.  This is not a complete list.

1. Extension of HIPAA privacy and security requirements to Business Associates and Subcontractors of Business Associates
Before the Mega Rule, Subcontractors who used or disclosed PHI were not subject to HIPAA.  Now, both Business Associates and third-party Subcontractors can be held accountable for unauthorized disclosures under the Mega Rule.  Business Associates and Subcontractors of Business Associates can be subject to compliance requirements and civil penalties for unauthorized disclosures.  Business Associates and Subcontractors must update Business Associate Agreements to reflect these changes. 
2. Breach redefined
When an impermissible access, acquisition, use or disclosure of PHI occurs, the Mega Rule presumes such transaction is a breach.  Prior to the Mega Rule, such transaction was not a breach unless it posed a significant risk of financial, reputational or other harm to the individual.  In order for a Covered Entity not to be required to notify the patient of the breach, it must demonstrate that there is a low probability that the information was compromised.  This is determined by examining the type and extent of the PHI involved, to whom the disclosure was made, if the PHI was actually acquired or accessed, and if the risk of unauthorized disclosure was mitigated.  This review must be documented according to the Covered Entity’s established policies and procedures.  If Covered Entities do not follow these guidelines, or have established policies and procedures, they could face monetary penalties for willful neglect.  
3. Updates to Notice of Privacy Practices (“NPPs”) and redistribution of NPPs
Covered Entities must update their NPPs, and redistribute the updated NPP.  The updated NPP must include a description of the disclosures that do and do not require authorization, the fact that:  patients can opt out of fundraising and marketing communications, patients can request disclosure restrictions, patients can access their PHI, and Covered Entities are legally required to notify patients whose PHI is breached.  It must also state that any disclosures not described in the NPP may only be made with authorization, and that relevant PHI may be disclosed to a deceased’s family member, friend, or representative if that person was involved in the patient’s care or payment for services (unless the patient expressed otherwise). 
4. Expansion of patient privacy and patient empowerment

The Mega Rule empowers patients to request further restrictions on disclosure of their PHI.  Covered Entities must comply with such requests if the disclosure is for payment or health care operations purposes, the disclosure is not required by law, or if the requested restriction applies to disclosure of a service which has already been paid for in full by someone other than the health plan.

Patients may also specify to whom PHI may or may not be disclosed (friends, family members, etc.).  In addition, patients have the right to access their PHI.  If the Covered Entity maintains PHI in electronic format, the Covered Entity, upon request, must provide the patient with electronic access to the PHI.  Covered Entities may charge patients a reasonable fee limited to the cost of supplies, labor, and postage.  Furthermore, if patients wish to amend their PHI, they have the right to do so (although there are several limited circumstances where this request may be refused). 
5.    More rigorous HIPAA enforcement
Under the Mega Rule, the Department of Health and Human Services is responsible for investigating private complaints of non-compliance alleging unauthorized disclosures due to willful neglect.  As required by the HITECH Act, these investigations and reviews may result in increased and tiered civil money penalties.  The penalties take into account whether Covered Entities or Business Associates should have known of the violation, if the violation was due to willful neglect or reasonable cause, whether the violation was corrected within 30 days, and whether the Covered Entity or Business Associate mitigated the harm.
6.    Option for patients to opt out of receiving fundraising and marketing communications  
When Covered Entities communicate with patients regarding fundraising, they must notify the patient clearly of the patient’s option to opt out of receiving such communications.  In addition, Covered Entities cannot sell patient information for fundraising and marketing purposes without authorization.  When seeking such authorization, the patient must be made aware that the provider will receive remuneration for disclosing PHI.  However, Covered Entities may continue to receive financial remuneration to provide refill reminders, or to send out other communications about a drug currently used by the patient as long as the remuneration is related to the costs of making the communication.

What should Covered Entities and Business Associates do before September 23?

Covered Entities and Business Associate should use the several days left before the compliance deadline to update policies and procedures, train staff accordingly, and become familiar with the Mega Rule in order to ensure compliance and avoid lofty penalties.  For further assistance, please contact one of the health law practice area attorneys at Pierce & Mandell, P.C.

Read William Mandell's Most Recent Article in Boston Bar Association's Health Law Reporter

Wednesday, July 10, 2013

William M. Mandell who heads Pierce & Mandell’s Health Law Practice authored an article entitled: “Should I Tell Someone?” Permissible Disclosures by Massachusetts Health Providers and the Need for Greater Statutory Clarification which was  published in the Boston Bar Association's Health Law Reporter Summer 2013 edition.  To read this article, click here.


Monday, July 01, 2013

The federal HHS Office of Civil Rights recently adopted final HIPAA regulations covering a broad range of topics, to strengthen privacy and security protections for individual health information.  This blog is another in a series examining these new regulatory requirements.   

By Dean P. Nicastro, Esq.

The new HIPAA Final Rule for Privacy, Security, Enforcement and Breach Notification (adopted in January 2013) creates new obligations for Business Associate Agreements (“BAA”) between physicians, hospitals and other health care providers (“Covered Entities”), and those contractors who perform services for them involving the use or disclosure of Protected Health Information (“PHI”).

As was mentioned in a previous blog, HIPAA now defines “Business Associate” (“BA”) to include a BA’s subcontractors who create, receive, maintain or transmit PHI on the BA’ behalf.  The new Final Rule goes on to require that a BAA between a Covered Entity and its BA must require the BA to ensure that the BA’s subcontractors comply with HIPAA privacy and security requirements.  Effectively, and as a mandate, this means that the Covered Entity’s BA must have in place a separate BAA with the BA’s subcontractor.

HIPAA makes clear that the Covered Entity need not have a BAA in place directly with the BA’s subcontractor. However, the Final Rule puts the burden on the Covered Entity to arrange for subcontractor compliance, by requiring the BA to obtain compliance assurance from its subcontractor.  Thus, HIPAA BAA’s between health care providers and their servicing vendors need to be revised and updated to include these “downstream” subcontractor compliance obligations.

Care should be exercised when drafting the updating revisions: for example, the main BAA should require that the downstream BAA mirror the BA’s privacy and security obligations; additionally, it may be advisable to expressly disavow any relationship of agency between the Covered Entity and the subcontractor.

Finally, when updating a BAA template, it would be helpful to include language of compliance with Massachusetts law and regulations that protect the security and disposal of data that contains personal information, like names and social security or financial account numbers.  Massachusetts consumer regulations require that a service provider contract be in place with vendors who access such data, so it is a good idea to have the HIPAA BAA serve as such a contract as well.  

In general, the HIPAA Final Rule must be complied with by September 23, 2013.  The federal HHS Office of Civil Rights has posted some helpful sample language for BAAs on its website.

Please contact the health law professionals at Pierce & Mandell for additional information on this subject.

CMS and OIG Propose to Amend Stark and Anti-Kickback Rules for EHR Donations

Wednesday, May 01, 2013
By Dean P. Nicastro

Last month, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) proposed similar amendments to the Stark exception and to the Anti-Kickback safe harbor for the donation of electronic health records (EHR).  The current rules permit hospitals, group practices and other entities to donate technology-related items and services to physicians, to be used to create, maintain, transmit or receive EHR.  Highlights of the proposed changes:

  • Eliminate the requirement that EHR must include an electronic prescribing component or interface ability
  • Change the procedure for deeming EHR software “interoperable,” so as to follow the current certification process employed by the Office of National Coordinator for Health Information Technology (ONC); and eliminate the 12-month prior timeframe for certification
  • Postpone the EHR sunset from December 31, 2013 to December 31, 2016

The two agencies believe that “sufficient alternative policy drivers” exist to advance electronic prescribing, and that the ONC certification program (which certifies to any edition of EHR certification criteria that is identified in the regulatory definition applicable at time of donation) is consistent with the objective of ensuring that EHR products are certified to the current standard of interoperability when they are donated.  In addition, the sunset extension is thought needed in order to help achieve more widespread adoption of EHR in the healthcare industry (the December 31, 2016 date corresponds with the closing timetable for Medicare/Medicaid EHR incentive programs; the agencies even suggest an extension to December 31, 2021).

The agencies have invited comment on the proposed amendments through June 10, 2013.  Also, they seek comment on whether to limit the class of permitted donors, so as to exclude certain ancillary suppliers, such as lab companies, durable medical equipment suppliers and independent home health agencies, and on other suggestions for preventing “data and referral lock-in” and for encouraging the free exchange of data.

The proposed changes are contained in the April 10, 2013 Federal Register.  Please contact the health law professionals at Pierce & Mandell for additional information on this subject.

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