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NewsOK Q&A: U.S. businesses react to newly enforced EU privacy law

oklahoma city health care attorney mary richard

Mary Richard is recognized as one of pioneers in Oklahoma healthcare law. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses GDPR, a newly enforced EU privacy law.

Q: What is the General Data Protection Regulation (GDPR)?

A: It’s a law regulating data protection and privacy for all individuals within the European Union (EU). It gives control to individuals over their personally identifiable information. It both standardizes the requirements throughout the EU and bolsters protections available to individuals amid well-publicized, costly data breaches in Europe. It’s a regulation rather than a directive, which means national governments within the EU don’t have to pass enabling legislation for these requirements to be effective. Rather, the regulation is directly binding on the members of the EU. The spirit of the General Data Protection Regulation also is embodied in recent legislation in the United Kingdom, providing consistency across Europe even though the U.K. withdrew from the EU effective in March. The regulation, passed two years ago, became effective May 22. Because of the length of time between passage and enforcement, there’s no transitional or grace period before compliance is required.

Q: How is this relevant to American businesses?

A: In certain circumstances the General Data Protection Regulation also applies to organizations and other businesses based outside of the EU if they collect and/or process personally identifiable information located within the EU. For example, U.S. companies offering a website to market their products or services to individuals within the European Community or scientific concerns actively engaged in recruiting individuals within the European Community to be subjects in clinical trials are required to comply. It’s important for such commercial concerns to act quickly to determine if they are covered by the General Data Protection Regulation as processors of data or collectors of such data from individuals within the EU. Concerned about the potential burden of compliance on foreign businesses, some international websites have taken steps to block EU users on the effective date, thereby removing the need to comply and ensuring against potential liability under the regulation. USA Today’s international website redirected users to simplified sites limited in scope. Other U.S. newspapers with European editions made them temporarily unavailable to readers in the EU. In another example of responses by U.S. companies, Instapaper, a read-it-later app, temporarily shut off access to European users to allow sufficient time for compliance.

Q: What type of data is protected by the General Data Protection Regulation and how’s it protected?

A: Personally identifiable information is anything that allows a living person to be identified directly or indirectly. Such data elements include name, email and home addresses, medical information, bank or other financial information, computer IP address and photos. A data processing officer must be appointed by businesses involved in processing or collecting data who is similar to a compliance officer with special information technology proficiency in managing and securing personal and sensitive data as well as a local representative for the company. Individuals have the right to the portability (access) of their stored data, erasure of data in certain circumstances, the right to file complaints with the data processing authority and the right to contract automated decision-making made on a solely algorithmic basis. Data breaches must be reported in a manner similar to the Health Information Portability and Accountability Act of 1996 and its amendments (HIPAA).

Q: You mentioned HIPAA. Is informed consent required for American businesses engaged in business in Europe similar to that required for HIPAA?

A: Personally identifiable information may be lawfully processed under the General Data Protection Regulation with informed consent or with a legal basis for doing so which ranges from legitimate interests of the entity collecting the data or a third party performing a task under official authority in the public’s interest, in compliance with the controller’s legal obligation, in fulfillment of a contract with a data subject, and to protect vital interests of a data subject or another person. There are some similarities to the HIPAA informed consent and the various exceptions to the consent requirement including the requirements of clarity and the opportunity to withdraw consent. As with HIPAA, individuals must be apprised of their privacy rights and their ability to withdraw consent at any time under the General Data Protection Regulation.

Q: Are there exceptions or limitations to an individual’s right of access to information?

A: Limitations to disclosure and the individual’s right of access to protected data exist for overriding interests such as national security. Further, in recognition of the importance of providing health care across country boundaries and clinical research to fight disease, the General Data Protection Regulation doesn’t apply to statistical and scientific analyses. A recognition of the need to maintain the integrity of clinical research resulted in the limitation of the erasure right of the individual. The strengthened data protections of the General Data Protection Regulation are limited in the face of requirements of good science although companies engaging in clinical research, including patient recruitment in the EU, will need to evaluate their data compliance plans considering the requirements of the newly enforced law. In addition, the General Data Protection Regulation doesn’t apply to data related to employer-employee relationships.

 

Published: 7/20/18; by Paula Burkes
Original article: https://newsok.com/article/5601938/qa-with-mary-holloway-richard-u.s.-businesses-react-to-newly-enforced-eu-privacy-law

NewsOK Q&A: Oklahoma Medicaid plans offer solution for costly prescription drugs

oklahoma city health care attorney mary richard

Mary Richard is recognized as one of pioneers in Oklahoma healthcare law. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses steps Oklahoma has taken to lower prescription drug costs for consumers.

Q: Oklahoma recently has been recognized by Secretary Alex Azar, of the U.S. Department of Health and Human Services, for innovations in its Medicaid prescription drug program designed to lower drug costs to the state. How was the state able to accomplish this feat?

A: Medicaid is a federal program that’s administered by the states. In Oklahoma, it’s administered by the Oklahoma Health Care Authority. So, while the state receives some federal funding, a good portion of Medicaid funds are supplied by the state. In order to reduce costs related to prescription drugs, Oklahoma applied to the Centers for Medicare & Medicaid Services (CMS) and was granted an amendment to the Oklahoma State Plan that facilitates prescription drug cost savings. The plan links the payment of a drug to its effectiveness and outcomes. This is essentially what we refer to as “value-based” prescription drug purchasing. CMS reports that “(t)he state plan amendment proposal submitted by Oklahoma will be the first state plan amendment permitting a state to pursue CMS-authorized supplemental rebate agreements involving value-based purchasing arrangements with drug manufacturers.” This program is part of the Trump administration’s “American Patients First” blueprint, designed to address rising drug prices.

Q: How will the amendment work in Oklahoma?

A: The amendment to the state plan, as approved by CMS, now allows Oklahoma to negotiate and enter into valued-based contracts with drug manufacturers. This means that, through identifying the most effective medications, the state can tailor its negotiations with manufacturers to drugs that have demonstrated the most success in treating patients, thereby achieving cost savings and efficiencies in treatment. Negotiating value-based contracts will supplement Oklahoma’s ability to control drug prices under its current participation in the Sovereign States Drug Consortium. The Consortium negotiates supplemental rebates on behalf of states. Oklahoma is free to accept or reject rebate offers.

Q: Are there other cost saving initiatives related to decreasing prescription drug costs?

A: Currently, certain drugs have a preferred status if they’re listed on the Medicaid State Supplemental Rebate Agreement. Almost every state Medicaid plan, including Oklahoma’s, gives the state the authority to negotiate supplemental rebate agreements with drug manufacturers. These agreements allow for rebates to be given to the state by manufacturers as least as large as those provided in the Medicaid national drug rebate agreement. Importantly, two other parts of the Trump administration’s plan to decrease drug costs include giving Medicare insurance plans greater ability to negotiate for the Medicare Program (Part B and prescription drugs) and to make drug prices transparent for consumers. The latter part of the president’s plan would require drugmakers to disclose list prices in public advertising.

 

Published: 7/10/18; by Paula Burkes
Original article: https://newsok.com/article/5600913/oklahoma-medicaid-plans-offer-solution-for-costly-prescription-drugs

NewsOK Q&A: For health care providers, safeguarding patients’ electronic health information is also an employment matter

oklahoma city health care attorney mary richard

Mary Richard is recognized as one of pioneers in Oklahoma healthcare law. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses how safeguarding patients’ electronic health information is an employment matter with the Oklahoman newspaper.

Q: In preparation for an employee or other members of a health care company’s workforce quitting, what preventive steps can be taken to ensure that patients’ health information is protected?

A: Two particular measures are critical to health care providers, in their role as employers, to protect the private patient information. Those are preparation and training. First, advance preparation is essential. Administrative, technical and physical safeguards are mandated by HIPAA (the Health Insurance Portability and Accountability Act) and its amendments, and just as we recommend with regard to all types of health care compliance and regulations, a compliance plan should be in place to provide security for protected health information electronically maintained. The person responsible for a health care practice or company’s IT should perform periodic risk assessments, and sufficient access termination procedures should also be in place. Second, an important part of prevention is proper training. Just as we recommend preparation to respond to identity theft, employers must identify the individuals responsible for safeguarding electronically maintained protected health information and responding to a breach, and provide them with appropriate training. Since health care is such a labor-intensive industry, a high rate of personnel turnover requires proportionate re-training and monitoring of employees regarding compliance with privacy and other regulatory requirements.

Q: You mentioned termination procedures — what procedures provide effective deterrents to unauthorized use or access to electronically maintained protected health information in such situations?

A: As a part of an overall separation procedure, there are some critical checkpoints along the way. Health care providers/employers are advised to standardize the process and create a checklist of steps to be taken when an individual leaves. Document that these steps have been taken, including the return of any company equipment. Next, if the company or practice is large enough to have departments, it is important to quickly alert the department or staff members responsible for changing access to electronically maintained protected health information, deactivating or deleting user accounts and monitoring access. Also, after these and other important steps are carried out, I recommend a post-termination audit to verify that all necessary steps to cut off access to electronically maintained protected health information have been taken.

Q: What steps must be taken to terminate access to electronically maintained protected health information?

A: Such steps, in addition to terminating user accounts and reclaiming computers, laptops, iPads and cellphones, should include terminating access to the physical space, which may require changing locks, access codes, and authorized individuals lists. Obviously, keys, fobs, ID badges, card keys and other items by which the former employee gained access to the physician space must be reclaimed or reprogrammed so that access by the former employee or other former member of your company’s workforce to secure areas with electronically maintained protected health information is no longer possible. For all former employees, and particularly for those with remote access, deactivation of any remote accounts and accessibility should reach all levels of access so that portals, web access and email services are no longer accessible.

 

Published: 5/9/18; by Paula Burkes
Original article: http://newsok.com/for-health-care-providers-safeguarding-patients-electronic-health-information-is-also-an-employment-matter/article/5593919

NewsOK Q&A: Certificate of need laws can bridle behavioral, other care

oklahoma city health care attorney mary richard

Mary Richard is recognized as one of pioneers in Oklahoma healthcare law. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses Oklahoma’s Certificate of Need laws with the Daily Oklahoman newspaper.

Q: What are Certificate of Need (CON) laws and what is the status of CON in Oklahoma?

A: The history of CON laws is an interesting one. Federal law required CON for facilities that received federal funds to construct facilities. By 1978, unique CON statutes were passed in 36 states. Although the federal mandate was repealed in 1987, many states still have CON laws in place. The CON system was intended by Congress as one mechanism for controlling healthcare costs by controlling development. The idea was that unnecessary beds or services would drive up the costs and miss system efficiencies and economies of scale. Development was broadly defined to include activities ranging from new development, acquisitions, mergers, management agreements, leases, stock purchases and changes in ownership via foreclosure. The Oklahoma legislature repealed CON laws in all areas except for psychiatric and chemical dependency services and long-term care.

Q: What are current requirements for developing long-term care and behavioral health services in Oklahoma under these statutory schemes?

A: For long-term care, the Oklahoma law provides for development of long-term care services in a “ … planned orderly economical manner consistent with and appropriate to services needed by people in various (parts of Oklahoma) ….” Development must match or reflect the need demonstrated in the CON application as evaluated by the state Department of Health. The statutes also enumerate the powers of the Department of Health with regard to long-term care facilities, and services. The law applies to long-term care facilities including nursing homes, specialized facilities such as long-term acute care and skilled nursing facilities and the nursing component of continuity of care and life care communities. For psychiatric and chemical dependency service facilities, the process is outlined in the statutes and includes application requirements, findings by the state Board of Health, providing bases for the board’s decision, the opportunity for appeal of the board’s decision and an explanation of potential penalties for failure to comply.

Q: Some writers and consultants in the healthcare industry contend that these laws no longer serve the purposes for which they were created by legislatures or fail to achieve the ostensible objectives. Is this fair criticism?

A: All segments of the healthcare industry are highly regulated. There is a good argument to be made that business decisions in the healthcare space are guided by reimbursement, the impact of effectiveness and outcome metrics, and classic business principles such as market share and that, while the original ideas supporting the CON effort may have been sound, the system now provides an additional hurdle and expenses in two areas of significant needs in our state — services to the elderly and others requiring long-term care and to those suffering with behavioral health diagnoses. More specifically, Oklahoma’s CON rules apply only to hospitals so that development for treatment facilities not considered “hospitals” by the Oklahoma Department of Health are not covered by the CON procedures and limitations. The result is that addiction treatment facilities providing services, including beds, only require approval of the Oklahoma Department of Mental Health and Substance Abuse Services, which does not have its own CON process and can be developed without hindrance.

Q: Is there interest among Oklahoma lawmakers to repeal the last vestiges of CON law in Oklahoma?

A: Although this issue has come up in the last several years, it has not been successful. No such legislation was proposed in the first regular session of this legislative term, which ended in May. In terms of the status of CON laws in the nation, as of 2016, 14 states had discontinued their certificate of need requirements and 34 continued with some remnant of the CON system.

Published: 10/12/17; by Paula Burkes
Original article: http://newsok.com/qa-with-mary-holloway-richard-certificate-of-need-laws-can-bridle-behavioral-other-care/article/5567643

NewsOK Q&A: Feds paid $60 million in ‘improper’ Medicare payments last year

From NewsOK / by Paula Burkes
Published: September 29, 2017
Click to see full story – Feds paid $60 million in ‘improper’ Medicare payments last year

Click to see Mary Holloway Richard’s attorney profile

Mary Richard is recognized as one of the pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families.

Q: In 2016 the federal government paid out $60 million in “improper payments” to Medicare and Medicare Advantage plans. What are improper payments?

A: The prohibition against improper payments applies to Medicare and to the Medicare Advantage plans which stand in the place of Parts A and B but offer more choices to patients in the private insurance market. Most are HMOs, PPOs and private fee-for-service plans. “Improper payments” refers to both underpayments and overpayments. The most common payment problems are traced to insufficient documentation of the care provided. Other problems are no documentation, failure to establish medical necessity and incorrect coding. Regulators tell us that the objective is to understanding the ordering practitioner’s reasoning in evaluating and diagnosing a patient, in considering alternative course of action and in selecting a specific treatment plan with the patient. Just as physicians have been trained to document robust informed consent, they are now being called upon to document their thought processes as a way of demonstrating the legitimacy of the treatment.

Q: What action can the federal government take once an improper payment has been identified by the Center for Medicare and Medicaid Services (CMS)?

A: The CMS is part of the Department of Health and Human Services and it has an investigative arm known as the Office of the Inspector General (OIG), which is the most robust of all federal agencies’ legal and investigative arms. The OIG can investigate a provider and refer the matter to the Department of Justice to bring a criminal or civil action against the provider that can result in repayments, penalties and even incarceration. Such actions also ultimately can result in exclusion from federal payment programs and even loss of the provider’s clinical license to practice. A demand for repayment can be based on an extrapolation of a statistical sample of a provider’s claims submission and payment history.

Q: How can providers avoid making claims that result in improper payments? Are there certain kinds of providers who are at the greatest risk for coding errors?

A: In the face of this regulatory environment, providers would do well to engage in periodic preventive spot audits of their medical records documentation, coding and billing activity. Billing regulations are increasingly complex and require advanced training not only of the practitioner, but also of his or her staff, billing company and supporting professionals such as accountants and attorneys. Continuing education, coding seminars and the like are the order of the day for persons with these responsibilities.

Q: What’s the potential impact of these billing errors on patients and on providers?

A: Improper documentation can be a result of mistakes, faulty documentation or fraud. Some documentation shortcomings can be traced back to the provider’s original training or education. Others relate to the electronic records formatting, which some experts argue fosters copying responses rather than creating medical record entries for each patient. Ideally, eliminating unnecessary claims benefits the health care system financially and so ultimately benefits the patient. However, in my experience, “false claims” often represent a failure on the business side of a medical practice or facility operations in a situation where quality services were actually performed. But once characterized as an overpayment, the amount paid by the Medicare contractor must be returned despite the fact that quality services were provided.

Mary Holloway Richard sourced in article investigating hospital merger

Mary Holloway Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families.

Mary Holloway Richard, Phillips Murrah Of Counsel Attorney and leader of the Firm’s Health Care Practice, was quoted in a Journal Record article by Sarah Terry-Cobo regarding an attempted merger by OU Medical System and how best to financially achieve that mission.

Read Richard’s comments from the article below:

OKLAHOMA CITY – When it comes to complicated relationships, sometimes it just takes the right partner. After a failed hospital merger was announced Monday, OU Medical System could still find its better half.

But making that match probably won’t be easy, said industry observers. Health care attorney Mary Holloway Richard said a potential partner needs the business expertise as well as the financial backing to purchase a large teaching hospital.

Richard said teaching hospitals have historically had higher costs than non-academic hospitals.

A potential partner has to evaluate the economic feasibility, regardless of whether parties are considering an outright acquisition or a joint venture, she said.

“Will it fit in with your overall business model?” Richard said. “(A teaching hospital) is a complex system, so how you incorporate that complex system into an existing system requires mastery of both the business model and the financial feasibility, as well as recognition of the compliance issues at play.”

Read the full article at the Journal Record.

Attorney Mary Holloway Richard sourced in CARE Act article

Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

Phillips Murrah Attorney Mary Holloway Richard was featured as a source in a Journal Record article by Sarah Terry-Cobo.

The article, titled “Complex prognosis: Hospital group, AARP disagree on CARE Act,” focuses on the 2014 Oklahoma Caregiver Advise, Record, Enable Act and the protections it adds.

From the article:

Mary Holloway Richard, a health care attorney at Phillips Murrah, said the CARE Act doesn’t provide anything fundamentally different for elderly patients than laws in place before it was passed. Though the caregiver designation is different than a legal power of attorney, the patient still must sign a written release before the hospital can give out information to another person, she said.

“You could achieve the same thing if you got a release-from-patient for my best friend or my cousin, and in the discharge note you explain the care plan, and the patient gives you the release,” Richard said.

Read the rest of the Journal Record article here.

 

NewsOK Q&A: Laptop losses, misdirected faxes and phishing scams can lead to health information breaches

From NewsOK / by Paula Burkes
Published: May 1, 2015
Click to see full story – Laptop losses, misdirected faxes and phishing scams can lead to health information breaches

Click to see Mary Holloway Richard’s attorney profile

Phillips Murrah’s Mary Holloway Richard provides medical providers tips for minimizing risk and damages related to health information breaches.

Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

Q: What do you recommend to hospitals, physicians and other providers to minimize the risk of a breach of confidential patient information and to lessen the degree of harm in the event of a breach?

A: I recommend creation in advance of a response process to enable a rapid, sensible response. The goals in such a plan (“Incident Response Plan” or “IRP”) are to demonstrate compliance with HIPAA (Health Insurance Portability and Accountability Act) and HITECH (Health Information Technology for Economic and Clinical Health) regulations and to mitigate any harm that may result from the breach.

Q: What specific steps should be taken to prepare for a breach?

A: The first step is to create an IRP that includes all appropriate parties and to appoint someone in the practice or facility who is knowledgeable about HIPAA and HITECH requirements. The second step is to make certain that the process created is a quick, sensible one. In addition, information technology (IT) components, such as encryption throughout the process, are imperative. The safe harbor provision of the breach notification rule establishes a certain standard of encryption and relieves the provider from breach notification responsibilities if the protected patient information has been properly encrypted. Most breaches result from lost IT assets such as phones, laptops and iPads. Fourth, the IRP must be supported by sufficient employee and staff training. I also recommend that you adequately document that this training took place. Finally, insurance should be in place to provide for risk transfer as needed. Cyberliability is a continually developing area along with a range of products that foresee types of breaches and predict costs that may be incurred.

Q: How do such losses occur?

A: Along with loss of IT assets, misdirected faxes, disposal of nonshredded records, inappropriate disposal or destruction of paper, such as placing material in a dumpster without shredding and mailing patient information to incorrect address. Intentional loss or compromise of data can occur through a combination of IT and social engineering, such as where a person is tricked into clicking on a hyperlink or revealing a password. This occurs with Spear phishing or false emails inserting malware in a system and is very difficult to control. In the case of Cryptolocker, the perpetrator makes a threat and requires payment to restore prevention. This also is called ransomware and can make the system and information completely inaccessible to everyone in your organization, effectively stymieing patient care and business operations.

Resolution of the “sustainable growth rate” issue

By Mary Holloway Richard.  View her attorney profile here.


medicare

Senate Passes the bill repealing Medicare’s sustainable growth rate (“SGR”) formula just in time to avoid the looming cuts (21%) to physician payments.

(See HERE our ongoing coverage leading up to this.)

Congressional members are purportedly patting themselves on the back as the bill goes to the President who has given assurances that he will sign it.

In the past weeks we have discussed possible amendments, but none of the amendments are included in the final legislation approved by the Senate.  The bill extends the Children’s Health Insurance Program (“CHIP”) for two years.  The bill also provides physician incentives sure to impact both reimbursement and physician contracting include incentives to shift more patients to risk-based payment models.  For physicians who are successful in this effort, as interpreted by CMS, the reimbursement will increase in 2019.

Approximately one-third of the cost of this package is offset by financial cuts to providers and increased costs to wealthier Medicare patients.  The bill also includes additional funding for community health centers and a six-month delay in the enforcement of the payment policy for short inpatient stays known as the “two midnights” rule.

Mary Holloway Richard is recognized as one of the pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

(UPDATE) What does all of the talk in the media about the “SGR” mean for physicians?

By Mary Holloway Richard. View her attorney profile here.


Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

(Updated 4/14/15)

What does all of the talk in the media about the “SGR” mean for physicians?

One of the important issues identified in the health care industry “crisis” and reform is the cost of providing services.  Focus has been on shifting payment from charges for visits and procedures to reimbursement according to certain metrics such as outcome and quality.  In addition, a ceiling on physician reimbursement has been much debated.  The Affordable Care Act (“ACA”) included the Medicare sustainable growth rate (“SGR”) formula for doing just that, although the SGR was actually created as part of the 1997 deficit reduction law designed to contain federal spending  by tying physician payments to an economic metric or growth target.

On Tuesday, March 24, 2015, Democrats and Republicans revealed the result of their negotiation and cooperation to offer an alternative to Medicare’s SGR formula.  The proposal calls for repeal of the SGR formula.  House Speaker John Boehner (R-OH) and Minority Leader Nancy Pelosi (D-CA) have arrived at this compromise to strengthen the financial picture for Medicare and to end the continuing threat of payment cuts to physicians.  According to the Association of American Medical Colleges, although medical school applications are up slightly since 2011, the United States faces a physician shortage of between 46,000 and 90,000 by 2015.  www.aamc.org/newsroom/aamcstat/,a=427828.  The economic incentives to the professional are an integral component in stabilizing the health care system in this country.  The House overwhelmingly approved the proposal on Thursday, March 26, 2015.

What does the SGR mean to physicians?  There is still great divergence between the Boehner (repeal Washington’s most famous gimmick) and Pelosi (Medicare payments for doctor services to seniors facilitating continuation of physician-patient relationship) perspectives.

What does the bipartisan proposal mean to physicians?  This will halt the cut that was to be implemented on April 1, 2015.  When the ACA was signed five years ago, that seemed like a long time away but was nonetheless worrisome.  It puts in place a 21.2% reduction in Medicare payments making it virtually impossible for many providers to support the operations of their practices or clinics.

This proposal is very similar to the one proposed in 2014 , and it includes a system of rewarding physicians based upon quality standards rather than output or number of services provided and fosters a focus on coordination of care, prevention and quality and key cost containment strategies.  All of these elements are part of a new accountability that is the cornerstone for allowing payment increases for doctors for the next five years during this period of transition.  In addition, if approved by the Senate, the bipartisan proposal would extend the Children’s Health Insurance Program (“CHIP”) with full funding through September 30, 2017.  It also provides for $7.2 billion funding for community health centers.  The cost of the House package is $200 billion

On Friday, March 27, 2015, the Senate adjourned without approving the Doc fix.  It apparently will take up the issue upon its return in mid-April.  In the meantime, CMS is poised to delay processing provider claims as of April 1, 2015, when the 21.2% cut was to go into effect.  However, CMS is warning that the cut will go into effect if the Senate fails to pass an SGR fix by April 15.  One complication may exist in the form of legislation introduced by a bipartisan Senate team, Senators Cardin (D-MD) and Collins (R-ME), to permanently repeal the caps on how much the program spends on rehabilitation therapy.  This unresolved issue may arise as an amendment to the legislation to be considered after the break and provides a reminder of how single issues or senators can ultimately frustrate the passage of legislation that has support from both parties.  Others in the Senate are critical that spending cuts will offset only a portion of the costs.  Conservatives have characterized this element of the plan as irresponsible.  The AARP is focused on increased costs to Medicare beneficiaries and will continue to lobby for changes to lower these costs.

Democrats may want amendments to extend the CHIP program four years, to remove the Hyde Amendment (abortion-related language), and to repeal the Medicare therapy cap.  Any amendments would, of course, send the legislation back through the House, and this appears to be an unattractive alternative to all concerned because of the remarkable support for this resolution from both parties.  A perhaps more significant complication is presented by the report issued last week by the Office of the Actuary of the Centers for Medicare and Medicaid Services (CMS) indicating that physician payments in which the 0.5% increases in Medicare payments over the next four years would come to a halt in 2020.  In that year a two-tiered system is phased in which is designed to encourage physicians to shift greater numbers of patients into risk-based models.  For physicians continuing to work within the traditional payment system, but who are scoring well on the quality metrics, remuneration will be awarded from a separate appropriation.  After 2024, the alternative payment track would increase annually by 0.75% which will be three times greater than the rates of other physicians. CMS is predicting that 2024 is the time when there will be a shortfall and payments will lag behind inflation.

On the one hand, Congress is fed up with required annual intervention for the past seventeen years to avoid scheduled cuts to physicians.  On the other hand, Congress is forced to rely on estimates to predict costs which places the federal government at risk of future payments not keeping up with the either the chosen formulae or with inflation.

(UPDATE) A look at the controversial Affordable Care Act on its fifth anniversary

By Mary Holloway Richard. View her attorney profile here.


Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

(Updated 4/7/15)
President Obama has taken the occasion of the fifth anniversary of the signing of the Affordable Care Act (“ACA”) to characterize continued activities on the Hill to repeal it as renegade special interest activities. The ACA continues to be a subject of debate both in terms of its accomplishments—how many are newly covered and how much will be saved—and in terms of its public support.

While the Associated Press reported on March 23, 2015, that public support was down 5% since its passage, as one who daily writes and advises health care clients on matters related to the ACA, I can say with certainty that the depth and breadth of increased regulation spawned by the ACA are changing the nature of the system.

Those changes include responsive movement toward integrated health systems, mergers and affiliations; transition from quantity- to quality-based reimbursement; the relaxation of HIPAA standards in some respects and its tightening in others in the context of EHR transformation; and increased direct and indirect costs to employers as a result of new responsibilities.

Nearly fifty changes have been made to the ACA as of March 2, 2015, and this suggests a continuing need for providers, employers and business owners to remain informed and responsive to the moving regulatory compliance target.

On Monday, March 30 the Supreme Court rejected a new challenge to the Affordable Care Act (“ACA”)  that targeted the Independent Payment Advisory Board (“IPAB”), a 15-member government panel which has been characterized as a “death panel” because of its intended role in cutting Medicare costs.   The IPAB was to convene when the target growth rate for Medicare (3.03%) is exceeded.  However, the growth rate is 1.15% according to CMS, and so the administration has not nominated any panel members.  In declining to take up the case, the Supreme Court left undisturbed the 9th US Circuit Court of Appeals in San Francisco dismissal of the lawsuit. The proponents of the ACA are calling this a win.  Coons v. Lew, No. 14-525.   Certiorari was denied by the United States Supreme Court on March 30, 2015.

SCOTUS order to stay executions doesn’t change anything

shutterstock_lethal-injectionThe Supreme Court of the United States stay order blocking three pending executions in Oklahoma, handed down Jan. 28, doesn’t actually change anything, said Phillip Murrah Director and one of the firm’s founders, Robert N. Sheets.

While there is much interest and coverage of the motion, no decision has been made that will change how death sentences are carried out – other than a mandate to remain in place for the time being.

While the occurrence is quite interesting, it is simply an order to halt executions until the highest court of the land has a chance to hear arguments and make a decision.

From The Supreme Court of the United States on Jan 28, 2015: Application (14A796) granted by the Court. Respondents’ application for stays of execution of sentences of death presented to Justice Sotomayor and by her referred to the Court is granted and it is hereby ordered that petitioners’ executions using midazolam are stayed pending final disposition of this case.

Wednesday’s order doesn’t address the death penalty. The State of Oklahoma is still able to execute condemned prisoners by any other means previously deemed constitutional, Sheets noted. The Stay also doesn’t make a determination about the controversial decision to use the drug midazolam as lethal injection agent during the execution process. It doesn’t determine anything about constituent ingredients. It doesn’t address process or propriety. It doesn’t make any kind of judgment, one way or the other.

What happened here in Oklahoma is simple – Oklahoma attorney general Scott Pruitt asked earlier this week for the stay, according to a report by The Associated Press:

“Rather than stop the executions himself, Oklahoma Attorney General Scott Pruitt took the unusual step of asking the justices for a stay. Oklahoma wants the right to resume executions if it finds a different suitable drug.  Pruitt said in a statement: “It is important that we act in order to best serve the interests of the victims of these horrific crimes and the state’s obligation to ensure justice in each and every case. The families of the victims in these three cases have waited a combined 48 years for the sentences of these heinous crimes to be carried out.”

The United State Supreme Court, defense attorneys for the condemned inmates and the Oklahoma Attorney General agreed that the state should wait on these executions until final disposition of the case. The executions are put on hold until the Court can hear Richard E. Glossip v. Kevin J. Gross.  Richard Glossip was the next inmate scheduled to be put to death

SCOTUS scrutiny: The drug and how it is administered

The Supreme Court will hear Glossip v. Gross in April and issue a decision in the summer. The focus of the case is the drug, midazolam, and whether it causes pain and suffering in the inmate. The drug is part of a drug combination used in the state’s lethal injection process. Last year, Oklahoma received worldwide attention after an execution using the same drug when terribly wrong.

During the execution process, midazolam (Midazolam Hydrochloride) is administered to the inmate, first, as a sedative. That injection, according to The New York Times, “was to be followed by injections of vecuronium bromide, a paralyzing agent that stops breathing, and then potassium chloride, which stops the heart.”

Phillips Murrah attorney, Mary Holloway Richard, a pioneer in healthcare law who has practiced in the area of clinical research and regulatory law for many years, said that the drug, itself, isn’t necessarily the problem. Rather, how and under what conditions it’s administered could be more at issue.

“To eliminate some of the mystique, this is the drug commonly known, and used, as Versed,” she clarified. “This drug is used in many venues and even for many different types of patients, including pediatric patients.”

A significant issue is raised by the exact recipe of the drug combination and the amount of Versed used, she added. “I keep seeing that it must be titrated properly.”

In other words, the dosage amount and duration of administration is very important to successful effect. Oklahoma has a three-drug protocol.

Also implicated is the manner in which the drug is administered. After the Clayton Lockett execution problems, Oklahoma released a report identifying insufficient training of those administering the drug and communication between prison and support staff, as well as a lack of contingency planning on the part of the Department of Public Safety.  The report also points to difficulties in starting the IV in Mr. Lockett.

More info: http://www.deathpenaltyinfo.org/state-lethal-injection

 

Healthcare cost-cutting trend ties money to results

By Mary Holloway Richard, Of Counsel

healthcare-shutterstock-02The trend toward decreasing costs in healthcare has seized upon value-based care – tying physician compensation to performance and outcome measures. These measures are also being used in contract negotiations with third party payors and healthcare plans.

Counsel for institutional and non-institutional providers are at the table providing advice about a number of important contractual terms and their ramifications including appropriate and measurable metrics for calculating bonuses and penalties and, if shared savings are at issue, how they should be split. For those who have been involved in negotiations of traditional fee-for-service contracts, this will seem like a fundamental change. It may also seem like a change that narrows the potential for disputes.

However, numerous issues will continue to be important to providers. For example:

  • Are the metrics used as incentives or penalties?
  • Are the selected benchmarks easily measurable and attainable?
  • Do they raise regulatory issues such as potentially impacting volume in an unacceptable way or spawn any other results that could be construed to be anticompetitive?

While these questions have yet to be answered by Oklahoma courts, we can look to decisions from other states and consider ourselves forewarned as to the nuances and potential pitfalls in negotiating and drafting these terms.

2015: The future for hospitals

By Mary Holloway Richard, Of Counsel

doctorIn a recent article in Modern Healthcare, Beth Kutscher identifies a rosier outlook for propriety hospitals than for not-for-profit facilities.

Some of those proprietaries are investor-owned chains, and an important part of their secret of financial health is their access to and reliance upon greater options for marketing services, economies of scale, and other cost saving programs.

Financially positive trends have come on the wings of the Affordable Care Act’s elevated patient volumes, better payor mix and declining expenses associated with bad debts. The proprietaries are concerned with stock prices and earnings and, like a family preparing for continued hard times, they actively pursue all possible ways to decrease expenses, including refinancing higher interest debt.

In largely rural states like Oklahoma, efforts to keep community hospitals alive include shopping for buyers and affiliating with stable hospital systems. However, rural hospitals owned by proprietaries, and even hospitals owned by not-for profit systems, are being taken off the block awaiting a more attractive market.

It is true that we witnessed the acquisition by Community Health Systems, one of the largest publicly-traded companies in the country, of Health Management Associates last year. But even so, CHS may now be eschewing large acquisitions and mergers in favor of other alternatives for financial stabilization.

In healthcare as in other industries, the proprietary sector offers important motivation for the not-for-profits.

Responding to Ebola

By Mary Holloway Richard, Of Counsel/Litigation

Guest Column in The Journal Record, Published Oct. 15, 2014

shutterstock_210544051-1Incidence of Ebola on American soil allows for review of legal underpinnings of the public health response to “catastrophic health emergencies.” This term means, for our purposes, occurrence of imminent threat of an illness or health condition that is believed to be caused by the appearance of an infectious agent that poses a high probability of a large number of deaths in the affected population or widespread exposure to the infectious or toxic agent that poses a significant risk of substantial future harm to a large number of people in the affected population (63 O.S. §6104).

The federal government’s rapid response derives its power from the Commerce Clause of the U.S. Constitution (42 U.S.C.A. §264, Section 361 of the Public Health Service Act). The secretary of the Department of Health and Human Services is authorized to take measures to prevent the spread of threat of disease from other countries to the U.S. and between states. Borders are being monitored more stringently. States and tribes have the political power to detail those within their borders in an effort to contain such a threat. Police power functions include isolation-quarantine, access to and use of private health information, closure, lockdown, curfews, and appropriation and destruction of property, including pets and other animals. Those powers are derived from the state’s right to take action against individuals for the good of the people at large.

Oklahoma State Health Department regulations provide for isolation and quarantine including proper due process for affected people (OAC 310:521-7-6). On Oct. 10, the Centers for Medicare and Medicaid Services issued a memorandum to state survey agency directors (the state Department of Health in Oklahoma) to strongly urge hospitals to fully implement recent Centers for Disease Control policies for Ebola, including hospital evaluation and preparedness checklists and algorithms to evaluate patients returning from countries affected by the disease.

Emerging legal issues include privacy rights, provider and volunteer liability, due process and Fourth Amendment protections for mandatory testing and screening of citizens, licensure and scope of practice issues for noninstitutional health services providers giving aid, myriad informed consent, right to refuse treatment, and social distancing and remote handling of citizens including the effect of Americans with Disabilities Act protections.

The Role of Telemedicine in Meeting the Behavioral Health Needs of Oklahomans and Attendant Legal Issues

Click here to view the publication in full: “The Role of Telemedicine in Meeting the Behavioral Health Needs of Oklahomans and Attendant Legal Issues” (Oct 4, 2014)