Regulation

CMS’s Andrew Slavitt talks with MMS about MACRA

Posted in Electronic Medical Records, Health Policy, Health Reform, Payment Reform, Regulation on May 26th, 2016 by MMS Communications – Comments Off on CMS’s Andrew Slavitt talks with MMS about MACRA

Editor’s Note: On April 27, 2016, the Department of Health and Human Services issued a Notice of Proposed Rulemaking to implement key provisions of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), bipartisan legislation that replaced the flawed Sustainable Growth Rate formula with a new approach to paying clinicians for the value and quality of care they provide.  In early May, the Massachusetts Medical Society sat down with Andrew Slavitt, Acting Administrator of the Centers for Medicare and Medicaid Services, to talk about the new rule and how it was developed.  More information on the Proposed Rule can be found here.

MMS:  Recently you said that you thought CMS had lost the hearts and minds of America’s doctors, and the new MACRA rule was an opportunity to win them back. Can you tell us how you got to that point and why you think the new proposed rule will change physicians’ perceptions?

CMS Acting Administrator Andrew Slavitt

CMS Acting Administrator Andrew Slavitt

MR. SLAVITT: I want to start with mentioning that the Quality Payment Program that we put out in a proposal comes at a very exciting time in the evolution of Medicare. The implementation of MACRA allows us to take the next transformative step in the Medicare program, by introducing the Quality Payment Program to pay physicians and other clinicians for quality, with a more flexible approach, common-sense approach.  MACRA repealed the SGR and streamlined the patchwork of Medicare programs that currently measure value and quality into a single framework where every physician and clinician has the opportunity to be paid more for providing better care for their patients.  MACRA builds on the important reforms of the Affordable Care Act, which increased the numbers of Medicare clinicians participating in alternative payment models, which are models that reward coordinated, innovative care.

But, there is a lot of fatigue that has come with all the changes over the years. We know it can feel like there are people that sit around thinking of ideas for how to make a physician’s job more difficult; when what is really happening is the accumulation of requirements over time, passed in a series of laws or that come through a series of regulations. If people don’t implement and manage them carefully, we end up in a situation where I think we are now –  where despite all of the best intentions, the burdens add up for those on the front lines where care is given or received.

If people don’t feel like they’re being heard, if they don’t feel like they have a voice, and if they don’t feel like the changes make sense for their practice, it can be incredibly demotivating.

We have approached the implementation of MACRA with the belief that physicians know best how to provide high quality care to our beneficiaries.  And we have taken an unprecedented effort to draft a proposal that is based directly on input from those on the front line of care delivery.  Before drafting the Quality Payment Program proposal, we reached out and listened to over 6,000 stakeholders, including state medical societies, physician groups, and patient groups to understand how the changes we are proposing may positively impact care and how to avoid unintended consequences.

The feedback we received shaped our proposed rule in important ways—and the dialogue is continuing. Based on what we learned, our approach to implementation is being guided by four principles, which I think are also consistent with the goals of the MACRA legislation.

  • One is to keep the patient at the center, always.
  • Two, give physicians more flexibility to control their own destiny and to control what gets measured, how it gets measured and have a little bit more say in how things work, because I think that flexibility is a critical ingredient to some of the issues that we talked about.
  • Three, is simply to do less. Find opportunities wherever we can to reduce the burden. It’s as simple as that.
  • Fourth is simplify, simplify, simplify. That is something we try to take an opportunity to do in every place we could, whether it’s in the use of technology, whether it’s in taking this patchwork of programs and consolidating them and, it will be in how we ultimately implement many of the other components. We have an opportunity to really make a big change. What we’re going to have to do well is continue to listen, provide as much flexibility as possible and simplify.

At the end of the day, after thoughtful and skillful execution, it will be time that tells us how well we have done.

MMS:  You also talk about user-driven policy design. Can you talk about what that means and how it influenced the new Meaningful Use rules now called Advancing Care Information?

MR. SLAVITT: Sure. It’s actually not that radical a concept in the real world. In the real world it might be called “talking to your customers about what they want.” Perhaps in Washington, though, it is a bit of a new concept.

A great example of user-driven policy design would be the visit that you led us on when we were in Massachusetts: Sitting down and listening to what people who deliver care say about the impact of our work at CMS. There is no magic to it: just listen; translate needs into actions; create and deliver; communicate and seek further input; continue to iterate.

In a nutshell the big trap when doing public policy is to do it from your desk. The opportunity we all have – and it’s quite exciting for the people in the agencies – is to really get out there and think about what it feels like at the kitchen table of the American family, what it feels like in the clinics where people get care and how to improve on that. It is a wholesale different way of approaching this work.

When we implemented ICD-10, we used a bit of this approach, I think successfully. We are attempting to roll it out more significantly with the Quality Payment Program. I think you’re exactly right, the Advancing Care Information proponent of MIPS is a critical aspect which we took in a significant amount of input on.

And like I said, continuing to listen and iterate is a very important aspect of user-driven policy design. We are in the phase now of listening to input. And even after we publish the final rule, we will listen and iterate.

MMS:  You’ve also compared the new MACRA proposal to the rollout of an iPhone. So if you’ll forgive me for expanding on that analogy, even in Massachusetts there are physicians who are still using flip phones. You’ve also said, and I’m paraphrasing, that it’s okay to have payment models that aren’t perfect as long as we learn from them. How do you see these perspectives fitting into the implementation of MACRA, e.g., opportunities for physicians who are not used to taking on risk, learning how to bear more risk without fearing that they’re going to lose their practices?

MR. SLAVITT: It’s really important to put in context what payment model and incentives are supposed to do. I have never met a physician, nor do I hope to meet a physician, who makes decisions on patient care based upon how they’re going to get paid. I don’t think that’s how physicians are wired.

The role of payment models and incentives is simply to reinforce what the clinician believes to be the right way to deliver care. If incentives are done well and done right, clinicians will get reinforcement financially; and the payment system gives them the opportunity and the dollars to invest and reinvest in the kinds of things that they believe are right for their practice and for their patients. We have to make sure it is clear that we know it is the clinical and cultural leadership that improves quality, not public policy.

The point I was making about the iPhone is that we are in early generations of some of these payment models. The clinicians who participate should be aware that models are meant to reinforce the good practice of medicine, but the models are not going to be perfect. The models are going to have to get better over time based upon how they get used in the real world and improved upon. For instance, in our second generation models we have made changes, like adding telemedicine or adding patient incentives to make sure that the patient is aligned with their physician in staying healthy.

And where did the changes come from?  They came from listening to physicians and patients. The physicians tell us this model would be better if it could do this, if it could do that. And that’s the thinking that has to continue. So, like any other good, user-driven program, we want an ongoing dialogue so that year over year the program improves for patients and clinicians.

MMS:  So on to interoperability, which I know is one of your concerns. You know it’s one of the physicians’ greatest frustrations. Secretary Burwell has said 90 percent of EMR vendors are committed to interoperability, which is great. I think I can hear physicians nationally groaning because they think they’ve heard this before. So what is it that CMS can do and HHS can do to make it real?

MR. SLAVITT: Let’s talk about what interoperability really is. This is such an important ingredient to improving health care. But interoperability in some respects needs to just be as simple as this: how can we collaborate for the best outcomes when a patient is going to experience different parts of our fragmented health care system? What we want out of interoperability is simple: having a patient referred for other care and understanding what happens at that visit; or communicating with the physician when a patient is discharged from the hospital to make sure they are taken care of and are healing at home.

As you mentioned, Secretary Burwell announced that companies representing 90 percent of EHRs are committing to three vital steps to real interoperability. I thank the many who have made this commitment. It has the potential to set us on a new course, but we all need to be more committed than ever to making sure that the substance of this pledge translates to reality.

And you’re exactly right about physicians groaning; we are not talking sending a man to the moon. We are actually expecting technology to do the things that it already does for us every day. So there must be other reasons why technology and information aren’t flowing in ways that match patient care.

Partly, I believe some of the reasons are actually due to bad business practices. But, I think some of the technology will improve through the better use of standards and compliance. And I think we’ll make significant progress through the implementation of API’s in the next version of EHR’s which will spur innovation by allowing for plug and play capability. But the reason that the pledge is important is because the private sector has to essentially change or evolve their business practices so that they don’t subvert this intent.

In some respects, you can look at me and you can look at the government and say, “Why don’t you just mandate that people do this?”  We have very few higher priorities, but the reality is that if we really want change, we need everybody to put pressure on people in the system to make the technology work. So, if you are a customer of a piece of technology that doesn’t do what you want, it’s time to raise your voice. We’re doing everything we can to make sure that the technology vendors stop focusing on meeting the regulations, so they can start focusing on their customers and their users, and design around the physicians’ needs, the caretakers’ needs, the patients’ needs.

MMS:  We reached out to other medical societies nationally to get some questions for this interview, and they’re all interested in MACRA’s Quality Payment Program, including MIPS and APMs. Many of the questions had a pretty common theme: Physicians are willing to be held accountable for what they’re doing and they know they’re going to be graded on it, so to speak, but they’re concerned about being held accountable for things that are not under their control, whether it’s care that’s not under their control or let’s say a non-compliant patient for whatever reason. The other part of it was registries; how can the medical community be more involved and engaged with CMS in the development of these registries. So your thoughts on those two issues?

MR. SLAVITT: They’re very good questions. First, I’ll just go back to my earlier comment, which is that these payment models are intended to be strong signals about the kind of activities that improve patient care. And so, yes, a physician will feel like there are some things that they’ve got to really influence and pieces of the puzzle that they don’t control; we are interested in hearing about those and making sure that those make sense.

However, patient compliance is a tough but critical part of the process, and efforts to communicate to patients and so forth are obviously part of what physicians do and have been doing for a number of years. At the same time, we’re hearing amazing stories from physicians in small practices and rural, underserved communities.  Motivated and driven with a passion for patient care, they are redesigning their care teams around their patient needs in ways that are having dramatic impacts in patient compliance and health outcomes.  Meaningful impacts, such as significantly improving A1C levels – even as practices expanded to take on sicker, under-insured patients – and significant increases on follow through for referrals on behavioral health and addition referrals.  These are improvements that matter in our communities and in our homes.  And we’re hearing physicians say, “This is incredible! We’re practicing medicine again!”

We work very hard to create what we call a core set of measures, which means that we want to be on the same page with every other payer that’s in a physician’s office so that a physician can focus on one way of doing things.

For specialists, we’ve done a lot of work and a lot of collaboration.  Eighty percent of our measure sets are specialty specific, and the vast majority of those measures come from physician leadership outside of CMS where people are saying this is the evidence-based state of practice, this is what we want. We spent a lot of time engaging the clinical community – medical societies and front-line physicians – to design a program that’s equally meaningful to a wide range of specialties that practice in very different settings.  There’s plenty of ways to be successful within the Quality Payment Program. In addition, for small practices, we’ve designed our proposed rule to provide support and flexibility that match their circumstances, including increased technical assistance, exemptions for small volume practices, allowances for medical home models, and a continued focus on reducing reporting burden.  Our teams are set up to evolve these rules and the clinical community needs to continue to be a strong partner in this process.

MMS:  You are in charge of the most powerful agency in the nation to effect changes in health care in this country at the time of greatest change in health care. So what do you see as your role in this position and the role of CMS in helping shape the future of health care?

MR. SLAVITT: I think it’s really to listen to and absorb the voice of the people that are doing great care every day. We have 140 million consumers that are a part of Medicare, Medicaid and the Children’s Health Insurance Program, and the Marketplace.

If you start with that, let’s talk about what their life is like. They’re increasingly mobile. They’re connecting to an often fragmented system where they’re not anchored. Many of these 140 million, the vast majority are on modest incomes or fixed incomes. They may have family-care needs, both with parents and with children. They worry about how they’re going to pay for the next prescription drug or about missing their bus to their next dialysis appointment. They worry about whether health care is going to become too expensive to manage.

So if you keep it at that fundamental level, it makes, I think, our job pretty clear: represent the needs of the people we serve and to make sure those needs are getting met. CMS will continue to shape health care by making sure these programs are preserved, as well as evolve to meet the needs of the patients.

The wrong way to do that is to put a bunch of policy ideas together in a black box and try to implement them.

The best way – and it is very exciting – is to manage these programs by capturing both the voice of the patients and of the voice of the clinicians, represent those the best we can, and drive towards the delivery of high quality care.

MMS:  Is there anything else you want to say?

MR. SLAVITT: I want to thank you all at the Mass. Medical Society for the visit we had in Boston in the physician’s office. It is so important that we figure out how to connect public policy to what happens on the ground and in the real world. It’s invaluable. And we have to keep it up. It’s not one-off. It must be a cultural commitment. In fact, in the month of May alone, we have 35 scheduled events to hear from a wide range of stakeholders and this outreach will remain an important ongoing part of our work. I personally have been meeting regularly with physician groups, including smaller and rural practices, and have spoken to thousands of physicians in different parts of the country about their work, the opportunities and challenges they face, and what this proposal means for them and their patients.

The second thing I’d say is for physicians who are looking at these new regulations, to please get engaged. There is no possible way, for all the thinking our team can do, that we can anticipate every consequence of what we are working on. And as we aim to provide you with meaningful flexibilities, reduce your burden, and simplify how things get done, please help us think about how these programs can fairly and objectively reward you for the quality of care you delivery.

With all of the work that went into the proposal, it is critical that we receive direct feedback from physicians and other stakeholders. We rely heavily on the feedback for people to say, “I see your intent but what is happening is there’s an unintended consequence or there is a better way to lead us.” If physicians don’t get engaged, then consequentially they will feel the impact of things that they really could have influenced, and we want them to see that we are listening.

I know Washington can feel so distant, policy-making can feel so distant, and I think people are just, sheer exhausted for good reason, so sending in feedback can feel too difficult or pointless. But if this is truly able to be moved forward with all the input of the people who take care of all the beneficiaries (who I like to think actually run Medicare every day), then these new improvements will go so much better, and the Medicare program, the patients in these programs, and the practice of medicine will be the better for it.

I recognize that it’s not the talk, but how we act together, that moves things forward. Which is why I think the change from Meaningful Use to this new, much simpler, much more flexible program of Advancing Care Information is so important because it’s intended to be, among other things, a proof point that we’re not just talk. We are willing to look at things that aren’t working and fix them because it’s for the good of our patients, your patients and for the good of the practice of medicine.

 

The President’s Podium: Reclassification of HCPs Reasonable

Posted in Drug Abuse, Health, opioids, Regulation on August 22nd, 2014 by MMS Communications – Comments Off on The President’s Podium: Reclassification of HCPs Reasonable

By Richard Pieters, M.D., President, Massachusetts Medical Society

The announcement today by the U.S. Drug Enforcement Administration that it is reclassifying hydrocodone combination products (HCPs) to a Schedule II drug – those substances with accepted medical uses deemed to have the highest potential for abuse and harm – is a reasonable step in the fight against prescription drug abuse – and long overdue.

The reclassification does raise important concerns for physicians and patients alike about access to appropriate treatment. Patients may have to make more visits to providers and pharmacists.  Physicians may have to write more prescriptions for shorter durations, and some physicians may prescribe alternative drugs that may be less beneficial or have adverse effects.

The Massachusetts Medical Society shares those concerns.  Physicians – always aware of the need to balance the alleviation of pain and the risks of addiction – recognize that patients who experience severe pain will always require treatment and should be able to get appropriate care and relief.

I have previously written about the challenges of prescription drug abuse, noting that the problem is severe, that addiction is a major public health problem that needs prevention and treatment, and that physicians must be part of the solution at the same time as the care and treatment of our patients remain paramount.

DEA has recognized the critical concern of physicians in issuing its new rule, by clearly stating that it “does not intend for legitimate patients to go without adequate care” and that “controlling HCPs as a schedule II controlled substance should not hinder legitimate access to the medicine.”

Further, DEA recognizes the role and responsibility of the physician in caring for his or her patient: “When a practitioner prescribes a medication that is a controlled substance for a patient,” it writes in its new ruling, “it must be because he/she has made a professional medical determination that it would be medically appropriate for the patient’s medical condition to treat with that specific controlled substance.”

The DEA’s reclassification of the most frequently prescribed opioid in the United States (nearly 137 million prescriptions for HCPs were dispensed in 2013), at the same time acknowledging physician concerns and professional judgment, is a sensible action in the face of a nationwide public health emergency of prescription drug abuse.

The complete DEA rule on the reclassification of HCPs is available here.

The President’s Podium appears periodically on the MMS Blog, offering Dr. Pieters’ commentary on a range of issues in health and medicine. 

With Portal Plagued by Problems, AMA, MMS and Others Urge Sunshine Act Delay

Posted in Pharmaceutical Industry, Regulation, sunshine act on August 5th, 2014 by MMS – Comments Off on With Portal Plagued by Problems, AMA, MMS and Others Urge Sunshine Act Delay

penThe American Medical Association, Massachusetts Medical Society, and 110 other state and specialty medical societies today asked the federal government to delay the public release of information about payments and other transfers of value to physicians from the pharmaceutical and medical device industries.

In a joint letter to Marilyn Tavenner (.pdf), administrator of the Centers for Medicare and Medicaid Services, the groups said that because of an “overly complex” registration process and a condensed time frame, it is “effectively impossible” for physicians to review and dispute reports by the August 27, 2014 deadline.

The reports are scheduled to be released to the public by Sept. 30, 2014. The letter recommends a release date of March 31, 2015. “This process must be streamlined and physicians must be given adequate time to review and dispute their reports,” the letter states.

The reports are mandated by the Physician Payments Sunshine Act, which was enacted in 2010. The report this year will cover activities from Aug. 1 to Dec. 31, 2013.

The joint letter also asked the CMS to:

  • Explicitly direct industry manufacturers to label as “disputed” any unresolved disputes between physicians and industry, even after the physician’s appeal is rejected by the manufacturer. CMS has no plans to mediate physician-industry disputes, even though physicians are already reporting significant errors in the data.
  • Exempt manufacturers from reporting about funding for continuing education activities when the manufacturer does not know the name of program faculty and other participants before the event. Current regulations require reports if industry learns of the identities before or after the event. “Our organizations are concerned that this would have a significant chilling impact on CE [continuing education], which runs contrary to the public interest,” the letter states.
  • Exempt medical textbooks, journal article supplements and reprints from public reporting. The letter states that these publications “represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients.”

The President’s Podium: Physician, Inc.

Posted in Health Policy, Health Reform, Leadership, Payment Reform, Regulation on March 18th, 2014 by MMS Communications – Comments Off on The President’s Podium: Physician, Inc.

By Ronald Dunlap, M.D., President, Massachusetts Medical Society

In my first post on this site last August, I called attention to a survey of DSC_0003 Dunlap 4x6 color 300 ppi_editednearly 3,500 physicians that found that 60 percent of physicians would not recommend their profession as a career.

I suggested that the finding was not surprising, as the high level of discontent within our profession is due mostly to the growing business and administrative requirements of medicine that we must meet and maintain. As we began our medical careers, few of us thought we would become “providers” in the health care “industry.”

The March edition of our member newsletter, Vital Signs, recognizes this reality with the theme of The Business of Being a Physician.  My President’s Message in that issue said “we cannot pretend that we can divorce ourselves from the financial realities battering the health care industry.”  Like it or not, the establishment of business principles in the profession of medicine long ago stopped being a trend; it has been a reality to an increasing extent, and is now widespread.

The business and financial aspects of medicine weigh on all of us. They threaten the viability of many practices and push physicians to make hard choices about their profession and careers.  They intrude into the physician-patient relationship, steal time from engaging our patients, and erode the control we should have over how we practice medicine and how we care for our patients.

The legislative, regulatory, and commercial mandates and requirements continue to increase. Some of these changes are positive; some not so much so. Collectively, however, they present enormous challenges.

At the Federal level, the Affordable Care Act has set regulations on such areas as quality reporting, physician ownership and referrals, medical homes, accountable care organizations and payment practices.  The presence of the Independent Payment Advisory Board, despite its inactivity, still looms, and the explosion of billing codes, known as the ICD-10, is scheduled to take effect later this year.

At the state level, legislative efforts such as Chapter 224 have added more requirements: insurance regulations governing such newly-named entities as “Risk-Bearing Provider Organizations,” proficiency with electronic medical records, and price transparency, just to name a few.  Regulations and requirements from insurers and regulators further add to our administrative load.

We are being inundated with compliance measures and calls for metrics and analytics and other databases, even when many practices are ill-equipped to provide such information given inadequate or nonexistent health information technology systems.

The Medical Society continues to speak out on these issues. In testimony before the Massachusetts Health Policy Commission in February, I pointed out that the rising number of requirements asked of physicians takes time away from patient care, adds to administrative demands, and raises the costs of practicing medicine.  I further said such requirements will drive small to mid-sized practices to merge or align with larger entities that have the ability to meet such requirements and that this could lead to further consolidations and higher costs in the health care market –a phenomenon already well underway in the Commonwealth.

On the national level, rising physician frustration with the direction of medicine is leading more of our colleagues into the political arena. A New York Times report of March 8  noted that “a heightened political awareness and a healthy self-regard that they could do a better job, are drawing a surprising large number [of physicians] to the power of elective office.”

Such political activism by physicians is rare at the state level.  Whether more physicians in national office, while a hopeful sign, will affect change remains to be seen. But it is likely to alter one critical dynamic: bringing added weight to the voice of physicians in the conversation about health care.  That is a key development.

It is imperative that those who propose changes to the practice of medicine recognize and understand how the consequences of those changes – intended and unintended – will affect the practice of medicine.  Who better to tell them than those of us on the front lines of patient care?  We must accept that we’re now part of an “industry” and that the “business of medicine” is here to stay due to cost constraints. It is necessary however, for physicians to have an unmistakable and conspicuous voice in how that business operates.

The President’s Podium appears periodically on the MMS Blog, offering Dr. Dunlap’s commentary on a range of issues in health and medicine.   

The President’s Podium: Mass. Medicine, After Cost Control

Posted in Board of Medicine, Electronic health records, Electronic Medical Records, Global Payments, Health IT, Health Policy, Health Reform, Regulation, Uncategorized on December 9th, 2013 by MMS Communications – 1 Comment

By Ronald Dunlap, M.D., President, Massachusetts Medical Society  

Massachusetts entered its second phase of reform with the 2012 passage of DSC_0003 Dunlap 4x6 color 300 ppi_editedChapter 224, cost control legislation officially titled “An Act Improving the Quality of Health Care and Reducing Costs Through Increased Transparency, Efficiency and Innovation.”

While the first phase, Chapter 54 passed in 2006, was indeed landmark legislation and served as the model for the Affordable Care Act, Chapter 224 alters the state’s health care industry perhaps like no other law.

The changes this law brings are vast, from payment reform to giving the Attorney General new powers in the health care marketplace. Although 224 does include some benefits for physicians (medical malpractice reform for one), other provisions pose significant challenges, particularly for physicians in small practices. Here are two that raise concern.

Health Information Technology (HIT) One of the biggest challenges presented by Chapter 224 is its embrace of health information technology. Physicians will be required – as a condition of licensure – to demonstrate proficiency in all aspects of health information technology by January 1, 2015.

While MMS supports HIT and recognizes its intent to improve patient care, this provision of the law could severely disrupt medical care. Because the statutory language creating the requirement is tied to Federal standards of “meaningful use” (which in turn is tied to participation in Medicare and Medicaid), it raises concerns that strict interpretation of this provision would lead to denial of license renewals for some 26,000 physicians.  Our state has a high certification rate for meaningful use, with more than 14,000 physicians having met stage 1 requirements, but nearly 40,000 physicians have a Massachusetts license, and most are not included in the population targeted for meaningful use certification.

Additionally, the costs of establishing HIT can be huge. The outlay for such items as implementation, maintenance, software and hardware upgrades, conversion to Federal ICD-10 codes, training, and data conversion could approach well over half a million dollars for some practices while not including the “opportunity loss of income” from decreased productivity.  While the law allows for assistance to providers for HIT, the level of help is unknown, and the financial burden can be crippling to small practices.

The law further requires all providers to implement fully interoperable electronic health records that connect to the statewide health information exchange by January 1, 2017 (a goal not in sight) and imposes penalties for noncompliance. These technologies are not only critical for physicians to practice medicine, but also to participate in quality measurement programs.  The specter of this kind of commitment to HIT, however, with its financial outlay, is certain to make physicians pause and think, especially those close to retirement.

MMS has had lengthy discussions with the Board of Registration in Medicine (responsible for implementing the HIT requirement) and has testified in support of legislation to delay this requirement and provide relief to physicians. Our voice has been heard, and we are hopeful such relief will be forthcoming.

Data Collection and Reporting Chapter 224 is equally enthusiastic about data collection and reporting.  It creates a “provider organization registration program,” requiring organizations to provide detailed information about their operations: costs, financial performance, utilization, total medical expenses, and patient referral practices, among other information.  This data is hard to extract from many EMR systems.

This information will be collected by the Center for Health Information and Analysis (CHIA), a new independent state agency created by 224 that takes over most of the responsibilities of the Division of Health Care Finance and Policy, which was abolished by the law. Physician groups are now required – for the first time – to submit such data. The law contains language focusing on the reporting on risk-bearing groups while exempting smaller groups, but the applicability of this language has not been fully tested yet, so it isn’t clear how reporting requirements will be enforced and upon whom.

On a promising note, CHIA Executive Director Aron Boros told our House of Delegates at the Interim Meeting on December 6 that CHIA’s goal is to gather “reliable and meaningful” information through an “engaged transparent operation.”  He believes his agency must be “transparent, open, and collaborative” to build credibility.

The law also stipulates that by January 1, providers must disclose to patients within two working days of their request, how much a proposed procedure or service costs and what the health plan offers as payment.

I am not optimistic that physicians will be prepared within a month’s time to inform patients about specific or estimated costs for all procedures. We are encouraging legislators and the Health Policy Commission to implement the law incrementally, by considering the most expensive procedures first.

HIT and data collection/reporting requirements are but two areas that Chapter 224 dramatically changes. These changes, coupled with constant concerns over Medicare reimbursements as well as added requirements such as those imposed by ICD-10 codes, continue to strain physician practices.

What policymakers and regulators must keep in mind is that, even in a highly sophisticated medical environment like Massachusetts, no less than 64 percent of our physicians are in practices with fewer than 25 physicians. Policies and regulations that burden these practices and reduce their viability will not only affect the quality of care but will also reduce health care access for Massachusetts residents.

The President’s Podium appears regularly on the MMS Blog, offering Dr. Dunlap’s commentary on a range of issues in health and medicine. For a section by section analysis of Chapter 224, click here.  

 

DPH Proposes New Regulations for Prescription Monitoring Program

Posted in Department of Public Health, Drug Abuse, Regulation on February 15th, 2013 by MMS – 8 Comments

Rules May Apply to All Physicians and Prescribers

The Department of Public Health this week presented draft regulations to the Public Health Council to implement changes to the state Prescription Drug Monitoring Program (PMP).

The draft regulations spell out the requirements for review of 12 months of prescribing history in the PMP database by all fully licensed physicians and other professionals for new patients and those who have not been seen in the past 12 months. This requirement appears to be proposed for any patient encounter, regardless of the likelihood of prescribing being indicated.

While there are some exceptions to the requirement listed and more possible in future guidelines, the MMS had hoped the proposed regulations would be more reflective of the demands of clinical practice than the initial draft has proven.

The MMS has engaged the DPH in discussions around the proposed regulations and on recent changes to the drug control registration program done without regulations or public comment and which require submission of email addresses and certification of compliance with the PMP requirements as a condition of receiving a state registration.

The MMS recognizes that limitations of the state database system and federal grant requirements for adherence to specific patient privacy protections have probably had an impact on the DPH in its decisions.

Physicians who cannot meet the new requirements are urged to contact the Department for a waiver of the email requirement. MMS government relations staff is interested in your experiences if you have been subject to a registration recall in 2013. We are also interested in your experiences with the PMP database .

A meeting with DPH staff on the proposed regulations and MMS’s concerns with changes to the drug registration process is scheduled for early March. The MMS continues to investigate options in responding to these initiatives.

There will be a public hearing on the regulations March 22. A final vote is likely at the April Public Health Council meeting.

Physicians are urged to review the proposed regulations and the DPH vision for the PMP program. Future MMS communications will provide more details.

– William Ryder, Esq.

Debate on Prescription Drug Bill Resolved; Goes to Governor for Signature

Posted in Drug Abuse, e-prescribing, Pharmaceutical Industry, Regulation on August 9th, 2012 by MMS Communications – 1 Comment

The Massachusetts House and Senate today resolved the debate over a proposed prescription drug monitoring bill intended to increase scrutiny of the way prescriptions are handled. The bill now goes to Governor Patrick for his signature.

According to State House News Service, the bill would limit the number of doctors who overprescribe medications that may be abused or illegally sold and would increase participation in the state’s Prescription Monitoring Program (PMP) by prescribers – a tactic that can be used to identify patients who might be engaged in “doctor shopping”  to gain drugs.

The compromise bill contains provisions that the MMS had advocated for: automatic enrollment in the Prescription Monitoring Program and a required check of the database only for new patients.  MMS had argued that automatic enrollment would increase registrations, currently numbering only 1,800 out of 40,000 some prescribers in the state, and that mandatory use of the system would negatively affect long-standing physician-patient relationships.

Under the bill, participation in the PMP by those who prescribe controlled substances would be mandatory, but enrollment becomes automatic upon license renewal – a provision that the Medical Society said would reduce administrative burdens on physicians and avoid a cumbersome process of paper applications. The bill also says prescribers would only be required to consult the PMP for new patients, and dropped a requirement that physicians check the database before prescribing painkillers to a patient for the first time –a condition the MMS had opposed, saying that any law should allow prescribers to use their professional judgment in treating a patient.

Among the bill’s other provisions as reported by the News Service: Medicaid patients who fill 11 prescriptions from four doctors or at four different pharmacies within 90 days would be put on a watch list; pharmacies would be prohibited from filling prescriptions for narcotics unless written by a doctor licensed and registered in-state, or in one of the five contiguous states to Massachusetts and Maine; a ban on the drug called “bath salts;” pharmacies and drug manufacturers must report thefts to local or state police and the Drug Enforcement Agency; prescriptions for controlled substances would have to be written by doctors on “secure,” tamper-proof prescription pads already required for Medicare and Medicaid patient; pharmacies will be required to sell drug lockboxes, but they will only have to advertise them near registers; the Department of Public Health will provide patient information on the dangers of Class II and Class III drugs; and a working group of physicians will be tapped to write a “best practices” guide for prescribing opioids.

 

Complete Rewrite of the Board of Registration in Medicine’s Regulations is Underway

Posted in Board of Medicine, Regulation on July 29th, 2011 by MMS – Comments Off on Complete Rewrite of the Board of Registration in Medicine’s Regulations is Underway

The state Board of Registration in Medicine has released a draft copy of newly revised proposed regulations governing licensing and the practice of medicine.

The new proposals come in three sections of 11, 66 and 23 pages respectively, and deal with discipline, licensing and the practice of medicine, and patient care assessment programs.

Hearings are likely in September. The MMS is still reviewing the regulations but it is clear that every aspect of the Board’s processes is included in the rewrite.

  • The regulations specify mandatory CME requirements in pain management, competence in electronic medical records and end of life care. The first two of these were required in some form by the state legislature.
  • License categories now include: retired, inactive, volunteer, administrative, restricted, full, limited and temporary.
  • Health care facilities are defined as anywhere medicine is practiced.
  • The definition of the practice of medicine now includes telemedicine when the patient information is generated in the Commonwealth.
  • A new process for CMEs is created by using the term continued professional development or CPDs instead. The Board gives itself the authority to approve activities, courses etc which may qualify for mandatory CPD hours.
  • Specifics on compliance with audits for continuing education requirements are listed.
  • Specifics on allowable corporate forms for the practice of medicine are included on page 43 of section 2.
  • Provisions are outlined for renewals of licensure without automatic revocation in limited circumstances where a renewal application is not complete.

Over the last decade, the Board has periodically reopened the regulatory hearing process but never completed a comprehensive rewrite and update. Previous proposed changes brought a fire storm of opposition and criticism from the medical community based primarily on concerns that the Board was overreaching its authority and poorly designing its regulatory framework in a variety of areas.

The Board’s regulatory structures are enormously complex and complicated by legal decisions and precedents. The MMS will continue to review the complex proposals with an eye towards our testimony and advocacy in the Fall. Comments on the proposals or specific questions may be sent to William Ryder, MMS Director of State Legislative and Regulatory Affairs, at wryder@mms.org.

— William Ryder