1.         CMS will allow one governing body to oversee multiple hospitals in a multi-hospital system.  CMS has also added a requirement that a member, or members, of the hospital’s medical staff be included on the single governing body as a means of ensuring communication and coordination between a single governing body and the medical staffs of individual hospitals in the health care system.

2.         CMS has implemented a requirement that hospitals maintain a log of all deaths occurring while patients are in restraints.  The log must be made available to CMS immediately upon request.  Previously, hospitals were required to report deaths that occurred while a patient was in soft, 2-point wrist restraints.  The amended regulations will remove the current requirement for hospitals to notify CMS of a patient’s death for patients who die when no seclusion has been used and the only restraints used on the patient were soft, non-rigid, cloth-like materials, which were applied exclusively to the patient’s wrists.  Reporting will also be eliminated for patients who died within 24 hours of having been removed from such restraints.

3.         CMS has broadened the definition of the term “medical staff” and will allow hospitals the flexibility to include other nonphysician practitioners (such as advanced practice nurses, physician assistants, etc.) as eligible candidates for medical staff membership in accordance with state law.  All such practitioners will function under the rules of the medical staff.  The medical staff will be required to examine the credentials of all eligible candidates and make recommendations for privileges and medical staff membership to the governing body.

4.         CMS has broadened the potential leadership role of podiatrists by allowing podiatrists to be responsible for the organization and conduct of the medical staff.

5.         The amendments will allow hospitals the option of having either a stand-alone nursing care plan or a single interdisciplinary care plan that addresses nursing and other disciplines.

6.         CMS will permit hospitals to have an optional program for patient/support person administration of appropriate medications.  The program must address the safe and accurate administration of specified medications; must ensure a process for medication security; must address self-administration training and supervision; and must include documentation of medication and self-administration.

7.         CMS has eliminated the requirement for nonphysician personnel to have specialized training in administering blood transfusions and intravenous medications and has clarified that those who administer blood transfusions and intravenous medications must do so in accordance with state law and approved medical staff policies and procedures.

8.         CMS has amended the Conditions of Participation to allow for drugs and biologicals to be prepared and administered on the orders of a practitioner other than a physician in accordance with hospital policy and state law.  Orders for drugs and biologicals ordered by nonphysician practitioners may also be documented and signed by the nonphysician practitioner in accordance with hospital policy and state law.

9.         The amendments will allow hospitals the flexibility to use standing orders.  The amended Conditions of Participation will require the medical staff, nursing staff, and pharmacy to approve written and electronic standing orders, order sets and protocols.  Orders and protocols must be based on nationally recognized and evidence-based guidelines and recommendations.

10.       The requirement of authentication of verbal orders within 48 hours has been eliminated.  Instead, CMS will defer to applicable state law to establish authentication time frames.

11.       CMS has made permanent the previous temporary requirement which specified that all orders, including verbal orders, must be dated, timed and authenticated by either the ordering practitioner or another practitioner who is responsible for the care of the patient and who is authorized to write orders by hospital policy in accordance with state law.

12.       Hospitals will no longer be required to maintain an infection control log.

13.       Hospitals will also no longer be required to maintain a single director of outpatient services position that oversees all outpatient departments in the hospital.

14.       CMS has eliminated the requirement that an organ recovery team that is working for a transplant center conduct a “blood type and other vital data verification” before organ recovery where the recipient is known.

15.       Language has been added to the Conditions of Participation specifying that drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’s quality assessment and performance improvement program.

As has been pointed out previously, the issue in healthcare is not just access, but affordability.  It appears that the Massachusetts legislature is now attempting to control healthcare costs by controlling the payments to healthcare providers.  There is no reason to believe that this approach ultimately will not also be taken at the federal level in regard to any federal healthcare program.  As pointed out in our recent blog regarding the Medicare Trustee Report, the laws currently on the books at the federal level for Medicare will, unless changed, require a 30.9% reduction in payments to physicians as of January 1, 2013.

The 2003 bulletin concluded that retainer agreements under which covered beneficiaries are required to pay a fee in addition to any cost sharing under their health benefits plan, was not acceptable.  The Departments took the position that many of the services provided under such retainer arrangements were already required under New Jersey law to be covered under most health benefit plans.  The Departments also found that retainer arrangements were inconsistent with the requirement under New Jersey law that all provider agreements assure that in network providers do not discriminate in the treatment of covered beneficiaries.  The Departments found that requiring a covered beneficiary to enter into a retainer contract was not acceptable when the physician participated in the beneficiary’s network, regardless of whether the services covered under the retainer contract supplemented or duplicated the services already covered under the health benefits plan.

In Bulletin No. 12-02, DOBI concludes that “some mutually beneficial arrangements between patients and doctors have been hindered” by the 2003 bulletin.  However, DOBI also stressed that a patient who enters into a retainer agreement with a network physician must continue to be able to receive the full benefit of their health benefit plan and not have to pay extra for already covered services.  DOBI concluded that retainer arrangements offered by in network physicians will not be considered a discriminatory practice if the following four safeguards are put in place:

• the participating provider agreement should provide that members cannot be charged in excess of their cost sharing obligations under the health benefits plan.  Any retainer agreement requiring an additional payment must be limited to services above and beyond the services covered under the plan, and those additional services must be clearly described by the physician to the patient.
• Health benefit plan members must have an unfettered right to an adequate network of participating providers who have not limited their practice by restricting patients to those who will enter into retainer agreements.  Health plans are directed not to include physicians who limit their practices to patients willing to enter into retainer agreements for purposes of establishing network adequacy.
• Plan materials available to members listing network providers should not include practices that are limited to patients buying retainer services unless they are identified as such.  Such physicians can either be excluded from the materials or the listing can include the retainer limitation.
• If a patient is already receiving services from a physician when the physician converts to a retainer practice, the patient must be entitled to all of the rights of a patient whose physician drops out of network.  This includes the right to continue to receive care for periods set forth in regulatory requirements, without making any retainer payments.

Finally, DOBI recognizes that a physician may limit the number of patients the physician will accept in order to provide the enhanced level of care required under a retainer arrangement.  Such limitations will not be considered discriminatory, even if the practice is closed to other patients, so long as the above requirements have been met.  Health benefit plans are not required to allow their network providers to limit their practices by retainer agreements, but are allowed to do so so long as the requirements of the bulletin are met.

“Without unprecedented changes in health care delivery systems and payment mechanisms, the prices paid by Medicare for health services are very likely to fall increasingly short of the costs of providing these services.  By the end of the long-range projection period, Medicare prices for hospital, skilled nursing facility, home health, hospice, ambulatory surgical center, diagnostic laboratory, and many other services would be less than half of their level under the prior law.  Medicare prices would be considerably below the current relative level of Medicaid prices, which have already led to access problems for Medicaid enrollees, and far below the levels paid by private health insurance.  Well before that point, Congress would have to intervene to prevent the withdrawal of providers from the Medicare market and the severe problems with beneficiary access to care that would result.  Overriding the productivity adjustments, as Congress has done repeatedly in the case of physician payment rates, would lead to substantially higher costs for Medicare in the long range than those projected under current law.”

As I stated last year regrettably, as can be seen by the Actuarial statement, radical changes will have to be undertaken to maintain the solvency of the Medicare program, and the question is whether those changes will be at the expense of the providers.

On April 2, 2012 at 44 N.J.R. 957, the Department of Corrections published proposed amendments to its rules governing research and health care experimentation in correctional facilities.

On March 19, 2012 at 44 N.J.R. 644, the Department of Health and Senior Services published notice of its proposal of amendments to its rules which would remove emergency medical service helicopters from the Certificate of Need process.

On March 19, 2012 at 44 N.J.R. 655, the State Board of Medical Examiners and the State Board of Pharmacy jointly published notice of their reproposal of new rules governing standards of practice for physicians and pharmacists who wish to enter into collaborative practice agreements for the management of patient drug related therapies.

On March 5, 2012 at 44 N.J.R. 554, the State Board of Psychological Examiners published notice of its proposed amendments to its rules governing unlicensed practice; temporary permits; supervision; and reinstatement following suspension of a license.

On March 5, 2012 at 44 N.J.R. 592, the Department of Human Services published notice of its adoption of amendments to its rules governing staff to consumer ratios in partial hospitalization programs.

On March 5, 2012 at 44 N.J.R. 594, the Department of Human Services published notice of its amendments to its rules governing reimbursement for partial hospitalization and independent clinic services.

On March 5, 2012 at 44 N.J.R. 596, the Department of Banking and Insurance published notice of its amendments to the standard Small Employer Health Benefit Plan to comply with the federal Affordable Care Act.

Massachusetts convened a state grand jury with subpoena power to subpoena the records of both insurance companies (payors) as well as the records of hospitals and physician groups (providers) to determine what was being paid to whom, and if possible, why.  As a result of the acquisition of what, up to that time, was very confidential information, the Attorney General of Massachusetts was able to issue a report showing the differentials between what is paid to some physicians and physician groups versus other physicians and physician groups for the same procedures as well as similar situations involving hospitals.

One of the major issues currently being debated under both “Romneycare” and “Obamacare” is cost.  While both of these approaches initially focus on access, neither of these approaches focus on cost containment.  What the activities in the State of Massachusetts shows is that it appears inevitable that the next step under “Obamacare”, will be to focus on costs just as the State of Massachusetts under “Romneycare” is focusing on costs.  (http://bostonglobe.com/metro/2012/03/07/speaker-deleo-annual-medical-cost-increases-could-held-percent-containment-bill/1EeY9HCeA9dqB80bO0yxkO/story.html)

What is clear is that the State of Massachusetts is experiencing both the additional cost to the health care delivery system as a result of the increased access to health care under “Romneycare”, as well as the historic increases experienced by the health care system.  From a provider point of view, what is disturbing is that the Massachusetts legislators appear to be lumping together the costs associated with increased demand and the  increase in costs due to normal economic pressures on the health care delivery system.  These normal increases include the cost of benefits to hospital or physician employees, as a simple example.

The Massachusetts situation needs close monitoring so that providers nationwide can see how their reimbursement may be altered and whether or not the increase in access and therefore the increase in costs associated with such demand will be paid for out of reimbursement to providers.

On February 21, 2012 at 44 N.J.R. 376, the Department of Banking and Insurance published notice of its proposal of new rules governing provider networks.  The purpose of the new rules is to establish standards relating to agreements entered into between health care providers and insurance companies, health service corporations, hospital service corporations, medical service corporations, HMOs and organized delivery systems.  The proposed rules would impose deadlines on the processing of physician credentialing applications, sets forth additional criteria for provider agreement, implements standards regarding the content and availability of provider network directories, and creates standards for the accuracy of information contained in provider directories.

On February 21, 2012 at 44 N.J.R. 494, the Department of Human Services published notice of its readoption with amendments to its rules governing managed health care services for Medicaid and New Jersey FamilyCare beneficiaries.